Abstract:
An apparatus and method for guiding a needle where a structure is disposed on an exterior of a sterile sheath to aid in guiding the needle with respect to the transceiver, which transceiver is not yet inserted into the sterile sheath. In one case, the needle guide is attached to the exterior of the sheath; in another, a needle guide adapter is attached to the exterior of the sheath; in still another, an adhesive is attached on the inside of the sheath to assist in attachment with the transceiver. In still another, a temporary adhesive cover is attached to the internal adhesive and is removable upon full insertion of the transceiver into the sheath.

Description:
CROSS REFERENCE TO RELATED APPLICATIONS 
     This application is a continuation-in-part of an application entitled Adhesive method and apparatus for guiding needles filed by Rick L. Pruter on May 10, 2002, having Ser. No. 10/063,753, and it claims the benefit of a provisional patent application entitled “Method and system for assisting vascular intubation with a medical imaging transceiver”, having Ser. No. 60/575,672, which was filed by Rick L. Pruter on May 28, 2004. 
    
    
     FIELD OF THE INVENTION 
     The present invention generally relates to needle guides for medical imaging transceivers, and more particularly relates to a universal needle guide for medical imaging transceivers which permit attachment to a medical imaging transceiver, independent of model. 
     BACKGROUND OF THE INVENTION 
     In recent years, hand-held medical imaging transceivers, such as ultrasound and gamma ray transceivers, have been used extensively for various medical imaging situations. Many clinics will use multiple transceivers. Some handheld transceivers are designed for external use, while trans-rectal and trans-vaginal transceivers are designed for use within body cavities. 
     In the past, each type of transceiver may require a different needle guide and/or a different mounting bracket to which a needle guide is attached. With numerous transceivers and numerous needle guide brackets, a medical imaging professional may become confused and frustrated as to what needle guide goes with which bracket and which transceiver, thereby reducing the efficiency of operations of the clinic. 
     Consequently, there exists a need for improved methods and apparatus for guiding needles in an efficient manner. 
     SUMMARY OF THE INVENTION 
     It is an object of the present invention to provide an apparatus and method for guiding a needle in an efficient manner. 
     It is a feature of the present invention to utilize a sterile sheath with an internal adhesive for affixing to a transceiver. 
     It is another feature of the present invention to include a removable internal adhesive cover inside said sterile sheath to facilitate ease of insertion of a medical imaging transceiver therein. 
     It is another feature of the present invention to include a sterile sheath with a needle guide attached thereto. 
     It is another feature of the present invention to include a needle guide adapter bracket attached to the sterile sheath. 
     It is an advantage of the present invention to achieve improved efficiency in guiding needles. 
     It is another feature of the present invention to have interlocking attachments disposed on an outside of a sheath. 
     It is another advantage of the present invention to provide for a common base sheath and various attachments for differing types of applications. 
     It is another feature of the present invention to include a hand-held display for locating veins. 
     It is another advantage to provide quick and easy deployment of equipment to be used to locate a vein. 
     The present invention is an apparatus and method for guiding needles designed to satisfy the aforementioned needs, provide the previously stated objects, include the above-listed features, and achieve the already articulated advantages. The present invention is carried out in a “technician burden-less” manner in a sense that the burden on a medical imaging of coupling one of a multiple of needle guides with one of a multiple of mounting brackets for one of a multiple of transceivers, has been greatly reduced. 
     Accordingly, the present invention is an apparatus and method including a sterile sheath which has a structure coupled thereto for assisting in affixing a needle guide to a transceiver. The present invention is also an apparatus for interlocking various pieces to an exterior of a common base sheath. The present invention is also a hand-held display apparatus for locating veins. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       The invention may be more fully understood by reading the following description of the preferred embodiments of the invention, in conjunction with the appended drawings wherein: 
         FIG. 1  is a perspective view of the present invention prior to attachment to a transceiver. 
         FIG. 2  is a perspective view of an alternate embodiment of the present invention which includes a bracket disposed on the transceiver. 
         FIG. 3  is a partially exploded perspective view of the apparatus of  FIG. 1 . 
         FIG. 4  is a partially exploded perspective view of an alternate embodiment of the needle guide of  FIG. 2 . 
