Patent Publication Number: US-2018028206-A1

Title: Multi-Lumen Catheter for Cardiac Device Deployment

Description:
This Application is a Continuation in Part to U.S. patent application Ser. No. 14/684,152 filed on Apr. 10, 2015, which is incorporated herein in its entirety by this reference thereto. 
     The disclosed technology relates generally to catheters and, more specifically, to multi-lumen catheters for device deployment in the cardiovascular system. 
    
    
     TECHNICAL FIELD 
     BACKGROUND 
     Heart disease and related heart conditions continue to be a serious health risk to the public at large. For example, atrial fibrillation is a serious medical condition that occurs when the atrial chamber beats out of rhythmic coordination with the ventricle chambers of the heart. If continuously left untreated, atrial fibrillation may cause the heart to weaken or prevent the blood from pumping effectively, thus increasing the likelihood of a heart failure or stroke. 
     Effective treatment options may include sealing the left atrial appendage with a cardiac device to help reduce the formation of clots in the left atrial appendage and minimizing the likelihood of a stroke. A catheter system may be used to deploy devices throughout the vascular system. For example, a catheter system may be used to deploy a cardiac device to specific locations within the heart (e.g., the left atrium). Conventional catheter technology, however, does not allow for efficient manipulation of cavities, such as the left atrial appendage. 
     Because the left atrial appendage is a long, tubular, hooked structure, safely deploying the cardiac device within the left atrium appendage requires not only careful precision, but also requires orienting the device perpendicular to the left appendage plane in order to ensure implant success of the cardiac device. Incorrectly positioning and deploying the cardiac device within the left atrial appendage may lead to ineffective treatment and increased likelihood of future heart complications, such as device embolism or Thrombus formation. Similar deployment precision issues are also present in the positioning and deploying of stents into the vascular system of patients. Incorrect positioning of the sheath, deployment wires and engaged catheters during such procedures can significantly impact the outcome. 
     BRIEF SUMMARY OF THE INVENTION 
     Embodiments disclosed herein are directed toward a cardiac device deployment system that enables manipulation and control of the cardiac device during deployment into a target position in the vasculature, while reducing the risk of damaging proximal anatomy. For example, some embodiments provide a multi-lumen catheter with a dual-lumen sheath configured to receive a shapeable guide-wire through a first lumen and a cardiac device, deployed with a cardiac device delivery system, through a second lumen. The shapeable guidewire may be used in concert with the cardiac device delivery system, to manipulate the cardiac device relative to the target anatomy such as by bending and repositioning the distal end of the multi-lumen sheath. 
     For example, the cardiac device may be a WATCHMAN device, and the cardiac device delivery system may be a catheter shaped to fit within the second lumen, and designed to hold the cardiac device at a distal end. The shapeable guidewire may be shaped with a substantially smaller cross-sectional circumference, such that the first lumen may also have a substantially smaller cross-sectional circumference than the second lumen. The shapeable guide-wire may comprise a shape-memory material, such that the guide-wire may be manipulated into a predetermined shape configuration before being advanced within the first lumen and may be manipulated once advanced through the first lumen to align and reposition the distal end of the sheath. The target anatomy may include any bodily structure requiring a treatment with a device delivered by the multi-lumen sheath or catheter, such as the heart, lung, kidney, bladder, abdominal cavities, and the like. Within the heart, the target anatomy may include any fold, cavity, or appendage, including blood supply arteries and the left atrial appendage. 
     In some embodiments, a balloon may be used in conjunction with the guidewire to protect the proximate anatomy from accidental scraping or puncture damage. For example, the balloon may be deployed through one of the lumens in the sheath or multi-lumen catheter in order to provide a protective bumper between the cardiac walls and the shapeable guidewire. Alternatively and preferred, the balloon can be employed as an anchor to substantially fix the distal end of the sheath bearing the delivery catheters and wires, so that the surgeon can concentrate on positioning the implant, knowing that the distal end of the sheath will substantially maintain its anchored position anchored by the balloon and balloon wire. 
     In one embodiment of the disclosure, a multi-lumen catheter device includes a sheath with a first lumen and a second lumen, each disposed within the sheath. The second lumen may have a cross-sectional circumference that is greater than the cross sectional circumference of the first lumen. For example, the first lumen may be a guidewire lumen shaped to receive a shapeable guidewire, and the second lumen may be a device lumen shaped to allow the cardiac device to move longitudinally from the proximal end of the catheter to the distal end of the catheter. The shapeable guidewire may be substantially smaller in diameter than the cardiac device and may incorporate a malleable material with shape memory. Due to the shape memory material, the distal end of the guide-wire may be articulated into a first shape prior to insertion into the second lumen, may bend into a second shape during deployment through the second lumen, and may reflex in to a third shape that is substantially similar to the first shape after the distal end of the guidewire extends beyond the distal end of the sheath. 
