Abstract:
An apparatus and method for guiding a needle in conjunction with a biopsy using an endocavity medical imaging device, where a non-reusable needle guide, which is relatively inexpensive which grasps the sheathed bracket firm, and holds the same in a set position based upon a protuberance having an intentionally low shear resisting capability.

Description:
CROSS REFERENCE TO RELATED APPLICATIONS 
   This is a continuation-in-part application of application Ser. No. 10/065,442 entitled “METHOD AND DISPOSABLE APPARATUS FOR GUIDING NEEDLES WITH AN ENDOCAVITY MEDICAL IMAGING DEVICE,” filed on Oct. 17, 2002, now abandoned, which application relates to application entitled “METHOD AND DISPOSABLE APPARATUS FOR GUIDING NEEDLES”, application Ser. No. 10/065,029, filed on Sep. 11, 2002, now U.S. Pat. No. 6,758,817, by Rick L. Pruter and Quanah Lee Bain. 

   BACKGROUND OF INVENTION 
   In recent years, handheld medical imaging transceivers, such as ultrasound and gamma ray transceivers, have been used extensively for various medical imaging situations. 
   In the past, the physician or medical professional typically will cover an ultrasound transceiver with a sterile sheath. Usually, under the sheath is a mounting bracket attached to the transceiver. A needle guide is then typically attached over the sheath and coupled to the underlying bracket. The sheath protects the transceiver and bracket. 
   While these needle guides have been used extensively in the past, they do have some drawbacks. First of all, these needle guides are not covered by the sheath and consequently, must be sterilized after each use or discarded. In the past, these needle guides have been substantial in size and in cost. The substantial nature of the needle guide can often result in the medical professional deciding to retain the needle guide and sterilize it even if the manufacturer intended it to be disposable. 
   Secondly, these needle guides are often at least partially inserted into a patient&#39;s rectum or vagina. When they are rotated in situ, discomfort can occur from any protuberance such as a needle guide coupled to the transceiver. 
   Consequently, there exists a need for improved methods and apparatus for guiding needles in an efficient manner. 
   SUMMARY OF 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 include a non-reusable needle guide. 
   It is another feature of the present invention to include a needle guide, bracket and transceiver combination which is free from large protruding surface features which could cause patient discomfort, especially when rotated in situ. 
   It is another feature of the present invention to include an enlarged needle-receiving area on a needle guide to facilitate quick insertion of the needle therein. 
   It is another feature of the present invention to include a needle guide-to-bracket attachment mechanism which is adapted for positive attachment to the bracket with a predetermined grasping force in a non-reusable manner. 
   It is an advantage of the present invention to achieve improved efficiency in guiding needles. 
   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 “physician burden-less” manner in a sense that the burden on a physician or other medical professional in guiding needles during the process of insertion into the needle guide, has been greatly reduced. Additionally, the system is carried out in a reduced discomfort manner in the sense that the patient discomfort associated with rotating a transceiver/bracket/needle guide combination in situ is reduced. Finally, the present invention is carried out in a disposable manner in the sense that the base and the clamp used to couple it to the sheathed bracket are designed to be used only once and then discarded. 
   Accordingly, the present invention is an apparatus and method including a needle guide with enlarged needle-receiving portions on the needle guide, and base-to-bracket locks which are non-reusable. 

   
     BRIEF DESCRIPTION OF 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 apparatus of the present invention in conjunction with a medical imaging transceiver. 
       FIG. 2  is an exploded perspective diagram of the apparatus of  FIG. 1  where the dashed lines represent lines along which the respective elements have been moved. Portions of sterilized sheath  241  are represented in a cross-sectional view. 
       FIG. 3  is an end view of the proximal end  134  of the needle guide  130 . 
       FIG. 4  is an exploded diagram of an alternate embodiment of the present invention which shows a front clip. 
       FIG. 5  is a cross-sectional view of the front clip of FIG.  4 . 
