Abstract:
Safe and convenient methods and devices for inexpensively and rapidly treating pseudoaneurysms and other subcutaneous pools of blood utilize an apparatus with an applicator that can be grasped by a user at its proximal end and which has a distal portion that can be percutaneously inserted into a pseudoaneurysm. The distal portion has at least one retaining structure on at least one surface; the retaining structure(s) serve to collectively retain a clotting agent as the distal portion is inserted into the pseudoaneurysm. The clotting agent in the retaining structure(s) is exposed to blood in the pseudoaneurysm and initiates a clotting cascade. Since the clotting agent is in the retaining structure(s) and is not forcibly injected into the blood, the clotting cascade causes blood to clot at or near the surface of the applicator. The clot is associated with the applicator until the distal portion of the applicator is removed from the pseudoaneurysm. Removing the applicator causes the patient&#39;s tissue to wipe the clot off of the applicator so that the clot remains in the pseudoaneurysm.

Description:
FIELD OF THE INVENTION  
         [0001]    The invention relates to the repair and closure of wounds and abscesses, especially pseudoaneurysms. More particularly, the invention relates to the percutaneous insertion of a clotting agent for the coagulation and closure of pseudoaneurysms caused by arterial entry as part of endoscopic treatment.  
         BACKGROUND OF THE INVENTION  
         [0002]    Numerous interventional medical procedures are performed by inserting medical instruments into patients via punctures in an artery. As a part of these procedures, patients are typically treated with anticoagulant agents that slow the clotting of their blood. When the instruments are removed, it is usual to apply pressure to the punctured artery to prevent bleeding. The presence of the anticoagulating agent increases the time that is required for the puncture to be sealed.  
           [0003]    One complication of these procedures is the formation of a pseudoaneurysm. A pseudoaneurysm is formed when blood seeps from the patient&#39;s blood vessel through the puncture site and forms a turbulent pool of unclotted blood underneath the skin. Due to the turbulence, the blood in the pseudoaneurysm fails to clot. The frequency of pseudoaneurysms is a problem that has increased in recent years because of the increased popularity of such procedures, the use of larger instruments, and the increased use of blood thinning drugs. The conventional form of treatment for pseudoaneurysms is to apply continuous pressure over the site of the injury to stop the turbulence and allow the blood to clot. Patients&#39; compression times vary from minutes to hours resulting in discomfort to the patient and, in the case of manual compression, to the caregiver. Following compression, the caregiver must typically verify the procedure&#39;s success by ultrasound. Oftentimes, compression is unsuccessful and surgical repair is required.  
           [0004]    One treatment for aneurysms and pseudoaneurysms is to deliver an expanding occlusive device that anchors inside the aneurysm. The occlusive device serves as a foreign body that initiates blood clotting around the foreign body. Examples of these types of occlusive devices and anchors are shown in U.S. Pat. Nos. 5,649,959, 6,063,070, 6,063,104, 6,139,564, 6,187,024 and 6,193,708. While effective, the disadvantage of using an occlusive device is that the occlusive device usually remains in the body. In the context of aneurysms deep in the body this does not present a serious problem, but in the case of pseudoaneurysms that are just under the skin and typically on the inside of the leg, the remnants of a foreign body under the skin may not be acceptable. The foreign body also carries a risk of possible infection.  
           [0005]    An alternative pseudoaneurysm treatment is to use a syringe or needle to inject a blood clotting agent directly into the pseudoaneurysm. Examples of this technique are described in Cope et al.,  Coagulation of Aneurysms by Direct Percutaneous Thrombin Injection,  147  American Journal of Roentgenology,  383-87 (1986), and U.S. Pat. No. 5,403,278. Once injected, the free-floating blood clotting agent reacts with the blood to form a clot that ultimately coagulates the pooled blood and seals the puncture site. Unfortunately, one of the inherent risks associated with direct injection of a clotting agent is that some of the clotting agent may be injected into the artery and cause small blood clots to form in the artery. These small clots can be swept away by the blood flowing in the artery and may subsequently become stuck in smaller blood vessels and block them. Clots that are stuck in the brain and block blood flow can cause strokes, while clots in the coronary arteries can result in myocardial infarction.  