     In another embodiment, a multi-lumen catheter device includes a sheath with a first lumen, a second lumen, and a third lumen disposed within the sheath. The second lumen may have a cross sectional circumference greater than the cross sectional circumference of the first lumen and the cross sectional circumference of the third lumen. For example, the first lumen may be a guide-wire lumen shaped to receive a shapeable guide-wire, the second lumen may be device lumen shaped to allow the cardiac device to move longitudinally from the proximal end of the catheter to the distal end of the catheter engaged within the multi lumen sheath. The third lumen may be a balloon lumen configured to receive and translate a balloon deployment system therethrough. The balloon deployment system may include a balloon located at the distal end of a balloon wire or guidewire. 
     Other features and aspects of the disclosed technology will become apparent from the following detailed description, taken in conjunction with the accompanying drawings, which illustrate, by way of example, the features in accordance with embodiments of the disclosed technology. The summary is not intended to limit the scope of any inventions described herein, which are defined solely by the claims attached hereto. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       The technology disclosed herein, in accordance with one or more various embodiments, is described in detail with reference to the following figures. The drawings are provided for purposes of illustration only and merely depict typical or example embodiments of the disclosed technology. These drawings are provided to facilitate the reader&#39;s understanding of the disclosed technology and shall not be considered limiting of the breadth, scope, or applicability thereof. It should be noted that for clarity and ease of illustration these drawings are not necessarily made to scale. 
         FIG. 1  is a diagram illustrating a cross-sectional view of a multi-lumen catheter, consistent with some embodiments disclosed herein. 
         FIG. 2  is a diagram illustrating a cross-sectional view of the multi-lumen catheter with a shapeable guidewire inserted, consistent with some embodiments disclosed herein. 
         FIG. 3  is a diagram illustrating a multi-lumen catheter deployed into the left atrium with a cardiac device positioned to seal the left atrial appendage, consistent with embodiments disclosed herein. 
         FIG. 4  is a diagram illustrating a multi-lumen catheter with a balloon guidewire and cardiac device disposed therein, consistent with some embodiments disclosed herein. 
         FIG. 5  is a diagram illustrating a cross-sectional view of a multi-lumen catheter, consistent with some embodiments disclosed herein. 
         FIG. 6  is a diagram illustrating a cross-sectional view of a multi-lumen catheter with a shapeable guidewire, a cardiac device, and a balloon guidewire inserted, consistent with some embodiments disclosed herein. 
         FIG. 7  is a diagram illustrating a multi-lumen catheter deployed into the left atrium with a cardiac device positioned to seal the left atrial appendage, consistent with some embodiments disclosed herein. 
         FIG. 8  is a flow chart illustrating a method for deploying a multi-lumen catheter into a target anatomy, consistent with some embodiments of this disclosure. 
         FIG. 9  is a flow chart illustrating a method for inserting a guidewire into a multi-lumen catheter, consistent with some embodiments disclosed herein. 
         FIG. 10  is a flow chart illustrating a method for manipulating a cardiac device with a shapeable guidewire within an atrium target anatomy, consistent with some embodiments disclosed herein. 
         FIG. 11  is a flow chart illustrating a method for inserting a distal balloon guidewire end into a multi-lumen catheter consistent with some embodiments of this disclosure. 
         FIG. 12  is a flow chart illustrating a method for deploying a multi-lumen catheter into an atrium target anatomy, consistent with some embodiments disclosed herein. 
         FIG. 13  depicts a particularly preferred mode of the MULTI-LUMEN delivery device herein, showing a sheath having lumens for a shapeable guidewire, a cardiac device and guidewire therefor, and a balloon with a balloon wire communicating therethrough, consistent with some embodiments disclosed herein. 
         FIG. 14  shows another particularly preferred mode of the multi-lumen delivery device herein, showing a sheath including lumens for a shapeable guidewire, a cardiac device and guidewire therefore, and a balloon engaged at a distal end of a balloon wire, all communicating through respective lumens from a proximal to distal end of the sheath. 
         FIG. 15  is a flow chart illustrating a method for deploying the multi-lumen catheter to position the distal end of the sheath in an anchored position adjacent the target anatomy for the cardiac or implant device. 
     
    
    
     The figures are not intended to be exhaustive or to limit the invention to the precise form of the device and method disclosed herein. It should be understood that the invention can be practiced with modification and alteration, and that the disclosed technology shall be limited only by the claims and the equivalents thereof as would occur to those skilled in the art. 
