Abstract:
An occlusion system is disclosed for use with a catheter having a catheter proximal end and a catheter distal end. The catheter further has a catheter wall with an outer catheter dimension at the catheter distal end and with the catheter wall defining a catheter lumen with a longitudinal axis extending from the catheter proximal end and through the catheter distal end. The occlusion system includes an occlusion member having an inner wall and an outer wall. The inner wall defines an occlusion member lumen extending throughout an axial length of the occlusion member. The outer wall is expandable between a contracted state with a first transverse dimension and an expanded state with a second transverse dimension. The second transverse dimension is greater than the outer catheter dimension. The occlusion member is sized for the occlusion member to be received at least partially around an exterior of the catheter lumen with the catheter received within the occlusion member lumen and advanced from the catheter proximal end toward the catheter distal end.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS  
       [0001]     This application discloses and claims material disclosed in commonly assigned U.S. patent applications Ser. Nos. ______, ______ and ______, filed concurrently herewith in the names of the same inventors as the present application and respectively entitled “VASCULAR OCCLUSION DELIVERY”, “RAPID BALLOON COUPLING SYSTEM” and “VASCULAR THERAPY DELIVERY SYSTEM” and assigned attorney docket numbers 15059.1US01, 15059.3US01 and 15059.4US01 respectively. 
     
    
     BACKGROUND OF THE INVENTION  
       [0002]     1. Field of the Invention  
         [0003]     This invention pertains to occlusion systems for use in vascular applications. More particularly, this invention pertains to endovascular devices which can be rapidly deployed during a catheter-based procedure.  
         [0004]     2. Description of the Prior Art  
         [0005]     Vascular catheters are well known for accessing treatment sites within a patient&#39;s vascular system. Examples of catheter systems can be found, for example, in U.S. Pat. No. 5,830,183 to Krieger dated Nov. 3, 1998, U.S. Patent Application Publication No. U.S. 2004/0143286A1 to Johnson et al., published Jul. 22, 2004, U.S. Patent Application Publication No. U.S. 2005/0059990A1 to Ayala et al., dated Mar. 17, 2005 and U.S. Patent Application Publication No. U.S. 2005/0107819A1 to Sater, published May 19, 2005. Other examples include U.S. Pat. No. 6,168,586 to Hahnen dated Jan. 2, 2001 and U.S. Pat. No. 6,679,871 to Hahnen dated Jan. 20, 2004.  
         [0006]     In addition to widespread use in coronary and peripheral arteries, catheter-based therapies are becoming increasingly frequent in neuro-interventional applications. For example, catheters may be used in neuro-interventional applications for delivery of occlusion devices to aneurysms in the brain. Such occlusion devices may include detachable balloons or coils to be placed in an aneurysm. Catheters may also be used for drug delivery to localized areas within the brain.  
         [0007]     Historically, catheters would be placed within the vasculature of the brain (e.g., a cerebral artery) by first advancing a guide wire under fluoroscopy through the vasculature and then passing a guiding catheter over the guide wire. Recently, a new generation of stiffer, pre-formed guiding catheters has been introduced for neuro-endovascular applications. A summary of clinical experience with such catheters is described in Putman et al., “Use of Large-Caliber Coronary Guiding Catheters for Neuro-Interventional Applications”,  American Journal of Neuro Radiology , pp 697-704 (April 1996).  
         [0008]     In addition to guide catheters, so-called micro catheters have also been used in neuro-interventional applications. Commonly, a guide catheter is advanced through the carotid artery until the distal tip is advanced to an optimal penetration location. A micro catheter is advanced over a guide wire through a guide catheter and beyond the distal tip to access narrower vessels with a more tortuous path. Guide catheters are commonly polymer material over metallic braiding with several stiffness zones and a soft distal tip. Micro catheters are commonly formed of braid or coiled materials coated with or alternatively, over-extruded with polymers. It will be appreciated that the invention of the present application is applicable to guide catheters, micro catheters as well as other therapeutic or diagnostic catheters and catheter delivery systems. These endovascular catheters can make it possible to deliver or perform a variety of therapeutic and diagnostic functions within the flow lumen. Examples include: occlusion of flow, measurement of physiologic pressures, removal of tissues, compaction or other alterations of tissue, deposit of permanent implants such as embolic particles, glues, coils, stents and balloons, dissolution of clot and delivery of drugs and other agents or injection of contrast media.  