       FIG. 6  is a cross-sectional view of the rear clip of FIG.  4 . 
   

   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, bracket and medical imaging transceiver system of the present invention generally designated  100 . The system  100  includes a medical imaging transceiver  110  which could be any type of imaging system or device, and a transceiver mounting bracket  120 , which is coupled to said medical imaging transceiver  110  for the purpose of facilitating coupling with needle guides and other instruments. Medical imaging transceiver  110  is preferably an endocavity transceiver. The term “endocavity” is used herein to refer to an object, apparatus, device, etc. which is sized, shaped and configured for trans-rectal and trans-vaginal use. Mounting bracket  120  can be coupled to medical imaging transceiver  110  in any suitable manner, such as clamps, screws, adhesive, etc. Transceiver/bracket covering sterile sheath ( FIG. 2 ) is disposed about mounting bracket  120  and medical imaging transceiver  110  in a well-known manner. Needle guide assembly  130  is shown having a needle guide enlarged proximal end  134  being enlarged with respect to side clamp leg  139 . 
   Mounting bracket  120  is preferably designed to firmly attach to medical imaging transceiver  110  and to fill in the space available about reduced cross section medical imaging transceiver middle section  116 . Mounting bracket  120  includes a mounting bracket distal end  122  and a mounting bracket proximal end  124 . Mounting bracket  120  preferably is a partial sleeve which is sized and configured to be placed over the reduced cross-section medical imaging transceiver middle section  116  and to firmly grasp medical imaging transceiver  110 . Mounting bracket  120  may have at its mounting bracket proximal end  124  a plurality of bracket clamp legs  125 . Now referring to  FIG. 2 , the mounting bracket  120  includes a mounting bracket needle guide receiving slot  226  and a mounting bracket needle guide receiving platform  228 , as well as a mounting bracket protuberance receiving void  227 . 
   Now Referring to  FIGS. 1 ,  2  and  3 , there is shown a needle guide  130  of the present invention. Needle guide  130  includes a needle guide distal end  132  and a needle guide enlarged proximal end  134  and a needle guide central cannula section  136 . Needle guide enlarged proximal end  134  is preferably larger than side clamp leg  139  and thereby creating a needle guide grasping depression  331 , ( FIG. 3 ) into which a person finger can rest when a force is applied to the needle guide  130  to separate it from the sheath covered mounting bracket  120 . Preferably, the orientation of side clamp leg protuberance  137 , side clamp leg  139  and mounting bracket protuberance receiving void  227  are such that when a lifting force is applied on needle guide enlarged proximal end  134 , the side clamp leg protuberance  137  is caused to shear off before side clamp leg  139  is spread sufficiently to allow non-destructive removal of the needle guide  130  from the sheathed mounting bracket  120 . Numerous other methods of securing needle guide  130  to mounting bracket  120  exist which would necessitate destruction upon removal. For example, needle guide  130  might include a bullet-nose plastic member which locks upon insertion and is only unlocked by destruction of the bullet-nose member. Still other well-known means of attachments could be used as well. 
   In operation, the apparatus and method of the present invention as described and shown in  FIGS. 1-3 , could function as follows: 
   Mounting bracket  120  is mounted on a medical imaging transceiver  110 . A transceiver/mounting bracket sterile sheath  241  is pulled over the medical imaging transceiver  110  and mounting bracket  120  combination. Needle guide  130  is pushed onto mounting bracket  120 , so that side clamp leg  139  separates (see dotted lines in  FIG. 3 ) to allow further depression until side clamp leg protuberance  137  slips into mounting bracket protuberance receiving void  227 , thereby firmly attaching needle guide  130  to the transceiver/mounting bracket sterile sheath  241  covered mounting bracket  120 . Needle guide central cannula section  136  fits into mounting bracket needle guide receiving slot  226 . When needle guide  130  is firmly attached to mounting bracket  120 , the medical professional can insert a needle or other instrument into needle guide enlarged needle receiving area  138  and then into the needle guide central cannula section  136 . Ultimately, the needle or other instrument is disposed beyond the mounting bracket distal end  122  and is able to enter a patient&#39;s tissue. 