     DETAILED DESCRIPTION OF VARIOUS EMBODIMENTS 
     The following description is not to be taken in a limiting sense, but is made merely for the purpose of describing the general principles of the disclosed embodiments. The present embodiments address the problems described in the background while also addressing other additional problems as will be seen from the following detailed description. Numerous specific details are set forth to provide a full understanding of various aspects of the subject disclosure. It will be apparent, however, to one ordinarily skilled in the art, that various aspects of the subject disclosure may be practiced without some of these specific details. In other instances, well-known structures and techniques have not been shown in detail to avoid unnecessarily obscuring the subject disclosure. 
     As illustrated in  FIG. 1 , one embodiment of the disclosure is a multi-lumen catheter device  100  that may include sheath  105  with a first lumen  110  and a second lumen  115  disposed within sheath  105 . The first lumen  110  may have a cross-sectional circumference smaller than the cross-sectional circumference of the second lumen  115 , and the sum of the cross-sectional diameters of first lumen  110  and second lumen  115  is less than the cross-sectional diameter of the sheath  105 . In some embodiments, first lumen  110  ranges between 3 and 10 French. In some embodiments, the second lumen  115  range between 10 and 30 French. Lumens of different sizes may be selected according to the applicable constraints, such as the requirement that the shapeable guidewire fit within the first lumen, the cardiac device fit inside the second lumen, both lumens to fit within the sheath, and the sheath to fit within all of the vasculature in the approach from a catheter entry site to the target anatomy (e.g., the vasculature between a femoral entry point and the heart). 
     In some embodiments, the multi-lumen catheter must be sized for use on a smaller patient anatomy (e.g., pediatric patients or animals), such that the multi-lumen catheter must be small enough to be inserted through a smaller anatomy, while also large enough to insert the proper device or tools through the multi-lumen catheter. In some examples, first lumen  110  may range between 5 and 8 French and the second lumen  115  may range between 10 and 14 French. 
     In another example, the multi-lumen catheter  100  may be utilized for veterinary treatment for an animal, such as a dog, cat, horse, cow, pig, and the like. Should the multi-lumen catheter be used to treat a horse for example, then the sheath and enclosed lumens should be sized to fit within the vasculature of a horse. For example, the first lumen,  110  may range between 10 and 15 French and the second lumen  115  may range between 15 and 25 French to accommodate the larger vascular anatomy of a horse. 
     As illustrated in  FIG. 2 , the first lumen may be a guidewire lumen  210  shaped to receive a shapeable guidewire  205  and the second lumen may be a device lumen  215  shaped to accept and enable the cardiac device to be advanced through the longitudinal axis of the device lumen using a device delivery catheter, starting at a proximal opening of the device lumen (not shown) and extending past a distal opening of the sheath  220 . The shapeable guidewire  205  may be fabricated from a malleable material with shape memory enabling the shapeable guidewire  205  to be formed into a desired first shape configuration, held temporarily in a second shape configuration (e.g., as the guidewire moves through the guidewire lumen), and then released such that the malleable material reflexes into a third shape configuration that nearly approximates the first shape-configuration. For example, the malleable material may include aluminum, copper, silicone, stainless steel, titanium, tungsten, or other metals or composite materials. These materials may be fabricated into a shape-memory alloy (SMA) such as Fe—Mn—Si, Cu—Zn—Al, Cu—Al—Ni, or NiTi (Nitinol). One of ordinary skill in the art would recognize that other shape-memory materials may be used to fabricate the guidewire. 
     Referring back  FIG. 2 , the varied broken lines of the shapeable guidewire  205  illustrate, by way of example, the flexible bending and varied configurations the shapeable guidewire  205  may be capable of configuring into. The different shape configurations are illustrated for exemplary purposes. One of ordinary skill in the art would recognize that other shape configurations are possible and may be desired depending on the particular target anatomy. 
     As described, the distal end of the shapeable guidewire  205  may be articulated into a first shape prior to insertion into the guidewire lumen  210 , bent to a second shape during deployment through the guidewire lumen  210 , and may reflex in to a third shape that approximates the first shape after the distal end of the shapeable guidewire  205  extends beyond past the distal end of the sheath  220 . In some examples, the guidewire may not fully reflex into a shape that approximates the third shape, such that the third shape may fall somewhere between the first shape and the second shape. In such a case, the first shape may be intentionally over-flexed with comparison to the desired third shape. For example, the guidewire may be initially bent further than the desired shape to compensate for the effect of running the guidewire through the guidewire lumen in an approach that may effectively straighten the guidewire, such that the guidewire does not completely reflex to its original shape configuration. 