         [0009]     When advancing a catheter through the neuro-vascular system, additional risks are encountered over those associated with advancing a catheter through coronary or peripheral vessels. Within the brain, much of the distal vasculature is typically one to four millimeters in diameter with thin fragile walls. Their profile, shape and flow paths, as viewed with conventional imaging technologies such as fluoroscopy, computer topography and magnetic resonance imaging reveals a complex network with many turns and twists creating a tortuous path. Further, unlike the coronary vessels or peripheral vessels, vasculature within the brain is not supported and reinforced by muscular tissue. Instead, the fragile blood vessels in the brain are typically surrounded by fluid or soft tissue making them more susceptible to risk of tearing or perforation.  
         [0010]     In the event a blood vessel within the brain is perforated during advancement of a catheter, it is desirable to rapidly isolate the perforation through occlusion or other techniques to prevent serious adverse consequences of blood flowing from the perforated vessel into the brain. However, providing such an occlusion mechanism can take an unacceptable length of time even under the care and direction of highly experienced interventional radiologists or other health care providers.  
         [0011]     It is an object of the present invention to provide an endovascular catheter delivery system which can be used in conjunction with a pre-placed catheter.  
         [0012]     It is another object of the present invention to provide a catheter that is designed to enable optimal therapy delivery that exploits the physical position and stability of a previously positioned catheter, that together, provide a superior therapeutic outcome than the original catheter can provide in and of itself. In other words, this system of catheters provides a therapeutic delivery system that utilizes the shaft of the first catheter, pre-positioned in place within the vasculature to navigate or track, over it, or through it, a second catheter that supplements the therapy with additional therapeutic advantage.  
         [0013]     It is another object of this invention to provide the physician a secondary or backup device that can be advanced, if desired, over the primary device in order to expand the possible combination of therapies that can be advanced to the targeted therapeutic site.  
         [0014]     It is another object of this invention to provide the physician with the option of offering combinations of several possible therapies: occlusion of flow, measurement of physiologic pressures, removal of tissues, compaction or other alterations of tissue, deposit of permanent implants such as embolic particles, glues, coils, stents and balloons, dissolution of clot and delivery of drugs and other agents. One therapy may be offered on the primary catheter and other may be offered on the secondary catheter.  
         [0015]     It is another object of this invention to provide rapid, accurate delivery of additional therapeutic value.  
         [0016]     It is another object of this invention to provide the physician/catheter operator additional and optional therapies to the patient  
       SUMMARY OF THE INVENTION  
       [0017]     According to a preferred embodiment of the present invention, an occlusion system is disclosed for use with a catheter having a catheter proximal end and a catheter distal end. The catheter further has a catheter wall with an outer catheter dimension at the catheter distal end and with the catheter wall defining a catheter lumen with a longitudinal axis extending from the catheter proximal end and through the catheter distal end. The occlusion system includes an occlusion member having an inner wall and an outer wall. The inner wall defines an occlusion member lumen extending throughout an axial length of the occlusion member. The outer wall is expandable between a contracted state with a first transverse dimension and an expanded state with a second transverse dimension. The second transverse dimension is greater than the outer catheter dimension. The occlusion member is sized for the occlusion member to be received at least partially around an exterior of the catheter lumen with the catheter received within the occlusion member lumen and advanced from the catheter proximal end toward the catheter distal end.  