           [0006]    Various attempts have been made to improve the conventional needle or syringe for injecting a medicament into a treatment site. U.S. Pat. Nos. 4,402,308, 4,578,061, 4,700,692, 5,129,882, 5,358,474, 5,562,613, and 5,906,599 describe needles or cannulas that have a mechanism for laterally ejecting a pellet or medicament once the device is inserted. U.S. Pat. Nos. 5,310,407, 5,443,481, 5,503,623, 5,766,157, 5,814,066, and 6,010,495 describe catheter-based devices for delivering medicaments or sealants through a catheter introduced into the vascular system of the patient. U.S. Pat. Nos. 4,411,657, 4,710,180, 4,790,830, 5,290,267, 5,628,734, 5,848,996, and 6,200,302 describe needles that are curved or that have a lateral-facing port for ejecting medicaments. U.S. Pat. Nos. 4,950,234, 6,027,471, and 6,059,749 describe different syringe arrangements for injecting sealants. In each of these devices, however, the pellet or medicament is still injected or ejected such that the possibility of having a clotting agent migrate into an artery remains. It would be desirable to provide a treatment that causes the blood in pseudoaneurysms to clot without creating a risk that clotting agents will be introduced into the blood stream. An ideal treatment would be safe, inexpensive, easily administered, and fast-acting.  
         SUMMARY OF THE INVENTION  
         [0007]    The current invention provides safe and convenient methods and devices for inexpensively and rapidly treating pseudoaneurysms and other pools of blood within the body. The invention includes an apparatus with an applicator that can be grasped by a user at its proximal end and which has a distal portion that can be percutaneously inserted into a pseudoaneurysm. The distal portion has at least one retaining structure on at least one surface; the retaining structure(s) serve to collectively retain a clotting agent as the distal portion is inserted into the pseudoaneurysm. The clotting agent in the retaining structure(s) is exposed to blood in the pseudoaneurysm and initiates a clotting cascade. Since the clotting agent is in the retaining structure(s) and is not forcibly injected into the blood, the clotting cascade causes blood to clot at or near the surface of the applicator. The clot is associated with the applicator until the distal portion of the applicator is removed from the pseudoaneurysm. Removing the applicator causes the patient&#39;s tissue to wipe the clot off of the applicator so that the clot remains in the pseudoaneurysm.  
           [0008]    In use, the retaining structure(s) of the applicator are associated with the clotting agent, for example, by dipping the retaining structure(s) into a solution of thrombin. The user creates an entry for introducing at least a portion of the distal portion of the applicator into the pseudoaneurysm and introduces at least a portion of the distal portion of the applicator into the pseudoaneurysm. The user thereby exposes at least a portion of the clotting agent to blood in the pseudoaneurysm. The clotting agent initiates a clotting cascade such that at least one clot is operably attached to the applicator. The user then waits until the clotting cascade has progressed sufficiently to make the clot larger than the entry and withdraws the applicator from the pseudoaneurysm so as to leave the clot within the pseudoaneurysm.  
           [0009]    One embodiment of the invention includes an apparatus with at least one spring member associated with the distal portion of the applicator. The spring member has coils that have spaces between them. These spaces may be used as a retaining structure for the clotting agent. The spring is introduced into the pseudoaneurysm and the clotting agent initiates a clotting cascade. Another embodiment includes an outer sleeve that is coaxial with at least one of the spring members and a plunger member that is operably engaged with the spring member(s). The plunger member is used to selectively extend the at least one spring member beyond the distal end of the outer sleeve so that the clotting agent is exposed to the blood. Alternatively, the plunger member is used to retract the outer sleeve to expose the spring member and the clotting agent to the blood. The clotting agent remains on or near the spring member as it is exposed to the blood.  
