Methods and apparatus for securing medical instruments to desired locations in a patient's body

Abstract

Devices and methods are provided for securely affixing a medical instrument to desired tissue in a patient's body, using a fixation agent. Such medical instruments may comprise localization wires or tissue acquisition instruments, such as biopsy instruments, for example. In the case of tissue acquisition instruments, the inventors have discovered significant advantages for securely affixing the distal end of the tissue acquisition instrument to a particular tissue target area. For example, such an approach permits the imaging environment to be uncoupled from the procedural environment so that expensive and often unavailable imaging equipment, such as stereotactic imaging equipment, need not be used. In a preferred embodiment, a bonding agent, such as adhesive, surgical glue, or a solvent, is used as the fixation agent.

1 . A medical device comprising a tube having a distal end, a proximal end, and a longitudinal axis, the device being adapted for placement of said distal end into a patient's body at a desired location, said medical device having a fixation agent disposed on said distal end, the fixation agent being adapted for affixing the distal end of said medical device at said desired location.  
   
   
       2 - 48 . (canceled)  
   
   
       49 . A medical device for securing a medical instrument to a desired location within a patient's body comprising: 
 a. a shaft having a distal end, a proximal end, and a longitudinal axis, and having a distal tip configured for advancement within a patient's body to a desired location; and    b. a fixation agent for fixing the distal end at the desired location which is selected from a group of fixation agents consisting of a bonding agent, an electrical heating agent, an electrosurgical cauterizing agent, and combinations thereof.    
   
   
       50 . The medical device as recited in Clam  49 , wherein the distal end of the device has at least one opening for dispensing bonding agent into the patient's body to fix the distal end at the desired location.  
   
   
       51 . The medical device as recited in  claim 50 , wherein the bonding agent is a surgical adhesive.  
   
   
       52 . The medical device as recited in  claim 51 , wherein the surgical adhesive is a cyanoacrylate.  
   
   
       53 . The medical device as recited in  claim 50 , wherein the bonding agent is a fibrin glue.  
   
   
       54 . The medical device as recited in  claim 50 , wherein the bonding agent is a solvent.  
   
   
       55 . The medical device as recited in  claim 50 , wherein the tube has a braided outer wall.  
   
   
       56 . The device of  claim 55  wherein the braided outer wall has an interstice which forms at least in part the at least one opening for dispensing the bonding agent.  
   
   
       57 . The medical device as recited in  claim 50 , wherein the shaft has an outer wall formed at least in part from a coil of material, which has at least one interstice for dispensing the bonding agent.  
   
   
       58 . The medical device as recited in  claim 50  having a tissue acquisition device with a longitudinal axis about which the medical device is rotatable, a cutting element disposed on the shaft for cutting surrounding tissue, and a bushing disposed on the shaft which has at least one opening and which is rotatable relative to the shaft, and wherein the bonding agent is dispensed through the at least one opening and affixes the bushing to the surrounding tissue, so that the instrument is secured to the desired location without preventing rotational movement thereof.  
   
   
       59 . The medical device as recited in  claim 49 , wherein the fixation agent is an electrosurgical element disposed on the distal end of the shaft, which coagulates tissue surrounding the distal end of the shaft to affix tissue to the distal end of the shaft.  
   
   
       60 . The medical device as recited in  claim 49 , wherein the fixation agent is an electrical heating element disposed on the shaft distal end which cauterizes tissue surrounding the shaft distal end and thereby causes the tissue to be affixed to the distal end of the shaft.  
   
   
       61 . The medical device of  claim 49 , wherein the fixation agent is a, bonding agent selected from the group consisting of adhesives, solvents, and combinations thereof.  
   
   
       62 . A medical device for securing medical instruments to a desired location in a patient's body comprising: 
 a. a shaft having a distal end configured for advancement within a patient's body to a desired location, a proximal end, a localization wire, and a longitudinal axis;    b. a fixation agent disposed on the distal end of the shaft which is adapted for affixing the distal end of the medical device at the desired location; and    c. a catheter having a lumen through which the localization wire is introduced into the patient's body.    
   
