Marker delivery device with releasable plug

Abstract

The invention is directed to marker delivery devices and methods of using such devices. The delivery devices embodying features of the invention include a delivery cannula with a discharge opening and a releasable plug disposed in the inner lumen of the delivery cannula so as to at least partially occlude the discharge opening. The releasable plug prevents ingress of tissue, body fluids and the like into the bore of the tube, and prevents the premature discharge of any markers proximal to the releasable plug from passing through the discharge opening before the distal end of the cannula is properly positioned at a desired location within a patient's body. The releasable plug preferably has an MRI detectable element. Preferably, at least one remotely detectable marker mass is provided in the inner lumen of the cannula proximal to the releasable plug.

What is claimed is:  
     
         1 . A marker delivery device for an intracorporeal tissue site, comprising: 
 a) an elongated delivery cannula which has a distal end, an inner lumen and a discharge opening in the distal end in communication with the inner lumen;    b) at least one remotely detectable marker mass which is disposed within the inner lumen of the delivery cannula; and    c) a releasable plug which has a remotely detectable element incorporated therein and which is disposed at least in part within a distal portion of the inner lumen distal to the remotely detectable marker mass so as to occlude the discharge opening in the distal end.    
     
     
         2 . The marker delivery device of  claim 1  wherein the releasable plug is formed at least in part of oxidized cellulose.  
     
     
         3 . The marker delivery device of  claim 1  wherein the releasable plug is formed at least in part of a material which expands in the presence of body fluids.  
     
     
         4 . The marker delivery device of  claim 1  wherein the releasable plug is formed at least in part of polyethylene glycol.  
     
     
         5 . The marker delivery device of  claim 4  wherein the polyethylene glycol of which the releasable plug is at least partially formed has a molecular weight of about 5000 to about 120,000 Daltons.  
     
     
         6 . The marker delivery device of  claim 4  wherein the polyethylene glycol of which the releasable plug is at least partially formed has a molecular weight of about 5000 to about 20,000 Daltons.  
     
     
         7 . The marker delivery device of  claim 4  wherein the polyethylene glycol of which the releasable plug is at least partially formed has a molecular weight of about 8000 to about 10,000 Daltons.  
     
     
         8 . The marker delivery device of  claim 1  wherein the releasable plug has a non-magnetic marker element which is remotely detectable by magnetic resonance.  
     
     
         9 . The marker delivery device of  claim 1  wherein the marker element is formed of a material selected from the group consisting of titanium, platinum, gold, iridium, tantalum, tungsten, silver, rhodium.  
     
     
         10 . The marker delivery device of  claim 1  wherein the at least one remotely detectable marker body is formed at least in part of fibrous material.  
     
     
         11 . The marker delivery device of  claim 10  wherein the at least one fibrous marker body has a radiographic detectable element  
     
     
         12 . The marker delivery device of  claim 10  wherein the at least one fibrous marker body is formed at least in part of a bioabsorbable fibrous material.  
     
     
         13 . The marker delivery device of  claim 10  wherein the at least one fibrous marker body is formed of oxidized cellulose.  
     
     
         14 . The marker delivery device of  claim 10  wherein at least one fibrous marker body is formed of oxidized regenerated cellulose.  
     
     
         15 . The marker delivery device of  claim 11  wherein the radiographically detectable element surrounds an exterior portion of the fibrous marker body.  
     
     
         16 . The marker delivery device of  claim 1  wherein at least one remotely detectable marker mass is formed of polymeric material selected from the group consisting of polylactic acids, polyglycolic acids, copolymers and blends thereof and is disposed in the inner lumen proximal to the releasable plug.  
     
     
         17 . The marker delivery device of  claim 15  wherein at least one remotely detectable fibrous marker body formed at least in part of bioabsorbable fibrous material selected from the group consisting of oxidized cellulose and oxidized regenerated cellulose is disposed proximal to the remotely detectable marker bodies formed of polymeric material.  
     
