Patent Publication Number: US-2023157697-A1

Title: System, apparatus, and method for creating a lumen

Description:
RELATED APPLICATIONS 
     This application is a continuation of U.S. patent application Ser. No. 17/991,742 filed Nov. 21, 2022, which claims priority to provisional patent applications U.S. Ser. No. 63/281,227 filed Nov. 19, 2021, U.S. Ser. No. 63/335,494 filed Apr. 27, 2022, and U.S. Ser. No. 63/354,421 filed Jun. 22, 2022, each of which are herein incorporated by reference in their entireties. 
    
    
     BACKGROUND OF THE INVENTION 
     The invention is a system, apparatus and method for creating a space (collectively the “system”). More specifically, the system creates a lumen within a body to facilitate the use of a medical device, such as the use of a catheter in a blood vessel. The term “lumen” means a “canal, duct, or cavity of a tubular organ.” Although the system can be implemented in a wide variety of different contexts, the original inspiration for the conceptualization of the system arose in the context of catheterization in the blood vessels of human beings. The system can facilitate catheterization by creating additional “working space” (i.e. the lumen) at a desired location within the body of a patient. The additional space can be created by transitioning from a low-profile operating mode into a high-profile operating mode. 
     I. Catheterization Procedures 
     The term “catheter” refers collectively to a wide range of medical devices that are inserted into the body to (1) diagnose a medical condition; (2) treat a medical condition; (3) deliver nourishment; or (4) deliver medicine. The term “catheter” is often used more specifically to refer to a tube inserted into the body of a patient for the purposes of (a) removing material from a location in the body of a patient and/or (b) delivering medicinal and/or nourishing material to a specific location within the body of a patient. Catheters can be used in a variety of locations for a variety of purposes within the body of a patient. Catheterization procedures are commonly involved in the diagnosis and treatment of the cardiovascular system, the excretory system, and other similar systems of a patient. 
     II. Cardiovascular Disease is a Global Threat 
     The circulation of blood is essential for a healthy body. Blood provides organs and individual cells with oxygen and nutrients necessary to sustain life. Blood also removes cellular metabolic waste products from the body. The proper flow of blood is a prerequisite for good health. At the center of the cardiovascular system is the heart, an organ responsible for pushing blood throughout the body. The heart functions as a pump at the center of a complex network of arteries and veins that make up the cardiovascular system. The cardiovascular system is thus responsible for the delivery of oxygen and nutrients and the removal of certain wastes throughout the body. The performance of the cardiovascular system can be evaluated in terms of cardiac output. 
     Unfortunately, age, disease, trauma, and/or other ailments can hinder the distribution of blood throughout the body. Cardiovascular diseases are a serious health problem in the United States and elsewhere. About 1 in 3 deaths in the US is attributed to cardiovascular disease, which includes heart attacks and strokes. According to the World Health Organization (“WHO”), cardiovascular diseases are the number one cause of death in world. An estimated 17.3 million people died of cardiovascular diseases in 2008, a number that represents 30% of all deaths occurring in that year. According to WHO estimates, the number of deaths caused by cardiovascular diseases will reach 23.4 million by 2030. 
     The Centers for Disease Control and Prevention (“CDC”) report that ‘“cardiovascular disease is the leading killer in every racial and ethnic group in America.’” Many health problems in the United States are either rooted in or manifested as cardiovascular disease. The most common type of heart disease in the United States is coronary artery disease (“CAD”). CAD occurs when plaque builds up in the arteries that supply blood to the heart. This can cause the arteries to narrow over time in a process called atherosclerosis. Plaque buildup can also cause chest pain or discomfort resulting from the inadequate supply of blood to the heart muscle. This is commonly referred to as a condition known as angina. Over time CAD can lead to an irregular heartbeat, a condition known as arrhythmia, and even heart failure. 
     III. Cardiovascular Catheterization Procedures 
     A variety of catheterization procedures are used in the prior art to diagnose and treat arterial disease. In the context of cardiovascular disease, a catheter is often a long, thin, flexible, hollow intravascular tube used to access the cardiovascular system of the body. Catheterization is most commonly conducted through the radial artery in the wrist (transradial catheterization) or the femoral artery of the groin (transfemoral catheterization). Catheterization can also be conducted through the elbow, neck, and other parts of the body. 
     A wide variety of intravascular procedures can be used to address cardiovascular health issues in human beings. Percutaneous coronary intervention (“PCI”) procedures are a type of intravascular procedure commonly referred to as “coronary angioplasty”, “balloon angioplasty” or simply “angioplasty”. Patients suffering from atheroscleroisis have narrowed or blocked coronary artery segments resulting from the buildup of cholesterol-laden plaque. Angioplasty is a medical procedure used to treat the narrowed coronary arteries of the heart. 
     During angioplasty, a cardiologist feeds a deflated balloon or other similar device to the site of the blockage. The balloon can then be inflated at the point of blockage to open the artery. A stent is often permanently placed at the site of blockage to keep the artery open after the balloon is deflated and removed. Angioplasty has proven to be a particularly effective treatment for patients with medically refractory myocardial ischemia. Unfortunately, it is not always possible to position the catheter in the desired location for the purposes of an angioplasty procedure. 
     IV. Problem of Access 
     Catheterization procedures can provide a valuable, effective, and minimally invasive option for diagnosing and treating cardiovascular problems and other types of medical problems. Unfortunately, it is not always possible for prior art tools and techniques to reach the blockage site with a catheter. Blockage within a blood vessel can block catheters as well as blood flow. Two common problems of access are vessel tortuosity and insignificant stenoses. The vessel pathway to the blockage that needs treatment may be very tortuous, which means it is very curved or serpentine and the angioplasty balloon catheter cannot be inserted through the tortuous vessel. Also, a portion of the vessel may be stenosed, which means there are smaller blockages that make the vessel too narrow and prevent insertion of the balloon catheter. These smaller blockages are usually not intended to be treated with balloon angioplasty. It would be desirable to empower health care providers with enhanced tools and methodologies for working around obstacles to the blockage site. 
     SUMMARY OF THE INVENTION 
     An example system for creating a lumen according to the present disclosure includes, among other possible things a balloon wound in a generally helical shape having an inner surface and an outer surface, and a support attached to at least one of the inner surface and the outer surface of the generally helical shape and constraining the balloon in the generally helical shape. The balloon has a first diameter in a low-profile operating mode and the generally helical shape has a second diameter in a high-profile operating mode, and the second diameter is larger than the first diameter. 
     An example system for creating a lumen according to the present disclosure includes, among other possible things, a balloon wound in a generally helical shape having an inner surface and an outer surface, and at least one clip constraining the balloon in the generally helical shape, the at least one clip including a center leaf and first and second receiving leaves on either side of the center leaf. Each of the first and second receiving leaves including a first opening and a second opening, the first opening receiving a first turn of the generally helical shape and a second opening receiving a second turn of the generally helical shape. The balloon has a first diameter in a low-profile operating mode and the generally helical shape has a second diameter in a high-profile operating mode, and the second diameter is larger than the first diameter. 
     An example system for creating a lumen according to the present disclosure includes a balloon wound in a generally helical shape having an inner surface and an outer surface, and at least one band connector constraining the balloon in the generally helical shape, the at least one band connector surrounding at least two successive turns of the generally helical shape. The balloon has a first diameter in a low-profile operating mode and the generally helical shape has a second diameter in a high-profile operating mode, and the second diameter is larger than the first diameter. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       Many features and inventive aspects of the system, are illustrated in the following drawings. However, no patent application can disclose all of the potential embodiments of an invention. In accordance with the provisions of the patent statutes, the principles and modes of operation of the system are explained and illustrated in certain preferred embodiments. However, it must be understood that the system may be practiced otherwise than is specifically explained and illustrated without departing from its spirit or scope. 
       The description of the system and the various illustrations of the system should be understood to include all novel and non-obvious combination of elements described herein, and claims may be presented in this or a later application to any novel and non-obvious combination of these elements. Moreover, the foregoing embodiments are illustrative, and no single feature or element is essential to all possible combinations that may be claimed in this or a later application. 
         FIG.  1   a    is a block diagram illustrating an example of a system for creating a lumen. 
         FIG.  1   b    is a flow chart diagram illustrating an example of a process for creating a lumen. 
         FIG.  1   c    is an environmental diagram illustrating an example of an expansion component in a low-profile operating mode. 
         FIG.  1   d    is an environmental diagram illustrating an example of an expansion component in a high-profile operating mode. 
         FIG.  2   a    is a hierarchy diagram illustrating an example of different embodiments of the system, including direct expansion embodiments and indirect expansion embodiments of the system. 
         FIG.  2   b    is a hierarchy diagram illustrating an example of different embodiments of the system, including expansion component balloon embodiments and expansion component non-balloon embodiments. 
         FIG.  2   c    is a hierarchy diagram illustrating an example of different types of balloons that can be utilized by the system. 
         FIG.  3   a    is diagram illustrating a partial and close-up view of the tubular balloon expansion component illustrated in  FIG.  3     b.    
         FIG.  3   b    is a diagram illustrating an example of an axial view of the tubular balloon expansion component. 
         FIG.  3   c    is a diagram illustrating an example of a top view of the tubular balloon expansion component. 
         FIG.  3   d    is a diagram illustrating an example of a side view of the tubular balloon expansion component. 
         FIG.  3   e    is a diagram illustrating an example of a cross-sectional view of a side view of the tubular balloon expansion component with an illustration of a space within the tubular balloon expansion component. 
         FIG.  3   f    is a diagram illustrating an example of a partial and close-up view of the tubular balloon expansion component illustrated in  FIG.  3     e.    
         FIG.  3   g    is a perspective and partial diagram illustrating an example of a tubular balloon expansion component. 
         FIG.  3   h    is a diagram illustrating an example of a front view of a pleated tubular expansion component, an example of a passive expansion component. 
         FIG.  3   i    is a diagram illustrating an example of a perspective view of tubular balloon expansion component. 
         FIGS.  3   j - m    illustrate an example of the tubular balloon of  FIGS.  3   e   - g.    
         FIGS.  3   n - p    illustrate another example tubular balloon with a triangular or generally triangular cross-section. 
         FIG.  4   a    is a flow chart diagram illustrating an example of a process for creating a lumen using a guide balloon embodiment of the system. 
         FIG.  4   b    is an environmental diagram illustrating an example of a process step where the guide balloon is inserted. 
         FIG.  4   c    is an environmental diagram illustrating an example of a process step where the guide balloon is inflated. 
         FIG.  4   d    is an environmental diagram illustrating an example of a process step where the expansion component in the form of a cover is advanced over the inflated guide balloon in order to expand the cover from a low-profile state into a high-profile state. 
         FIG.  4   e    is an environmental diagram illustrating an example of a process step where the cover is positioned as desired within the body of the patient to create a lumen at the desired location. 
         FIG.  4   f    is an environmental diagram illustrating an example of a process step where the guide balloon is deflated and removed, creating a lumen within the cover. 
         FIG.  4   g    is an environmental diagram illustrating an example of a process step where a stent catheter is inserted through the space created by the cover. 
         FIG.  5   a    is a flow chart diagram illustrating an example of a process for creating a lumen using an insertion component embodiment of the system. 
         FIG.  5   b    is an environmental diagram illustrating an example of a process step where the cover is inserted into the body of the patient. 
         FIG.  5   c    is an environmental diagram illustrating an example of a process step where an insertion component is inserted into the cover (a type of expansion component) positioned within the body of the patient to expand the distal section of the expansion component and to create the desired lumen at the desired location. 
         FIG.  5   d    is an environmental diagram illustrating an example of a process step where a stent catheter is inserted through the cover. 
         FIG.  6   a    is a flow chart diagram illustrating an example of a process for creating a lumen using a sheathed balloon embodiment of the system. 
         FIG.  6   b    is an environmental diagram illustrating an example of a process step where a sheath covers the sheathed balloon during insertion the sheathed balloon. 
         FIG.  6   c    is an environmental diagram illustrating an example of a process step where the sheath and the sheathed balloon within the sheath are positioned as desired within the body of the patient. 
         FIG.  6   d    is an environmental diagram illustrating an example of a process step where the sheath is withdrawn. This causes the balloon to self-expand because it is no longer constrained by the sheath, triggering the creation of the additional working space (i.e. lumen) within in the body of the patient. 
         FIG.  6   e    is an environmental diagram illustrating an example of how the expanded sheathed balloon can create or enhance the lumen at the desired location within the body of the patient. 
         FIG.  6   f    is an environmental diagram illustrating an example of a process step where the stent catheter is inserted into the patient through the working space created by the presence of the balloon in a high-profile operating mode. 
         FIG.  6   g    is an environmental diagram illustrating an example of a process step where the sheath is advanced to collapse the balloon for removal. 
         FIG.  7   a    is a diagram illustrating a perspective view of a helix and matrix configuration that includes a tubular balloon constrained in the shape of a helix by a weave functioning as a matrix. 
         FIG.  7   b    is a diagram illustrating an example of a side view of the helix and matrix configuration of  FIG.  7     a.    
         FIG.  7   c    is a diagram illustrating an example of an axial view of the helix and matrix configuration of  FIGS.  7   a    and  7   b.    
         FIG.  7   d    is a diagram illustrating an example of a perspective section view of the helix and matrix configuration of  FIGS.  7   a   - 7   c.    
         FIG.  7   e    is a diagram illustrating an example of close-up view of the illustration in  FIG.  7     d.    
         FIG.  7   f    is a hierarchy diagram illustrating an example of different components and component configurations that can be utilized in a helix balloon embodiment of the system. 
         FIG.  7   g    shows another example helix balloon having a triangular or generally triangular cross-section when bound. 
         FIGS.  8   a - f    show an example helix balloon with tubules. 
         FIGS.  9   a - c    show an example tubular balloon with connector(s). 
         FIGS.  10   a - b    show an example tubular balloon with an inner support. 
         FIGS.  11   a - b    show an example tubular balloon with an outer support. 
         FIGS.  12   a - d    show examples of tubular balloons with inner/outer supports. 
         FIGS.  13   a - c    show an example mandrel for assembling a tubular balloon with an outer support. 
         FIGS.  14   a - g    show an example tubular balloon with a clip. 
         FIGS.  15   a - c    show an example tubular balloon with a band connector. 
         FIGS.  16   a - b    show an example mandrel for assembling a tubular balloon with an outer support. 
         FIGS.  17   a - b    show an example tubular balloon with coextruded restraints. 
         FIGS.  18   a - c    show an example tubular balloon with a strip having a series of flaps. 
         FIGS.  19   a - c    show an example tubular balloon with a scalloped restraint. 
     
