Patent Publication Number: US-11660112-B2

Title: Method and system for reduction of contamination in needle guides

Description:
CROSS REFERENCE TO RELATED APPLICATIONS 
     This application is a continuation application of the non-provisional patent application having the Ser. No. 13/446,788 filed Apr. 13, 2012, now U.S. Pat. No. 10,736,655, which application claims the benefit of the filing date of the provisional patent application having Ser. No. 61/476,069 filed Apr. 15, 2011, the contents of which are incorporated herein in their entirety by this reference. 
    
    
     FIELD OF THE INVENTION 
     The present invention generally relates to medical equipment, and more particularly relates to medical equipment which must be covered with a sheath during medical procedures, and even more particularly relates to methods and systems for reducing contamination of interior spaces of a needle/cannula guide when disposed outside of a sheath around an endocavity transducer. 
     BACKGROUND OF THE INVENTION 
     In recent years, medical professionals have used various types of biopsy systems to collect tissue from internal regions of the body. These biopsy systems are typically either enclosed in a sterile disposable sheath prior to use on any patient, or they are cleaned after use. The biopsy system or transceiver may be a mechanical or electro-mechanical device. Often a sheath is placed over the biopsy system and then a needle/cannula guide is coupled to the biopsy system but on the outside of the sheath. In such configurations, the needle guide is not protected by the sheath. 
     When the sheath covered system with an externally mounted needle guide is inserted into a rectal or vaginal cavity or surgical incision, contaminants may enter and contaminate internal sections of the needle guide. It is well known to use a second sheath to cover the entire combination including the previously externally mounted needle guide. 
     While such double sheath procedures have been used extensively in the past, the doubling of these sheaths doubles the sheath cost and is more time consuming and, therefore, even more costly. 
     Consequently, there exists a need for improved methods and systems for protecting internal sections of needle guides mounted to sheath covered biopsy systems in an efficient manner, while simultaneously maintaining the sterile or aseptic state of the internal spaces in the needle guide when portions of the entire combination are inserted into a body cavity. 
     SUMMARY OF THE INVENTION 
     It is an object of the present invention to provide a system and method for covering portions of needle guides which are mounted to sheath covered biopsy systems in an efficient manner. 
     It is a feature of the present invention to utilize a sterile hole cover which is configured to cover an otherwise exposed needle or cannula exit hole in an externally mounted needle guide. 
     It is another feature of the present invention to include a relatively small adhesive needle hole cover. 
     It is an advantage of the present invention to provide reduced ability for contamination to enter inside a needle guide when it is inserted into a body cavity. 
     It is another advantage of the present invention to reduce cost for protecting needle guides which are not covered by a sheath. 
     The present invention is an apparatus and method for covering exit needle holes for needle guides for use with biopsy systems 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 “wasted time-less” manner in a sense that the time consumed, in adding a second full sheath over the needle guide, has been eliminated. The invention is also accomplished in a “tear-less” or “contamination-less” manner in the sense that the contamination that may be exposed to the internal areas of the needle guide through a tear in a outer sheath of a double sheath arrangement, after a needle is caused to exit the inside of the outer sheath, has been reduced. 
     Accordingly, the present invention is a system and method including a self-sealing needle or cannula exit hole cover for use on a needle guide mounted outside of any sheath. 
    
    
     
       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 an exploded perspective view of the contamination reducing system of the present invention, which shows a needle guide with a detached exit hole cover. 
         FIG.  2    is a perspective view of the contamination reducing system of  FIG.  1   , which shows a needle guide with an attached exit hole cover, where the dotted line shows the now covered exit hole. 
         FIG.  3    is a perspective view of the present invention attached to a sheath covered biopsy system. 
         FIG.  4    is a perspective view of the contamination reducing system of the present invention, which shows a needle guide with attached terminal boot, where the dotted line shows the now covered exit hole. 
         FIG.  5    is a perspective view of the contamination reducing system of the present invention with a terminal boot which is integrated into a pocket at the end of a sheath, where the dotted line shows the now covered exit hole. 
     
    
    