           [0010]    The clotting agent need only be applied or deposited onto the applicator of the invention. When the clotting agent is exposed to the blood, it remains at or near the applicator as it reacts with the blood. The clotting agent thus maintains a safe distance from the patient&#39;s blood vessels. Even in a turbulent blood flow, it has been observed that the clot sticks to and remains otherwise associated with the preferred embodiment of the applicator. In contrast, a prior art method of injecting clotting agents into the blood separates the clotting agent from the injection apparatus with the result that the clotting agent does not remain near the injection apparatus. Moreover, the injection process uses a highly concentrated stream of clotting agent that can exit a pseudoaneurysm without being reacted and enter the patient&#39;s blood stream to cause an unwanted clot.  
           [0011]    An embodiment of the invention includes a retaining structure with a roughened, irregular surface that facilitates retention of the wettable clotting agent. Alternatively, the retaining structure is a roughened, irregular surface that holds wet or dry clotting agents. Embodiments of the retaining structure also include an applicator with a notch or an indentation, or a plurality of notches or indentations. The notches or indentations may be configured to hold large amounts of material, for example several milliliters of fluid or several tenths of a gram of a solid, or to accept only very small amounts of material, for example, only a fraction of a microgram of solid or fractions of a microliter of liquid. Embodiments include retaining structures that have smaller retaining structures within them.  
           [0012]    Another embodiment of the invention includes an apparatus that has an applicator and a stylet. The stylet is adapted to create an entry in a patient&#39;s skin that is used by the applicator. The stylet may be integral with the applicator or a separate part. In one embodiment, the stylet is a sharp tip on the applicator. In another embodiment, the stylet is a sharp edge on an introducer that is used to create an entry for the applicator. A user manipulates the stylet to create an entry in a patient&#39;s skin through which the applicator is introduced.  
           [0013]    A clotting agent for use with the present invention may be a liquid or powder. Many materials are known to initiate clotting and these materials may be used as a substitute for the clotting agent or in combination with the clotting agent. Such clot initiating materials include enzymes or polymers that occur in nature and synthetic materials that have been observed to initiate blood clotting.  
       
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0014]    [0014]FIG. 1 is a perspective view of an embodiment of the invention.  
         [0015]    [0015]FIG. 2 is a perspective view of a preferred embodiment of the invention.  
         [0016]    [0016]FIG. 3 is an enlarged, fragmentary, plan view of the distal end of FIG. 2.  
         [0017]    [0017]FIG. 4A is a perspective view depicting a step of loading the applicator of FIG. 2.  
         [0018]    [0018]FIG. 4B is a perspective view depicting a step of loading the applicator of FIG. 2.  
         [0019]    [0019]FIG. 5 is a fragmentary, plan view of the distal end of an embodiment of the invention.  
         [0020]    [0020]FIG. 6 is a fragmentary, plan view of the distal end of another embodiment of the invention.  
         [0021]    [0021]FIG. 7 is a plan view of another embodiment of the invention.  
         [0022]    [0022]FIG. 8 is a fragmentary, plan view of the distal end of another embodiment of the invention.  
         [0023]    [0023]FIG. 9 is a fragmentary, plan view of the distal end of another embodiment of the invention.  
         [0024]    [0024]FIG. 10 is a fragmentary, plan view of the distal end of another embodiment of the invention.  
         [0025]    [0025]FIG. 11 is a fragmentary, plan view of the distal end of another embodiment of the invention.  
         [0026]    [0026]FIG. 12 is a fragmentary, plan view of the distal end of another embodiment of the invention.  
         [0027]    [0027]FIG. 13 is a fragmentary, plan view of the distal end of another embodiment of the invention.  
         [0028]    [0028]FIG. 14 depicts a cross-sectional view of a pseudoaneurysm within a patient&#39;s body.  
         [0029]    [0029]FIG. 15 is a perspective view of a kit in accordance with a preferred embodiment of the invention. 