    
    
     DETAILED DESCRIPTION 
     The invention is a system, apparatus and method for creating a space (collectively the “system”). More specifically, the system creates a lumen within a body to facilitate the use of a medical device, such as the use of a catheter in a blood vessel. The term “lumen” means a “canal, duct, or cavity of a tubular organ.” Although the system can be implemented in a wide variety of different contexts, the original inspiration for the conceptualization of the system arose in the context of catheterization in the blood vessels of human beings. The system can facilitate catheterization by creating additional “working space” (i.e. the lumen) at a desired location within the body of a patient. The additional space can be created by transitioning from a low-profile operating mode into a high-profile operating mode. The additional space can enable the use of other medical devices by overcoming the problems of conventional access such as vessel tortuosity or insignificant stenoses. The system enables a balloon angioplasty catheter or stent catheter can be inserted through the passageway or tunnel of the lumen past the access problems and onto the desired location. 
     All of the numbered elements illustrated in the drawings and discussed in the text below that pertain to structural components rather than process steps are defined in the glossary provided in Table 1 below. 
     I. Overview 
     The system can create a lumen in the body of a patient. That lumen can be used to position a medical device, such as a catheter, that can potentially save the life of the patient. The system can be described in terms of interacting entities, components, operational attributes, and processes. 
     A. Entities 
     As illustrated in  FIG.  1   a   , a system  100  is an interface between a healthcare provider  92  and a body of a living organism, i.e. a patient  90 . The provider  92  is typically a physician, although nurses, paramedics, physician assistants, veterinarians, and other health care professionals can potentially act as providers  92  in certain contexts. The patient  90  is typically a human being, but other organisms can constitute patients  90  in certain contexts. The system  100  is a tool that the provider  92  can use to benefit the health status of the patient  90 . 
     B. System 
     The purpose of the system  100  is to create “working space” (i.e. a lumen  120 ) within the body of the patient  90  sufficient to enable the positioning and use of a medical device  80  such as a catheter within the body of the patient  90 . The system  100  can be implemented in a wide variety of different ways. The system  100  can be used to improve the health of the patient  90  and to even save the life of the patient  90 . 
     C. Medical Devices and Medical Procedures 
     A wide variety of different medical devices  80  and medical procedures  81  can benefit from the lumen  120  created by the system  100 . Examples of potentially useful medical devices  80  include but are not limited to all types of catheters, stents, patient monitoring applications, and other similar invasive devices. 
     A catheter device is potentially any device inserted into the body of a patient  90 . The term “catheter device” refers collectively to a wide range of medical devices that are inserted into the body to (1) diagnose a medical condition; (2) treat a medical condition; (3) delivery nourishment; or (4) deliver medicine. The term “catheter device” is often used more specifically to refer to a tube inserted into the body of a patient  90  for the purposes of (a) removing material from a location in the body of a patient  90  and/or (b) delivering medicinal and/or nourishing material to a specific location within the body of a patient  90 . Catheters can be used in a variety of locations for a variety of purposes within the body of the patient  90 . Catheterization procedures are commonly involved in the diagnosis and treatment of the cardiovascular system, the excretory system, and other systems of a patient  90 . 
     The system  100  was originally conceived for the purpose of serving providers  92  involved in providing medical procedures  81  such as coronary vascular procedures. Examples of such procedures include but are not limited to Percutaneous Coronary Intervention (PCI), Percutaneous Coronary Angiogram (PCA), Chronic Total Occlusions (CTO), Stent implantation, Atherectomy, and Embolic Protection. The system  100  can be particularly useful in the context of transradial catheterizations (catheterizations in which the catheter initially enters the body of the patient  90  through the radial artery) because transradial catheterizations typically involve catheterization devices with a relatively smaller profile and relatively sparse space in which to operate. The system  100  in its varying embodiments can also be used in a variety of contexts that involve cardiovascular care and the treatment of wholly different conditions. 
     The system  100  can also be used to deliver constituents such as drugs, biological agents, or excipients. For instance, any part of the system  100  such as the matrix  114  or the tubular balloon  112  (discussed in more detail below) can be loaded with constituents or encapsulated constituents according to any known method. When the system  100  is used in a blood vessel, contact between elements of the system  100  causes the constituents to be released into the vessel. 
     The system  100  can also be used to temporarily improve blood perfusion in a vessel that is tortuous or includes other obstacles such as obstructions or blockages. 
     The system  100  can also be used to address perforations or lesions in a vessel by being deployed at the perforation or lesion as discussed in more detail below, to apply pressure to it and seal or reduce the size of the perforation or lesion, allowing blood flow to continue through the vessel. 
     The system  100  can also be used in conjunction with obtaining hemostasis of an access site. At the end of a catheterization procedure, when the last catheter or sheath is removed from the vessel (artery or vein), the hole in the vessel must be closed. Closing the hole in the vessel is referred to as hemostasis. The hole in the vessel is referred to as the access site. The system  100  can be deployed as discussed in more detail below at the access site to ensure continued perfusion through the vessel and act as a closure device. The system  100  is deployed in such a way as to cover the access site. This stops bleeding at the access site. With the system  100  in place over the access site, the vessel can naturally close, or ‘self-heal.’ When hemostasis of the access site is complete, the system  100  can be removed. The system  100  can be particularly advantageous for obtaining hemostasis of large bore access sites, such as the ones for TAVR (transcatheter aortic valve replacement) procedures. In this example, the system  100  could obviate the need for surgical closure (suture closure) of the large bore access site. 
     D. Lumen 
     A lumen  120  is a space created within the patient  90  by the system  100 . The lumen  120  is often referred to as a “canal, duct, or cavity within a tubular organ”. The lumen  120  is the “working space” within the patient  90  in which the medical device  80  is positioned. In many embodiments of the system  100 , the lumen  120  is located within the expansion component  110  and the expansion component  110  is at least substantially in the form a hollow tube, with the lumen  120  comprising the hollow core of the expansion component  110 . 
     E. Expansion Component 
     An expansion component  110  is the device capable of existing in at least two operating modes  130 , a low-profile operating mode  132  and a high-profile operating mode  134 . 
     There are a wide variety of different embodiments of expansion components  110  that can be incorporated into a wide variety of different embodiments of the system  100 . In many embodiments of the system  100 , the expansion component  110  can transform from a high-profile operating mode  134  back into a low-profile operating mode  132  when the expansion component  110  is no longer needed. In many embodiments, it will be easier for the provider  92  to remove the expansion component  110  from the patient  90  when the expansion component  110  is in a low-profile operating mode  132 . 
     Expansion components  110  can be categorized as direct vs. indirect. Some embodiments of the system  100  utilize balloons as expansion components  110  while other embodiments of the system  100  utilize non-balloon expansion components  110 . 
     F. Operating Modes/States 
     The expansion component  110  can operate in two or more operating modes  130  (which can also be referred to as states  130 . The low-profile operating mode  132  is typically the most convenient operating mode  130  in which to insert the expansion component  110  into the patient  90  prior to creating the lumen  120 . The low-profile operating mode  132  is also typically the most convenient operating mode  130  in which the provider  92  can remove the expansion component  110  after the lumen  120  is created and after the medical device  80  has been positioned correctly within the patient  90 . 
     Some embodiments of the system  100  will involve one or more intermediate operating modes between the low-profile operating mode  132  and the high-profile operating mode  134 . 
     G. Process Flow View 
     The system  100  can be described as a series of process steps as well as a configuration of interacting elements.  FIG.  1   b    is a flow chart diagram illustrating an example of a method for creating a lumen  120 . 
     At  200 , the expansion component  110  is inserted within the patient  90 . Different embodiments of the system  100  can involve different types of expansion components  110  to create lumen  120  for different types of medical devices  80 . 
     At  202 , the expansion component  110  is positioned within the patient  90 . Different embodiments of the system  100  can involve a wide variety of different locations within the body of the patient  90 . 
     At  204 , the operating mode  130  of the expansion component  110  is changed from a low-profile operating mode  132  into a high-profile operating mode  134  in order to create a lumen  120 . It is the lumen  120  that serves as the “working space” for the proper positioning and use of the medical device  80 , such as a catheter. 
     In many embodiments, after the lumen  120  is created and medical device  80  is properly positioned, the expansion component  110  is transformed back from a high-profile operating mode  134  into a low-profile operating mode  132  to facilitate the removal of the expansion component  110  from the body of the patient  90 . 
     H. Operating Environment 
     The system  100  can be implemented in a wide variety of different operating environments and locations. The process of determining which embodiment of the system  100  is best suited for a particular context should begin with identifying the desired medical device  80  to be used at the desired location. The appropriate expansion component  110  can then be identified and selected. 
       FIG.  1   c    is an environmental diagram illustrating an example of an expansion component  110  in a low-profile operating mode  132 . The expansion component  110  is being positioned to a desired location  88  within a blood vessel  91  in the patient  90 . 
       FIG.  1   d    is an environmental diagram illustrating an example of an expansion component  110  that has been transformed (i.e. expanded) from a low-profile operating mode  132  into a high-profile operating mode  134 . 
     I. Ancillary Components 
     In many embodiments of the system  100 , the expansion component  110  is but one component of many. For example, in the illustrations of  FIGS.  1   c  and  1   d    the expansion component  110  can interfaces with certain ancillary components, such as a guide catheter  121  and a guide wire  122 . In navigating the various narrow blood vessels  91  a variety of guide catheters  121  and guide wires  122  may be utilized to position the expansion component  110  to the desired location  88 . Such components may be part of the system  100 , but the use of ancillary components will vary widely between different embodiments of the system  100 . The system  100  can include virtually any prior art component useful to the provider  92  in addressing the needs of the patient  90 . 
     II. Alternative Embodiments 
     Many features and inventive aspects of the system  100  are illustrated in the figures and described in the text of this application. However, no patent application can disclose all of the potential embodiments of an invention. In accordance with the provisions of the patent statutes, the principles and modes of operation of the system  100  are explained and illustrated in certain preferred embodiments. However, it must be understood that the system  100  may be practiced otherwise than is specifically explained and illustrated without departing from its spirit or scope. 
     The description of the system  100  and the various illustrations of the system  100  should be understood to include all novel and non-obvious combination of elements described herein, and claims may be presented in this or a later application to any novel and non-obvious combination of these elements. Moreover, the foregoing embodiments are illustrative, and no single feature or element is essential to all possible combinations that may be claimed in this or a later application. 
     There are various categories that can be useful in describing various embodiments of the system  100 . 
     A. Direct vs. Indirect 
     With respect to all embodiments of the system  100 , the expansion component  110  expands from a low-profile operating mode  132  into a high-profile operating mode  134  to create a lumen  120 . For some embodiments of the expansion component  110 , the transformation between operating modes  130  is accomplished directly by the expansion component  110  while in other embodiments of the expansion component  110 , the transformation between operating modes is accomplished only indirectly by the expansion component  110 . 
       FIG.  2   a    is a hierarchy diagram illustrating examples of direct expansion embodiments  101  as well as indirect expansion embodiments  102 . Indirect expansion embodiments  102  involve expansion components  110  that expand or shrink due to other components of the system  100 . In contrast, direct expansion components  101  involve expansion components  110  that can change operating modes  130  without the use of other components of the system  100 . 
     Direct expansion embodiments  101  can include but are not limited to a tubular balloon embodiment  103  and a helix balloon embodiment  104 . Direct expansion embodiments  101  typically involve “inflating” a balloon with a substance such as liquid to expand from a low-profile operating mode  132  into a high-profile operating mode  134 . Some embodiments may utilize a gas, but it is often not desirable to risk inserting bubbles of air or other gases in the blood vessels  91  of patients  90 . 
     Indirect expansion embodiments  102  can include but are not limited to a guide balloon embodiment  105  (where an expansion component  110  in the form of a cover  116  expands by advancing upon an inflated guide balloon  115 ), an insertion component embodiment  106  (where an expansion component  110  in the form of a cover  116  expands through the insertion of an insertion component  117  into the expansion component  110 ), and a sheath embodiment  107  (where the sheathed balloon  118  inflates when no longer constrained by the sheath  119 ). Indirect expansion embodiments  102  utilize other components of the system  100  to “inflate” to a high-profile operating mode  134  and to “deflate” to a low-profile operating mode  132 . Guide balloon embodiments  105  of the system  100  use an expansion component  110  that is advanced over an inflated balloon to expand the expansion component  110 . Insertion component embodiments  106  of the system  100  use a insertion component  117  that is inserted into the expansion component  110  to expand the expansion component  110 . Sheath embodiments  107  utilize a sheath to constrain an expansion component  110  that would otherwise exist in an expanded state. 
     B. Expansion Component Balloons vs. Non-Balloons 
     Just as different embodiments of the system  100  can be categorized on whether the expansion component  110  is directly or indirectly expanded, the various embodiments of the system  100  can also be categorized on the basis of whether the expansion component  110  is some type of balloon (which inflates using air, some other gas, some form of liquid or fluid, or through the use of mechanical means) or whether the expansion component  110  is not a balloon. 
       FIG.  2   b    is a hierarchy diagram illustrating examples of both expansion component balloon embodiments  108  and expansion component non-balloon embodiments  109 . 
     Examples of expansion component balloon embodiments  108  can include but are not limited to tubular balloon embodiments  103 , helix balloon embodiments  104 , and sheath embodiments  107 . 
     Examples of expansion component non-balloon embodiments  109  can include but are not limited to guide balloon embodiments  105  and insertion component embodiments  106 . 
     C. Active vs. Passive Expansion Components 
     Many differences in various embodiments of the system  100  are dictated by the differences in the expansion components  110  of the different embodiments. Two overarching categories of expansion components  110  can be differentiated on the basis of whether they are “active” or “passive”. 
     1. Active Expansion Components/Active Apparatuses 
     a. Balloon without Sheath 
     The embodiment of the system  100  illustrated in  FIGS.  3   a - 3   g    involves an inflatable balloon as the expansion component  110 . That embodiment of the system  100  has a balloon as the expansion component  110  that can be in either a low-profile state  132  or a high-profile state  134  (i.e. an expanded state). The system  100  is transitioned between states  130  by inflating or deflating the expansion component  110  (i.e. the balloon). The system  100  has an “active” control through the inflation and deflation feature. 
     b. Balloon with Sheath 
     An alternate embodiment of an active control system  100  is a self-expanding balloon with a sheathed balloon  118  as the expansion component  110 . The system  100  would have a balloon that self-expands. Active control of the system  100  is through the use of a sheath  119  that covers the balloon. The device is in the low-profile state  132  when the sheath  119  covers the self-expanding balloon. In this state  132  the system  100  can be inserted to the required location. The low-profile state  132  will facilitate insertion in an atraumatic manner. In this state  132 , the system  100  will be able to interface with other necessary devices, such as a 0.014 coronary guide wire and a guide catheter. When the system  100  is properly positioned at the required location, the sheath  119  is retracted by active control which allows the expansion component  110  to self-expand to the expanded high-profile state  134 . In the expanded high-profile state  134  the system  100  can enable the performance of medical procedures  81  involving the insertion of other medical devices  80  such as a catheter device. It will provide a space  120  through which other devices can be inserted. When the expanded state  134  is not required anymore, the sheath  119  can be advanced over the balloon  118  with active control and transition the system  100  back to the low-profile state  132 . 
