System for creating a lumen

Abstract

An exemplary system for creating a lumen according to the present disclosure includes, among other things, a balloon wound into a generally helical shape having an inner surface and an outer surface, and a support attached to at least one of the generally helical inner and outer surfaces and constraining the tubular 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, the second diameter being greater than the first diameter. Other exemplary systems for creating a lumen and methods for creating a lumen in an artery are also disclosed.

Description

[Technical field]

[0001] The present invention relates to a system, device and method for creating a space. (Related Applications) This application claims priority to U.S. Provisional Patent Application No. 63 / 281,227, filed November 19, 2021, U.S. Provisional Patent Application No. 63 / 335,494, filed April 27, 2022, and U.S. Provisional Patent Application No. 63 / 354,421, filed June 22, 2022, each of which is incorporated by reference in its entirety. This application also claims priority to International Application No. PCT / US22 / 24803, filed April 14, 2022, which claims priority to U.S. Provisional Patent Application No. 63 / 174,718, filed April 14, 2021. The aforementioned international application is a continuation-in-part of U.S. Patent Application No. 17 / 379,423, filed July 19, 2021, which is a continuation-in-part of U.S. Patent Application No. 15 / 881,280, filed January 26, 2018, which is a divisional application of U.S. Patent Application No. 15 / 445,234, filed February 28, 2017, which is a continuation-in-part of U.S. Patent Application No. 14 / 524,834, filed October 27, 2014, which claims priority to U.S. Provisional Patent Application No. 61 / 896,052, filed October 26, 2013, and U.S. Provisional Patent Application No. 61 / 973,510, filed April 1, 2014, which are incorporated herein by reference in their entireties. U.S. Patent Application No. 17 / 379,423, filed July 19, 2021, U.S. Patent Application No. 15 / 881,280, filed January 26, 2018, U.S. Patent Application No. 15 / 445,234, filed February 28, 2017, and U.S. Patent Application No. 14 / 524,834, filed October 27, 2014, are all incorporated by reference herein in their entireties. [Background technology]

[0002] The present invention is a system, apparatus, and method (collectively, the "system") for creating space. More specifically, the system creates a lumen within the body to facilitate the use of a medical device, such as the use of a catheter within a blood vessel. The term "lumen" means a tube, conduit, or cavity of a tubular organ. Although the system can be implemented in a wide variety of different contexts, the initial inspiration for the conceptualization of the system arose in catheterization in human blood vessels. The system can facilitate catheterization by creating additional "working space" (i.e., a lumen) at a desired location within the patient's body. The additional space can be created by transitioning from a low-profile to a high-profile operating mode.

[0003] I. Catheterization Procedure

[0004] The term "catheter" collectively refers 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 nutrition, or (4) deliver medication. The term "catheter" is often used more specifically to refer to a tube that is inserted into a patient's body for the purposes of (a) removing a substance from a location within the patient's body and / or (b) delivering medicinal and / or nutritional substances to a specific location within the patient's body. Catheters can be used in a variety of locations for a variety of purposes within a patient's body. Catheterization procedures generally involve the diagnosis and treatment of a patient's cardiovascular, excretory, and other similar systems.

[0005] II. Cardiovascular disease is a global threat

[0006] Blood circulation is essential for a healthy body. Blood supplies organs and individual cells with the oxygen and nutrients necessary to sustain life. Blood also removes cellular metabolic waste products from the body. Proper flow of blood is a prerequisite for good health. At the center of the cardiovascular system is the heart, the organ responsible for pumping blood throughout the body. The heart acts as a pump at the center of the complex network of arteries and veins that make up the cardiovascular system. Thus, the cardiovascular system is responsible for the delivery of oxygen and nutrients, as well as the removal of certain waste products, throughout the body. The performance of the cardiovascular system can be evaluated in terms of cardiac output.