   
       63 . The medical device as recited in  claim 62 , wherein the fixation agent is a bonding agent, and the catheter has a second lumen which accommodates the bonding agent.  
   
   
       64 . A medical device for securing medical instruments to a desired location in a patient's body comprising: 
 a. a shaft having a distal end configured for advancement within a patient's body to a desired location, a proximal end, and a longitudinal axis and    b. an expandable mechanical fixation agent which is configured for affixing the distal end of the shaft to the desired location.    
   
   
       65 . The medical device as recited in  claim 64 , wherein the mechanical fixation agent is a Mallicot structure.  
   
   
       66 . The medical device as recited in  claim 64 , wherein the mechanical fixation agent is a rolled stent and an axially movable sleeve, and the stent is exposed and unrolls to engage surrounding tissue and affix the distal end of the device when the sleeve is moved proximal to the stent.  
   
   
       67 . The medical device as recited in  claim 64 , wherein the mechanical fixation agent is a radially expandable and retractable basket which is actuatable to extend outwardly into tissue surrounding the distal end of the device to engage the tissue and thereby anchor the distal end of the shaft to the desired location.  
   
   
       68 . The medical device as recited-in  claim 64 , wherein the mechanical fixation agent is a wire.  
   
   
       69 . The medical device as recited in  claim 64 , wherein the mechanical fixation agent is an anchor.  
   
   
       70 . A tissue acquisition instrument for retrieving tissue at a body site comprising 
 a. a longitudinal axis;    b. a distal end with a distal tip configured for advancement within a patient's body;    c. a cutting element having a contracted configuration for delivery to the body site and an expanded configuration for separating tissue from the body site;    d. a lumen containing a bonding agent and at least one opening disposed at the distal end for dispensing the bonding agent to surrounding tissue; and    e. a mechanical fixation element disposed proximal to the distal end which has an expanded configuration for securing the tissue acquisition instrument at a predetermined desired location, in order to insure that the tissue acquisition instrument remains in place during a tissue acquisition procedure and which has a fully retracted configuration with a transverse dimension of the bendable legs which is smaller than the expanded configuration.    
   
   
       71 . The tissue acquisition instrument as recited in  claim 70 , wherein the instrument is rotatable about the longitudinal axis and wherein a bushing is disposed on the instrument which is rotatable relative to the instrument and which has an electrical heating element disposed on the bushing which cauterizes and bonds to the bushing when the electrical heating element is energized so that the instrument is secured to a location without preventing rotational movement thereof.  
   
   
       72 . The tissue acquisition instrument as recited in  claim 70 , wherein the instrument is rotatable about the longitudinal axis and wherein the instrument has a bushing disposed on the instrument which is rotatable relative to the instrument and wherein the bonding agent dispensed through the at least one opening affixes the bushing to the surrounding tissue, so that the instrument is secured in a desired location without preventing rotational movement thereof.  
   
   
       73 . The tissue acquisition instrument as recited in  claim 70 , wherein the bonding agent comprises a surgical adhesive.  
   
   
       74 . The tissue acquisition instrument as recited in  claim 73 , wherein the surgical adhesive is a cyanoacrylate.  
   
   
       75 . The tissue acquisition instrument as recited in  claim 70 , wherein the bonding agent is a fibrin glue.  
   
   
       76 . The tissue acquisition as recited in  claim 70  wherein the bonding agent is a solvent.  
   
   
       77 . A tissue acquisition instrument for retrieving tissue at a body site comprising: 
 a. a longitudinal axis;    b. a distal end with a distal tip configured for advancement within a patient's body;    c. a cutting element which has a contracted configuration for delivery to the body site and an expanded configuration for separating tissue from the body site;    d. and a mechanical fixation element which is a Mallicot structure, which is disposed proximal to the distal end, which has an expanded configuration for securing the tissue acquisition instrument at a predetermined desired location, in order to insure that the tissue acquisition instrument remains in place during a tissue acquisition procedure and which has a fully retracted configuration with a transverse dimension of the bendable legs which is smaller than the expanded configuration.    
   