     
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0018]      FIG. 1  is a plan view of a rapid delivery occlusion system according to a preferred embodiment of the present invention and shown in exploded format relative to a prior art catheter;  
         [0019]      FIG. 2  is a cross sectional view of an occlusion member of the occlusion system of  FIG. 1  shown in a contracted state;  
         [0020]      FIG. 3  is the view of  FIG. 2  showing the occlusion member in an expanded state and prior to inflation of a balloon;  
         [0021]      FIG. 4  is the view of  FIG. 3  following inflation of a balloon;  
         [0022]      FIG. 5  illustrates advancement of the occlusion system of  FIG. 1  with the occlusion member in the state of  FIG. 2  being advanced through a guide catheter residing within a blood vessel;  
         [0023]      FIG. 6  is the view of  FIG. 1  following advancement of the occlusion member beyond a distal tip of the guide catheter and with the occlusion member shown in the state of  FIG. 3 ;  
         [0024]      FIG. 7  is the view of  FIG. 6  with the occlusion member retracted onto a distal tip of the catheter and with occlusion member in the state of  FIG. 3 ;  
         [0025]      FIG. 8  is the view of the  FIG. 7  with the occlusion member inflated to the state of  FIG. 4 ;  
         [0026]      FIG. 9  is a perspective view of a rapid delivery occlusion system according to a second embodiment of the present invention;  
         [0027]      FIG. 9A  is a schematic representation of a blood vessel with branches and showing a microcatheter with a distal tip in a branch;  
         [0028]      FIG. 9B  is the view of  FIG. 9A  with an occlusion provided proximal to the distal tip of the microcatheter;  
         [0029]      FIG. 10  is a perspective view of a distal end of the occlusion system of  FIG. 9 ;  
         [0030]      FIG. 11  is a view taken along line  11 - 11  of  FIG. 10 ;  
         [0031]      FIG. 12  is a view taken along line  12 - 12  of  FIG. 10 ;  
         [0032]      FIG. 12A  is a view of  FIG. 12  with a balloon element inflated;  
         [0033]      FIG. 13  is a plan view of a third alternative embodiment of a rapid delivery occlusion system;  
         [0034]      FIG. 14  is a side elevation view, taken partially in section and in exploded format of a still further alternative embodiment of a rapid delivery occlusion system;  
         [0035]      FIG. 15  is a plan view of the occlusion system of  FIG. 14  in a sterile package;  
         [0036]      FIG. 16  is a side sectional view of a further embodiment of the present invention in place on a micro catheter;  
         [0037]      FIG. 16A  is the view of  FIG. 16  showing an alternative embodiment;  
         [0038]      FIG. 17  is a view taken along line  17 - 17  of  FIG. 16 ;  
         [0039]      FIG. 18  is a view taken along line  18 - 18  of  FIG. 16 ;  
         [0040]      FIG. 19  is an end view, partially in section, of a shuttle member carried on a micro catheter shaft;  
         [0041]      FIG. 20  is a perspective view of the shuttle of  FIG. 19  and showing a micro catheter shaft in phantom lines;  
         [0042]      FIG. 21  is a side elevation view of a still further embodiment of the present invention;  
         [0043]      FIG. 22  is a view taken along line  22 - 22  of  FIG. 21 ;  
         [0044]      FIG. 22A  is a view taken along line  22 A- 22 A of  FIG. 21 ;  
         [0045]      FIG. 23  is a side sectional view of a distal end of the apparatus of  FIG. 21 ;  
         [0046]      FIG. 24  is a side elevation view of the still further embodiment of the present invention;  
         [0047]      FIG. 25  is a view taken along line  25 - 25  of  FIG. 24 ;  
         [0048]      FIG. 25A  is a view taken along line  25 A- 25 A of  FIG. 24 ;  
         [0049]      FIG. 26  is a side elevation view shown partly in section of a still further embodiment of the present invention; and  
         [0050]      FIG. 27  is a view taken along line  27 - 27  of  FIG. 26  and additionally showing an internal guide catheter.  
     
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT  
       [0051]     With reference to the various drawing figures in which identical elements are numbered identically throughout, a description of a preferred embodiment of the present invention will now be provided.  
         [0052]     Throughout, description may be made of certain selected materials which may be used in a preferred embodiment of the present invention. However, it will be appreciated that material selection may vary as will occur to one of ordinary skill in the art. It is intended that all materials used within the apparatus of the present invention shall be biocompatible materials selected for safe use within human vasculature and susceptible to withstanding the rigors of sterilization procedures in accordance with regulations of the United States Food and Drug Administration or similar regulatory authorities in other countries.  
         [0053]     With initial reference to  FIGS. 1-8 , a first embodiment of the present invention will now be described. In  FIG. 1 , an occlusion system  10  is shown for use with a conventional prior art catheter C. This embodiment describes a convenient method to convert a guide catheter into an occlusion device.  