[0007] Unfortunately, age, disease, trauma, and / or other illnesses can impede the distribution of blood throughout the body. Cardiovascular disease is a serious health problem in the United States and elsewhere. Approximately one-third of deaths in the United States are attributable to cardiovascular disease, including heart attacks and strokes. According to the World Health Organization ("WHO"), cardiovascular disease is the number one cause of death in the world. In 2008, an estimated 17.3 million people died from cardiovascular disease, which represents 30% of all deaths that occurred that year. According to WHO estimates, the number of deaths caused by cardiovascular disease will reach 23.4 million by 2030.

[0008] The Centers for Disease Control and Prevention ("CDC") reports that "cardiovascular disease is the leading cause of death among all racial and ethnic groups in America." Many health problems in the United States are rooted in or manifest 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 narrow the arteries over time in a process called atherosclerosis. Plaque buildup can also cause chest pain or discomfort resulting from an inadequate supply of blood to the heart muscle. This is commonly referred to as a condition known as angina pectoris. Over time, CAD can lead to irregular heartbeats, a condition known as arrhythmia, and even heart failure.

[0009] III. Cardiovascular Catheterization Procedures

[0010] In the prior art, various catheterization procedures are used to diagnose and treat arterial disease. In cardiovascular disease, a catheter is often a long, thin, flexible, hollow intravascular tube used to access the body's cardiovascular system. Catheterization is most commonly performed through the radial artery in the wrist (transradial catheterization) or the femoral artery in the groin (transfemoral catheterization). Catheterization can also be performed through the elbow, neck, and other parts of the body.

[0011] A wide variety of endovascular procedures can be used to address cardiovascular health problems in humans. A percutaneous coronary intervention ("PCI") procedure is one type of endovascular procedure commonly referred to as "coronary angioplasty," "balloon angioplasty," or simply "angioplasty." Patients suffering from atherosclerosis develop narrowed or blocked coronary artery segments due to the buildup of cholesterol-containing plaque. Angioplasty is a medical procedure used to treat narrowed coronary arteries of the heart.

[0012] In angioplasty, the cardiologist delivers a deflated balloon or other similar device to the site of the blockage. The balloon can then be inflated at the blockage to open the artery. A stent is often permanently placed at the site of the 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 place a catheter at the desired location for the purpose of the angioplasty procedure.

[0013] IV. Access Issues

[0014] Catheterization procedures can provide a valuable, effective, and minimally invasive option for diagnosing and treating cardiovascular and other types of medical problems. Unfortunately, with prior art tools and techniques, it is not always possible to reach the site of the blockage with a catheter. Blockages in the blood vessels can block the catheter as well as blood flow. Two common problems of access are vessel tortuosity and minor stenosis. The vascular pathway to the blockage needing treatment can be very tortuous, meaning that the vascular pathway is very curved or tortuous, and an angioplasty balloon catheter cannot be inserted through the tortuous vessel. Also, portions of the blood vessels can be stenotic, meaning that there are smaller blockages that narrow the vessel too much and prevent the insertion of a balloon catheter. These smaller blockages are not usually intended to be treated with balloon angioplasty. It would be desirable to give healthcare providers enhanced tools and methodologies to work around obstacles to the site of the blockage. Summary of the Invention

[0015] An exemplary system for creating a lumen according to the present disclosure includes, among other things, a balloon wound into a generally helical shape having an inner surface and an outer surface, and a support attached to at least one of the generally helical inner and outer surfaces to constrain the balloon in the generally helical shape, the balloon having a first diameter in a low profile mode of operation, and the generally helical shape having a second diameter in a high profile mode of operation, the second diameter being greater than the first diameter.

[0016] An exemplary system for creating a lumen according to the present disclosure includes, among other things, a balloon wound into 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 central leaf and first and second receiving leaves on either side of the central leaf. Each of the first and second receiving leaves includes a first opening and a second opening, the first opening receiving the first turn of the generally helical shape and the second opening receiving the second turn of the generally helical shape. The balloon has a first diameter in a low profile mode of operation, and the generally helical shape has a second diameter in a high profile mode of operation, the second diameter being greater than the first diameter.