         FIG. 5  is an exploded view of a modular attachment mechanism of the present invention. 
         FIG. 6  is a perspective view of the combined handheld medical imaging transceiver system with the semi-rigid sterile imaging cup and integrated introducer system of the present invention. 
         FIG. 7  is an enlarged view of an alternate embodiment of the introducer of the present invention. 
         FIG. 8  is a cross-sectional view of an alternate embodiment of the present invention in a stowed position. 
         FIG. 9  is a cross-sectional view of the alternate embodiment of  FIG. 8  where the introducer has been separated and the adhesive strips are partially removed from a void. 
     
    
    
     DETAILED DESCRIPTION 
     Now referring to the drawings wherein like numerals refer to like matter throughout, and more specifically referring to  FIG. 1 , there is shown a needle guide/transceiver assembly  100  of the present invention, which includes a needle guide  102 . Needle guide  102  is coupled to medical imaging device  103 , which could be an ultrasound transducer, gamma ray transceiver or other imaging device. Needle guide  102  is preferably a plastic material, such as ABS or equivalent; however, other materials, such as aluminum, surgical steel, and any other suitable material could be substituted. Needle guide  102  is coupled to sterile sheath  104  by exterior adhesive  106 . Sterile sheath  104  can be a latex sheath or other material known for use with sheaths and sterile sheaths for medical imaging transceivers. Exterior adhesive  106  can be a contact adhesive applied to sterile sheath  104  or needle guide  102 , or it may be adhesive tape. It should be understood that the exterior adhesive  106  can be replaced with an ultrasonic weld or any similar means of attaching matter to a sheath. 
     Now referring to  FIG. 2 , there is shown a needle guide assembly of the present invention, having a needle guide  202  coupled through a sterile sheath  204  to a transceiver mounting bracket  210  disposed on a medical imaging device  103 . 
     Now referring to  FIG. 3 , there is shown an exploded view of the needle guide system of  FIG. 1 , which includes an internal adhesive material  312  disposed on the inside of sterile sheath  104 . Internal adhesive material  312  is disposed adjacent to, but on opposing sides of, sterile sheath  104  from exterior adhesive  106 . Internal adhesive material  312  is covered by cover for internal adhesive material  314 . Cover for internal adhesive material  314  is shown as an integral part of elongated adhesive cover removing pull  108 . In a preferred embodiment, elongated adhesive cover removing pull  108  is a strip of material which is folded over at the bottom end to form cover for internal adhesive material  314 . It should be understood that cover for internal adhesive material  314  and elongated adhesive cover removing pull  108  need not be integral, nor need they be the same material. 
     Now referring to  FIG. 4 , there is shown an adapter  402  having a protruding central portion  404  and non-protruding area  406 . Adapter  402  can be attached to sterile sheath  204  in a manner similar to the way needle guide  102  is attached to sterile sheath  104 . Adapter  402 , after it has been affixed to sterile sheath  204 , may be coupled to transceiver mounting bracket  210  by mating with a surface structure  408  disposed on transceiver mounting bracket  210 . 
     In operation, the apparatus and method of the present invention as described and shown in  FIGS. 1 and 3 , could function as follows: 
     Medical imaging device  103  is inserted into sterile sheath  104 . Elongated adhesive cover removing pull  108  is pulled to expose internal adhesive material  312 . Internal adhesive material  312  is then pressed against medical imaging device  103 . Needle guide  102 , which has been previously attached to sterile sheath  104  via exterior adhesive  106  or other means, can be used for normal clinical activities. 
     With respect to the embodiment of the present invention shown in  FIGS. 2 and 4 , the system could function as follows: 
     Transceiver mounting bracket  210  is mounted on medical imaging device  103 . The medical imaging device  103  is inserted into sterile sheath  204 . Adapter  402 , which has been previously mounted on sterile sheath  204  as discussed above, is mated to surface structure  408 . Adapter  402 , with its protruding central portion  404  and non-protruding area  406 , then can be mated with needle guide  202 , thereby coupling needle guide  202  with medical imaging device  103 . 