     Another potential alternative means to achieve a self-expanding expansion component  110  is to use materials with a spring feature. Many metals have a spring feature, such as stainless steels. Alternately, shape memory metals such as Nitinol could be used to achieve a self-expanding feature. It is envisioned that there may be other materials, either metals or non-metals, which could be used to achieve a self-expanding feature. These materials can be used to make a structure that serves as a “sheathed balloon”  118 . In some embodiments, the sheathed balloon  118  can be similar to other types of balloons  111 . In other embodiments, the sheathed balloon  118  can be a self-expanding braid structure  124 . 
     2. Passive Expansion Components/Passive Apparatuses 
     A passive control system is a system  100  that has two or more operating modes  130 , and the system  100  is passively transitioned between the states  130  instead of actively transitioned between states  130 . 
     a. Pleated Expansion Component 
     One embodiment of a passive control is a pleated expansion component  110  as illustrated in  FIGS.  3   h  and  3   i   . The expansion component  110  of the system  100  would be made with pleats. The pleats cause the expansion component  110  to have a low-profile state  132 . The expansion component  110  is small because of its pleated shape. When a different medical device  80  is inserted into the space  120 , or pleated expansion component  110 , it will passively expand to the larger expanded state 134  to allow the other medical device  80  to pass through. The other medical device  80  will force the pleats to expand outward to form a larger space  120  and a more expanded expansion component  110 . For this embodiment, the system  100  is passively transitioned between the two states  130  by the insertion of the assisted device, not the active operation of the system  100  by the operator. 
     b. Elastic Expansion Component 
     An alternate embodiment of a passive control system  100  is an elastic expansion component  110 . The elastic expansion component  110  would be made of elastic or stretchable materials. The expansion component  110  would be made in the low-profile state  132 . Its cross section is likely to be a round shape, but other shapes are possible, such as elliptical. When a different medical device  80  is inserted into to the elastic expansion component  110  it will passively expand to a larger state to allow the other medical device to pass through. The other medical device  80  will force the elastic expanding component  110  to form a larger space  120 . For such an embodiment, the system  100  is passively transitioned between the two states  130  instead of actively transitioned by the operator. A system  100  of this design could be made from a variety of materials, such as medical grade silicones or urethanes. 
     D. Embodiment Categories 
     As illustrated in both  FIG.  2   a    and  FIG.  2   b   , the various embodiments of the system  100  can be organized into categories. As illustrated in  FIG.  2   c   , many different embodiments of the system  100  can utilize some form of a balloon  111 . Some embodiments of the system  100  can utilize a balloon  111  with a default state of uninflated that require inflation to transition from a low-profile operating mode  132  into a high-profile operating mode  134  (i.e. the tubular balloon  112  and the helix balloon  113 ). Other embodiments of the system  100  use the balloon  111  not as the expansion component but as a mechanism for expanding the expansion component  110  from a low-profile operating mode  132  into a high-profile operating mode  134  (i.e. the guide balloon  115  on which a cover  116  is advanced). Still other embodiments utilize a balloon  111  that has a default state of inflated or that self-inflates (i.e. a sheathed balloon  118 ). A sheathed balloon  118  transitions from a low-profile operating mode  132  into a high-profile operating mode  134  when it is removed from the constraining sheath  119 . The sheathed balloon  118  can be returned to the low-profile operating mode  132  by being positioned back within the sheath  119 . 
     The system  100  can be implemented using expansion components  110  that are (1) integrated into a single stand-alone device with other components of the system  100 ; (2) a non-integrated collection of components configured to function with certain supporting components; (3) a magnitude of integration that falls between these two polar opposites. 
     As indicated by the various arrows in FIG,  1   a , the system  100  can directly interact with both the patients  90  and providers  92 . Such a system  100  can be implemented in a wide variety of different alternative embodiments. Some embodiments of the system  100  can be single stand-alone components, such as an expandable balloon  111 . Other embodiments of the system  100  can involve configurations of multiple components which may be permanently attached to each other, or merely configured to temporarily act in concert with each other. 
     The system  100  can be used in conjunction with virtually any catheter device  80  and as part of virtually any catheterization procedure. It facilitates a catheterization procedure by aiding the insertion of medical devices  80  such as various catheters and potentially other devices to the desired location  80  in the body of the patient  90  that cannot otherwise be reached without the space  120  created by the system  100  transitioning from a low-profile operating environment  132  into a high-profile operating environment  134 . 
     By way of example, an angioplasty balloon catheter or a stent catheter may not otherwise able to be placed in the desired location  88  where the blockage is located. The system  100  can facilitate inserting the balloon or stent  123  (i.e. the catheter device) to the blockage. 
     The advantage of the system  100  is that it can be inserted to required locations by itself that medical devices  80  such as catheters cannot be inserted by themselves. The ability to exist in either of two states  130  enables the system  100  to have this advantage. Unlike medical devices  80  such as catheterization devices that expand to remove blockage in an artery, the system  100  can be configured for the purpose of merely expanding sufficiently to create operating space for the catheter device. The operating space  120  is in the form of a lumen or passageway created by the expanded state of the system  100 . Other catheterization devices can pass through the operating space  120  in order to be inserted to their desired location  88 . The operating space  120  can create safe passage for catheterization devices  88  through tortuous (serpentine) vessels  91  or past stenoses that impinge vessels  91 . The system  100  may temporarily straighten out tortuous vessels or dilate stenosed areas. 
     The system  100  works in a supportive role with respect to a medical device  80 , such as catheter. In the context of cardiovascular catheterization, the system  100  is typically inserted into coronary arteries, or other arteries or veins (collectively “vessels”  91 ). The system  100  can be appropriately sized and constructed to accomplish the desired task of creating an additional space  120  for the desired catheter device at the desired location  88 . The system  100  can have two or more states  130 , with a low-profile state  132  for insertion and removal of the device, and an expanded state  134  for coronary stabilization. 
     The original context inspiring the conception of the system  100  was to facilitate percutaneous coronary intervention (PCI) procedures, or other similar intravascular procedures. However, the system  100  can be configured for use with virtually any catheter device and any catheterization procedure. 
     The system  100  can be made from biocompatible medical grade materials, such as polymers (plastics) and metals. The system  100  may be made from materials or have coatings that give it additional features. It may have a hydrophilic feature. It can be made using various manufacturing methods, such as extrusion, injection molding, thermal forming, thermal bonding, wire forming methods, laser manufacturing methods or other manufacturing methods. It will be made in such a way that it can be properly packaged and sterilized. Likely sterilization methods would be e-beam radiation, gamma radiation, ethylene oxide (EO) gas sterilization or nitrous oxide (NO2) gas sterilization. 
     1. Tubular Balloon Embodiments 
     In a tubular balloon embodiment  103  of the system  100 , the expansion component  110  is a tubular balloon  112 .  FIGS.  3   a - 3   i    pertain to tubular balloon embodiments  103  of the system  100 . 
     The tubular balloon  112  can be inflated with air, other forms of gas, water, and other forms of liquids or fluids. In some tubular balloon embodiments  103 , the tubular balloon  112  can be inflated with mechanical means such as a spring that is uncompressed or other similar means. The tubular balloon  112  can have a burst rating of up to 27 atm according to any known method of burst rating balloons. 
     2. Helix Balloon Embodiments 
     In a helix balloon embodiment  104  of the system  100 , the expansion component  110  is a helix balloon  113 , i.e. a tubular balloon  112  that is constrained by a matrix  114  to form an at least substantially helical shape.  FIGS.  7   a - 7   e    illustrate examples of helix balloon embodiments  104 . 
     Just as with tubular balloon embodiments  103 , helix balloon embodiments  104  can utilize a wide variety of different inflating mechanisms. 
     Helix balloon embodiments  104  can be highly desirable because of the impact of the matrix  114 , which can selectively increase the rigidity of the expansion component  110  so that it can be inserted into locations  88  that a tubular balloon  112  without a matrix  114  will not be able to reach. As illustrated in  FIG.  2   c   , helix balloons  113  can be implemented as conventional inflatable balloons, but also as a self-expanding helix component  141  or as a mechanically-expanding helix component  142 . 
       FIG.  7   g    shows another example helix balloon  113 ′. The helix balloon  113  discussed above is wound to have a generally circular cross-section and define a generally circular lumen  120 . In the example of  FIG.  7   g   , the helix balloon  113 ′ is wound to have a triangular or generally triangular cross-section and define a generally triangular lumen  120 ′. The triangular cross-section provides certain benefits such as improved compactness when the helix balloon  113 ′ is collapsed into the low-profile operating mode  132 . These benefits are the same as those discussed below for the triangular tubular balloon  112 ′ and shown in  FIGS.  3   n   - p.    
     3. Sheath Embodiments 
     A sheath embodiment  107  of the system  100  uses a balloon  111  that does not require inflation to transition from a low-profile operating mode  132  into a high-profile operating mode  134 .  FIGS.  6   a - 6   g    pertain to sheath embodiments  107  of the system  100 . A sheathed balloon  118  transitions from a low-profile operating mode  132  into a high-profile operating mode  134  when it is removed from the constraining sheath  119 . The sheathed balloon  118  can be returned to the low-profile operating mode  132  by being positioned back within the sheath  119 . 
     As illustrated in  FIG.  2   c   , a sheathed balloon  118  can be implemented as a braid balloon  124 . 
     4. Guide Balloon Embodiments 
     A guide balloon embodiment  105  of the system  100  involves an expansion component  110  that is not a balloon  111 . Rather, the expansion component  110  is a cover  116  that is advanced over a preceding inflated balloon, i.e. a guide balloon  115 .  FIGS.  4   a - 4   g    illustrated examples of guide balloon embodiments  105  of the system  100 . 
     5. Insertion Component Embodiments 
     Insertion component embodiments  106  of the system  100  need not use any kind of balloon  111  in the expansion/shrinkage processes. In an insertion component embodiment  106  of the system  100 , an insertion component  117  is inserted into the expansion component  110  to cause the expansion component  110  to expand from a low-profile operating mode  132  into a high-profile operating mode  134 . The expansion component  110  in an insertion component embodiment  106  of the system  100  can be a cover  116 , such as another catheter. Insertion component embodiments  106  are illustrated in  FIGS.  5   a   - 5   d.    
     III. Tubular Balloon Embodiments 
     Some embodiments of the system  100  will utilize a single tubular balloon  112  to serve as the expansion component  110  to facilitate the transition between a low-profile state  132  and a high-profile state  134  that can create a lumen  120  for the applicable medical device  80 , such as a balloon angioplasty catheter or stent  123 , at the desired location  88  in the body of the patient  90 . 
     The “working space” or lumen  120  created by the expansion of a tubular balloon  112  into a high-profile operating mode  134  is created within the tubular balloon  112 . Examples of different types of expansion components  110  can include inflatable balloons  112  with a “donut hole” space (see  FIGS.  3   a - 3   i   ), 
     As discussed above, some embodiments of the system  100  can be configured to expand/contract using different technologies and different component configurations. In some embodiments of the system  100 , the expansion of the system  100  is achieved through an expansion component  110  that is part of the system  100 . In other embodiments, the expansion of the system  100  is achieved by the expansion of a separate component/device in the system  100  that is expanded, and used to then expand or allow for the expansion of the system  100 . For example, the removal of a sheath  119  can trigger the expansion of the sheathed balloon  118  in a sheath embodiment  107  of the system  100  (see  FIGS.  6   a - 6   g   ). 
     Tubular balloons  112  can be implemented in a wide variety of different ways. Some embodiments of tubular balloons  112  as expansion components  110  can use an inflation tube  150  connected to a valve  151  on the tubular balloon  112  to inflate the tubular balloon  112 . The valve  151  acts as a connector, and in some examples, can optionally include flow control features. 
     Tubular balloons  112  can be inflated using air, other forms of gases, water, and other forms of liquids or fluids. Tubular balloons  112  can also be inflated using mechanical means such as springs. Some embodiments of tubular balloons  112  can involve a balloon  111  that self-inflates. 
     For tubular balloon embodiments  103  that require active inflation, the valve  151  is typically positioned at the proximal end of the balloon  112 , which would be like the ‘tail’ end of the balloon  112 . The valve  151  is connected to an inflation tube  150 . The tube  150  runs longitudinally to the inflatable lumen  120 . The inflatable lumen is at the distal end, which would be like the ‘business’ end. The overall length is approximately 100-120 cm (39.4-47.2 inches). The inflatable balloon  112  is approximately 35 mm (1.38 inches). The inflation tube  150  is approximately 65-85 cm (25.6-33.5 inches) in some embodiments of the system  100 . The system  100  can be constructed to have a low-profile state  132 , which would be a deflated or collapsed state. The low-profile diameter size would be small enough to fit into the required arterial locations and to interface with other medical devices  80  used during the procedure. The low-profile diameter size would be approximately 0.030-0.060 inch (0.76-1.52 mm). 
       FIG.  3   a    is a diagram illustrating a partial and close-up view of the system  100  in  FIG.  3   b   . A partial example of the inflatable balloon  112  is illustrated along with the accompanying lumen  120  and the tube  150  that facilitates inflation/deflation. 
       FIG.  3   b    is a diagram illustrating an example of an axial view of the system  100 . The lumen  120  created by the system  100  is in the form of a “donut hole” at the center of the expansion component  110 . 
       FIG.  3   c    is a diagram illustrating an example of a top view of the system  100 . 
       FIG.  3   d    is a diagram illustrating an example of a side view of the system  100 . 
       FIG.  3   e    is a diagram illustrating an example of a cross-sectional view of a side view of the system  100  with an illustration of a lumen  120  within the system  100 . 
       FIG.  3   f    illustrates a close-up and partial view of  FIG.  3     e.    
     As shown in  FIGS.  3   e - g   , in some examples, the tubular balloon  112  has a dual-wall construction that includes an inner wall  400  and an outer wall  402 . A space  404  is defined between the inner and outer walls  400 / 402 . The space  404  is configured to receive fluid via the inflation tube  150  as discussed above. When the space  404  is filled with fluid, the tubular balloon  112  is expanded into the high profile operating mode  134  where the tubular balloon  112  has a cylindrical shape that defines the lumen  120 . The inflation tube  150  is in fluid communication with the space  304  via the valve  151 . 
     The tubular balloon  112  has two opposed ends  112   a / 112   b . The valve  151  could be located at one end  112   a  or could be at a different location along the length of the tubular balloon  112 . If the valve  151  is at one of the opposed ends  112   a , then the other of the opposed ends  112  could be sealed or otherwise closed off to maintain fluid pressure within the space  404  when the tubular balloon  112  is in the high profile operating mode. If the valve  151  is at a different location along the length of the tubular balloon  112 , then both of the ends  112   a / 112   b  of the tubular balloon  112  could be sealed or otherwise closed off. 
     As discussed above, the inflation tube  150  may include a connector  251  at an opposite end from the valve  151 , shown in  FIG.  3   j   . The connector  251  can be configured to mate with a syringe or fluid line as would be known for medical applications in order to communicate fluid to/from the tubular balloon  112 . 
     The tubular balloon  112  could be straight, as shown in  FIG.  3   j   , or curved, as shown in  FIG.  3   k   . The tubular balloon  112  could be noncompliant (e.g., rigid), and therefore fixed in the straight/curved shape. In another example, the tubular balloon  112  is semi-complaint or complaint (e.g., flexible), and can alternate between the straight and curved shapes. 
     The tubular balloon  112  could have flat ends  112   a / 112   b  as shown in  FIG.  3   j   . A flat end has a plane that is parallel, coaxial, or colinear to an axis A of the tubular balloon  112 . In another example, shown in  FIGS.  3   l  and  3   m   , the tubular balloon  112  could have angled ends  112   a / 112   b . One or both ends could be angled. Angled ends have a plane that is angled with respect to the axis A. 