   
       78 . The tissue acquisition instrument as recited in  claim 77 , wherein the mechanical fixation agent is a rolled stent and an axially movable sleeve and wherein the stent is exposed and unrolls to engage the surrounding tissue and affix to the distal end of the medical device when the sleeve is moved proximally to the stent.  
   
   
       79 . The tissue acquisition instrument as recited in  claim 77 , wherein the tissue specimen has a transverse dimension and the Mallicot structure is configured to have a transverse dimension smaller than the transverse dimension of the tissue specimen.  
   
   
       80 . The tissue acquisition instrument as recited in  claim 77 , wherein the cutting element has a transverse dimension and the Mallicot structure is configured to have a transverse dimension smaller than the transverse dimension of the cutting element.  
   
   
       81 . A tissue acquisition instrument for retrieving a tissue specimen at a body site comprising: 
 a. a longitudinal axis;    b. a distal end with a distal tip configured for advancement within a patient's body;    c. a cutting element which has a contracted configuration for delivery to the body site and an expanded configuration for separating tissue from the body site and    d. a mechanical fixation element which is a radially expandable and retractable basket, which is disposed proximal to the distal end, which has an expanded configuration for securing the tissue acquisition instrument at a predetermined desired location, in order to insure that the tissue acquisition instrument remains in place during a tissue acquisition procedure and which has a fully retracted configuration with a transverse dimension which is smaller than the expanded configuration.    
   
   
       82 . The tissue acquisition instrument as recited in  claim 81 , wherein the tissue specimen has a transverse dimension and the radially expandable and retractable basket is configured to have a transverse dimension smaller than the transverse dimension of the tissue specimen.  
   
   
       83 . The tissue acquisition instrument as recited in  claim 81 , wherein the cutting element has a transverse dimension and the radially expandable and retractable basket is configured to have a transverse dimension smaller than the transverse dimension of the cutting element.  
   
   
       84 . A tissue acquisition instrument for retrieving tissue at a body site comprising: 
 a. a longitudinal axis;    b. a distal end with a distal tip configured for advancement within a patient's body;    c. a-cutting element which has a contracted configuration for delivery to the body site and an expanded configuration for separating tissue from the body site;    d. a mechanical fixation element disposed proximal to the distal end which has an expanded configuration for securing the tissue acquisition instrument at a predetermined desired location, in order to insure that the tissue acquisition instrument remains in place during a tissue acquisition procedure and which has a contracted configuration with a transverse dimension which is smaller than the expanded configuration for delivery to a target site; and    e. a bushing which is disposed on the instrument, which is rotatable relative to the instrument, and which has an electrosurgical element disposed on the bushing which coagulates and bonds surrounding tissue to the bushing when the electrosurgical element is energized so that the instrument is secured in a desired location without preventing movement thereof.    
   
   
       85 . A tissue acquisition instrument for retrieving tissue at a body site comprising: 
 a. an elongated shaft having a distal portion, a proximal portion and a longitudinal axis;    b. a distal end with a distal tip configured for advancement within a patient's body;    c. a cutting element which has a contracted configuration for delivery to the body site and an expanded configuration for separating tissue from the body site; and    d. a mechanical fixation element disposed proximal to the distal end which has an expanded configuration for securing the tissue acquisition instrument at a predetermined desired location, in order to insure that the tissue acquisition instrument remains in place during a tissue acquisition procedure, and which has a fully retracted configuration with a transverse dimension which is smaller than the expanded configuration and a hinged linkage configured to have a transverse dimension smaller than a transverse dimension of a tissue specimen.    
   
   
       86 . A method for performing a tissue acquisition procedure comprising the steps of: 
 a.) providing a tissue acquisition instrument having a distal end, a proximal end, a longitudinal axis, and a cutting element;    b) placing the distal end of the instrument in a patient's body, so that the distal end is disposed in a desired tissue location and    c) affixing the distal end of the instrument to the desired tissue location by performing a step selected from the group consisting of dispensing a bonding agent from the distal end into surrounding tissue, activating an electrosurgical element, activating an electrical heating element, and combinations thereof.    
   