[0017] An exemplary system for creating a lumen according to the present disclosure includes a balloon wound into 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 encircling at least two consecutive turns of the generally helical shape, the balloon having a first diameter in a low profile mode of operation, and the generally helical shape having a second diameter in a high profile mode of operation, the second diameter being greater than the first diameter.

[0018] Many features and inventive aspects of the system are illustrated in the following drawings. However, a patent application cannot disclose all of the potential embodiments of an invention. In accordance with the provisions of the patent statutes, the principle and mode of operation of the system has been described and illustrated in certain preferred embodiments. However, it should be understood that the system may be practiced otherwise than as specifically described and illustrated without departing from its spirit or scope.

[0019] The description of the system and its various exemplifications should be understood to include all novel and non-obvious combinations of the elements described herein, and claims may be presented to any novel and non-obvious combinations of these elements in this or a later application. 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. [Brief description of the drawings]

[0020] [Figure 1a] FIG. 1 is a block diagram illustrating an example of a system for creating a lumen.

[0021] [Figure 1b] FIG. 13 is a flow chart illustrating an example of a process for creating a lumen.

[0022] [Figure 1c] FIG. 1 is an environmental diagram illustrating an example of extended components in a low profile mode of operation.

[0023] [Figure 1d] FIG. 13 is an environmental diagram illustrating an example of extended components in a high profile mode of operation.

[0024] [Figure 2a] FIG. 2 is a hierarchical diagram illustrating an example of different embodiments of the present system, including direct and indirect extension embodiments of the present system.

[0025] [Figure 2b] FIG. 1 is a hierarchical diagram illustrating an example of different embodiments of the system, including an expansion component balloon embodiment and an expansion component non-balloon embodiment.

[0026] [Figure 2c] FIG. 2 is a hierarchical diagram illustrating an example of different types of balloons that may be utilized by the present system.

[0027] [Figure 3a] FIG. 3b shows a close-up view of a portion of the tubular balloon expansion component shown in FIG. 3b.

[0028] [Figure 3b] FIG. 1 illustrates an example of an axial view of a tubular balloon expansion component.

[0029] [Figure 3c] FIG. 1 illustrates an example of a top view of a tubular balloon expansion component.

[0030] [Figure 3d] FIG. 1 illustrates an example of a side view of a tubular balloon expansion component.

[0031] [Figure 3e] FIG. 1 illustrates an example of a cross-sectional view of a side view of a tubular balloon expansion component, showing the space within the tubular balloon expansion component.

[0032] [Figure 3f] FIG. 3c shows an example of a close-up view of a portion of the tubular balloon expansion component shown in FIG. 3e.

[0033] [Figure 3g] FIG. 2 is a perspective partial view of an example of a tubular balloon expansion component.

[0034] [Figure 3h] FIG. 13 illustrates an example of a front view of a pleated tubular expansion component, showing an example of a passive expansion component.

[0035] [Figure 3i] FIG. 1 illustrates an example of a perspective view of a tubular balloon expansion component.

[0036] [Figure 3j] An example of a tubular balloon is shown in Figures 3e to 3g. [Figure 3k] An example of a tubular balloon is shown in Figures 3e to 3g. [Figure 3l] An example of a tubular balloon is shown in Figures 3e to 3g. [Figure 3m] An example of a tubular balloon is shown in Figures 3e to 3g.

[0037] [Figure 3n] 1 illustrates another exemplary tubular balloon having a triangular or near-triangular cross-section. [Figure 3o] 1 illustrates another exemplary tubular balloon having a triangular or near-triangular cross-section. [Figure 3p] 1 illustrates another exemplary tubular balloon having a triangular or near-triangular cross-section.

[0038] [Figure 4a] FIG. 13 is a flow chart diagram illustrating an example of a process for creating a lumen using a guide balloon embodiment of the present system.

[0039] [Figure 4b] FIG. 13 is an environmental diagram illustrating an example process step in which a guide balloon is inserted.

[0040] [Figure 4c] FIG. 1 is an environmental diagram illustrating an example process step in which a guide balloon is inflated.