     
    
     DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS  
       [0030]    A perspective view of a preferred embodiment of the invention is shown in FIG. 1. The invention includes proximal shaft  10 . Attached to proximal shaft  10  is mid shaft  20 . Proximal slide  30  is located on the proximal end of the proximal shaft  10 . Distal slide  40  is located on the distal end of the proximal shaft  10 . Attached to the distal end of mid shaft  20  is finger wing  50 . Luer tip  60  is attached to the distal end of the mid shaft  20 . Attached to the distal side of luer tip  60  is hollow needle  70 . Piston  80  resides within hollow needle  70 . Distal projection  90  is depicted as projecting from the distal end of piston  80 .  
         [0031]    A perspective view of another embodiment of the invention is shown in FIG. 2. The invention contains piston housing  100  with slidable piston handle  110 . Slidable piston handle  110  is mounted on piston handle grip  120 . At the proximal end of piston housing  100  is piston body cap  130 . Piston handle channel  140  runs the length of piston housing  100 . At the distal end of piston housing  100  is luer tip  60 . Attached to the distal side of luer tip  60  is hollow needle  70 . Residing within and protruding from hollow needle  70  is piston  80 . Distal projection  90  is depicted as projecting from the distal end of piston  80 .  
         [0032]    [0032]FIG. 3 depicts a fragmentary view of the distal end of the embodiments of FIGS. 1 and 2. Extending out of hollow needle  70  is piston  80 . At the distal tip of piston  80  is distal projection  90 . Distal projection  90  is preferably a spring member comprised of a coiled wire that preferably pigtails into loops  160  once deployed. In one embodiment, the distal projection  90  is formed of superelastic Nitinol. In alternative embodiments, the distal projection  90  is made of silica, copper, gold or other suitable thrombogenic materials. In one embodiment, the length of distal projection  90  is  4  inches long but the length can vary according to application up to 12 inches long, although longer lengths may be used for other embodiments. Preferably, the pitch of distal projection  90  is such that small interstitial spaces  170  are formed between adjacent coils of the distal projection  90 . Pitches of the distal projection  90  can preferably range between 0.015 to 0.036 inches. Similarly, the preferred diameter of the distal projection  90  can range between 0.010 inches to 0.040 inches.  
         [0033]    It will be recognized that both the interstitial spaces  170 , as well as the larger structure of the loops  160  serve to define retaining structures for purposes of the present invention. In one embodiment, the pitch of distal projection  90  is sized to provide a holding capacity of 100-400 US units of thrombin per inch. In alternative embodiments, other suitable thrombogenic materials are used in place of thrombin. Distal projection  90  can be provided in either a thrombogenically pre-coated or uncoated form. As will be described, other alternative retaining structures can also be utilized to accomplish the retention function of the clotting agent in accordance with the present invention. In one embodiment, distal projection  90  may receive a surface treatment such as roughening treatment with a hydrophilic substance to facilitate capture and retention of the thrombogenic material. In addition, alternative embodiments may utilize a packing mechanism through which thrombin or appropriate thrombogenic materials can be imparted to a retaining structure.  
         [0034]    [0034]FIGS. 4A and 4B depict perspective views of the hemostatic capture apparatus of the invention as shown in FIG. 1 that is preferably used in a two step process of loading the clotting agent  230  onto the applicator as will be described. At the distal end of the invention is wetting agent vial  180 . Rubber septum  190  is located in the open end of wetting agent vial  180 . A liquid wetting agent  200  is located inside the wetting agent vial  180 . Dry clotting agent vial  210  is also shown attached to the distal end of the invention. Rubber septum  220  is preferably located in the open end of dry clotting agent vial  210 . Dry clotting agent  230  is located inside dry clotting agent vial  210 .  
         [0035]    [0035]FIG. 5 contains a fragmentary, plan view of the distal end of an embodiment of the invention. In this embodiment, a wire applicator  240  extends from hollow needle  70  to form the retaining structures in accordance with the present invention. In this embodiment, the coiled wire applicator is not configured to establish a series of loops when extended. The details of the construction, arrangement, and pitch of the coiled wire are preferably similar to those described with respect to the embodiment shown in FIG. 3, although other configurations could be adopted as long as a desired quantity of clotting agent  230  was able to be retained by the applicator. For example, multiple separate coiled wire applicators  240  could be extended from hollow needle  70 .  