     In another example shown in  FIGS.  3   n - p   , the tubular balloon  112 ′ has a triangular or generally triangular cross-section. Thus the lumen  120  also has a triangular or generally triangular cross-section. The triangular cross-section allows the tubular balloon  112 ′ to more compactly collapse into the low-profile operating mode  132  as compared to the cylindrical tubular balloon  112  discussed above, and may also have certain manufacturing advantages. 
     As shown in  FIG.  3   o   , the triangular cross-section may include dimples or indents  405  on one, two, or three sides of the triangle. The dimples or indents  405  further assist the tubular balloon  112 ′ into collapsing into a compact low-profile operating mode  132  by providing folding points to encourage folding of the tubular balloon  112 ′. 
       FIG.  3   p    shows the tubular balloon  112 ′ collapsed in the low-profile operating mode  132 . As shown, when collapsed, the three points of the triangular cross-section each form a leaflet  407  that is essentially flat and folds circumferentially around an axis of the tubular balloon  112 ′. This further contributes to the compact nature of the tubular balloon  112 ′ when in the low-profile operating mode  132 . Moreover, the tubular balloon  112 ′ still has a small lumen  120 ′ in the low-profile operating mode  132 . This small lumen  120 ′ can receive a guide wire  122  as discussed in more detail below. 
     Either of the tubular balloons  112 / 112 ′ can be made by blow molding, in one example. In some examples. The tubular balloon  112 ′ is made with a cylindrical shape like the tubular balloon  112 , and then is pressed, molded, or otherwise formed into the triangular shape. 
     In some examples shown in  FIGS.  9   a - c   , the tubular balloon  112  includes one or more connections  406  where the inner wall  400  is connected to the outer wall  402  such that there is no space  404  between the inner and outer walls  400 / 402  at the connection  406 . The connection  406  can provide additional structural integrity to the tubular balloon  112 . The connection  406  also prevents the inner wall  400  from collapsing into the lumen  120  when the tubular balloon  112  is in the high profile operating mode  134 . In other words, the connection  406  acts against the pressure forces exerted on the inner wall  400  when the space  404  is filled with fluid. The tubular balloon  112  may include one or more connections  406 . 
     The connection  406  could be made in a variety of ways. For instance, the connection  406  could be made by bonding the inner and outer walls  400 / 402  together using any known adhesive that is suitable for the material of the inner and outer walls  400 / 402  and for medical applications. Any known material that is suitable for medical applications could be used for the tubular balloon  112 , however, some non-limiting examples include PET (polyethylene terephthalate), nylons, engineered nylons, polyamides, polyurethanes, nylon elastomers, and other thermoplastic elastomers. In another example, the connection  406  could be made by fusing the inner and outer walls  400 / 402  together using a thermal bonding technique such as laser welding or any other known technique that is suitable for the material of the inner and outer walls  400 / 402  and for medical applications. 
     In the example of  FIG.  9   a   , the connection  406  is a point or dot. In other words, the connection  406  does not extend across a substantial radial or circumferential extent of the tubular balloon  112 . The tubular balloon  112  can include one or more point or dot connections  406 . The point or dot connections  406  could be distributed on the tubular balloon  112  in any pattern such as circumferential or axial rows, or any other pattern. 
     In another example, shown in  FIGS.  9   b - c   , the connection  406  is a line or rib that extends along a circumferential or axial extent of the tubular balloon  112 . In some examples, the connections  406  extend along less than the entire radial or circumferential extent of the tubular balloon  112  in order to maintain a single common space  404  throughout the entire tubular balloon  112  for receiving the fluid from the inflation tube  150  as discussed above. In the particular example of  FIGS.  9   b - c   , the tubular balloon includes multiple ribs that extend along a majority, e.g,. greater than 50% but less than 100%, of the circumferential extent of the tubular balloon  112 . The rib or line connections  406  could be evenly spaced along the axial extent of the tubular balloon  112  as shown in  FIGS.  9   b - c   , though other arrangements/distributions are also contemplated. 
     IV. Guide Balloon Embodiments 
     Some embodiments of the system  100  anticipate that a guide balloon  115  is used in conjunction with the system  100 . The guide balloon  115  can help position the system  100  within the body of the patient  90 . 
       FIG.  4   a    is a flow chart diagram illustrating an example of a process for enhancing catheterization performed by a guide balloon embodiment  105  of the system  100 . 
     At  302 , the guide balloon  115  is inserted into the body of the patient  90 .  FIG.  4   b    is an environmental diagram illustrating an example of a process step where the guide balloon  115  is inserted. At the beginning of a coronary catheterization procedure a guide catheter  121  or similar medical device  80  can be inserted to the femoral or radial artery, and the guide catheter will be advanced until it accesses the right or left coronary ostium. The ostium is the start of the coronary artery. It is where the artery branches off the aorta. A guide wire  122  will be inserted through the guide catheter  121  and into the coronary artery beyond the point where treatment is to be conducted. The guide balloon  115  of the system  100  will be inserted over top of the guide wire  122  and through the guide catheter  121  into the artery. The guide balloon  115  is in a deflated state while it is inserted. It is inserted past any tortuous areas or stenosis. 
     Returning to  FIG.  4   a   , at  304  the guide balloon  115  is inflated.  FIG.  4   c    is an environmental diagram illustrating an example of a process step where the guide balloon  115  is inflated. The guide balloon  115  is inflated after it is properly positioned. It can be inflated pneumatically with a gas such as air or hydraulically with a liquid. It is most likely to be inflated which a 50-50 mixture of sterile saline and contrast media. It may be inflated to lower pressures of 1-4 atmospheres or higher pressures up to 16 atmospheres. The inflated outside diameter of the guide balloon  115  may be less than, equal to, or greater than the diameter of the artery. The guide balloon  115  may temporarily straighten any tortuous areas of the artery, either completely or partially. 
     Returning to  FIG.  4   a   , at  306  the cover  116  is advanced over the guide balloon  115 .  FIG.  4   d    is an environmental diagram illustrating an example of a process step where the cover  116  is advanced over the inflated guide balloon  115 . The expansion component  110 , which is the core component of the system  100 , is inserted over top of the guide balloon  115  and through the guide catheter  121 . In this embodiment of the system  100  the expansion component  110  may be either a self-expanding design or a fixed diameter design. As the expansion component  110  exists the distal end of the guide catheter  121  it will track over top of the inflated guide balloon  115 . The guide balloon  115  outside diameter and the expansion component  110  inside diameter will be specifically designed for an optimum interface. The interface may be a slip fit design, a line-to-line fit design, or an interference design. The interface design will aid insertion of the expansion component  110  and make insertion as atraumatic as possible to eliminate or prevent arterial wall damage. 
       FIG.  4   e    is an environmental diagram illustrating an example of a cover  116  expanded over a guide balloon  115 . The guide balloon  115  serves the important task to eliminate or prevent arterial wall damage from the leading edge of the expansion component  110  while it is being inserted, even though the leading edge may be design with its own atraumatic tip. To this end, the guide balloon  115  may intentionally be longer than the expansion component  110 . It may be two times or more than the length of the expansion component  110 . 
     Returning to  FIG.  4   a   , at  308  the guide balloon  115  is deflated.  FIG.  4   f    is an environmental diagram illustrating an example of a process step where the guide balloon  115  is deflated and removed. The guide balloon  115  is deflated and removed after the expansion component  110  is properly positioned. The expansion component  110  may be designed to maintain straightening of the artery after the guide balloon  115  is removed. 
     Returning to  FIG.  4   a   , at  310  the guide balloon  115  is removed. The expansion component  110  may be either a self-expanding design or a fixed diameter design for this embodiment of the system  100 . The expansion component  110  will create space  120  in the artery in the form of a lumen. Other devices  80  can pass through the space  120  created by the system  100  when it is in the high-profile expanded state  134 , such as an angioplasty balloon, a stent catheter, or some other form of similar medical device  80 . 
     At  312 , a stent  123  is positioned through the system  100 .  FIG.  4   g    is an environmental diagram illustrating an example of a process step where a stent  123  is inserted through the space  120  created by the system  100 . 
     The system  100  is removed from the artery when it is not needed anymore. The artery would regain its natural shape. This embodiment of the system  100  would interface with the other catheterization devices  80  used during the procedure, such as the guide wire  122 , guide catheter  121 , balloon catheters and stent  123 . 
     V. Insertion Component Embodiments 
       FIG.  5   a    is a flow chart diagram illustrating an example of a process for enhancing catheterization performed by an insertion component embodiment  106  of the system  100 . This embodiment of the system  100  uses an insertion component  117  that is inserted into the expansion component  110  of a cover  116 . In some embodiments, the insertion component  117  can be attached to the guide catheter  121 . 
     At  322 , the cover  116  attached to the guide catheter  121  is inserted into the body of the patient  90 .  FIG.  5   b    is an environmental diagram illustrating an example of a process step where the cover  116  is inserted into the body of the patient  90 . At the beginning of a typical coronary catheterization procedure a guide catheter  121  will be inserted to the femoral or radial artery, and the catheter  121  will be advanced until it accesses the right or left coronary ostium. The ostium is the start of the coronary artery. It is where the artery branches off the aorta. A guide wire  122  will be inserted through the guide catheter  121  and into the coronary artery beyond the point where treatment is to be conducted. For this embodiment of the expansion component  110 , which is in the form of a cover  116 , the cover  116  will often be an integral part of the guide catheter  121 . The cover  116  can be connected to the distal end of the guide catheter  121  as pat of the manufacturing process for those components. 
     Returning to  FIG.  5   a   , at  324  an insertion component  117  is inserted into the cover  116 .  FIG.  5   c    is an environmental diagram illustrating an example of a process step where an insertion component  117  is inserted into the cover  116  positioned within the body of the patient  90  to expand the distal section of the cover  116 . An insertion component  117  would be inserted into the inside the entire length of the connected expansion component  110  (i.e. the cover  116 ) and guide catheter  121 . As it is inserted it will expand the expansion component  110  (i.e. the cove  116 ) to the high-profile state  134 . 
     Returning to  FIG.  5   a   , at  326  a stent catheter  123  is inserted into the body of the patient  90  through the insertion component  117 .  FIG.  5   d    is an environmental diagram illustrating an example of a process step at  326 . The nested structure of the high-profile state  134  expansion component  110  and the insertion component  117  will create space  120  through which other medical devices  80  can be inserted, such as an angioplasty balloon catheter or a stent catheter  123 . 
     The expansion component  110  (i.e. the cover  116 ) of the system  100  and insertion component  117  will be removed when they are not needed anymore. 
     The expansion component  110  of this embodiment can be made with shape memory materials, a braid construction, a pleated design or any other expandable design structure. 
     Shape memory materials can be metallic or non-metallic. Nitinol is one possible metallic material that could be used. The expansion component  110  could be made from Nitinol and the memorized shape would be the low-profile state  132 . This memorized low-profile state  132  would enable the connected expansion component  110  and guide catheter  121  to be inserted into the coronary artery past the ostium, tortuous areas and any stenoses. The insertion component  117  would be used to actively transition the expansion component  110  from the low-profile state  132  to the high-profile state  134 . Non-metallic shape memory polymers could also be used to construct the expansion component  110  and accomplish the same result. 
     A braid structure could be used to construct the cover  116 . The braid would be made to the size of the low-profile state  132 . The woven mesh pattern of the braid has space in the interstices between its wires. This would allow it to expand to the high-profile state  134  when the insertion component  117  is inserted. 
     A pleated design could be used to make the cover  116 . The pleated design would be made to the size of the low-profile state  132 . The insertion component  117  would unfold the pleats, when it is inserted, allowing it to transition to the high-profile state  134 . 
     VI. Sheathed Balloon Embodiments 
       FIG.  6   a    is a flow chart diagram illustrating an example of a process of enhancing catheterization performed by a sheath covered embodiment  107  of the system  100 . In this category of embodiments, expansion component  110  of the system  100  is self-expanding. The sheath  119  allows for the expansion component  110  to exist in a low-profile mode  132  by constraining the expansion component  110 . Once the expansion component  110  is released from the sheath  119 , the expansion component  110  (such as a sheathed balloon  118 ) expands into a high-profile operating mode  134 . 
     The self-expanding feature can be made with self-expanding materials, such as a braid structure. The braid structure is cylindrical in shape. The wall of the cylinder is constructed of the woven mesh of the braid. The ends of the cylinder are open. The braid would be designed with space in its weave pattern, which would allow the braid structure to exist in either the high-profile self-expanded state  134  or the low-profile state  132 . 
     At  350 , the system  100  with sheath  119  (and the encapsulated expansion component  110  such as a sheathed balloon  118 ) is inserted into the body of the patient  90 .  FIG.  6   b    is an environmental diagram illustrating an example of a process step where a sheath  119  covers the system  100  during insertion. The expansion component  110  could be compressed to a low-profile state  132  and inserted into a sheath  119 . The sheath  119  would cover the expansion component  110  keeping it in the low-profile state  132 . The expansion component  110  and sheath  119  would be inserted through the guide catheter  121  and into the artery  91  as one unit. 
     Returning to  FIG.  6   a   , at  352  the system  100  is positioned within the body of the patient  90 .  FIG.  6   c    is an environmental diagram illustrating an example of a process step where the sheath  119  and system  100  are positioned as desired within the body of the patient  90 . The expansion component  110  and sheath  119  would have an appropriate low-profile size, strength, and flexibility to be inserted past any tortuous areas or stenosis 
     Returning to  FIG.  6   a   , at  352  the sheath  119  is withdrawn.  FIG.  6   d    is an environmental diagram illustrating an example of a process step where the sheath  119  is withdrawn; causing the system  100  to self-expand and triggering the creation of the additional working space  120  within in the body of the patient  90  for the purposes of catheterization. The sheath  119  is removed after the system  100  is properly positioned. The expansion component  110  will automatically deploy because of its self-expanding feature. The expansion component creates space  120  in the artery. 
     Returning to  FIG.  6   a   , at  354  the system  100  is expanded into a high-profile state  134 .  FIG.  6   e    is an environmental diagram illustrating an example of how the expanded system  100  can straighten out an artery within the body of the patient  90 . The expansion component  110  may partially or completely straighten any artery tortuosity. The straightening effect would be transient. When the system  100  is withdrawn the artery would regain its natural shape 
     Returning to  FIG.  6   a   , at  356  the stent catheter  123  is inserted through the system  100 .  FIG.  6   f    is an environmental diagram illustrating an example of a process step where the stent catheter  123  is inserted into the patient  90  through the working space  120  created by the presence of the system  100  in a high-profile operating mode  134 . Other devices can pass through the space  120  created by the system  100  when it is in the high-profile expanded state  134 , such as an angioplasty balloon catheter or stent  123 . 
     Returning to  FIG.  6   a   , at  358  the sheath  119  is advanced to collapse the system  100  for removal.  FIG.  6   g    is an environmental diagram illustrating an example of a process step where the sheath  119  is advance to collapse the system  100  for removal. The system  100  can be removed when it is not needed any more. The sheath  119  is advanced over the expansion component  110  causing it to collapse to the low-profile state  132 , and then the expansion component  110  and sheath  119  are removed together as one unit. 
     An alternate embodiment of this form of the system  100  uses a self-expanding braid structure  124  to serve as the sheathed balloon  118 . The construction of the braid  124  can be designed to provide optimum performance. Braid  124  characteristics such as number of wires, shape of wire, wire material, pitch, uniform pitch, variable pitch and weave pattern can be chosen to obtain the desired performance. More or less wires, and wire material, can affect strength and flexibility of the component. Round wires or flat wires can affect wall thickness. Pitch and weave pattern can affect expansion strength and profile size. 
     Stainless Steel or Nitinol are likely materials for the braid  124  wire, however other metals or non-metals can possibly be used. Stainless Steel can be formulated with ‘spring’ characteristics enabling it to self-expand. Nitinol is a metallic alloy of nickel and titanium. It is in a class of metals known as ‘shape memory’ . A nitinol-based expansion component can be made with a shape memory of the high-profile expanded state  134 , enabling it to self-expand. There are also shape memory polymers that can be used to construct the expansion component. 