         [0054]     Throughout the present description, the catheter C is described as the conventional guiding catheter of extruded polymer material. It will be appreciated the present invention is applicable to micro-catheters or other tubular instruments inserted within a patient&#39;s body.  
         [0055]     The catheter C has a main body length of approximately 90 to 100 cm and terminating at a soft distal tip DT with a length L′ of 2 mm. A proximal end of the catheter C includes a prior art luer hub connected to a rotating hemostasis valve having a tool access port AP and an injection port IP. The access port AP is for admitting tools such as guide wires, micro catheters or the like into the internal lumen IL. The injection port IP is commonly used for pressure monitoring, for injection of contrast media or other fluids.  
         [0056]     Catheters C come in many sizes with a typical length L being about 90 to 100 centimeters. The outside diameter of the catheter C can range from 5 to 9 French. The fore-going dimensions are representative of guide catheters. Micro-catheters are typically about 150 cm long with a diameter tapering from 3.5 to about 2 French. Guide wires are commonly ⅔ to 1.5 French.  
         [0057]     For purpose of illustration and not intended to limit the applicability of the present invention, a typical catheter C has a length L of 100 cm, outside diameter of 7 French and an internal lumen IL with an internal diameter commonly of about 0.073 inches. The internal lumen IL is not shown in  FIG. 1  but is shown in  FIGS. 2-8 .  
         [0058]     As previously described, the catheter C is advanced through the vasculature to a target location. For example, the catheter C can be advanced through the carotid artery of a patient until the distal tip DT attains positioning near the site to be treated or a branching artery. Prior art occlusion devices such as detachable balloons, micro catheters for use with coils or the like may be admitted through the access port AP and discharged from the soft flexible distal tip DT to the target location. The catheter C can also be used to pass a balloon catheter through the guide catheter C for further advancement to a desired location within the vasculature.  
         [0059]     A clinical risk in advancing catheters such as guide catheters or micro catheters through the vasculature of the brain includes inadvertent perforation of the vessel by the catheter C. In such event, it is recognized to be desirable to occlude the blood vessel in a very rapid manner to prevent stroke or other serious adverse consequences. The desired occlusion blocks blood flow through the annular space defined by opposing surfaces of the micro catheter or guide catheter and the blood vessel. The occlusion system  10  of the present invention provides for such rapid deployment of an occlusion member in an emergency situation.  
         [0060]     The occlusion system  10  includes an occlusion member  12  at a distal end of the occlusion system  10 . An elongated advancing member  14  has a distal end  16  secured to the occlusion member  12 . A proximal end of the advancing member  14  is provided with an inlet port  18  for injection of an inflation fluid as will be described.  
         [0061]     With reference to  FIGS. 2-4 , the occlusion member  12  is shown in greater detail. The occlusion member  12  is a double-walled balloon preferably formed of silicone to have an outer wall  20  and an inner wall  22 . Axial ends  24 ,  26  of the inner and outer walls  22 ,  20  are molded together to define a sealed chamber  28  positioned between the inner wall  22  and outer wall  20 . A spring  30  is molded within the inner wall  22  and biased to urge the inner wall  22  to an expanded state illustrated in  FIG. 3 .  
         [0062]     With reference to use with a typical  7  French catheter C as described above, in the expanded state of  FIG. 3 , the cylindrical occlusion member  12  has an outside diameter OD of about 0.117 inches (about 3.0 mm) and an inside diameter ID of about 0.095 inches (about 2.4 mm) defining an inner lumen  25 . It will be appreciated that the specific sizing of a particular occlusion member  12  will vary for individually sized catheters as will be apparent to one of ordinary skill in the art.  
         [0063]     The inner and outer walls  22 ,  20  are formed with a wall thickness of about 0.005 inches (about 0.13 millimeters). The spring  30  is preferably highly elastic material such as nickel-titanium alloy (more commonly known as nitinol) or other highly elastic material. The advancing member  14  is preferably a hypo tube structured of medical grade stainless steel material with an outer diameter OD′ of about 0.016 inches (about 0.41 millimeters) and an inner diameter ID′ of about 0.012 inches (about 0.30 millimeters).  