     Once deployed through the guidewire lumen, the distal end of the guidewire may be used as a second point of contact on a proximal side of the cardiac device to enable precise manipulation of the cardiac device. In one example, the configured first shape of the shapeable guidewire  205  may be determinant upon the size and shape of the cardiac device to be deployed to the target anatomy, such as the left atrial appendage. In another example, the first configured shape of the distal end of the shapeable guidewire  205  may be determinant upon the shape and dimensions of the target anatomy, as well as the areas proximate to the target anatomy. 
     As illustrated in  FIG. 3 , a multi-lumen catheter  300  with a guidewire lumen  310  and a device lumen  320  allows for the simultaneous insertion, transport, and placement of shapeable guidewire  305 , through a first lumen, and cardiac device  315 , through a second lumen, from an entry point to a target anatomy. For example, the entry point may be an area on a subject&#39;s skin where the multi-lumen catheter may enter the vascular anatomy. Example entry points include a jugular vein, subclavian artery, subclavian vein, brachial artery, femoral arteries, and the femoral vein. In one embodiment, a shapeable guidewire  305  may be inserted through the guidewire lumen  310  and a cardiac device  315  may be inserted through the device lumen  320  to deploy the shapeable guidewire  305  and cardiac device  315  in to the left atrial appendage  330 . 
     As further illustrated in  FIG. 3 , multi-lumen catheter  300  enables distal ends of the shapeable guidewire  305  and the cardiac device  315  to be simultaneously present within the left atrium  325 . As such, the distal end of the shapeable guidewire  305  is used to orient and manipulate the deployment of the cardiac device  315  within the left atrial appendage  330  by applying more or less pressure to a proximal side of the cardiac device  315 , in coordination with pressure applied to the proximal side of the cardiac device from its own deployment catheter, which is advanced through the device lumen of the multi-lumen catheter. Thus, coordinated pressure may be applied to each contact point through the guidewire and/or the deployment catheter as needed to effectively manipulate the cardiac device into its final position (e.g., to seal the left atrial appendage). 
     In other embodiments, as illustrated in  FIG. 4 , a multi-lumen catheter  400  may be configured to receive a balloon. For example, guidewire lumen  405  may be configured to receive a balloon deployment device  410  in addition to a shapeable guidewire (not shown), and device lumen  420  may be configured to receive a cardiac device  425 . The balloon deployment device  410  may be a catheter, guidewire, or other balloon deployment device known in the art. Balloon deployment device  410  may include at its distal end balloon  415 . In some embodiments, balloon  415  may be detachable from balloon deployment device  410 . For example, balloon  415  may be detached from balloon deployment device  410  after the balloon is placed near the left atrial appendage. The balloon deployment device may then retracted, freeing the guidewire lumen  405  for use with a shapeable guidewire. The shapeable guidewire may then be advanced through guidewire lumen until the distal end of the shapeable guidewire extends beyond the distal end of sheath  430 , but abuts against balloon  415 , such that balloon  415  protects any internal anatomy from damage caused by moving the distal end of the shapeable guidewire within the target anatomy. 
     In other embodiments, balloon  415  may be affixed to the distal end of the balloon deployment device  410 . For example, balloon  415 , as affixed to the distal end of balloon deployment device  410 , may be advanced through guidewire lumen  405  and pushed past the distal end of the sheath  430 , and balloon  415  may be manipulated toward the left atrial appendage with balloon deployment device  410 . 
     In several embodiments, either or both of the distal ends of the shapeable guidewire and balloon deployment device  410  include a radiopaque material, such that they will be visible using an x-ray imaging system. For example, the tip of the shapeable guidewire may incorporate a radiopaque material. 
     In some embodiments, balloon  415  at the distal end of balloon deployment device  410  may be configured in a deflated state prior to insertion into guidewire lumen  405 , and the balloon may then be inflated after the balloon extends past the distal end of sheath  430 . By way of example only, the inflated balloon  415  provides a protective bumper relative to its immediate vicinity, such as the vasculature, cardiac wall, or other proximate anatomy of the target anatomy. The protective bumper may protect the proximate anatomy from accidental scraping or puncture caused by the tools or devices deployed into the target anatomy using multi-lumen catheter  400 . For example, deployed balloon  415  may be positioned between the atrium walls and the cardiac device  425  and/or shapeable guidewire (not shown), such that balloon  415  protects the atrium walls from being scratched or punctured from the shapeable guidewire. 