   Now referring to  FIGS. 4 and 5 , there is shown an alternate embodiment of the present invention, which includes a medical imaging transceiver  110  and a dual clip needle guide mounting bracket  420  and a dual clip needle guide  430 . Dual clip needle guide mounting bracket  420  is similar to mounting bracket  120  except for the variations required to mate with the dual clip needle guide  430  instead of the needle guide  130 . Dual clip needle guide mounting bracket  420  couples to medical imaging transceiver  110  as described above with respect to mounting bracket  120 . Dual clip needle guide  430  includes a dual clip needle guide front clip end  432  and a dual clip needle guide needle inlet end  434 . Dual clip needle guide needle inlet end  434  includes a dual clip needle guide funnel  438  and a dual clip needle guide bracket leg  439 . Dual clip needle guide  430  also includes a dual clip needle guide front clip end  432  which is separated by the cannula  436 . Dual clip needle guide front clip end  432  includes a front leg  431 , which has a dual clip needle guide leg protuberance  502  disposed along its inside distal end. Dual clip needle guide leg protuberance  502  includes a dual clip needle guide leg protuberance leading edge  504 , a dual clip needle guide leg protuberance insertion contact surface  506 , a dual clip needle guide leg protuberance seated contact surface  508  and a dual clip needle guide leg protuberance to leg void  510 . 
   Dual clip needle guide front clip end  432  also includes a second dual clip needle guide leg protuberance  512 , a dual clip needle guide front cannula section  520  and a dual clip needle guide front flat base section  530 . 
   Now referring to  FIG. 6 , there is shown a cross-sectional view of dual clip needle guide needle inlet end  434 , which includes a dual clip needle guide rear clip leg protuberance  602 , dual clip needle guide rear leg protuberance leading edge  604 , dual clip needle guide rear leg protuberance insertion contact surface  606 , dual clip needle guide rear leg protuberance seated contact surface  608  and dual clip needle guide rear leg protuberance to leg void  610  and a second dual clip needle guide rear leg protuberance  612 . 
   The alternate embodiment of  FIGS. 4-6  operates as follows: 
   The dual clip needle guide  430  is pressed down onto dual clip needle guide mounting bracket  420 . Dual clip needle guide leg protuberance insertion contact surface  506  and dual clip needle guide rear leg protuberance insertion contact surface  606  contact the exterior of dual clip needle guide mounting bracket  420 . Dual clip needle guide bracket leg  439  and front leg  431  spread apart as dual clip needle guide  430  is pressed harder downward. When dual clip needle guide leg protuberance  502  and dual clip needle guide rear clip leg protuberance  602  reach voids in the side of dual clip needle guide mounting bracket  420 , they are forced into such voids. When dual clip needle guide leg protuberance  502  and dual clip needle guide rear clip leg protuberance  602  are in the voids, they firmly hold the dual clip needle guide  430  to the dual clip needle guide mounting bracket  420 . 
   When the dual clip needle guide  430  is to be removed, upward pressure is applied to the dual clip needle guide needle inlet end  434  and dual clip needle guide front clip end  432 . Because of the reduced thickness associated with dual clip needle guide leg protuberance to leg void  510  and dual clip needle guide rear leg protuberance to leg void  610 , the dual clip needle guide leg protuberance  502  and the dual clip needle guide rear clip leg protuberance  602  respectively, are deformed beyond their elastic limits, and dual clip needle guide  430  becomes removable from the voids in dual clip needle guide mounting bracket  420 . Once dual clip needle guide leg protuberance  502  and dual clip needle guide rear clip leg protuberance  602  are deformed beyond their elastic limits, they are no longer capable of causing the dual clip needle guide  430  to be firmly attached to dual clip needle guide mounting bracket  420 . 
   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 or other elongated medical instrument. 
   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.