         [0064]     The advancing member passes through the inner lumen  25 . The distal end  16  of the advancing member  14  is curved and attached to the distal end  12 A of the occlusion member  12 . An interior lumen  31  of the advancing member  14  is in fluid flow communication with the sealed chamber  28 .  
         [0065]     As illustrated in  FIG. 2 , the occlusion member  12  may be contracted against the bias of spring  30  to a contracted state illustrated in  FIG. 2  with the occlusion member  12  fully received within the internal lumen IL of the catheter C.  
         [0066]     With the construction thus described, the use of the occlusion system  10  can now be described with reference to  FIGS. 5-8 .  
         [0067]     In the event of an emergency situation requiring occlusion of the blood vessel BV in which the catheter C resides, the occlusion member  12  is urged against the bias of spring  30  to the contracted state of  FIG. 2  and admitted through the access port AP into the lumen IL of the catheter C.  
         [0068]     The physician advances the occlusion system  12  through the length L of the catheter C by pushing on the advancing member  14 . The material of the advancing member  14  is sufficiently rigid to permit pushing on proximal end of the advancing member  14  to cause advancement of the distal end  16  of the advancing member  14 . The distal end  16  pulls the occlusion member  12  throughout the length of the catheter C as illustrated in  FIG. 5  in the direction of arrow A.  
         [0069]     The occlusion system  10  is advanced throughout the entire length of the catheter C until the occlusion member  12  is advanced passed the distal tip DT as illustrated in  FIG. 6 . With the occlusion member  12  advanced past the distal tip DT, the occlusion member  12  expands to its expanded state of  FIG. 3  by the urging of spring  30  until an inner diameter ID of the occlusion member is greater than the outer diameter of the catheter C.  
         [0070]     With the occlusion member  12  expanded, the occlusion system  10  is retracted. The physician pulls on the advancing member  14  until the inner wall  22  of the occlusion member  12  surrounds the distal tip DT as illustrated in  FIG. 7 . With the occlusion member  12  so retracted, fluid (such as saline or the like) is admitted into the inlet port  18  and advanced throughout the lumen  31  of the advancing member  14  into the sealed chamber  28 .  
         [0071]     The fluid pressure in the chamber  28  causes the outer wall  20  to balloon radially outwardly as illustrated in  FIGS. 4 and 8 . The highly flexible inner wall  22  is restrained from ballooning inwardly by reason of the opposing material of the distal tip DT.  
         [0072]     Inflation of the balloon of the occlusion member  12  causes the outer wall  20  to abut the opposing surfaces of the blood vessel BV. This restricts blood flow past the catheter C. In the event of a tear or perforation distal to the distal tip DT, in a cerebral artery, the occlusion member  12  prevents blood flow through the artery BV and out of the tear into the brain tissue. With the emergency occlusions so provided, the physician can then take necessary steps to repair the perforation or otherwise treat the patient.  
         [0073]      FIGS. 9-12A  illustrate an alternative embodiment of the invention where an occlusion system  10 ′ is advanced along a pre-positioned catheter (as previously described) along the outer surface of the catheter rather than through the lumen of the catheter as in the embodiment of  FIGS. 1-8 . This design is particularly advantages where the catheter C is a microcatheter.  
         [0074]      FIG. 9A  illustrates the use of a microcatheter in a main cerebral vessel CV which branches into multiple cerebral vessel branches CB 1 , CB 2 , CB 3  and CB 4 . The physician has advanced a distal tip DT of a microcatheter MC into the third branch CB 3  for delivery of a therapy (e.g., delivery of stent, coil or therapeutic agent). In this environment, hemodynamics (such as rate or turbulence of blood flow) may make such delivery difficult. A temporary occlusion proximal to the distal tip DT can interrupt blood flow until the therapy is delivered. Such an occlusion is shown as a balloon OC in the main branch CV in  FIG. 9B . The invention of  FIGS. 9-12A  provides a convenient and rapid method for creating such occlusion when the need arises.  
         [0075]     The occlusion system  10 ′ includes an occlusion member  12 ′ at a distal end of an advancing member  14 ′. At a proximal end of the system  10 ′, an inlet port  18 ′ is provided for admitting a pressurized fluid.  