         [0036]    For purposes of the present invention, the retaining structure(s) are intended to define a sufficient volume of space for retaining an aliquot of clotting agent  230  associated with the applicator  240  during the procedure as will be described. The amount of clotting agent  230  necessary for a given medical procedure would depend upon the nature of the procedure and the particular clotting agent  230 . For example, if the clotting agent  230  is dry powdered thrombin, and the wetting agent  200  is saline, it is preferred that between 100 and 400 units of thrombin are effectively retained per inch by the retaining structures  240 . In a preferred embodiment, coiled wire applicator  240  is approximately 4 inches long such that between about 400 and 1600 units of thrombin are introduced in order to treat a typical pseudoaneurysm created as a result of a vascular access procedure and having a blood pool of at least about 2 centimeters in diameter and preferably having a volume ranging between about 4 cc and 65 cc. Existing medical literature indicates that most pseudoaneurysms can be resolved by injection of between 100 to 1500 units of thrombin.  
         [0037]    Although the preferred embodiment of the present invention has been described with respect to a wetting process for adhering or otherwise associating the clotting agent with the applicator, it will be understood that alternative techniques may also be used. For example, the clotting agent could be provided in a gelatinous or semi-liquid or tacky form so that the clotting agent would stick to the retaining structures without the need for wetting the applicator. Alternatively, the clotting agent could be attracted to the applicator by application of electrostatic charge.  
         [0038]    [0038]FIG. 6 contains a fragmentary, plan view of the distal end of another embodiment of the invention. In this embodiment, a set of retractable fingers  250  extend from hollow needle  70 . Although only a pair of fingers  250  are shown, it will be understood that numerous arrangements of the number and configurations of such fingers  250  could be accomplished within the scope of  20  the present invention. Preferably, the retractable fingers  250  are arranged to hold larger clumps of the clotting agent  230 . Alternatively, more fingers  250  could be arranged in closer parallel arrangement to one another to provide retaining structure for smaller sizes of clotting agent. In another embodiment, the retaining fingers  250  can be utilized to secure an intermediate carrier structure, such as a sponge or structure having a porous surface, that is carried by the retaining fingers  250  and holds the clotting agent  230 .  
         [0039]    [0039]FIG. 7 is a plan view of another embodiment of the invention. On the proximal end is stylus handle  260  with multiple grooved handle grips  270 . Applicator  280  is attached to the distal end of stylus handle  260 . Near the distal end of applicator  280  are defined retaining structures  290 . In this embodiment, the retaining structures  290  can be created by defining a roughened surface portion of the applicator  280 , or more preferably, by creating a textured region having surface structure which will retain the clotting agent  230 , particularly after the distal end of applicator  280  has been wetted. In this embodiment, applicator  280  is a convex point stylet tip  300  that serves as a stylet for creating a puncture to access the pseudoaneurysm.  
         [0040]    [0040]FIG. 8 shows an alternative embodiment of the invention. Near the distal end of the applicator  280  is a recessed clotting agent retaining structure  310 . The recessed retaining structure  310  has a cross-sectional diameter that is smaller than the cross-sectional diameter of application  280 . Preferably, micro structures  315  are provided in the recess  310  that serve to enhance the ability of the recess  310  to retain the clotting agent  230 . Such micro structures  315  can include porous coatings, abrasions, indentations, scorings, filaments, or fabric structures or the like. At the distal end of the applicator  280  is a concave point stylet tip  320 .  
         [0041]    [0041]FIG. 9 shows an alternative embodiment of the applicator of the invention. Near the distal end of applicator  280  is at least one indented retaining structure  330 . Indented retaining structure  330  can also be provided with micro structures to enhance the retention of clotting agent  230 . At the distal end of applicator  280  is a chiseled stylet tip  340 . Preferably, indented retaining structure  330  is formed of a cutaway portion that leaves sufficient structural integrity to the remainder of the applicator  280  to allow stylet tip  340  to be effectively used to create a puncture.  