     DETAILED DESCRIPTION 
     Now referring to the drawings wherein like numerals refer to like matter throughout, and more specifically referring to  FIGS.  1  and  2   , there is shown a needle guide system of the present invention generally designated  10 , which includes a needle or biopsy cannula guide  200 , of the prior art, which can be similar to many different prior art needle guides especially those having an elongated central section  340  which is configured to have a rear or proximal portion  330  thereof remain outside of the body when the front or distal portion  320  is inserted into the body orifice near the tissue to be penetrated by the needle or biopsy cannula. The guide  200  is attached to the ultrasound transducer  100 , but only after the ultrasound transducer is covered with a sheath  150 . 
     The present invention is a method and system for protecting the inside of the needle guide from contamination without the use of a complete second sheath. 
     Instead, a relatively small membrane  300  is disposed over a needle or cannula exiting hole  310  (shown with dashed lines in  FIG.  2   ) on the front end  320  of the needle guide  200 , this membrane  300  covers the exit hole  310  of the needle guide  200  so that when it is inserted into a patient there is no contamination entering the inside of the needle guide  200  via the exit hole  310 . When the transducer  100 , with associated sheath  150  and attached needle guide  200  is inserted into the rectal or vaginal cavity, a needle is then pressed through the membrane  300  into the patient&#39;s tissue. The needle pierces the membrane  300  but, in one embodiment, the membrane  300  while remaining attached to the needle guide  200 , also clings to the needle or biopsy cannula so as to reduce contamination from entering the inside of the needle guide  200 . 
     The membrane  300  can be a small piece of material similar to that used for sheaths or other suitable materials. The membrane  300  may be held in place by an adhesive which bonds with the outside of the needle guide  200 . The membrane can also be welded to the needle guide  200 . Ideally the membrane  300  is an elastic material, but any material could be used. For example, regular transparent tape placed over the needle exit hole  310  of a needle guide  200  could be a very crude example of a membrane  300 . When the needle or cannula  400  is removed from the patient and retracted into the needle guide  200 , the membrane  300  may cling to the needle and reduce contaminants from being drawn into the needle guide  200  on the exterior of the needle. 
     The membrane  300  however, in one embodiment, will specifically exclude any type of cover which covers any substantial portion of the transducer  100  so as to provide substantial shielding (either primary or secondary redundant shielding) of the transducer  100  from contaminants. Additionally, the membrane  300 , in one embodiment, shall not include any material which covers substantially all of the needle guide  200 . In another embodiment, the membrane  300  might cover the entire needle guide  200 . 
     The membrane  300  can also be used to detect whether the guide  200  has been previously used, in such cases the membrane will be broken. 
     In one embodiment, the membrane  300  can be used on numerous different types of needle guides. In another embodiment, the membrane  300  may be custom fit for a particular needle guide. 
     The membrane  300  in one embodiment could be attached by the physician or other medical imaging professional before the insertion of the needle guide  200  into the patient. In another embodiment, the membrane  300  could be attached to the needle guide  200  by the manufacturer or other assembly, inspection or certification personnel. 
     Now referring to  FIG.  4   , there is shown an embodiment of the present invention which utilizes a boot  400 , instead of the membrane  300 , of  FIGS.  1 - 3   . Boot  400  may extend over the exit hole  310  and also extend around the entire front or distal end of needle guide  200 . The material and method of attachment of boot  400  can be similar to membrane  300 . In  FIG.  4   , the boot  400  is separate from the sheath  150  and may be attached to the needle guide  200  by the physician or by the manufacturer or other personnel. 
     Now referring to  FIG.  5   , there is shown a system of the present invention where the boot  400  of  FIG.  4    is incorporated into an exterior pocket  500 , which is located on sheath  550 . Sheath  550  may be similar to sheath  150  except for the pocket  500  and the boot  400 . In an alternate embodiment, the combination of the pocket  500  and the exterior of the sheath  550  adjacent to the pocket  500  may essentially form a boot which functions much like boot  400  of  FIG.  4   . 
     In operation, the apparatus and method of the present invention as described in  FIGS.  1 - 3    could function as follows: the biopsy system  100  is covered with a sheath  150  and then a needle guide  200  is attached thereto on the exterior of the sheath  150 , the combination of the biopsy system  100 , sheath  150  and needle guide  200  (with membrane  300  attached thereto) is inserted into a body cavity of a patient. When the distal portion of the biopsy system  100  and the distal portion of needle guide  200  are inside the body cavity, the needle is inserted into the proximal end  330  of needle guide  200  and passes through an intermediate channel or cannula  342  and then the needle is manipulated from the proximal end  330  of the needle guide  200 . Tissue may be removed from the patient via the needle/cannula and retracted from the needle guide  200  which is also removed from the patient. The boot  400  would function very similarly to the system with membrane  300 . 
     The pocket  500  would work very similarly except that the distal end of the needle guide would be covered by the boot  400  or pocket  500  by inserting the distal end of the needle guide into the boot  400  or pocket  500 , which is already attached to sheath  550 , which has already been disposed over the biopsy system  100 . 
     Throughout this description, reference is made to sterile or a sterile sheath or other sterile items. It should be understood that this could refer to any state of cleanliness with respect to living organisms or a media upon which living organisms could grow. The present invention is intended to cover items that are aseptic, as well as sterile. 
     Throughout this description, reference is made to a physician. The present invention is intended to apply to any person, such as, but not limited to, physicians, physicians&#39; assistants, nurses, medical imaging specialists, veterinarians, veterinarians&#39; assistants, industrial clean room technicians, etc. 
     Throughout this description, reference is made to a biopsy system or other medical equipment. The present invention may be applicable to any environment, such as, but not limited to, medical, veterinary or clean room applications, etc. 
     Throughout this description the term needle is used to refer to an elongated object that enters a patient&#39;s tissue, it should be understood that this term is intended to refer to cannulas as well as needles. Similarly the term needle guide as used herein is intended to refer to cannula guides, which are capable of guiding cannulas. 
     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.