     The braid  124  can be covered with an inner and outer liner to make it atraumatic and prevent arterial wall damage. The inner and outer liners would expand and collapse with the system  100 . 
     The sheath  119  may have an atraumatic tip to aid insertion and eliminate or reduce damage to the artery wall. 
     The expansion component  110 , sheath  119  or both items could have radio-opaque features so they can be visualized with fluoroscopic imaging. 
     This embodiment of the system  100  can interface with the other catheterization devices used during the procedure, such as the guide wire  122 , guide catheter  121 , balloon catheters, stent  123 , as well as other medical devices  80 . 
     VII. Helix Balloon Embodiments 
     Helix balloon embodiments  104  of the system  100  are similar to tubular balloon embodiments  103  of the system  100 , except that in a helix balloon embodiment  104  of the system  100 , the balloon  111  is constrained and shaped by a matrix  114  the configures the shape of the balloon  111  into a helix balloon  113 . The helix balloon  113  is defined by multiple turns  213  of the tubular balloon  112 , which forms a helix shape. 
     A. Helix Balloon 
     Just as a tubular balloon  112  can be inflatable, self-inflating, or mechanically expanding, a helix balloon  113  can change operating modes  130  in precisely the same ways using the same technologies and principles of chemistry and physics. The tubular balloon  112  could have a dual-wall construction, as described above, or could have another construction such as a continuous tube. 
     An example helix balloon  113  is shown in  FIGS.  8   a - f    (discussed in more detail below). The helix balloon  113  is defined between opposed ends  113   a/   113   b  and along an axis A. The axis A can be straight, as in  FIG.  8   a   , or curved, as in  FIG.  8   b   . The helix balloon  113  may be compliant or flexible to enable bending, or may be rigidly fixed in a straight or bent shape. 
     In one example shown in  FIG.  8   f    (discussed in more detail below), an inflation tube  150  is configured to mate with the tubular balloon  112  at a valve  151  as discussed above. In this way, the inflation tube  150  fluidly connects a space  212  within the tubular balloon  112  with a fluid source (not shown). Therefore, fluid such as saline can be provided or removed from the tubular balloon  112  to cause the helix balloon  113  to deflate or expand between the low profile operating mode  132  and the high profile operating mode  134  as discussed above. The valve  151  could be located at an end of the tubular balloon  112  that corresponds to one of the opposed ends  113   a/   113   b  of the helix balloon  113  or could be at a different location along the length of the helix balloon  113 . If the valve  151  is at one of the opposed ends  113   a , then the other end of the tubular balloon  112  (e.g., the end of the tubular balloon  112  that corresponds to the other of the opposed ends  113   b  could be sealed or otherwise closed off to maintain fluid pressure within the space  212  when the helix balloon  113  is in the high profile operating mode  134 . If the valve  151  is at a different location along the length of the helix balloon  113 , then both of the ends of the tubular balloon  112  could be sealed or otherwise closed off. 
     As discussed above, the inflation tube  150  may include a connector  251  at an opposite end from the valve  151 . The connector  251  can be configured to mate with a syringe or fluid line line as would be known for medical applications in order to communicate fluid to/from the tubular balloon  112 . 
     It should be understood that the description herein for the helix balloon  113  is equally applicable to the helix balloon  113 ′ shown in  FIG.  7   g    and discussed above. 
     B. Matrix 
     A mechanism or configuration of mechanisms that keep the balloon  111  in the shape of a helix balloon  113 . The matrix  114  maintains the helical shape of the helix balloon  113  in all operating modes  130 . The matrix  114  can be implemented in a wide variety of different embodiments, including but not limited to a weave  145 , a bonding agent  146 , a thermally formed connection  147 , a matrix cover  148 , and a flange  149 . The cross sectional shape of the helix balloon  113  can be maintained differently in different operating modes  130 . For example, the cross section of the helix balloon  113  would otherwise be round in an inflated state (high-profile operating mode  134 ) and flat in a deflated state (low-profile operating mode  132 ). The matrix  114  can maintain the helical shape in both states. The matrix  114  needs both flexibility and strength to properly perform its function. 
     The matrix  114  can include a medicinal component  126 , a mechanism or configuration of mechanisms that enable medicinal capabilities to the system  100 . The medicinal component  126  may include diagnosis or treatment of a medical condition, or delivery of medicine or nutrient. The matrix  114  may contain vaso-active agents to cause vasoconstriction or vasodilation, depending on what may be required. Such an agent may be transient or longer lasting. Nitric oxide is an example of a vaso-active agent that can dilate a vessel, which would make the vessel bigger (larger diameter) until the agent wears off. The matrix  114  may contain any of the class of drug coatings that prevent intimal hyperplasia. Intimal hyperplasia often is a physiologic response to an angioplasty procedure resulting in restenosis of the treated area, which in layman&#39;s terms is a clogged stent  123 . 
     1. Weave 
     A weave  145  can be a configuration of one or more threads  144  that can contain the balloon  111  in the shape of a helix balloon  113 . The weave  145  can use as many or as few threads  144  as desired. In many embodiments, between 10-12 threads  144  uniformly distributed about the helix balloon  113  is a particular desirable configuration. The weave  145  would wrap around the helix balloon  113  as the helix balloon  113  makes consecutive passes of the helical shape. 
     2. Bonding Agent 
     A chemical means to constrain the shape of the helix balloon  113 . The matrix  114  can be made from a bonding agent  146  that is applied to a balloon  111  to secure its shape as a helix balloon  113 . A bonding agent  146  can be used by itself or with other components to maintain the helical shape of the helix balloon  113 . Consecutive passes of the helical shape can be bonded to adjacent passes. A wide variety of bonding agents including but not limited to adhesive glues or silicone can be used as possible bonding agents  146 . The bonding agent  146  may be applied using dip coating techniques. 
     3. Thermally Formed Connection 
     A constraint on the helix balloon  113  that is implemented through the application of heat. A wide range of thermal forming techniques known in the prior art can be used to connect adjacent passes of the helical shape together. The aggregate configuration of thermally formed connections  147  can by itself or in conjunction with other components, constitute the matrix  114 . 
     4. Matrix Covering 
     A matrix cover  148  is a relatively thin sheet or a collection of thin sheets that overlay the balloon  111  to shape it into a helix balloon  113 . The matrix cover  148  can contain the helix balloon  113  and maintain its helical shape. The matrix cover  148  can be made from a fabric or other similar material suitable for the particular location  88  in the patient  90 . The matrix cover  148  can cover a single pass of the helical shape, multiple passes or all passes. The matrix cover  148  can be used by itself or in conjunction with other components to constitute the matrix  114 . The matrix cover  148  may be applied using dip coating techniques as well as other plausible manufacturing methods. 
     5. Flange 
     A flange  149  is a rim, collar, or ring that secures the balloon  111  into the shape of a helix balloon  113 . The cross-section of the helix balloon  113  can have one or more flanges  149 . Adjacent passes of the helical shape can be connected together by the flange  149 . The connected flanges  149  in the aggregate can form the matrix component  114 . Flanges  149  can be connected using a weave  145 , a bonding agent  146 , a thermally formed connection  147 , a matrix cover  148 , and/or potentially other means. 
     6. Tubules 
     In one example, shown in  FIGS.  8   a - e   , the matrix component  114  includes tubules  200  arranged circumferentially around the helix balloon  113 . The tubules  200  run parallel to the axis A of the helix balloon  113  between adjacent turns  213   a ,  213   b  of the helix balloon  113  in order to constrain the helix balloon  113  in the helical shape and assist in maintaining the lumen  120  as will become apparently from the below description. 
     The tubules  200  can be made of the same material as the helix balloon  113  or a different material than the helix balloon  113 . Any known material that is suitable for medical applications could be used, however, some non-limiting examples include PET (polyethylene terephthalate), nylons, engineered nylons, polyamides, polyurethanes, nylon elastomers, and other thermoplastic elastomers. The tubules  200  can be non-compliant (e.g., rigid), semi-compliant, or compliant (e.g., flexible). Similarly the helix balloon  113  can be non-compliant (e.g., rigid), semi-compliant, or compliant (e.g., flexible). The tubules  200  and helix balloon  113  can have the same, similar, or difference compliance. 
     Each tubule  200  spans between opposed ends  202   a / 202   b . One of the ends  202   a  meets a first turn  213   a  of the helix balloon  113  and the other of the ends  202   b  meets a second turn  213   b  adjacent the first turn  213   a.    
     The tubules  200  can be integral with the helix balloon  113  or can be separate structures that are attached to the helix balloon  113  according to any known method suitable for the material(s) of the tubules  200  and helix balloon  113  and for medical applications. In either example, the tubules  200  are hollow structures having a space  204 . The space  204  is in fluid communication with the space  212  of the tubular balloon  112  so that the tubules inflate with the helix balloon  113  when the helix balloon  113  is expanded from the low-profile operating mode  132  to the high-profile operating mode  134  as described above. The tubules  200  and helix balloon  113  can have a burst rating of up to about 27 atm according to any known method of burst rating balloons. In this way, the tubules  200  assist in maintaining the lumen  120  when the helix balloon  113  is in the high-profile operating mode  134  by providing structural support for the helix balloon  113  that impedes collapsing of the helix balloon  113  into the lumen  120 . 
     As shown in  FIGS.  8   a - b   , the tubules  200  are spaced apart from one another by a distance x. The tubules  200  have a length y defined as the distance between ends  202 . The length y corresponds to a distance between adjacent turns  213   a/   213   b  of the helix balloon  113  (which is known as the pitch of a helix). In the example of  FIGS.  8   a - f   , the distance x is constant, meaning the tubules  20  are evenly spaced about the circumference of the helix balloon  113 . However, in other examples the, the distance x could be variable, meaning the tubules  200  have a different circumferential distribution around the helix balloon  113 . The distances x and y can be selected to provide flexibility in the helix balloon  113  when it is in the high-profile operating mode  134 . For instance, areas of the helix balloon  113  that require bending could have less tubules  200  so as not to impede the movement of the helix balloon  113  in that localized area and with respect to other areas. 
     The tubules  200  have a diameter d ( FIG.  8   e   ) that is in one example the same as the diameter of the tubular balloon  112  that is constrained in a helix to form the helical balloon  113 . In other examples, the diameter d of the tubules  200  can be different from the diameter of the tubular balloon  112 . 
     7. Inner Support 
     In one example, shown in  FIGS.  10   a - b   , the matrix component  114  includes an inner support  300  arranged inside the helix balloon  113  created by the tubular balloon  112 . The inner support  300  is attached to an interior surface  213   c  of the helical balloon  113 , e.g., the surface  213   c  facing the lumen  120  when in the high profile operating mode  134 . The inner support  300  can be non-compliant (e.g., rigid), semi-compliant, or compliant (e.g., flexible). Similarly the helix balloon  113  can be non-compliant (e.g., rigid), semi-compliant, or compliant (e.g., flexible). The inner support  300  and helix balloon  113  can have the same, similar, or difference compliance. In some examples, the inner support  300  is perforated, e.g., is formed from a mesh. 
     When the helix balloon  113  is expanded from the low-profile operating mode  132  to the high-profile operating mode  134  as described above, the inner support  300  has a generally cylindrical shape and supports the helix balloon  113  in the helical shape to maintain the lumen  120 . The inner support  300  also maintains the distance y between adjacent turns  213   a/   213   b  of the helix balloon  113  (which is known as the pitch of a helix). In some examples, the distance y is zero or near zero, meaning adjacent turns  213   a/   213   b  of the helix balloon  113  are touching one another. In other examples, the distance y is greater than zero. 
     The inner support  300  can be made from any medical grade biocompatible material such PET (polyethylene terephthalate), nylon polymers, or thermoplastic polyurethane, as non-limiting examples. In a particular example, the inner support  300  is made from a “thin film” material with a thickness on the order of a tenth of a millimeter. The inner support  300  can be made from the same material or a different material than the tubular balloon  112 . 
     In the example of  FIGS.  10   a - b   , the inner support  300  is continuous, e.g., it forms a continuous generally cylindrical shape when the helix balloon  113  is in the high profile operating mode  134 . In other examples, the inner support  300  is discontinuous, and includes several strips of material, like the discontinuous outer support comprising multiple strips  350   a / 350   b  discussed below. 
     The inner support  300  is attached to the helix balloon  113  in such a way that the inner support  300  does not become detached from the helix balloon  113  when the helix balloon  113  is used as described herein. For instance, the tubular balloon  112  can be attached to the inner support  300  by any appropriate adhesive known in the art for the material of the tubular balloon  112 /inner support  300  that is also biocompatible. In other examples, the tubular balloon  112  can be attached to the inner support  300  by a thermal bond, such as a thermal weld, an RF (radio frequency) weld, an ultrasonic weld, a laser weld, or the like. The attachment can be continuous, e.g., along the entire inner surface  213   c  of the helix balloon  113 , or discontinuous, e.g., only at certain points along the inner surface  213   c.    
     8. Outer Support 
     In one example shown in  FIGS.  11   a - b   , the matrix component  114  includes an outer support  350 . The outer support  350  can be used together with the inner support  300  discussed above, or on its own. The outer support  350  can be similar to the inner support  300 , except that it is attached to an outer surface  213   d  of the helix balloon  113 . Like the inner support  300 , the outer support  350  can be made from any medical grade biocompatible material such PET (polyethylene terephthalate), nylon polymers, or thermoplastic polyurethane, as non-limiting examples. In a particular example, the outer support  350  is made from a “thin film” material with a thickness on the order of a tenth of a millimeter. The outer support  350  can be made from the same material or a different material than the tubular balloon  112 . In some examples, the outer support  350  is perforated, e.g., is formed from a mesh. 
     The outer support  350  can be attached to the helix balloon  113  by an adhesive or thermal bond in such a way that the outer support  350  does not become detached from the helix balloon  113  when the helix balloon  113  is used as described herein, as discussed above for the inner support  300 . In one example, the attachment can be by a plurality of connectors  352 , as shown in the example of  FIGS.  11   a - b   . The connectors  352  can be filaments or threads similar to the threads  144  discussed above. In another example, the connectors  352  can be strips of material that is the same material of the outer support  350  or a different material than the outer support  350 . The connectors  352  form loops that wrap around the turns  213   a/   213   b  of the helix balloon  113  to connect the turns  213   a/   213   b  to the outer support  350 . The connectors  352  can be connected to the outer support  350  and helix balloon  113  by any of the attachment methods discussed herein, such as by adhesive or by thermal bonding. There can be connectors  352  on each turn  213   a/   213   b  in one example, but in other examples, only some of the turns  213   a/   21   b  have connectors  352 . Additionally, there can be several connectors circumferentially spaced about the outer surface  213   d  such that certain turns  213   a/   213   b  have multiple connectors  352 . In all cases, there are sufficient connectors  352  to maintain the helical shape of the helix balloon  113  and the lumen  120  in the high profile operating mode  134 . 
     The outer support  350  can be continuous such that it forms a continuous generally cylindrical shape when the helix balloon  113  is in the high profile operating mode  134 , as shown in  FIG.  11   a - b   . In other examples, the outer support can be discontinuous, and can include multiple strips or pieces  350   a / 350   b  as show in  FIGS.  12   a - b   . Several strips  350   a / 350   b  can be arranged circumferentially around the outer surface  213   d  of the helix balloon  113 . In some examples, the strips  350   a / 350   b  have end portions  354  that fold across ends  113   a / 113   b  of the helix balloon  113  and into the interior surface  213   c  of the helix balloon  213 . 
     In one particular example, shown in  FIG.  12   c   , the helix balloon  113  can have a flattened profile at the outer surface  213   d , so that a cross-section of tubular balloon  112  is hemispherical. The flattened profile provides a larger surface area for bonding the tubular balloon  112  to the outer support  350 . Moreover, it should be understood that in other examples, the flattened profile can additionally or alternatively be at the inner surface  213   c  in cases where an inner support  300  is used. 
     In another particular example, shown in  FIG.  12   d   , both an inner support  300  and an outer support  350  are used. In this example, the inner and outer supports  300 / 350  can be bonded to one another between successive turns  213   a/   213   b  of the helix balloon  113 . 