         [0042]    [0042]FIG. 10 shows an alternative embodiment of the invention. Near the distal end of applicator  280  are multiple indented retaining structures  350  defined along a longitudinal axis of the applicator  280 . Like the indented retaining structure  330 , the multiple indented retaining structures  350  can also be provided with micro structures to enhance the retention of clotting agent  230 . At the distal end of applicator  280  is a chiseled stylet tip  340 .  
         [0043]    [0043]FIG. 11 shows an alternative embodiment of the invention. Near the distal end of applicator  280  are at least two recessed clotting agent retaining structures  360  defined along a common longitudinal portion of applicator  280 . Like the indented retaining structure  330 , the parallel recessed retaining structures  360  can also be provided with micro structures to enhance the retention of clotting agent  230 . At the distal end of the applicator  280  is a chiseled stylet  340 .  
         [0044]    [0044]FIG. 12 shows an alternative embodiment of the invention. Applicator  282  has a plurality of delivery perforations  390  defined around an exterior of the distal tip. The delivery perforations or indentions  390  can be defined in any number of sizes and shapes. In one embodiment, the applicator  282  is a hollow tube and the perforations can extend from the surface of the applicator  282  through to a central lumen  270 . In this embodiment, the distal tip is a spherical rounded end  282  that is not equipped to be utilized as a stylet.  
         [0045]    [0045]FIG. 13 shows an alternative embodiment of the invention. The applicator  284  is comprised of a solid applicator rod  400 , preferably having a rod cap  410  at its distal end. An application wire structure  420  is coiled around the length of solid applicator rod  400 . In one embodiment, application wire structure  420  is a metal wire that may be coiled, perforated or porous. In another embodiment, application wire structure  420  is comprised of a polymeric multi-filament cord.  
         [0046]    [0046]FIG. 14 shows a cross-section of a pseudoaneurysm. Pseudoaneurysm  430  is located below the surface of the skin  440 . Blood pool  450  is supplied via pseudoaneurysm neck  460 . Pseudoaneurysm neck  460  is located at injury site  470  of blood vessel  480 .  
         [0047]    In constructing the embodiments of the invention, materials appropriate to percutaneous devices should be used. For piston housing components including the proximal shaft  10 , mid shaft  20 , piston housing  100  and piston body cap  130  appropriate materials of construction include: fluoropolymers, Acetil (Delrin), other low friction polymers or other suitable polymers. Components to be gripped or biased by the user including proximal slide  30 , distal slide  40 , finger wings  50 , luer tip  60  slidable piston handle  110 , piston handle grip  120  and piston grip  150  will optimally be constructed of polycarbonate or other stiff, rigid polymer materials. The hollow needle  70  is optimally constructed of an appropriate grade of stainless steel. The thrombin delivery components including the piston  80 , stylus  90 , spring coil  160 , and other delivery embodiments are optimally constructed of superelastic Nitinol, a combination of Nitinol and stainless steel or an appropriate grade of stainless steel.  
         [0048]    In practice, the preferred embodiment is used following the location and diagnosis of a pseudoaneurysm  430 . The medical personnel acquire wetting agent vial  180 . Hollow needle  70  is inserted through rubber septum  190  and into wetting agent  200 . Piston  80  is extended into wetting agent  200  by biasing proximal slide  30  and distal slide  40 . Stylus  90  comes into contact with wetting agent  200 . Wetting agent  200  coats the interstitial spaces  170  between in distal projection  90 . Piston  80  and distal projection  90  are retracted within the hollow needle  70  by biasing proximal slide  30  and distal slide  40 . Hollow needle  70  is withdrawn through the rubber septum  180 .  