     
         18 . The marker delivery device of  claim 1  wherein the releasable plug tip is formed at least in part of fibrous material.  
     
     
         19 . The marker delivery device of  claim 18  wherein the fibrous releasable plug tip has a radiographic detectable element.  
     
     
         20 . The marker delivery device of  claim 18  wherein the releasable plug tip is formed at least in part of a bioabsorbable fibrous material.  
     
     
         21 . The marker delivery device of  claim 18  wherein the fibrous releasable plug tip is formed of oxidized cellulose.  
     
     
         22 . The marker delivery device of  claim 18  wherein the fibrous releasable plug tip is formed of oxidized regenerated cellulose.  
     
     
         23 . The marker delivery device of  claim 19  wherein the radiographically detectable element surrounds an exterior portion of the fibrous releasable plug tip.  
     
     
         24 . The marker delivery device of  claim 18  wherein at least one remotely detectable marker mass is formed of polymeric material selected from the group consisting of polylactic acids, polyglycolic acids, copolymers and blends thereof and is disposed in the inner lumen proximal to the fibrous releasable plug.  
     
     
         25 . The marker delivery device of  claim 21  wherein the fibrous releasable plug tip is formed at least in part of bioabsorbable fibrous material selected from the group consisting of oxidized cellulose and oxidized regenerated cellulose is disposed proximal to the remotely detectable marker bodies formed of polymeric material.  
     
     
         26 . The marker delivery device of  claim 1  including a plunger which is slidably disposed within the inner lumen of the cannula and which has a distal end proximal to marker bodies in the inner lumen.  
     
     
         27 . A marker delivery device for an intracorporeal tissue site, comprising: 
 a) an elongated delivery cannula which has a distal end, a discharge opening in the distal end and an inner lumen extending to and in communication with the discharge opening; and    b) a releasable plug which has an MRI detectable marker element incorporated therein and which is disposed at least in part within a distal portion of the inner lumen so as to occlude the discharge opening in the distal end.    
     
     
         28 . The marker delivery device of  claim 27  wherein the releasable plug is formed at least in part of a material selected from the group consisting of oxidized cellulose or oxidized regenerated cellulose.  
     
     
         29 . The marker delivery device of  claim 27  wherein the releasable plug is formed at least in part of a material which expands in the presence of body fluids.  
     
     
         30 . The marker delivery device of  claim 29  wherein the releasable plug is formed at least in part of polyethylene glycol.  
     
     
         31 . The marker delivery device of  claim 27  wherein at least one remotely detectable marker body is slidably disposed within the inner lumen of the delivery cannula proximal to the releasable plug.  
     
     
         32 . The marker delivery device of  claim 31  wherein the at least one remotely detectable marker body disposed proximal to the releasable plug is formed at least in part of fibrous material.  
     
     
         33 . The marker delivery device of  claim 32  wherein the fibrous marker body is expandable upon contact with body fluid or other water based fluid.  
     
     
         34 . The marker delivery device of  claim 32  wherein the fibrous material is bioabsorbable.  
     
     
         35 . The marker delivery device of  claim 34  wherein the fibrous material is oxidized cellulose.  
     
     
         36 . The marker delivery device of  claim 34  wherein the fibrous material is oxidized regenerated cellulose.  
     
     
         37 . The marker delivery device of  claim 32  wherein the at least one marker body formed of fibrous material has a radiographic imageable element.  
     
     
         38 . The marker delivery device of  claim 37  wherein the radiographically detectable element surrounds a portion of the fibrous marker body.  
     
     
         39 . The marker delivery device of  claim 27  wherein a plunger is slidably disposed within the inner lumen of the cannula with a pusher end proximal to the marker bodies in the inner lumen.  
     
     
         40 . The marker delivery device of  claim 27  wherein the MRI detectable marker element is about 0.5 to about 5 mm in maximum dimension.  
     
     
         41 . The marker delivery device of  claim 27  wherein the MRI detectable marker element is about 1 to about 3 mm in maximum dimension.  
     