     Now referring to  FIG. 5 , there is shown an exploded view of an alternate embodiment of the present invention. An attachment  502  is shown coupled to sheath  104  (disposed around device  103 ) via adhesive  106  similar to  FIG. 1 . Attachment  502  could be ultrasonically welded to sheath  104  or attached in some other manner. Attachment  502  is not a needle guide. Attachment  502  is an intermediate piece which serves as a platform upon which other devices may be attached. Attachment  502  may be a wedge shape so as to provide for an angular relationship between the needle guide  520  and the device  103 . Attachment  502  is shown having an inside surface  504  and an outside surface  506  with a plurality of mating voids  508  therein. Mating voids  508  are configured to mate with mating protuberances  510  on intermediate interlocking attachment  512 . Intermediate interlocking attachment  512  is one type of intermediate attachment which could be used to adjust the location or orientation of the needle guide  520 . Other types of intermediate interlocking attachments, both angular and non-angular, could be used with varying shapes and dimensions. Intermediate interlocking attachment  512  could be the only such type of device, or it could be one of a series of such interlocking devices disposed between the needle guide  520  and the attachment  502 . A combination of angular and non-angular interlocking attachments can be used to change the location and orientation of the needle guide  520 . The intermediate interlocking attachment  512  may have voids  508  and protuberances  510  thereon. Needle guide  520  is shown having protuberances  510  thereon as well. 
     It should be understood that various other ways of connecting intermediate angular and non-angular attachments could be used to change the location and orientation of the needle guide  520  or similar device. 
     In  FIG. 6 , there is shown a medical instrument guiding system of the present invention generally designated  1100 . Medical instrument guiding system  1100  includes a low resolution symbol display screen  1102 , which may be liquid crystal display or any other suitable display. Low resolution symbol display screen  1102  is described as a low resolution display because it is believed that many of the beneficial aspects of the present invention can be achieved with such a display. It should be understood that the low resolution symbol display screen  1102  could in fact be a high resolution display if it is desired to provide more detailed information. 
     Similarly, medical instrument guiding system  1100  includes a medical imaging system transceiver section  1104  which could be a low power and low resolution medical imaging transceiver. It should also be understood that while low power and low resolution may be preferable, in some circumstances, high power and high resolution could be used as well. 
     The term “low power” is used to refer to a medical imaging transmitter which is designed primarily for superficial or relatively small penetration depths into the tissue. The medical imaging systems transceiver section  1104  is described as being low resolution because it is believed that when predetermined symbols are used to display veins, and the location and general orientation of the vein is all that is necessary for the vascular intubation, any additional resolution is not essential. 
     It is believed that one of the key aspects of the present invention is the realization that the typical high power and high resolution medical imaging devices, with their concomitant relatively large size, price and power consumption, is not essential for assisting in vascular intubation. 
     In a preferred embodiment, the medical imaging systems transceiver section  1104  has a fixed angle of transmission which produces a scanned area similar to that shown by medical imaging field of view boundary symbol  1134  on the display  1102 . 
     Medical instrument guiding system  1100  includes an introducer system  1110  which includes an introducer catheter section  1112  and an introducer needle receiving section  1114  and comes with introducer adhesive strips  1116  attached thereto for securing the introducer to the patient&#39;s skin once the vascular intubation has been successful. 
     Introducer system  1110  is preferably integrated with the semi-rigid sterile imaging cup  1144 , which is shown disposed over the medical imaging system&#39;s transceiver section  1104 . Introducer system  1110  is held at a constant angle with respect to medical imaging systems transceiver section  1104  by introducer upper guide  1118  and introducer lower guide  1120 . Upper guide  1118  is shown having a circular shaped void  1119  therein for receiving the needle receiving section  1114  therein. Introducer upper guide  1118  and introducer lower guide  1120  can be structurally part of the underlying medical imaging systems transceiver section  1104 , or they may, as shown, be structurally part of the semi-rigid sterile imaging cup  1144 . Of course, a variable angle could be used if desired. Dashed projected needle path symbol  1130  is a representation of the projected path of the introducer system  1110  as it proceeds into the tissue. The medical instrument guiding system  1100  could be configured to display a solid line  1138  or other symbol for the actual introducer catheter section  1112  as it is detected by the medical imaging systems transceiver section  1104 . 