[0041] [Figure 4d] FIG. 13 is an environmental diagram illustrating an example process step in which an expansion component in the form of a cover is advanced over an inflated guide balloon to expand the cover from a low-profile state to a high-profile state.

[0042] [Figure 4e] FIG. 13 is an environmental diagram illustrating an example of a process step in which a cover is positioned at a desired location within a patient's body to create a lumen at the desired location.

[0043] [Figure 4f]FIG. 13 is an environmental diagram illustrating an example process step in which the guide balloon is deflated and removed to create a lumen in the cover.

[0044] [Figure 4g] FIG. 13 is an environmental diagram illustrating an example process step in which a stent catheter is inserted through the space created by the cover.

[0045] [Figure 5a] FIG. 13 is a flow chart diagram illustrating an example of a process for creating a lumen using an insertion component embodiment of the present system.

[0046] [Figure 5b] FIG. 1 is an environmental diagram illustrating an example process step in which a cover is inserted into a patient's body.

[0047] [Figure 5c] FIG. 1 is an environmental diagram illustrating an example of a process step in which an insertion component is inserted into a cover (a type of expansion component) positioned within a patient's body to expand a distal portion of the expansion component and create a desired lumen at a desired location.

[0048] [Figure 5d] FIG. 1 is an environmental diagram illustrating an example process step in which a stent catheter is inserted through a cover.

[0049] [Figure 6a] FIG. 13 is a flow chart diagram illustrating an example of a process for creating a lumen using a sheathed balloon embodiment of the present system.

[0050] [Figure 6b] FIG. 13 is an environmental diagram illustrating an example process step in which a sheath covers a sheathed balloon during insertion of the sheathed balloon.

[0051] [Figure 6c]FIG. 1 is an environmental diagram illustrating an example of a process step in which a sheath and a sheathed balloon within the sheath are positioned at a desired location within a patient's body.

[0052] [Figure 6d] 1 is an environmental diagram illustrating an example process step in which the sheath is withdrawn, causing the balloon to self-expand since it is no longer constrained by the sheath, creating additional working space (i.e., lumen) within the patient's body.

[0053] [Figure 6e] FIG. 1 is an environmental diagram illustrating one example of how an expanded sheathed balloon can create or reinforce a lumen at a desired location within a patient's body.

[0054] [Figure 6f] FIG. 13 is an environmental diagram illustrating an example of a process step in which a stent catheter is inserted into a patient through a working space created by the presence of a balloon in a high profile mode of operation.

[0055] [Figure 6g] FIG. 13 is an environmental diagram illustrating an example process step in which a sheath is advanced to collapse the balloon for removal.

[0056] [Figure 7a] FIG. 13 shows a perspective view of a helix and matrix configuration, comprising a tubular balloon constrained in the shape of a helix by weaving that acts as a matrix.

[0057] [Figure 7b] FIG. 7b shows an example of a side view of the spiral and matrix configuration of FIG. 7a.

[0058] [Figure 7c] FIG. 7c shows an example of an axial view of the spiral and matrix configurations of FIGS. 7a and 7b.

[0059] [Figure 7d] FIG. 7B shows an example of a perspective cross-sectional view of the spiral and matrix configurations of FIGS. 7a-7c.

[0060] [Figure 7e] FIG. 7c shows an example of an exemplary close-up of FIG. 7d.

[0061] [Figure 7f] FIG. 2 is a hierarchical diagram illustrating one example of different components and component configurations that may be utilized in a spiral balloon embodiment of the present system.

[0062] [Figure 7g] 1 illustrates another exemplary spiral balloon having a triangular or near-triangular cross section when joined.

[0063] [Figure 8a] 1 illustrates an exemplary spiral balloon with canaliculi. [Figure 8b] 1 illustrates an exemplary spiral balloon with canaliculi. [Figure 8c] 1 illustrates an exemplary spiral balloon with canaliculi. [Figure 8d] 1 illustrates an exemplary spiral balloon with canaliculi. [Figure 8e] 1 illustrates an exemplary spiral balloon with canaliculi. [Figure 8f] 1 illustrates an exemplary spiral balloon with canaliculi.