       FIGS.  13   a - c    show a mandrel  375  which can be used to assemble the helix balloon  113  with the outer support  350 . The mandrel  375  includes threads  377  which defined spaces  379  configured to receive the tubular balloon  112  to form the helix balloon  113 . The tubular balloon  112  is wound into the spaces  377 , and then the outer support  350  is arranged over the mandrel  375  with the tubular balloon  112 . The mandrel  375  locates the tubular balloon  112  with respect to the outer support  350  for attachment by any of the methods discussed above. In examples where connectors  352  are used, the connectors  352  can be arranged on the mandrel  375  before winding the tubular balloon  112  in the spaces  377 . In a particular example, the mandrel  375  has notches or grooves  381  that are configured to receive the connectors  352 . 
     9. Clip 
     In one example shown in  FIG.  14   a - g   , the matrix component  114  includes one or more clips  500 . As best seen in  FIG.  14   a   , which depicts a clip  500  in a flattened or unfolded state, and  FIG.  14   d   , which depicts a perspective view of the clip  500  in a folded state, each clip  500  includes a center leaf  502 , first and second receiving leaves  504   a/   504   b  on either side of the center leaf  502 , and first and second foldover leaves  506   a / 506   b  flanking each of the receiving leaves  504   a/   504   b . Hinge points  505  separate the center leaf  502  from the first and second receiving leaves  504   a/   504   b  and the first and second receiving leaves  504   a/   504   b  from the first and second foldover leaves  506   a / 506   b . The hinge points  505  can include grooves to enable folding of the clip  500  of the clip at the hinge points  505 , as discussed in more detail below. However, other means of creating a hinge point  505  are also contemplated. The receiving leaves  504   a/   504   b  include openings  508  configured to receive successive turns  213   a/   213   b  of the helix balloon  113 . The openings  508  are dimensioned to accommodate the diameter of the tubular balloon  112 . The openings  508  can be centered along the length of the receiving leaves  504   a/   504   b  (discussed in more detail below), or can be arranged closer to the center leaf  502  than the foldover leaves  506   a / 506   b . The clip  500  has a width W that corresponds to the number of openings  508 /number of turns  213   a/   213   b  of the helix balloon  113  configured to be received in the clip  500 . 
     As best shown in  FIGS.  14   g   , the clip  500  is arranged so that the successive turns  213   a/   213   b  of the helix balloon  113  are received in the openings  508  and the center leaf  502  rests along an outer surface of the helix balloon  113 . For instance the tubular balloon  112  can be wound into the clip  500  to form the helix balloon  113 . The foldover leaves  506   a / 506   b  are folded towards the center leaf  502  as best seen in  FIGS.  14   e  and  14   g   , thereby trapping the successive turns  213   a/   213   b  of the helix balloon  113  between the center leaf  502  and the foldover leaves  506   a / 506   b  to maintain the helical shape. In the folded state, the foldover leaves  506   a / 506   b  are on the inner surface/lumen  120  side of the helix balloon  113 . The foldover leaves  506   a / 506   b  are arranged at about a 90 degree angle with respect to the receiving leaves  504   a/   504   b  and the receiving leaves  504   a/   504   b  are arranged at about a 90 degree angle with respect to the center leaf  502  in the folded state. 
     As best seen on  FIG.  14   a   , the center leaf  502  has a length Lc, the receiving leaves  504   a/   504   b  have a length Lr, and the foldover leaves  506   a / 506   b  have a length Lf. In a particular example, Lc is greater than Lr, which is greater than Lf. In general, Lr is greater than the diameter D of the tubular balloon  112 . For instance Lr may up to about 50% greater than the diameter of the tubular balloon. 
     The length Lf of the foldover leaves  506   a / 506   b  can be selected such that they meet one another in the folded state. In another example, the foldover leaves  506   a / 506   b  have a length Lf such that they overlap one another in the folded state, as shown in  FIG.  14   f   . In yet another example, the foldover leaves  506   a / 506   b  have a length Lf such that they do not touch or overlap one another in the folded state, as shown in  FIGS.  14   b    and  14   d.    
     As shown in the example of  FIGS.  14   a  and  14   c   , respectively, the matrix component  114  can include one clip  500  or multiple clips  500  spaced circumferentially about the helix balloon  113 . Though two clips  500  are shown in  FIG.  14   c   , more clips could be used in other examples. 
     In certain examples, shown in  FIG.  14   f   , the matrix component  114  includes cylindrical supports  510  which surround the portions of the helix balloon  113  which are received in the openings  508 . The supports  510  can be more rigid than the helix balloon  113 , and help to maintain the helical shape of the helix balloon  113  as well as provide mechanical protection to the helix balloon  113 . The supports  510  can be separate from or be integral with the clip  500 . 
     The clip  500  can be made form a compliant, semi-compliant or non-compliant biocompatible polymeric material such as PET (polyethylene terephthalate), Pebax®, nylon, polyurethanes or a combination thereof. In certain examples, the clip  500  is made from polymer material that is between about 0.06 and 0.1 mm thick. 
     10. Band Connector 
     In one example shown in  FIGS.  15   a - c   , the matrix component  114  includes one or more band connectors  550 . Each band connector  550  surrounds around two or more successive turns  213   a/   213   b  to maintain the helical shape of the helix balloon  113 . For instance, as shown in the example of  FIG.  15   c   , three band connectors  550  could be used. In this particular example, the three band connectors  550  are spaced evenly about the circumference of the helix balloon, e.g., each band connector  550  is separated from adjacent band connectors by about 120 degrees. However, other arrangements are contemplated. 
     Each band connector  550  is a rectangular complaint or semi-compliant or noncompliant sheet that is configured to be folded into the folded state shown in  FIGS.  15   a - b    over the successive turns  213   a/   213   b  of the helix balloon  113 . The band connector  550  could be made of, for example, Pebax®, TPU (thermoplastic polyurethane), TPE (thermoplastic elastomer), epoxy, nylon, PET, or acrylate. The sheet has a thickness t (shown in  FIG.  15   b   ) which can be between about 0.05 and 0.02 mm, in some examples. The folding results in an overlapping portion  552  in which ends  554   a/   554   b  of the band connector overlap one another and are secured to one another to provide the folded state in which the band connector  550  maintain the shape of the helix balloon  113 . The securing can be by adhesion with an adhesive, heating, welding, bonding, or pressurization. 
     For an example band connector  550  that is noncompliant, it may be formed of multiple separate pieces that are assembled and connected to one another by a locking mechanism or bonding/other method of connection suitable for the material. 
     In the folded state, the band connector  550  has a folded length L and a folded width W. The overlapping portion  552  has a length Lo, which in some examples is greater than about 3 mm. The length of the sheet in the unfolded state is selected to provide the folded length L and folded width W, taking into account the length Lo of the overlapping portion  552 . For instance, the width W can be selected such the folded band connector  550  fits around the diameter D of the tubular balloon  112  as shown in  FIG.  15   b   . The width W is therefore equal to D+2t. In a particular example, the width W is between about 0.5 and 2 mm. The length L is selected to surround a desired number of successive turns  213   a/   213   b  of the helix balloon  113 . The length L is therefore equal to about n*D+2*t where n is the number of successive turns  213   a/   212   b  around which the band connector  550  wraps. In some examples, n is 3-5. 
     In some examples, overlapping band connectors  550  could be used. For instance, for a set of 10 turns  213   a/   213   b  of the helical balloon, turns 2-5 could be subject to one band connector  550 , and turns 4-7 could be subject to another band connector  550 , and so on. The band connectors  550  can thus be staggered/overlapped along the axial length and circumference of the helix balloon  113 . In some examples the band connectors  550  can be connected to one another such as by any of the connection methods discussed above for the overlapping portion  552 . 
       FIGS.  16   a - b    show a mandrel  575  which can be used to assemble the helix balloon  113  with the band connector  550 . The mandrel  575  includes threads  577  which define spaces  579  configured to receive the tubular balloon  112  to form the helix balloon  113 . The mandrel includes at least one groove  581  configured to receive a portion  550   a  of the band connector. The tubular balloon  112  is then wound into the spaces  577  over the portion  550   a  of the band connector. A second portion  550   b  of the band connector is then folded into the folded state around the helix balloon  113  and joined to the first portion  550   a , e.g., at the overlapping portion  552  as discussed above, as shown in  FIG.  16   b   . 
     The mandrel  575  of  FIGS.  16   a - b    can also be used for assembling the helix balloon  113  with the clip  500  discussed above. In one example, the center leaf  502  of the clip  500  can be placed in the groove  581  of the mandrel  575  and the foldover leaves  504   a/   504   b  are arranged such that the tubular balloon  112  can be wound into the spaces  577  through the openings  508  and over the center leaf  502 . The foldover leaves  504   a/   504   b  can then be moved to the folded position such as the one shown in  FIG.  14   d    and in some examples, can be held in the folded position by a thin strip of tape or other material. 
     11. Coextruded Restraint 
     In one example shown in  FIGS.  17   a - b   , the matrix component  114  includes a plurality of restraints on adjacent turns 213 a/   213   b  of the helix balloon  113 . The restraints are tabs  600  that extend from the turns  213   a/   213   b  of the helix balloon. One or both of the tabs  600  have a length L that is longer than half of a distance y between adjacent turns  213   a/   213   b  of the helix balloon  113  (which is known as the pitch of a helix). Therefore, the tabs  600  overlap one another at an overlapping portion  602 . The length L can be between about 0.5 mm to 2 mm in some examples. The width W can also be between about 0.5 mm to 2 mm. Overlapping tabs  600  may have the same or different widths W. The thickness of the tabs can be between about 0.05 mm to 0.02 mm in some examples. 
     The tabs  600  are bonded at the overlapping portion  602  to constrain the turns  213   a/   213   b  of the helix balloon  113 . The bonding can be by any known method suitable for the material of the tabs  600 , such as by an adhesive, welding, pressurization, etc. 
     Several tabs  600  may be formed at predetermined distances along the helix balloon  113  so that when the helix balloon  113  is wound to define a lumen  120  with a desired diameter, the tabs  600  of successive turns  213   a/   213   b  overlap one another. For instance, when the helix balloon  113  is wound into the helix, the tabs  600  may be spaced 120 degrees from one another around the circumference of the helix. In another example, the tab  600  may be a continuous tab formed along the length of the unwound helix balloon  113  so that when the helix balloon  113  is wound the tab  600  overlaps itself at the overlapping portion  602  between adjacent turns  213   a/   213   b.    
     As shown in  FIG.  17   c   , in some examples, the tabs  600  includes a lip  604  at the distal end of the tab  600 . The lips  604  of adjacent tabs  600  interact with one another at the overlapping portion  602  to improve the bond/join of the tabs  600 . In this example, the tabs  600  may be aligned or may be offset from one another to facilitate engagement of the lips  604  as shown in  FIG.  17     c.    
     The tabs  600  are co-extruded with the helix balloon  113 . That is, the tabs  600  are formed as the helix balloon  113  is being formed and therefore are integral with the helix balloon  113 . The tabs  600  can be the same or different material as the tubular balloon  112 . The tabs  600  can  0 comprise, for example, PET (polyethylene terephthalate), nylons, engineered nylons, polyamides, polyurethanes, nylon elastomers, and other thermoplastic elastomers. 
     13. Strip with Flaps 
     In one example shown in  FIGS.  18   a - c   , the matrix component  114  includes a strip  700  with a series of flaps  702  corresponding to the turns  213   a/   213   b  of the helix balloon  113 . The flaps  702  wrap around the turns  213   a/   213   b  of the helix balloon as shown in  FIGS.  18   b - c    to connect the strip  700  to the helix balloon  113  and constrain the helix balloon  113  in the helix. The strip  700  can be long enough to span the axial length of the wound helix balloon  113 , in some examples. 
     In other examples, the strip  700  only spans some of the turns  213   a/   213   b  of the helix balloon  113 . More than one strip  700  may be used. In a particular example, the matrix component  114  includes three strips  700  arranged about 120 degrees from one another along the circumference of the helix balloon  113 . 
     The flaps  702  each have a length L and width W ( FIG.  18   a   ) that is between about 0.5 mm and about 2 mm. The thickness of the flaps may be between about 0.05 mm and 0.2 mm. The length L is longer than the circumference of the tubular balloon  112  so that when the flap  702  wraps around each turn  213   a/   213   b , it overlaps itself at an overlapping portion  704 . The flap  702  can be secured to itself at the overlapping portion  704  and/or can be secured to the tubular balloon  112  by any suitable method such as by an adhesive, welding, pressurization, etc. 
     The mandrel  375  of  FIGS.  13   a - c    can be used to assemble the helix balloon  113  with the strip  700 . The strip is arranged so that the flaps  702  correspond to spaces  379 . The flaps  702  extend over the spaces  379 . The tubular balloon  112  is wound into the spaces  379  over the flaps  702 . The flaps  702  are then wrapped around the turns  213   a/   213   b  and attached as discussed above. 
     The strip  700  can be the same or different material as the tubular balloon  112 . The strip  700  can comprise, for example, PET (polyethylene terephthalate), nylons, engineered nylons, polyamides, polyurethanes, nylon elastomers, and other thermoplastic elastomers. 
     12. Scalloped Restraint 
     In one example shown in  FIGS.  19   a - c   , the matrix component  114  includes a scalloped restraint  800 . The scalloped restraint  800  includes two scalloped strips  802   a / 802   b  each pre-formed with scallops  804  having a semi-spherical profile and corresponding to the curvature of the tubular balloon  112 . The scalloped strips  802   a / 802   b  are arranged so that the tubular balloon  112  is sandwiched between them, constraining the helix balloon  113  in the helix. The scalloped strips  802   a 6   / 802   b  are bonded at joined portions  806  between each successive turn  213   a/   213   b  of the helix balloon by any suitable method, such as by an adhesive, welding, pressurization, etc. 
     The scalloped restraint  800  can be long enough to span the axial length of the wound helix balloon  113 , in some examples. In other examples, the scalloped restraint  800  only spans some of the turns  213   a/   213   b  of the helix balloon  113 . More than one scalloped restraint  800  may be used. In a particular example, the matrix component  114  includes three scalloped restraint  800  arranged about 120 degrees from one another along the circumference of the helix balloon  113 . 
     The scalloped restraint  800  can be the same or different material as the tubular balloon  112 . The scalloped restraint  800  can comprise, for example, PET (polyethylene terephthalate), nylons, engineered nylons, polyamides, polyurethanes, nylon elastomers, and other thermoplastic elastomers. 
     The scalloped strips  802   a / 802   b  each have a width W ( FIGS.  19   b - c   ) that is between about 0.5 mm and about 2 mm. The thickness of the scalloped strips  802   a / 802   b  may be between about 0.05 mm and 0.2 mm. 
     The mandrel  375  of  FIGS.  13   a - c    can be used to assemble the helix balloon  113  with the scalloped restraint  800 . One of the scalloped strips  802   a  is arranged over the mandrel  375  so that the scallops  804  fit into the the spaces  379 . The tubular balloon  112  is wound into the spaces  379  over the scalloped strip  802   a . The other of the scalloped strips  802   b  is then laid over the helix balloon  113  and the scalloped strips  802   a / 802   b  are joined at the joined portions. 
     In some examples, the scalloped strips  802   a / 802   b  can be joined into a single long strip that can be folded over itself to provide two opposed scalloped strips  802   a / 802   b  (similar to the band connector  500  discussed above). 
     C. Examples 
       FIG.  7   a    is a diagram illustrating a perspective view of a helix  113  and matrix  114  configuration that includes a tubular balloon constrained in the shape of a helix by a weave  145  functioning as a matrix  114 . The central lumen  120  inside the helix is 0.058 inches, which is created by wrapping the tubular balloon  112  around a mandrel and secured by the matrix  114 . Twelve threads  144  that are 0.002 inches in diameter form the matrix  114 . 
       FIG.  7   b    is a diagram illustrating an example of a side view of the helix  113  and matrix  114  configuration of  FIG.  7     a.    
       FIG.  7   c    is a diagram illustrating an example of a planar front view of the helix  113  and matrix  114  configuration of  FIGS.  7   a  and  7   b   . As illustrated in the figure, the 12 threads are uniformly spaced around the helix balloon  113 . 
       FIG.  7   d    is a diagram illustrating an example of a perspective section view of the helix  113  and matrix  114  configuration of  FIGS.  7   a   - 7   c.    
       FIG.  7   e    is a diagram illustrating an example of a close-up view of the illustration in  FIG.  7     d.    
       FIG.  7   f    is a hierarchy diagram illustrating various examples of different helix balloon  113  and matrix components  114 . As illustrated by the dotted line in the figure, the matrix  114  is an optional component although often a highly desirable one. As illustrated in the Figure, a helix balloon  113  can be implemented as a self-expanding helix component  141 , a mechanically-expanding helix component  142 , as well as the inflatable helix balloon  113  illustrated in  FIGS.  7   a - 7   e   . As illustrated in the Figure, the matrix  114  can be implemented as a weave  145 , a bonding agent  146 , a thermally formed connection  147 , and a matrix cover  148 . As discussed above, the matrix  114  can include a medicinal component  126 . 
     Viii. GLOSSARY/INDEX 
     Table 1 below is a chart linking together element numbers, element names, and element descriptions. 
     