     Low resolution symbol display screen  1102  shows a symbol  1140  which represents the target vein. Here, the symbol  1140  in an exemplary embodiment is not a detailed depiction of the actual vein being intubated. Instead, a simplified standardized view of a vein is displayed. It is believed that in a medical imaging system assisted vascular intubation procedure, it may not be necessary to consider the vein with any more structural specificity than to think of it as a cylinder located and oriented in a particular way at a particular location and depth below the skin. It may even be sufficient to provide information about the location of the cylinder and not its orientation. In other words, in certain situations, it may not even be necessary to provide information regarding the orientation of the cylinder. It is believed that the use of simplified standardized symbols, such as the circular or cylindrical symbol  1140 , the projected path  1130 , etc., allows the present invention to effectively utilize a display and transceiver combination with lower resolution and, therefore, lower processing requirements and display quality requirements, which often lead to a lower power consumption and lower cost system overall. 
     In operation, the apparatus of the present invention could be used as follows: 
     A hand-held medical imaging transceiver  1104  is inserted into a semi-rigid sterile imaging cup  1144 , which has disposed in its bottom, a reservoir of gel  1202  which is ruptured when the hand-held medical imaging transceiver  1104  is inserted to the point that a snap or other positive feedback occurs. (In the alternative, gel can be squirted into the semi-rigid sterile imaging cup  1144 .) 
     Top actuator  1106  is depressed to start medical imaging systems transceiver section  1104  and low resolution symbol display screen  1102 . 
     Medical instrument guiding system  1100  is aligned with a vein using visual clues provided on low resolution symbol display screen  1102 . 
     The introducer catheter section  1112  is pushed into the tissue and proceeds along dashed projected needle path symbol  1130  until it contacts the vein. At this point, the solid line  1138  should extend to the target symbol  1140 . 
     At this point, vascular intubation occurs in accordance with known medical procedures. For example, the introducer  1110  is separated from the sterile cup  1144  and laid down so it can be inserted coaxially into the vein. Once the introducer is inserted, the adhesive strips  1116  can be used to hold the introducer in place. 
     Now referring to  FIG. 7 , there is shown an alternate embodiment of the upper guide  1  section of  FIG. 6 . Instead of needle receiving section  1114  fitting into a void  1119  as shown in  FIG. 6 , a void  1319  is associated with the needle receiving section  1314 , and the upper guide  1318  mates with the void  1319 . 
     In an exemplary embodiment of the present invention, the adhesive strips  1116  may be stowed away during the initial stages of the vascular intubation process. Once the tipping of the introducer away from the transceiver section  1104  occurs, the adhesive strips  1116  can be deployed. In  FIG. 6 , adhesive strips are shown in an unfurled configuration. However, during the initial stages of the intubation procedure, they may be folded back and attached to the upper guide  1118 . 
     In  FIG. 7 , the adhesive strips are shown while they are still stowed next to the upper guide  1318 . 
     Now referring to  FIG. 8 , there is shown a view of the adhesive strips  1116  disposed inside a void  1401  in upper guide  1118 .  FIG. 9  shows the embodiment of  FIG. 8  after the needle receiving section  1414  has been separated from the upper guide  1118  and the adhesive strips are partially removed from void  1401 . 
     Throughout this description, reference is made to a medical imaging system, because it is believed that the beneficial aspects of the present invention would be most readily apparent when used in connection with medical imaging; however, it should be understood that the present invention is not intended to be limited to imaging, and should be hereby construed to include other medical tools, equipment and methodologies as well, where it is desirable to guide a needle. 
     While the figures and the detailed description herein are focused upon a general-purpose abdominal transceiver, it is intended that the present invention be read to include within the claims endo-cavity transceivers and any other medical imaging device irrespective of its manner of use. 
     It is thought that the method and apparatus of the present invention will be understood from the foregoing description and that it will be apparent that various changes may be made in the form, construct steps, and arrangement of the parts and steps thereof, without departing from the spirit and scope of the invention or sacrificing all of their material advantages. The form herein described is merely a preferred exemplary embodiment thereof.