         [0076]     The advancing member  14 ′ is a split tube construction having an inner diameter approximate to the outer diameter of the catheter C. The advancing member  14 ′ is made of any flexible material which is elastically biased to a circular shape but which can be spread open along the split to be placed on the shaft of a catheter.  
         [0077]     The advancing member  14 ′ has an inner lumen  31 ′ extending along its axial length as illustrated in  FIG. 11 . At the proximal end of the advancing member  14 ′ a tube  18   a ′ connects the inlet port  18 ′ with the lumen  31 ′.  
         [0078]     The occlusion member  12 ′ is a double walled balloon having a plastic inner wall  22 ′ and a silicone outer wall  20 ′ sealed at their axially edges. Opposing surfaces of the walls  20 ′,  22 ′ define a sealed chamber  28 ′. A distal tubing  18   b ′ connects the sealed chamber  28 ′ with the lumen  31 ′.  
         [0079]     The inner wall  22 ′ is preferably formed of a plastic having sufficient rigidity to permit a balloon inflation without distorting the wall  22 ′. The wall  22 ′ has an axial slit  23 ′ along its axial length. The material of the wall  22 ′ is selected for the wall  22 ′ to be sufficiently flexible and elastic to permit it to be opened to be snapped onto the outer circumference of the catheter C. In a rest state, the slit  23 ′ is closed as illustrated in phantom lines in  FIG. 10 .  
         [0080]     With the construction thus described, the occluding member  12 ′ may be snapped on to a guide catheter or other catheter and advanced along the length of the catheter by a physician pushing on the advancing member  14 ′. The axial rigidity of the advancing member  14 ′ and the tubes  18   a ′ and  18   b ′ transmit the advancing force to the occlusion member  12 ′ to advance it along the length of the catheter.  
         [0081]     The occlusion member  12 ′ may be positioned at any point along the length of the catheter C. Fluid is then injected to the inlet port  18 ′ to inflate the outer wall  20 ′ as illustrated in  FIG. 12A . The inflation of the balloon  20 ′ occludes the space between the catheter and the blood vessel. The system  10 ′ can be rapidly placed onto a catheter that has already been introduced into a blood vessel and rapidly advanced along the length of the blood vessel to a desired occlusion location.  
         [0082]      FIGS. 13-15  illustrate a still further embodiment of the present invention. In  FIG. 13 , the catheter C has a modified coupling port CP′ which, like the prior art, has an injection port IP′ and access port AP′. Differing from the prior art, the coupling port CP′ has an emergency balloon port BP′ preloaded with an occlusion system  10 ″. The occlusion system  10 ″ includes a micro balloon an occlusion member  12 ″ connected to an inlet port  18 ″ by a tubular advancing member  14 ″.  
         [0083]     Unlike the annular balloons of the previously described embodiments, the balloon  12 ″ has no central lumen. Instead, in the event of a need for rapid occlusion, the advancing member  14 ″ is pushed distally by the physician to advance the balloon  12 ″ throughout the length of the catheter C and beyond the distal tip DT at which point fluid can be injected into the inlet port  18 ″ and fully inflate the balloon  12 ″ for complete occlusion of the blood vessel distally to the distal tip DT as illustrated in phantom lines in  FIG. 13 . With the embodiment of  FIG. 13  the rapid deployment occlusion system  10 ′ is preloaded in a novel catheter design with a novel coupling port CP′.  
         [0084]      FIGS. 14 and 15  illustrate an alternative to the embodiment of  FIG. 13 . In  FIGS. 14 and 15 , the occlusion system  10 ′″ is provided for attachment to a conventional catheter C having a conventional coupling port CP with convention access port AP and convention injection port IP.  
         [0085]     The embodiment of  FIG. 14  includes an accessory coupling  50 ′″ having a generally Y-shaped configuration and includes an attachment end  52 ′″ adapted for direct attachment to the access port AP. The accessory coupling  50 ′″ has an elongated cylindrical body  54 ′″ which extends in axial alignment with the access port AP when the attachment end  52 ′″ is attached to the access port AP. The main body  54 ′″ has a lumen  56 ′″ extending throughout its length and open at a proximal end  58 ′″ for insertion of tools, guide wires, micro catheters or other devices which the physician would normally desire to place through the access port AP during an interventional procedure.  