     
         42 . A marker delivery device system for an intracorporeal site within a patient, comprising: 
 a. an elongated delivery cannula which has a distal end, a discharge opening in the distal end and an inner lumen extending to and in communication with the discharge opening;    b. a releasable plug disposed within the inner lumen so as to at least partially occlude the discharge opening; and    c. at least one remotely detectable, short term marker disposed within the inner bore proximal to the releasable plug; and    d. at least one fibrous marker disposed within the inner lumen proximal to the at least one short term marker.    
     
     
         43 . The marker delivery device of  claim 42  wherein the releasable plug is formed at least in part of a material which expands in the presence of body fluids.  
     
     
         44 . The marker delivery device of  claim 42  wherein the releasable plug is formed at least in part of polyethylene glycol.  
     
     
         45 . The marker delivery device of  claim 42  wherein the releasable plug is covered with polyethylene glycol.  
     
     
         46 . The marker delivery device of  claim 42  wherein at least one remotely detectable marker body is slidably disposed within the inner lumen of the delivery cannula distal to the releasable plug.  
     
     
         47 . The marker delivery device of  claim 42  wherein the at least one remotely detectable marker body disposed distal to the releasable plug is formed at least in part of fibrous material.  
     
     
         48 . The marker delivery device of  claim 47  wherein the fibrous material is bioabsorbable.  
     
     
         49 . The marker delivery device of  claim 46  wherein the fibrous material is oxidized cellulose.  
     
     
         50 . The marker delivery device of  claim 46  wherein the fibrous material is oxidized regenerated cellulose.  
     
     
         51 . The marker delivery device of  claim 46  wherein the at least one marker body formed of fibrous material has a radiographic imageable element  
     
     
         52 . The marker delivery device of  claim 51  wherein the radiographically detectable element surrounds a portion of the fibrous marker body.  
     
     
         53 . The marker delivery device of  claim 42  wherein a plunger is slidably disposed within the inner lumen of the cannula with a pusher end proximal to the marker bodies in the inner lumen.  
     
     
         54 . The marker delivery device of  claim 42  wherein the releasable plug has a non-magnetic, MRI detectable marker element incorporated therein.  
     
     
         55 . The marker delivery device of  claim 54  wherein the non-magnetic, MRI detectable marker element is formed of a material selected from the group consisting of titanium, platinum, gold, iridium, tantalum, tungsten, silver and rhodium.  
     
     
         56 . The marker delivery device of  claim 54  wherein the non-magnetic, MRI detectable marker element is about 0.5 to about 5 mm in maximum dimension.  
     
     
         57 . The marker delivery device of  claim 54  wherein the non-magnetic, MRI detectable marker element is about 1 to about 3 mm in maximum dimension.  
     
     
         58 . A marker delivery device for an intracorporeal tissue site, comprising: 
 a) an elongated delivery cannula which has a distal end, an inner lumen and a discharge opening in the distal end in communication with the inner lumen;    b) at least one remotely detectable marker mass which is formed at least in part of particulate and which is disposed within the inner lumen of the delivery cannula; and    c) a releasable plug which has a remotely detectable element incorporated therein and which is disposed at least in part within a distal portion of the inner lumen distal to the remotely detectable marker mass so as to occlude the discharge opening in the distal end.    
     
     
         59 . The marker delivery device of  claim 58  wherein the marker mass is remotely detectable by ultrasound.  
     
     
         60 . The marker delivery device of  claim 58  wherein the particulate of the marker mass is formed of bio-resorbable material.  
     
     
         61 . The marker delivery device of  claim 58  wherein the particulate has a particle size of about 20 to about 2000 microns.  
     
     
         62 . The marker delivery device of  claim 58  wherein the particulate has a particle size of about 100 microns to about 1500 microns.  
     
     
         63 . The marker delivery device of  claim 58  wherein the particulate has a particle size of about 500 microns to about 900 microns.  
     