         [0049]    The medical personnel then acquire dry clotting agent vial  210 . Hollow needle  70  is inserted through rubber septum  220 , either directly or coaxially through a cannula  222 , and into dry clotting agent  230 . Piston  80  is extended into dry clotting agent  230  by biasing proximal slide  30  and distal slide  40 . Distal projection  90  comes into contact with dry clotting agent  230 . Dry clotting agent  230  coats the now wetted interstitial spaces  170  in coiled wire  90 . Piston  80  and distal projection  90  are retracted with the hollow needle  70  by biasing proximal slide  30  and distal slide  40 . Preferably, cannula  222  is used to prevent the dulling of needle  70  as the needle is inserted through the rubber septum  220  or  190  and is also provided with an appropriate standoff height to prevent the tip of the needle  70  from bottoming out in the vial  210  or  180 . Once distal projection  90  is retracted, the hollow needle  70  is withdrawn through rubber septum  220 .  
         [0050]    Gripping finger wing  50 , the medical personnel insert hollow needle  70  through the patient&#39;s skin  440  until hollow needle  70  has accessed pseudoaneurysm  430 . Proximal slide  30  and distal slide  40  are biased and piston  80  along with distal projection  90  emerge from hollow needle  70  and into blood pool  450  of pseudoaneurysm  430 . Dry clotting agent  230  retained in interstitial spaces  170  causes thrombosis and clotting to occur inside blood pool  450  on the surface of distal projection  90 . Following clot formation, proximal slide  30  and distal slide  40  are biased causing piston  80  and distal projection  90  to be withdrawn through hollow needle  70 . As distal projection  90  enters hollow needle  70 , the blood clot is removed from coils  160  and is left under skin  440  for resorption into patient&#39;s body. Using finger wing  50 , the medical personnel remove hollow needle  70  from the patients skin  440 .  
         [0051]    Referring to FIG. 15, a kit  500  can be provided that includes an apparatus  510  having a proximal handle  520  and a distal portion  530  having a needle  70  with a distal projection  90 , a wetting agent vial  180 , a dry clotting agent vial  210  and a pair of cannulas  222  contained within a tray  550  that is sterilized and sealed, preferably by a pealable sheeting material  560 . The apparatus  510  may be any of the embodiments of the invention as previously described. The vials  180  and  210  are used in the manner as has been described, with the vial  210  containing sufficient clotting agent  230  necessary for treating a single patient. Preferably, the amount of clotting agent  230  in kit  500  is sufficient to treat any size pseudoaneurysm. Alternatively, different kits  500  may be provided having different sizes or arrangements of apparatus  510 , or having vials  210  containing different quantities or compositions of clotting agents  230 . Preferably, tray  550  and sheeting material  560  are plastic materials and tray  550  includes corresponding compartments individually associated with each of the items included in kit  500 . In one embodiment, the needle  70  is contained in a separate compartment from the proximal portion  510  of the apparatus  500 . In another embodiment, a separate stylet can be provided as part of the components of the kit  500 . It will be recognized that numerous alternative sterile packaging arrangements known in the art could also be utilized to create kit  500 .  
         [0052]    Though a complete description of the preferred embodiment is provided, this is in no way meant to limit the application of the present invention. To one schooled in the art, it is clear that the embodiments contained in the remaining figures could be similarly used to accomplish thrombosis of a pseudoaneurysm. It is also clear that many types and forms of clotting agents could be used in conjunction with the present invention. These hemostatic agents include but are not limited to natural or synthetic compounds including modified derivatives such as thrombin, collagen, fibrinogen, oxidized cellulose, gelatin, chitosan, alginic acid, astringents such as tannic acid and vasoconstrictors such as epinephrine and angiotensin II or any combination of the above.  
         [0053]    While the present invention is directed most particularly to pools of blood in the form of pseudoaneurysms, it will be understood that the present invention is capable of directly percutaneously treating any volume of blood within a patient for the purpose of forming a clot in that volume of blood. Examples of such other volumes of blood treatable by the present invention include aneurysms, hematomas, endoleaks or even a quantity of flowing blood.