         [0086]     Extending at an acute angle to the main body  54 ″′ is an occlusion port  60 ″′ containing a balloon  12 ′″ having an advancing member  14 ′′ and an inlet port  18 ′″as referenced in the embodiment of  FIG. 13 .  
         [0087]     Accordingly, after attachment of end  52 ′″ to the access port AP, the end  58 ′′ serves as the access port for the coupled assembly permitting the physician to use the catheter C in a conventional manner and to admit accessory tools such as guide wires, micro catheters or the like through the inlet  58 ′″ and through the access port AP and into the catheter. In the event of a perforation, the occlusion balloon  12 ′″ is advanced through the catheter as described with reference to  FIG. 13 .  
         [0088]     With the assembly described, no time is wasted in providing the occlusion in an emergency situation.  
         [0089]     The occlusion member  10 ′″ may be individually packaged in a sealed, sterile package  100  illustrated in  FIG. 15  which may include an opaque backing  102  with a clear cover  104  with the contents sterilized through any conventional manner acceptable to regulatory authorities such as the United States Food and Drug Administration. Such sterilization techniques are readily known to those skilled in the art.  
         [0090]     With the invention of  FIGS. 14 and 15 , when a physician is performing an interventional procedure with a catheter where it is believed that risk of perforation may exist, the surgeon may, in advance of such procedure, open the package  100  and attach the occlusion system  10 ′″ to the conventional port CP so that emergency occlusion is instantly available in the event of an unintended perforation.  
         [0091]     In  FIG. 16 , a balloon delivery system  100  is shown deployed on a micro catheter MC. The balloon delivery system includes a tubular body  102  having a main lumen  104  and an inflation lumen  106 .  
         [0092]     A slit  108  is formed through the main tubular body  102  in communication with the main lumen  104 . Accordingly, the tubular body  102  may be open at the slit  108  and placed around the external diameter of the micro catheter MC with the micro catheter MC residing within the main lumen  104 .  
         [0093]     The tubular body  102  terminates at a distal end  110 . A tube  112  with internal lumen  114  is bonded to the distal end of the inflation lumen  106 . The tube  112  terminates at a distal end  116 .  
         [0094]     The distal end  116  of the tube  112  is surrounded by a silicone balloon  118 . The balloon  118  has its proximal end bonded to the tube  112  by adhesive  120 . A side port  122  is formed in the tube  112  to admit inflation fluid into the space defined between the balloon  118  and the tube  112 .  
         [0095]     The balloon  118  has a distal hub  124  bonded to a silicone shuttle  126 . The shuttle  126  is bonded to a metal clip  128  having two windings  131 ,  132  such that the clip  130 ,  132  can be mounted by snapping it on to a micro catheter MC. The clip  128  may be formed of any flexible material such as thin stainless steel or nitinol. While the balloon  118  and the silicone shuttle  126  are shown as separate elements bonded by adhesive or otherwise, they could be molded as a single piece.  
         [0096]     With the apparatus thus described, a delivery system  100  can be mounted on a catheter such as a micro catheter MC by snapping the clip  128  around the outside diameter of the micro catheter and by opening the main body  102  at the slit  108  to receive the body of the micro catheter within the main lumen  104 . The delivery system  100  can then be advanced along the length of the micro catheter until the balloon  118  is in the region of an area of desired occlusion. At such point, fluid can be admitted to the lumen  106  which passes into the space between the tube  112  and the balloon  118  to inflate the balloon  118  and create a desired occlusion.  
         [0097]      FIG. 16A  illustrates an alternative embodiment to  FIG. 6 . In  FIG. 16A  the microcatheter MC is shown as having a balloon tip BT for purpose of illustrating the versatility of the present invention. The microcatheter could be identical to the microcatheter MC in  FIG. 16  and without a balloon tip BT.  