     
         64 . The marker delivery device of  claim 58  wherein the particulate has bubble cavities.  
     
     
         65 . The marker delivery device of  claim 64  wherein the bubble cavities of the particulate is about 10 microns to about 500 microns in maximum dimension.  
     
     
         66 . The marker delivery device of  claim 64  wherein the bubble cavities of the particulate are about 50 microns to about 200 microns.  
     
     
         67 . The marker delivery device of  claim 60  wherein the particulate is formed at least in part of bio-resorbable polymeric material selected from the group consisting of poly(esters), poly(hydroxy acids), poly(lactones), poly(amides), poly(ester-amides), poly(amino acids), poly(anhydrides), poly(ortho-esters), poly(carbonates), poly(phosphazines), poly(thioesters), poly(urethanes), poly(ester urethanes), polysaccharides, polylactic acids, polyglycolic acids, polycaproic acids, polybutyric acids, polyvaleric acids, and copolymers, polymer alloys, polymer mixtures, and combinations thereof.  
     
     
         68 . The marker delivery device of  claim 60  wherein the particulate is formed at least in part of bio-resorbable polymeric material selected from the group consisting of polylactic acids, polyglycolic acids, polycaproic acids, and copolymers, polymer alloys, polymer mixtures, and combinations thereof.  
     
     
         69 . The marker delivery device of  claim 52  wherein the bio-resorbable material comprises about 65% by weight polylactic acid and about 35% by weight polyglycolic acid.  
     
     
         70 . The ultrasound-detectable biopsy marker mass of  claim 58 , wherein said bio-resorbable polymeric material comprises a polymeric material having an average molecular weight of less than about 60 kD selected from the group consisting of polylactic acid and polycaproic acid polymers, copolymers, polymer alloys, polymer mixtures, and combinations thereof.  
     
     
         71 . The marker delivery device of  claim 60  wherein the particulate has a bulk density of about 0.8 g/ml to about 1.1 g/ml.  
     
     
         72 . The marker delivery device of  claim 60  wherein the particulate is held together by a binding agent.  
     
     
         73 . The marker delivery device of  claim 72  wherein the binding agent is selected from the group consisting of gelatin, polyethylene glycol, polyvinyl alcohol, glycerin, acrylic hydrogels, organic hydrogels, polysaccharides and combinations thereof.  
     
     
         74 . The marker delivery device of  claim 60  wherein the marker mass comprises gelatin and bio-resorbable polymeric particulate material having bubble cavities.  
     
     
         75 . The marker delivery device of  claim 74  wherein the gelatin binding agent is selected from the group consisting of bovine collagen, porcine collagen, ovine collagen, equine collagen, synthetic collagen, agar, synthetic gelatin, and combinations thereof.  
     
     
         76 . An intracorporeal marker comprising an expandable bioabsorbable fibrous body with a radiopaque marker element secured to the fibrous body.  
     
     
         77 . The intracorporeal marker of  claim 76  wherein the radiopaque marker element is incorporated into the fibrous body.  
     
     
         78 . The intracorporeal marker of  claim 76  wherein the radiopaque marker is disposed about the fibrous body.  
     
     
         79 . The intracorporeal marker of  claim 76  wherein the radiopaque marker is incorporated into the fibrous body.  
     
     
         80 . The intracorporeal marker of  claim 76  wherein the fibrous body is formed at least in part of a bioabsorbable material selected from the group consisting of oxidized cellulose, oxidized regenerated cellulose, polylactic acid, a copolymer of polylactic acid and glycolic acid, and polycaprolactone.  
     
     
         81 . The intracorporeal marker of  claim 80  wherein the cellulose is oxidized, regenerated cellulose.  
     
     
         82 . The intracorporeal marker of  claim 76  wherein the fibrous body is formed of material which swells in the presence of body fluids or other water based fluids.  
     
     
         83 . The intracorporeal marker of  claim 76  wherein the fibrous body is formed at least in part of woven fabric.  
     