   
       87 . The method as recited in  claim 86 , wherein the step of affixing the distal end of the instrument is performed by dispensing a bonding agent from the distal end into surrounding tissue.  
   
   
       88 . The method of  claim 87 , wherein the bonding agent is selected from the group consisting of adhesives, solvents, and combinations thereof.  
   
   
       89 . The method as recited in  claim 86 , wherein the step of affixing the distal end of the instrument is performed by activating an electrosurgical element and operating it to coagulate tissue surrounding the distal end of the instrument, to an extent that the tissue bonds to the instrument distal end.  
   
   
       90 . The method as recited in  claim 86 , wherein the step of affixing the distal end of the instrument is performed by activating an electrical heating element and operating it to cauterize tissue surrounding the distal end of the instrument, to an extent that the tissue bonds to the instrument distal end.  
   
   
       91 . A biopsy device for separating a tissue specimen from a target site within a patient, comprising: 
 a. an elongated shaft having a distal shaft portion, a proximal shaft portion, a tissue penetrating distal tip and a longitudinal axis;    b. a radially expandable, longitudinally oriented tissue cutting component which is secured to the distal shaft portion proximal to the distal tip, which has a distal end and a proximal end and which has a contracted configuration for delivery to the target site and an expanded configuration for cutting the tissue specimen from supporting tissue at the target site; and    c. a tissue fixation component disposed on the elongated shaft between the proximal and distal ends of the tissue cutting component to be fixed to the tissue specimen.    
   
   
       92 . The device of  claim 91  wherein the tissue fixation component includes a bushing which is disposed on the shaft between the ends of the tissue cutting component, which has at least one discharge opening and which is rotatable relative to the shaft, and wherein a bonding agent is dispensed through the at least one opening to affix the bushing to the tissue specimen.  
   
   
       93 . The device of  claim 91 , wherein the bonding agent is at least in part a surgical adhesive.  
   
   
       94 . The device of  claim 93  wherein the surgical adhesive is at least in part a cyanoacrylate.  
   
   
       95 . The device of  claim 91 , wherein the bonding agent is at least in part a fibrin glue.  
   
   
       96 . The device of  claim 91  wherein the bonding agent is at least in part a solvent.  
   
   
       97 . The device of  claim 91 , wherein the tissue fixation component includes a Mallicot structure.  
   
   
       98 . The device of  claim 91 , wherein the tissue fixation component includes an expandable stent.  
   
   
       99 . The device of claim.  98  wherein an axially movable sleeve is disposed about the expandable stent, and removal of the sleeve allows the stent to expand and thereby be fixed to the tissue specimen.  
   
   
       100 . The device of  claim 91 , wherein the tissue fixation component includes a radially expandable and retractable basket.  
   
   
       101 . The device of  claim 91  wherein the tissue fixation component has at least one expandable band.  
   
   
       102 . The device of  claim 101  wherein the at least one expandable band is split at its center to form a tissue engaging protruding portion.  
   
   
       103 . The device of  claim 102  wherein the tissue engaging protruding portion extends distally.  
   
   
       104 . The device of  claim 103  wherein the tissue engaging protruding portion extends proximally.  
   
   
       105 . The device of  claim 101  wherein the tissue fixation component has a plurality of protruding portions, with at least one protruding portion extending distal and at least one protruding portion extending proximal.  
   
   
       106 . The device of  claim 105  wherein the protruding portions are part of split bands.  
   
   
       107 . The device of  claim 91  wherein the penetrating distal tip has an electrosurgical tissue cutting element.  
   
   
       108 . The device of  claim 107  wherein the electrosurgical tissue cutting element lies in a plane perpendicular to the longitudinal axis of the elongated shaft.  
   
   
       109 . The device of  claim 107  wherein the electrosurgical tissue cutting element is configured for connection to a RF power source.