         [0098]     In the embodiment of  FIG. 16A , the shuttle  126  is mounted to a hollow catheter  110 ′ having an internal lumen  112 ′ extending throughout its length. The distal tip  111 ′ of the catheter  110 ′ extends beyond the shuttle and is affixed thereto. With this embodiment, after placing the original microcatheter MC′, the physician may find it desirable top have an additional lumen in the blood vessel. The hollow catheter  110 ′ can be snapped onto the microcatheter MC′ by snapping the shuttle onto the microcatheter MC′ and using the microcatheter MC′ as a guide to deliver the second catheter  110 ′ to a desired position in the blood vessel. The newly delivered catheter  110 ′ can then be used to deliver therapeutic devices or agents or contract media.  
         [0099]      FIG. 21  is a side elevation view of a still further embodiment of the present invention. In  FIG. 21 , a delivery system  200  is shown having a distal end of length LD and a proximal length of L P .  
         [0100]     The proximal portion L P  is connected to an adapter having a wire port  202  and an inflation port  204 . The proximal length L p  is a tube  206  having a lumen  208  and a concave surface  210  to receive a micro catheter MC. The distal portion LD is an extension of the tubular portion  206  and includes a portion  212  which defines a main body lumen  214  sized to receive the micro catheter MC.  
         [0101]     At its distal end, a silicone balloon  216  surrounds the body portion  212 . The balloon  216  is a cylinder of silicone as previously described and bonded to the external surfaces of the body portions  212 ,  206  by adhesive  218 . The adhesives also act to define an internal balloon lumen  220  defined between the opposing surfaces of the silicone  216  and the surfaces  212 ,  206 .  
         [0102]     A port  222  is formed through the sidewall of tube  206  into communication with inflation lumen  208 . The port  222  is positioned in fluid flow communication with the lumen  220  so that inflation fluid can flow from the lumen  208  into the lumen  220  of the balloon to inflate the balloon  216 . An adhesive plug  224  is placed within the lumen  206  distal to the port  222  to seal the lumen  206  distally.  
         [0103]      FIG. 1  also shows a well-known toughy adapter  203  to be inserted within the wire port  202  to crimp a guide wire (not shown) and hold the wire accurately positioned. The guide wire is passed through the wire port  202  is admitted to the lumen  206 . The guide wire can then be removed from the lumen when it is desired to admit inflation fluid into the lumen  208 .  
         [0104]     The proximal length L P  is sized to have a length to reside within the length of a guide wire through which a micro catheter MC is placed. The distal length LD is in practice approximately  30 - 40  centimeters long to track a micro catheter and advance the balloon  216  to a desired occlusion site.  
         [0105]      FIGS. 24 and 25  illustrate an alternative embodiment of that of  FIGS. 21-23 . Elements of  FIGS. 24, 25  and  25 A are numbered identically to those of  FIGS. 21-23  with the addition of an apostrophe to distinguish the embodiments. In both of  FIGS. 21 and 22  an x-ray marker  230  is provided at distal end of the balloon to permit fluoroscopic recognition of the placement of the balloon. In the embodiments of  FIGS. 24 and 25 , a wire lumen  208   a ′ is provided within the main body. A wire  209  is permanently placed within the lumen  208   a ′ to add stiffening to the apparatus  200 ′ along its length to aid in advancement of the delivery system to a desired location.  
         [0106]      FIGS. 26 and 27  illustrate a still further embodiment of the present invention where delivery system  300  is positioned over a guide catheter GC (shown only in cross-section in  FIG. 27 ). The delivery system  300  includes a main body portion  302  having a plurality of splines  304  on its internal surface. The splines  304  oppose an external surface of the guide catheter GC to define a plurality of individual lumens  306  for delivery of an inflation fluid. The lumens  306  are in fluid flow communication with the interior of a balloon  308  having a lumen  310 . The ends of the lumen  310  are sealed by adhesives  312 .  
         [0107]     Having disclosed the forgoing concepts in a preferred embodiment, it will be appreciated that modifications and equivalents may occur to one of ordinary skill in the art. It is intended that such modifications and equivalents be included within the scope of the claims which are appended hereto. It will be recognized that the devices described in the present application may be provided with radial opaque markers at any convenient point along their length or at the distal tip of the occlusion devices to permit visualization under fluoroscopy. Elements may be coated with any lubricious coating known in the art to facilitate smooth advancement of the occlusion members along or through the catheter.