     
         84 . The intracorporeal marker of  claim 76  wherein the fibrous body is formed at least in part of felt fabric.  
     
     
         85 . The intracorporeal marker of  claim 76  wherein the fibrous body is compressed.  
     
     
         86 . The intracorporeal marker of  claim 85  wherein the compressed fibrous body has incorporated therein a binding agent to hold the fibrous body in the compressed condition.  
     
     
         87 . The intracorporeal marker of  claim 86  wherein the binding agent is selected from the group consisting of water soluble polymers selected from the group consisting of polyvinyl alcohol, polyethylene glycol and polyvinyl pyrollidone.  
     
     
         88 . The intracorporeal marker of  claim 76  wherein the fibrous body includes at least one bioactive component selected from the group consisting of therapeutic and diagnostic agents incorporated therein.  
     
     
         89 . The intracorporeal expandable marker of  claim 88  wherein the incorporated therapeutic or diagnostic agent is selected from the group consisting of a hemostatic agent, an anesthetic agent, a coloring agent, an antibiotic agent, an antifungal agent, an antiviral agent, a chemotherapeutic agent and a radioactive agent.  
     
     
         90 . The intracorporeal expandable marker of  claim 78  wherein the fibrous body contains a bioabsorbable material selected from the group consisting of polylactic acid, a co-polymer of polylactic acid and glycolic acid, polycaprolactone, collagen and mixtures thereof, including mixtures with the oxidized cellulose.  
     
     
         91 . The intracorporeal expandable marker of  claim 78  wherein the fibrous body includes a binding agent.  
     
     
         92 . The intracorporeal expandable marker of  claim 76  wherein the radiographically detectable marker element is disposed at a central portion of the fibrous body.  
     
     
         93 . The intracorporeal expandable marker of  claim 76  wherein a constricting member holds a portion of the fibrous body to prevent its expansion.  
     
     
         94 . The intracorporeal expandable marker of  claim 93  wherein the constricting member holds a central portion of the fibrous body to prevent its expansion.  
     
     
         95 . The intracorporeal expandable marker of  claim 76  wherein the radiographically detectable marker element is a constricting member which holds a portion of the fibrous body to prevent its expansion.  
     
     
         96 . The intracorporeal expandable marker of  claim 95  wherein the radiographically detectable constricting member holds a central portion of the fibrous body to prevent its expansion.  
     
     
         97 . The intracorporeal expandable marker of  claim 96  wherein the constricted fibrous body is configured to expand into a bow-tie shape when exposed to body fluid or other water based fluid.  
     
     
         98 . The intracorporeal expandable marker of  claim 76  wherein the fibrous body has a core formed of bioabsorbable felt surrounded by a bioabsorbable fabric jacket.  
     
     
         99 . The intracorporeal expandable marker of  claim 95  wherein the radiographically detectable marker element is a radiopaque wire element clamped about a central exterior portion of the fibrous body.  
     
     
         100 . The expandable intracorporeal marker of  claim 95  wherein the fibrous mass has been compressed at least 25%.  
     
     
         101 . An intracorporeal marker comprising a compressed expandable bioabsorbable fibrous body which has been compressed and bound in the compressed condition.  
     
     
         102 . The intracorporeal marker of  claim 101  wherein the fibrous body is bound by a binding agent selected from the group consisting of water soluble polymers selected from the group consisting of polyvinyl alcohol, polyethylene glycol and polyvinyl pyrollidone.  
     
     
         103 . The intracorporeal marker of  claim 101  wherein the fibrous body is about 0.5 mm to about 12 mm in diameter.  
     
     
         104 . The intracorporeal marker of  claim 101  wherein the fibrous body is, about 1 to about 8 mm in diameter.  
     
     
         105 . The intracorporeal marker of  claim 101  wherein the fibrous body is about 5 to about 30 mm in length.  
     
     
         106 . The intracorporeal marker of  claim 101  wherein the fibrous body is about 10 to about 25 mm in length.