     In other embodiments, as illustrated in  FIG. 5 , multi-lumen catheter device  500  may include three lumens. For example, a sheath  505  may include a first lumen  510 , a second lumen  515 , and a third lumen  520 , each disposed within the sheath  505 . The second lumen  515  is shaped to have a cross-sectional circumference greater than the cross-sectional circumference of the first lumen  510  and the second lumen  515 , and the first lumen  510 , second lumen  515 , and third lumen  520  each fit within the cross-sectional circumference of the sheath. The determination of the select third lumen size may be determined upon the type of tool to be inserted through the third lumen. For example, the third lumen  520  may be between 5 and 20 French, or may be smaller or larger depending on the shape and size of the device being inserted. 
     As illustrated in  FIG. 6 , the first lumen may be a guidewire lumen  605  configured to receive a shapeable guidewire  610 , the second lumen may be a device lumen  615  configured to receive a cardiac device  620 , and the third lumen may be a balloon lumen  625  configured to receive a balloon deployment device  630 . In one embodiment, multi-lumen catheter  600  allows for the simultaneous insertion of shapeable guidewire  610 , cardiac device  620 , and balloon deployment device  630  from an entry point, such as a femoral artery  705 , as further illustrated in  FIG. 7 . For example, with shapeable guidewire  710 , cardiac device  715 , and balloon deployment device  720  all simultaneously present in left atrium  725  near the left atrial appendage  730 , shapeable guidewire  710  may guide and orient cardiac device  715  within the left atrial appendage  730 , while balloon  740  provides a protective bumper to protect the atrial walls from the shapeable guidewire  710 . 
       FIG. 8  is an example flow diagram that illustrates a method for deploying a multi-lumen catheter to deliver a shapeable guidewire and device to a designated target anatomy. As illustrated in  FIG. 8 , embodiments of method  800  include inserting a sheath end into an entry point at step  805 . The insertion point may be the jugular vein, subclavian artery, subclavian vein, brachial artery, femoral arteries, the femoral vein, or any other entry point as known in the art. 
     Still referring to  FIG. 8 , the method may also include inserting the shapeable guidewire into the guidewire lumen, such that the distal end of the shapeable guidewire extends past the distal end of the sheath at step  810 . The method may also include inserting a cardiac device through the device lumen and into the left atrium at step  815 . The cardiac device may be positioned near the target anatomy, such as the left atrial appendage, and manipulated to mechanically align the cardiac device perpendicular to the left atrial appendage plane at step  820 . As the cardiac device is deployed, the distal end of the sheath and shapeable guidewire may be retracted at step  825 . 
       FIG. 9  is an example flow diagram that illustrates a method  900  for preparing and inserting the shapeable guidewire into the guidewire lumen. Method  900  may include configuring the shapeable guidewire into a first shape at step  905 . By way of example, the configuration of the first shape may be determinant upon the size and shape of the selected device to be deployed and anticipated approach to the target anatomy. For example, if the approach to the target anatomy requires that the cardiac device take a downward slope after leaving the distal end of the sheath, to reach the target anatomy, then the shapeable guidewire may be bent at a distal end to approximate the same downward bend. In some examples, the shapeable guidewire must be initially bent more than the approach to the target anatomy would require, because the travel through the guidewire lumen will partially re-straighten the guidewire. Even though the guidewire may comprise a shape-memory material, once the distal end of the guidewire extends beyond the distal end of the sheath, the guidewire may not completely regain its initial shape, but instead may enter into a third shape that closely approximates the initial shape. Accordingly, slightly over-bending the guidewire into the first shape may compensate for the straightening effect that occurs during transport through the guidewire lumen. 
     The guidewire must be sufficiently large with respect to its cross-sectional diameter to maintain its shape and sufficient tensile strength to push, manipulate, and/or orient the cardiac device within the target anatomy, but also must be sufficiently small with respect to its cross-sectional diameter to fit within the sheath, and ultimately, the vasculature, alongside the cardiac device delivery system and lumen. 
     In one example implementation of the disclosure, method  900  includes disposing the shapeable guidewire through the guidewire lumen at step  910 . As described above, because the shapeable guidewire is transported through the restrictive confinement of the shapeable guidewire lumen, the configured first shape of the distal guidewire end may transform into a second shape (e.g., the shapeable guidewire may straighten during transport through the guidewire lumen). The shapeable guidewire may reflex in to a third shape that is substantially similar to the first shape after shapeable guidewire is extended past the confinement of the distal end of the sheath. As the distal end of the shapeable guidewire reaches the left atrium, the shapeable guidewire, in concert with the cardiac device delivery system, manipulates, orients, aligns, and guides the cardiac device within the left atrial appendage at step  920 . 