       
         
           
               
               
               
             
               
                 TABLE 1 
               
               
                   
               
               
                 # 
                 Name 
                 Description 
               
               
                   
               
             
            
               
                   
               
            
           
           
               
               
               
            
               
                 80 
                 Medical Device 
                 A device that serves a medical purpose within the body of the 
               
               
                   
                   
                 patient 90. The system 100 creates the lumen 120 in order to 
               
               
                   
                   
                 provide space for the medical device 80 to be positioned at a 
               
               
                   
                   
                 desired location 88 within the body of the patient 90. 
               
               
                 81 
                 Medical 
                 A process performed on or in a patient 90 by a provider 92 for the 
               
               
                   
                 Procedure 
                 purpose of benefiting the health status of the patient 90. 
               
               
                   
                   
                 Examples of medical procedures 81 that can benefit from the 
               
               
                   
                   
                 creation of a lumen 120 or the enhancement of a lumen 120 can 
               
               
                   
                   
                 include but are not limited to Percutaneous Coronary Intervention 
               
               
                   
                   
                 (PCI), Percutaneous Coronary Angiogram (PCA), Chronic Total 
               
               
                   
                   
                 Occlusions (CTO), Stent implantation, Atherectomy, and Embolic 
               
               
                   
                   
                 Protection. Although the system 100 was originally devised to 
               
               
                   
                   
                 assist providers 92 with respect to coronary vascular procedures, 
               
               
                   
                   
                 the system 100 can benefit patients 90 in other contexts. 
               
               
                 88 
                 Desired Location 
                 A position within the body of the patient 90 that the provider 92 
               
               
                   
                   
                 desires to create a lumen 120 for the insertion of a medical device 
               
               
                   
                   
                 80 and/or the performance of a medical procedure 81. 
               
               
                 90 
                 Patient 
                 The beneficiary of the medical device 80. The patient 90 is the 
               
               
                   
                   
                 organism in which the lumen 120 is created for the purposes of 
               
               
                   
                   
                 positioning and utilizing the medical device 80. The system 100 
               
               
                   
                   
                 can be used with respect to a wide variety of different types of 
               
               
                   
                   
                 patients 90 including but not limited to, human beings, other 
               
               
                   
                   
                 types of mammals, other types of animals, and other living 
               
               
                   
                   
                 organisms. 
               
               
                 91 
                 Blood Vessel 
                 A passageway in the body of the patient 90 through which blood 
               
               
                   
                   
                 circulates. 
               
               
                 92 
                 Provider 
                 A person who provides health care assistance to the patient 90. 
               
               
                   
                   
                 The provider 92 is typically a physician 92, but other 
               
               
                   
                   
                 professionals such as nurses, paramedics, physician assistants, 
               
               
                   
                   
                 etc. may also act as providers 92 with respect to the system 100. 
               
               
                 100 
                 System 
                 A collection of components that collectively provide for the 
               
               
                   
                   
                 functionality of creating a space 120 within a body. 
               
               
                 101 
                 Direct Expansion 
                 Embodiments of the system 100 that directly inflate or deflate the 
               
               
                   
                 Embodiments 
                 expansion component 110 in order to change operating modes 
               
               
                   
                   
                 130. Direct expansion embodiments 101 can include but are not 
               
               
                   
                   
                 limited to a balloon 111, such as a tubular balloon embodiments 
               
               
                   
                   
                 103 and helix balloon embodiments 104. 
               
               
                 102 
                 Indirect 
                 Embodiments of the system 100 that utilize other components of 
               
               
                   
                 Expansion 
                 the system 100 to expand or shrink the expansion component 
               
               
                   
                 Embodiments 
                 110. Indirect expansion embodiments 102 can include but are not 
               
               
                   
                   
                 limited to guide balloon embodiments 105 (expansion component 
               
               
                   
                   
                 110 expands by advancing on a guide balloon 115), insertion 
               
               
                   
                   
                 component embodiments 106 (expansion component 110 expands 
               
               
                   
                   
                 by the insertion of an insertion component 117), and sheathed 
               
               
                   
                   
                 balloon embodiments 107 (expansion component 110 expands 
               
               
                   
                   
                 when it is removed from and no longer constrained by the sheath 
               
               
                   
                   
                 119). 
               
               
                 103 
                 Tubular Balloon 
                 An embodiment of the system 100 where the expansion 
               
               
                   
                 Embodiments 
                 component 110 is a tubular balloon 
               
               
                 104 
                 Helix Balloon 
                 An embodiment of the system 100 where the expansion 
               
               
                   
                 Embodiments 
                 component 110 is a helix balloon. 
               
               
                 105 
                 Guide Balloon 
                 An embodiment of the system 100 where a the expansion 
               
               
                   
                 Embodiments 
                 component 110 is advanced over a guide balloon 115 (which is a 
               
               
                   
                   
                 type of balloon 111) that is in an inflated state in order to expand 
               
               
                   
                   
                 the expansion component 110 from a low-profile operating mode 
               
               
                   
                   
                 132 into a high-profile operating mode 134. 
               
               
                 106 
                 Insertion 
                 An embodiment of the system 100 where an insertion component 
               
               
                   
                 Component 
                 is inserted into the expansion component 110 to expand the 
               
               
                   
                 Embodiments 
                 expansion component 110 from a low-profile operating mode 132 
               
               
                   
                   
                 into a high-profile operating mode 134. 
               
               
                 107 
                 Sheathed 
                 An embodiment of the system 100 where a sheathed balloon 118 
               
               
                   
                 Balloon 
                 is removed from a sheath 119 to change from a low-profile 
               
               
                   
                 Embodiments 
                 operating mode 132 into a high-profile operating mode 134. The 
               
               
                   
                   
                 sheathed balloon 118 expands when no longer constrained by the 
               
               
                   
                   
                 sheath 119. 
               
               
                 108 
                 Expansion 
                 Embodiments of the system 100 that involve some type of a 
               
               
                   
                 Component 
                 balloon 111 as the expansion component 110. Examples of 
               
               
                   
                 Balloon 
                 expansion component balloon embodiments 108 can include but 
               
               
                   
                 Embodiments 
                 are not limited to tubular balloon embodiments 103, helix balloon 
               
               
                   
                   
                 embodiments 104, and sheath embodiments 107. 
               
               
                 109 
                 Expansion 
                 Embodiments of the system 100 that do not involve an expansion 
               
               
                   
                 Component Non- 
                 component 110 that is a balloon 111. Examples of expansion 
               
               
                   
                 Balloon 
                 component non-balloon embodiments 109 can include but are not 
               
               
                   
                 Embodiments 
                 limited to guide balloon embodiments 105 (expansion component 
               
               
                   
                   
                 110 is advanced onto an inflated guide balloon 115) and insertion 
               
               
                   
                   
                 component embodiments 106 (insertion component 117 such as a 
               
               
                   
                   
                 second guide catheter 121 is inserted into the expansion 
               
               
                   
                   
                 component 110). 
               
               
                 110 
                 Expansion 
                 Potentially any mechanism that can expand from a low-profile 
               
               
                   
                 Component 
                 operating mode 132 into a high-profile operating mode 134 to 
               
               
                   
                   
                 create the space 120. 
               
               
                 111 
                 Balloon 
                 An at least semi-flexible container, such that filling the container 
               
               
                   
                   
                 changes the shape of the container. Balloons can be inflated with 
               
               
                   
                   
                 air, other types of gasses, water, and other types of liquids. Some 
               
               
                   
                   
                 embodiments of balloons 111 can be inflated utilizing mechanical 
               
               
                   
                   
                 means. Many categories of expansion components 110 are 
               
               
                   
                   
                 balloons 111 (tubular balloon embodiments 103, helix balloon 
               
               
                   
                   
                 embodiments 104, and sheathed balloon embodiments 107) or are 
               
               
                   
                   
                 used in conjunction with balloons 111 (guide balloon 
               
               
                   
                   
                 embodiments 105). 
               
               
                 112 
                 Tubular Balloon 
                 A balloon 111 with a “donut hole” in the center of the balloon 
               
               
                   
                   
                 111. When the tubular balloon 112 is inflated, the “donut hole” at 
               
               
                   
                   
                 the center of the balloon 111 is the lumen 120. 
               
               
                 113 
                 Helix Balloon 
                 A balloon 111 that is helix or helical shaped, like a coil or spring. 
               
               
                   
                   
                 The center of the helix can be used to create a lumen 120 when 
               
               
                   
                   
                 the helix balloon 113 expands from a low-profile state 132 into a 
               
               
                   
                   
                 high-profile state 134. The helix balloon 113 may be coupled 
               
               
                   
                   
                 with a matrix 114 to reinforce and augment the desired shape and 
               
               
                   
                   
                 structural attributes of the helix balloon 113. 
               