       FIG. 10  is a flow diagram that illustrates method  1000  for preparing and deploying a cardiac device with a multi-lumen catheter. As shown, a method for preparing and deploying a cardiac device with a multi-lumen catheter includes disposing the cardiac device through a device lumen. The method may also include extending the cardiac device past the distal end and in proximity to the target anatomy (e.g., into the left atrium) at step  1010 . The method may also include aligning the cardiac device to a plane perpendicular to a target plane (e.g., the desired radial plane for the cardiac device, wherein the radial plane is orthogonal to the surrounding target anatomy walls), at step  1015 . The method may also include deploying the cardiac device at step  1020 . For example, the cardiac device may be opened into a fully deployed position with an enlarged cross-sectional diameter matching the cross-sectional diameter of the target anatomy, and the sheath may be retracted from the cardiac device, leaving the cardiac device in place. 
       FIG. 11  is a flow diagram that illustrates a method  1100  for protecting the proximate areas of the target anatomy. The method includes disposing a sheath through the vasculature to reach a target anatomy at step  1105 . The method may also include disposing a balloon delivery device through the guidewire lumen, such that the distal end of the balloon delivery device extends past the distal end of the sheath at step  1110 . For example, the balloon delivery device may be a balloon guidewire. 
     In one example, the balloon attached at the distal end of the balloon delivery device is transported through the guidewire lumen in a deflated state. The balloon is then inflated after the balloon extends past the distal end of the sheath and in close proximity to the target anatomy. In one embodiment, the balloon is placed near the target anatomy (e.g., the left atrial appendage), the balloon is detached from the distal end of the balloon delivery device, and the balloon delivery device is retraced from the multi-lumen catheter and entry point at step  1115 . 
     In some embodiments, the method may also include disposing a shapeable guidewire through the guidewire lumen at step  1120 . The shapeable guidewire may be manipulated to abut against the balloon, such that the balloon provides a protective bumper between the target anatomy and the distal end of the shapeable guidewire. The method may also include disposing a cardiac device through the device lumen at step  1125 . 
     In further embodiments, the method may also include using the shapeable guidewire and a cardiac device delivery system (e.g., a guidewire designed to deploy the cardiac device through the device lumen) in concert to align the cardiac device to a target plane at step  1130 . During the alignment process, the balloon continues to protect the surrounding anatomy from accidental scraping or puncture damage from the shapeable guidewire. The cardiac device may then be deployed into the target anatomy at step  1135 . 
       FIG. 12  is a flow diagram that illustrates a method  1200  for deploying a shapeable guidewire, cardiac device, and balloon guidewire through a multi-lumen catheter to a designated target anatomy. Method  1200  provides an example of maneuvering a cardiac device into the target anatomy while reducing the risk of damaging the proximate anatomy. The method includes disposing a balloon deployment device through a third lumen at step  1205 . For example, the balloon deployment device may be advanced through the third lumen, the shapeable guidewire may be advanced through the first lumen, and the cardiac device may be advanced through the second lumen using a device delivery catheter, all at the same time, at step  1215 . The method may also include extending the distal end of the balloon deployment device (e.g., a balloon guidewire) past the distal end of the sheath at step  1215 . 
     The shapeable guidewire may be advanced through the guidewire lumen such that the distal end of the shapeable guidewire extends past the distal end of the sheath, and positioned to abut with a proximal end of the balloon at step  1220 , such that the balloon is positioned between the shapeable guidewire and the target anatomy. By way of example, the shapeable guidewire and the balloon guidewire, located at the distal end of the multi lumen sheath, may then be simultaneously manipulated towards the target anatomy. In another example, prior to inserting the shapeable guidewire into the guidewire lumen, the distal end of the shapeable guidewire end may be configured to a first shape, as described with respect to  FIG. 9 . 
     The cardiac device may be advanced through the cardiac lumen using a device delivery catheter, and advanced towards the target anatomy. In one example, with the balloon guidewire and shapeable guidewire already present within the target anatomy, the cardiac device may be located in close proximity to the target anatomy such that the shapeable guidewire can align, manipulate, and guide the placement of the cardiac device in a target plane (e.g., perpendicular to a longitudinal axis of the left atrial appendage) at step  1225 . The cardiac device may then be deployed and the sheath retracted. 
     Depicted in  FIG. 13 , is a particularly preferred mode of the multi-lumen delivery device herein. As shown in  FIG. 13 , the multi-lumen sheath  1310  has a first lumen  1312  adapted for translation of the shapeable guidewire  1313  therethrough. The multi-lumen sheath  1310  also has the second lumen  1314  adapted for translation of the cardiac device  1320  therethrough as well as a third lumen  1316  which terminates a distance from the distal end  1322  of the multi lumen sheath  1310 . 
     This mode of the device and method herein, is particularly preferred as it provides a means for the surgeon to achieve an anchor for the multi-lumen sheath  1310  such that the distal end  1322  is held in position once a balloon  1324  engaged to a balloon wire  1326  of the balloon deployment device  1325  is inflated and anchored at an anchoring position in an intersecting or adjacent blood vessel such as the pulmonary vein  1328 . Once anchored, the balloon wire  1326  engaged with the balloon  1324  forms a fixed rail on which the sheath  1310  can be translated toward and away from the target anatomy. 
     In this mode of the device herein, the multi-lumen sheath  1310  can be advanced to position the distal end  1322  adjacent the target anatomy such as the atrial appendage  1330 , wherein the balloon deployment device  1325  is translated through the third lumen  1316  whereupon it exits the third lumen  1316  and the multi-lumen sheath  1310  a distance from the distal end  1322 . This is important because it allows the distal end  1322  to be manipulated for lateral position on the balloon wire  1326  and extension portion  1319  to be manipulated for angle and axis by the shapeable guidewire  1313 , after the balloon  1324  is inflated to anchor it. As shown the balloon  1324  is inflated to anchor it in the pulmonary vein  1328 . So anchored, the engaged balloon wire  1324  is also fixed in position anchored to the balloon  1324 . This allows the user to translate the multi-lumen sheath  1310  toward and away from the anchored balloon  1324  and manipulate the position of the distal end  1322  within the blood vessel. A lock, such as a clamp (now shown), can engage the balloon wire  1326  to the multi-lumen sheath  1310  at the proximal end, thereby fixing the position of the multi-lumen sheath on the balloon wire  1326  and fixing the position of the distal end  1322 . 
     With the balloon  1324  anchored, and the lateral position of the distal end  1322  substantially fixed by the lock or clamp holding the multi lumen sheath  1310  on the balloon wire  1326 , the surgeon can then use the shapeable guidewire  1313  to bend and manipulate an angle and axial position or alignment of an extension portion  1319  of the multi-lumen sheath  1310  within the vein or artery. The sheath  1310  is flexible so manipulating the shapeable guidewire  1313  within or projecting from the extension portion  1319  allows for easy adjusting of the angle of the extension portion  1319  which extends between the exit aperture  1317  of the third lumen  1316  and the distal end  1322  of the multi lumen sheath  1310 . This allows the user to position the distal end  1322  and the axis of the lumen carrying the implant correctly. 
     Additionally, with the lateral position of the distal end  1322  fixed by the engaged balloon wire  1326  and anchored balloon  1324 , it makes it much easier for the surgeon to employ the shapable guidewire  1313  to place the distal end  1322  and axis of the second lumen  1314  or a lumen carrying the device to be implanted, aligned with the axis of the atrial appendage  1330  or other target anatomy for implantation of a cardiac device  1320  such as a stent or the WORKMAN or another device where a precise placement prior to final implantation is extremely important. Further, should positioning of the distal end  1322  laterally be required, the sheath can be slid in its axial engagement on the balloon wire  1326 . 
     The device shown in  FIG. 14 , operates in a substantially similar fashion to the device as shown in  FIG. 13 . However, the balloon  1324  in this mode when anchoring in a blood vessel intersecting or adjacent the target anatomy for the cardiac device  1320  or other implant, includes an opening  1329  therein to allow for the passage of blood flow once the balloon  1324  is anchored in the blood vessel or body tissue of choice. The balloon  1324  in this mode has an appearance somewhat like a donut, and once inflated, a perimeter edge  1331  contacts and compresses against the interior of the chosen blood vessel or body tissue, shown as the pulmonary vein  1328  for convenience. Additionally, an annular recess  1333  can depend into the surface of the perimeter edge  1331  of the balloon  1324 . This annular recess  1333  in the inflated balloon  1324  causes tissue surrounding the balloon  1324  against which the perimeter  1331  compressively engages, to protrude and engage slightly into the annular recess  1333 . This engagement of tissue into the annular recess  1333  significantly enhances the anchoring of the balloon  1324  into the chosen blood vessel or body passage or the like. 
     The annular recess  1333  could also be formed into other shaped balloons such as the balloon  1324  of  FIG. 13 . 
       FIG. 15  is a flow chart illustrating a method for deploying the multi-lumen sheath  1310  or catheter device of  FIGS. 13 and 14 , to position the distal end adjacent the target anatomy for the cardiac or implant device, and then anchor it in place using the inflated balloon and a locked connection of the balloon wire to the multi-lumen sheath. Any numerals referring to components are references to those in  FIGS. 13-14 . 