               
                 114 
                 Matrix or Matrix 
                 A mechanism or configuration of mechanisms that keep the 
               
               
                   
                 Component 
                 balloon 111 in the shape of a helix balloon 113. The matrix 114 
               
               
                   
                   
                 maintains the helical shape of the helix balloon 113 in all 
               
               
                   
                   
                 operating modes 130. The matrix 114 can be implemented in a 
               
               
                   
                   
                 wide variety of different embodiments, including but not limited 
               
               
                   
                   
                 to a weave 145, a bonding agent 146, a thermally formed 
               
               
                   
                   
                 connection 147, a cover 148, and a flange 149. The cross 
               
               
                   
                   
                 sectional shape of the helix balloon 113 can be maintained 
               
               
                   
                   
                 differently in different operating modes 130. For example, the 
               
               
                   
                   
                 cross section of the helix balloon 113 would otherwise be round 
               
               
                   
                   
                 in an inflated state (high-profile operating mode 134) and flat in a 
               
               
                   
                   
                 deflated state (low-profile operating mode 132). The matrix 114 
               
               
                   
                   
                 can maintain the helical shape in both states. The matrix 114 
               
               
                   
                   
                 needs the both flexibility and strength to properly perform its 
               
               
                   
                   
                 function. The matrix 114 can also be referred to as a matrix 
               
               
                   
                   
                 component 114. 
               
               
                 115 
                 Guide Balloon 
                 The balloon 111 used in conjunction with a cover 116 to change 
               
               
                   
                   
                 the cover 116 from a low-profile operating mode 132 into a high- 
               
               
                   
                   
                 profile operating mode 134. 
               
               
                 116 
                 Cover 
                 The expansion component 110 can be implemented as a cover 
               
               
                   
                   
                 116 to the guide balloon 115 or to the insertion component 117. 
               
               
                   
                   
                 In the context of an insertion component embodiment 106, the 
               
               
                   
                   
                 cover 116 can be an integral part of a customary guide catheter 
               
               
                   
                   
                 121 in the form of an extension on the distal end of the guide 
               
               
                   
                   
                 catheter 121. In many such embodiments, the cover 116 can be 
               
               
                   
                   
                 permanently and irremovably attached from the guide catheter 
               
               
                   
                   
                 121 at the time of manufacture. The cover 116 can also be 
               
               
                   
                   
                 referred to as an expandable cover. 
               
               
                 117 
                 Insertion 
                 A device that is inserted into the expansion component 110 to 
               
               
                   
                 Component 
                 trigger the expansion of the expansion component 110 from a 
               
               
                   
                   
                 low-profile operating mode 132 into a high-profile operating 
               
               
                   
                   
                 mode 134. In some embodiments, the insertion component 117 
               
               
                   
                   
                 can be a second guide catheter 121. 
               
               
                 118 
                 Sheathed 
                 A balloon 111 that is naturally in an expanded state. The sheathed 
               
               
                   
                 Balloon or 
                 balloon 118 changes from a low-profile operating mode 132 into 
               
               
                   
                 Sheath Balloon 
                 a high-profile operating mode 134 when it is removed from a 
               
               
                   
                   
                 sheath 119. The sheath 119 compresses a sheathed balloon 118 
               
               
                   
                   
                 from what would otherwise be a high-profile operating mode 134 
               
               
                   
                   
                 into a low-profile operating mode 132. In the some 
               
               
                   
                   
                 embodiments, the sheathed balloon 118 is a braid 124. 
               
               
                 119 
                 Sheath 
                 A container of the sheathed balloon 118. The sheath 119 
               
               
                   
                   
                 constrains the sheathed balloon 118 such that the sheathed 
               
               
                   
                   
                 balloon 118 remains in a low-profile operating mode 132 so long 
               
               
                   
                   
                 as the sheathed balloon 118 remains within the sheath 119. Upon 
               
               
                   
                   
                 removal from the sheath 119, the sheathed balloon 118 expands 
               
               
                   
                   
                 from a low-profile operating mode 132 into a high-profile 
               
               
                   
                   
                 operating mode 134. 
               
               
                 120 
                 Lumen 
                 Space in the body of the patient 90 that is created by system 100. 
               
               
                   
                   
                 “Lumen” 120 is a medical term of art. The space is typically in 
               
               
                   
                   
                 the shape of a passageway or tunnel through the expansion 
               
               
                   
                   
                 component 110 for use by other medical devices 80 and/or in the 
               
               
                   
                   
                 performing of medical procedures 81 in the treatment of a patient 
               
               
                   
                   
                 90. The transition of the expansion component 110 from a low- 
               
               
                   
                   
                 profile operating mode 132 into a high-profile operating mode 
               
               
                   
                   
                 134 creates a lumen 120. 
               
               
                 121 
                 Guide Catheter 
                 A tube through which other medical devices 80 or the expansion 
               
               
                   
                   
                 component 110 and other components of the system 100 can be 
               
               
                   
                   
                 inserted and positioned within the patient 90. Guide catheters 121 
               
               
                   
                   
                 are a very common and fundamental medical device 80 used for 
               
               
                   
                   
                 vascular catheterization procedures. Different embodiments of 
               
               
                   
                   
                 the system 100 can involve zero, one, two, or even 3 or more 
               
               
                   
                   
                 guide catheters 121. 
               
               
                 122 
                 Guide Wire 
                 A wire or similar cord used to “guide” other medical devices 80 
               
               
                   
                   
                 to the desired location 88 within the patient 90. It can also be 
               
               
                   
                   
                 used to connect different components of the system 100 to each 
               
               
                   
                   
                 other. It is often useful to have a relatively thin wire 122 act in 
               
               
                   
                   
                 the lead of other components of the system 100. The guide wire 
               
               
                   
                   
                 122 is a very common and fundamental medical device 80 used 
               
               
                   
                   
                 for vascular catheterization procedures. 
               
               
                 123 
                 Stent 
                 A type of medical device 80 that can be implanted within the 
               
               
                   
                   
                 blood vessel 91 of a patient 90 to keep the vessel 91 open for 
               
               
                   
                   
                 blood flow. Some embodiments of the system 100 are intended 
               
               
                   
                   
                 to create a lumen to facilitate inserting the stent 123 to the desired 
               
               
                   
                   
                 location 88. The stent 123 can also be referred to as a stent 
               
               
                   
                   
                 catheter. 
               
               
                 124 
                 Braid or Braid 
                 A type of self-expanding sheathed balloon 118 and a type of 
               
               
                   
                 Balloon 
                 expansion component 110. The construction of the braid 124 can 
               
               
                   
                   
                 be designed to provide optimum performance. Braid 124 
               
               
                   
                   
                 characteristics such as number of wires, shape of wire, wire 
               
               
                   
                   
                 material, pitch, uniform pitch, variable pitch and weave pattern can 
               
               
                   
                   
                 be chosen to obtain the desired performance. More or less wires, 
               
               
                   
                   
                 and wire material, can affect strength and flexibility of the 
               
               
                   
                   
                 component. Round wires or flat wires can affect wall thickness. 
               
               
                   
                   
                 Pitch and weave pattern can affect expansion strength and profile 
               
               
                   
                   
                 size. 
               
               
                 125 
                 Attachment Wire 
                 A wire that is attached to a balloon 111 or other form of expansion 
               
               
                   
                   
                 component 110. Unlike a guide wire 122, the expansion 
               
               
                   
                   
                 component 110 does not move along the wire 125, but is fixed to 
               
               
                   
                   
                 the wire 125. 
               
               
                 126 
                 Medicinal 
                 A substance used in diagnosing and/or treating a disease, illness, 
               
               
                   
                 Component 
                 or medical condition in a patient 90. Some embodiments of the 
               
               
                   
                   
                 matrix 114 can include a medical component 126, typically in the 
               
               
                   
                   
                 form of a coating on the matrix 114. The matrix 114 may contain 
               
               
                   
                   
                 vaso-active agents to cause vasoconstriction or vasodilation, 
               
               
                   
                   
                 depending on what may be required. Such an agent may be 
               
               
                   
                   
                 transient or longer lasting. Nitric oxide is an example of a vaso- 
               
               
                   
                   
                 active agent that can dilate a vessel, which would make the vessel 
               
               
                   
                   
                 bigger (larger diameter) until the agent wears off. The matrix 114 
               
               
                   
                   
                 may contain any of the class of drug coatings that prevent intimal 
               
               
                   
                   
                 hyperplasia. Intimal hyperplasia often is a physiologic response to 
               
               
                   
                   
                 an angioplasty procedure resulting in restenosis of the treated area, 
               
               
                   
                   
                 which in layman&#39;s terms is a clogged stent 123. 
               
               
                 130 
                 Operating Mode 
                 A status or state of the expansion component 110. The expansion 
               
               
                   
                   
                 component 110 includes at least two operating modes 130: (a) a 
               
               
                   
                   
                 low-profile operating mode 132; and (b) a high-profile operating 
               
               
                   
                   
                 mode 134. Some embodiments of the system 100 may involve 
               
               
                   
                   
                 one or more operating modes 130 between the two extremes of a 
               
               
                   
                   
                 low-profile operating mode 132 and a high-profile operating 
               
               
                   
                   
                 mode 134. Many embodiments of the expansion component 110 
               
               
                   
                   
                 can transform from a high-profile operating mode 134 back into a 
               
               
                   
                   
                 low-profile operating mode 132 when the lumen 120 is no longer 
               
               
                   
                   
                 required or desired. The operating mode 130 can also be referred 
               
               
                   
                   
                 to as a state 130. 
               
               
                 132 
                 Low-Profile 
                 The operating mode 130 of the expansion component 110 in 
               
               
                   
                 Operating Mode 
                 which the size of the space 120 is not maximized. Can also be 
               
               
                   
                   
                 referred to as a low-profile state 132. 
               
               
                 134 
                 High-Profile 
                 The operating mode 130 of the expansion component 110 in 
               
               
                   
                 Operating Mode 
                 which the size of the lumen 120 is maximized. Can also be 
               
               
                   
                   
                 referred to as a high-profile state 134. 
               
               
                 141 
                 Self-Expanding 
                 A helix balloon 113 that self-expands. In other words, the natural 
               
               
                   
                 Helix 
                 default state of a self-expanding helix component 141 is a high- 
               
               
                   
                 Component 
                 profile operating mode 134 rather than a low-profile operating 
               
               
                   
                   
                 mode 132. 
               
               
                 142 
                 Mechanically- 
                 A helix balloon 113 that utilizes mechanical means such as 
               
               
                   
                 Expanding Helix 
                 springs to “inflate” (i.e. to transition between operating modes 
               
               
                   
                 Component 
                 130) rather than a gas or liquid. 
               
               
                 144 
                 Thread 
                 A cord, fiber, wire, ribbon, strip or other strand of material used 
               
               
                   
                   
                 in a weave 145. 
               
               
                 145 
                 Weave 
                 A weave 145 can be a configuration of one or more threads 144 
               
               
                   
                   
                 that can contain the balloon 111 in the shape of a helix balloon 
               
               
                   
                   
                 113. The weave 145 can use as many or as few threads 144 as 
               
               
                   
                   
                 desired. In many embodiments, between 10-12 threads 144 
               
               
                   
                   
                 uniformly distributed about the helix balloon 113 is a particular 
               
               
                   
                   
                 desirable configuration. The weave 145 would wrap around the 
               
               
                   
                   
                 helix balloon 113 as the helix balloon 113 makes consecutive 
               
               
                   
                   
                 passes of the helical shape. 
               
               
                 146 
                 Bonding Agent 
                 A chemical means to constrain the shape of the helix balloon 113. 
               
               
                   
                   
                 The matrix 114 can be made from a bonding agent 146 that is 
               
               
                   
                   
                 applied to a balloon 111 to secure its shape as a helix balloon 
               
               
                   
                   
                 113. A bonding agent 146 can be used by itself or with other 
               
               
                   
                   
                 components to maintain the helical shape of the helix balloon 
               
               
                   
                   
                 113. Consecutive passes of the helical shape can be bonded to 
               
               
                   
                   
                 adjacent passes. A wide variety of bonding agents including but 
               
               
                   
                   
                 not limited to adhesive glues or silicone can be used as possible 
               
               
                   
                   
                 bonding agents 146. The bonding agent 146 may be applied 
               
               
                   
                   
                 using dip coating techniques. 
               
               
                 147 
                 Thermally 
                 A constraint on the helix balloon 113 that is implemented through 
               
               
                   
                 Formed 
                 the application of heat. A wide range of thermal forming 
               
               
                   
                 Connection 
                 techniques known in the prior art can be used to connect adjacent 
               
               
                   
                   
                 passes of the helical shape together. The aggregate configuration 
               
               
                   
                   
                 of thermally formed connections 147 can by itself or in 
               
               
                   
                   
                 conjunction with other components, constitute the matrix 114. 
               
               
                 148 
                 Matrix Cover 
                 A relatively thin sheet or a collection of thin sheets that overlay 
               
               
                   
                   
                 the balloon 111 to shape it into a helix balloon 113. The matrix 
               
               
                   
                   
                 cover 148, which can also be referred to as a covering 148, can 
               
               
                   
                   
                 contain the helix balloon 113 and help maintain its helical shape. 
               
               
                   
                   
                 The matrix cover 148 can be made from a fabric or other similar 
               
               
                   
                   
                 material suitable for the particular location 88 in the patient 90. 
               
               
                   
                   
                 The matrix cover 148 can cover a single pass of the helical shape, 
               
               
                   
                   
                 multiple passes or all passes. The matrix cover148 can be used 
               
               
                   
                   
                 by itself or in conjunction with other components to constitute the 
               
               
                   
                   
                 matrix 114. The matrix 148 may be applied using dip coating 
               
               
                   
                   
                 techniques as well as other plausible manufacturing methods. 
               
               
                 149 
                 Flange 
                 A flange is a rim, collar, or ring that secures the balloon 111 into 
               
               
                   
                   
                 the shape of a helix balloon 113. The cross-section of the helix 
               
               
                   
                   
                 balloon 113 can have one or more flanges 149. Adjacent passes 
               
               
                   
                   
                 of the helical shape can be connected together by the flange 149. 
               
               
                   
                   
                 The connected flanges 149 in the aggregate can form the matrix 
               
               
                   
                   
                 component 114. Flanges 149 can be connected using a weave 
               
               
                   
                   
                 145, a bonding agent 146, a thermally formed connection 147, a 
               
               
                   
                   
                 matrix cover 148, and/or potentially other means. 
               
               
                 150 
                 Inflation Tube 
                 A passageway to the balloon 111, such as a tubular balloon 112 
               
               
                   
                   
                 or a helix balloon 113 that is used to inflate the balloon 111 with 
               
               
                   
                   
                 air or whatever gas or liquid is used to inflate the balloon 111. 
               
               
                 151 
                 Valve 
                 The connection between the inflation tube 150 and the balloon 
               
               
                   
                   
                 111.