     As shown in a first step  1510 , and using the device herein such as in  FIGS. 13 and 14 , the sheath is advanced through the vasculature of the patient, to position the distal end proximal to the desired target anatomy for an implant such as a cardiac device. In a subsequent step  1512  to the first step  1510 , the shapeable guidewire is advanced through a first lumen in the multi lumen sheath or catheter. In a subsequent step  1514  to the first step  1510 , a balloon deployment device with a balloon engaged to a balloon wire, is translated through the third lumen to an exit aperture  1317 . Subsequent to step  1514 , the balloon  1324  at the end of the balloon wire  1326 , is deployed  1518  by being inflated and anchored in position in a chosen vein or artery or body cavity proximate to the target anatomy but preferably in a vascular passage intersecting or adjacent that of the target anatomy. The anchoring of the balloon  1324  secures the engaged balloon wire  1326  in place allowing the user, such as a surgeon, to thereafter translate the multi-lumen sheath  1310  or catheter on the balloon wire  1326  and thereby reposition the distal end  1322  with accuracy. As noted, a lock or clamp can be engaged between the balloon wire  1326  and the multi-lumen sheath  1310  at any time, to fix the sheath in position so that the surgeon can concentrate on moving the distal end  1322  to the correct angle and axial position. 
     In another step  1520  the cardiac device  1320  is advanced through the second lumen  1324  and to an exit therefrom at the distal end  1322 . To align the cardiac device  1522  with the target anatomy plane, the distal end of the multi-lumen sheath  1310  or catheter can be adjusted in angle and lateral position on the balloon wire  1326 , to a proper position which will axially center the cardiac device  1320  and place in the proper plane or laterally advanced position. This aligning of the cardiac device  1522  can be accomplished by the surgeon translating the entire multi-lumen sheath  1310  toward or away from the target anatomy with the balloon  1324  anchored and rending the balloon wire  1326  to form essentially a rail for such translation. 
     Additionally or in combination with the translation of the sheath, this aligning  1522  of the cardiac device can also be accomplished by manipulation of the shapeable wire  1313 , which will cause the extension portion  1319  of the sheath, to change axial positioning since the fixed balloon wire  1326  holds the multi lumen sheath at and on the opposite side of the exit aperture  1317  in place. Essentially the extension portion  1319  can be tilted in any of four directions or axes, by the manipulation of the shapeable guidewire  1313 . 
     In a final step, with the distal end  1322  of the multi-lumen sheath positioned at the correct angle and axial alignment by the previous alignment  1522 , deployment  1524  of the device into the target anatomy occurs. Proper alignment  1522  of course can be ascertained during that step and prior to this step of deployment  1524  by conventional means such as ultrasound or fluoroscopy. 
     Although the disclosed technology is described above in terms of various exemplary embodiments and implementations, it should be understood that the various features, aspects and functionality described in one or more of the individual embodiments are not limited in their applicability to the particular embodiment with which they are described, but instead can be applied, alone or in various combinations, to one or more of the other embodiments of the disclosed technology, whether or not such embodiments are described and whether or not such features are presented as being a part of a described embodiment. Thus, the breadth and scope of the technology disclosed herein should not be limited by any of the above-described exemplary embodiments. 
     Terms and phrases used in this document, and variations thereof, unless otherwise expressly stated, should be construed as open ended as opposed to limiting. As examples of the foregoing: the term “including” should be read as meaning “including, without limitation” or the like; the term “example” is used to provide exemplary instances of the item in discussion, not an exhaustive or limiting list thereof; the terms “a” or “an” should be read as meaning “at least one,” “one or more” or the like; and adjectives such as “conventional,” “traditional,” “normal,” “standard,” “known” and terms of similar meaning should not be construed as limiting the item described to a given time period or to an item available as of a given time, but instead should be read to encompass conventional, traditional, normal, or standard technologies that may be available or known now or at any time in the future. Likewise, where this document refers to technologies that would be apparent or known to one of ordinary skill in the art, such technologies encompass those apparent or known to the skilled artisan now or at any time in the future. 
     The presence of broadening words and phrases such as “one or more,” “at least,” “but not limited to” or other like phrases in some instances shall not be read to mean that the narrower case is intended or required in instances where such broadening phrases may be absent. The use of the term “module” does not imply that the components or functionality described or claimed as part of the module are all configured in a common package. Indeed, any or all of the various components of a module, whether control logic or other components, can be combined in a single package or separately maintained and can further be distributed in multiple groupings or packages or across multiple locations. 
     Additionally, the various embodiments set forth herein are described in terms of exemplary block diagrams, flow charts and other illustrations. As will become apparent to one of ordinary skill in the art after reading this document, the illustrated embodiments and their various alternatives can be implemented without confinement to the illustrated examples. For example, block diagrams and their accompanying description should not be construed as mandating a particular architecture or configuration.