[0064] [Figure 9a] 1 illustrates an exemplary tubular balloon with a connector. [Figure 9b] 1 illustrates an exemplary tubular balloon with a connector. [Figure 9c] 1 illustrates an exemplary tubular balloon with a connector.

[0065] [Figure 10a] 1 illustrates an exemplary tubular balloon having an inner support. [Figure 10b] 1 illustrates an exemplary tubular balloon having an inner support.

[0066] [Figure 11a] 1 illustrates an exemplary tubular balloon having an outer support. [Figure 11b] 1 illustrates an exemplary tubular balloon having an outer support.

[0067] [Figure 12a] 1 shows an example of a tubular balloon with inner / outer support. [Figure 12b] 1 shows an example of a tubular balloon with inner / outer support. [Figure 12c] 1 shows an example of a tubular balloon with inner / outer support. [Figure 12d] 1 shows an example of a tubular balloon with inner / outer support.

[0068] [Figure 13a] 1 illustrates an exemplary mandrel for assembling a tubular balloon having an outer support. [Figure 13b] 1 illustrates an exemplary mandrel for assembling a tubular balloon having an outer support. [Figure 13c] 1 illustrates an exemplary mandrel for assembling a tubular balloon having an outer support.

[0069] [Figure 14a] 1 illustrates an exemplary tubular balloon with a clip. [Figure 14b] 1 illustrates an exemplary tubular balloon with a clip. [Figure 14c] 1 illustrates an exemplary tubular balloon with a clip. [Figure 14d] 1 illustrates an exemplary tubular balloon with a clip. [Figure 14e] 1 illustrates an exemplary tubular balloon with a clip. [Figure 14f] 1 illustrates an exemplary tubular balloon with a clip. [Figure 14g] 1 illustrates an exemplary tubular balloon with a clip.

[0070] [Figure 15a] 1 illustrates an exemplary tubular balloon with a band connector. [Figure 15b] 1 illustrates an exemplary tubular balloon with a band connector. [Figure 15c] 1 illustrates an exemplary tubular balloon with a band connector.

[0071] [Figure 16a] 1 illustrates an exemplary mandrel for assembling a tubular balloon having an outer support. [Figure 16b] 1 illustrates an exemplary mandrel for assembling a tubular balloon having an outer support.

[0072] [Figure 17a] 1 illustrates an exemplary tubular balloon with a co-extruded restraint. [Figure 17b] 1 illustrates an exemplary tubular balloon with a co-extruded restraint.

[0073] [Figure 18a] 1 illustrates an exemplary tubular balloon with a strip having a series of flaps. [Figure 18b] 1 illustrates an exemplary tubular balloon with a strip having a series of flaps. [Figure 18c] 1 illustrates an exemplary tubular balloon with a strip having a series of flaps.

[0074] [Figure 19a] 1 illustrates an exemplary tubular balloon having a scalloped restraint. [Figure 19b] 1 illustrates an exemplary tubular balloon having a scalloped restraint. [Figure 19c] 1 illustrates an exemplary tubular balloon having a scalloped restraint. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0075] The present invention is a system, apparatus, and method (collectively, the "system") for creating space. More specifically, the system creates a lumen in the body to facilitate the use of medical devices, such as the use of a catheter in a blood vessel. The term "lumen" means a tube, conduit, or cavity of a tubular organ. While the system can be implemented in a wide variety of different contexts, the initial inspiration for the conceptualization of the system arose in catheterization in human blood vessels. The system can facilitate catheterization by creating additional "working space" (i.e., a lumen) at a desired location within the patient's body. The additional space can be created by transitioning from a low-profile to a high-profile operating mode. The additional space can enable the use of other medical devices by overcoming traditional access problems, such as vessel tortuosity or minor stenosis. The system allows a balloon angioplasty catheter or stent catheter to be inserted to a desired location through a luminal passageway or tunnel, overcoming access problems.

[0076] All numbered elements shown in the drawings and described in the text below that relate to structural components rather than process steps are defined in the glossary provided in Table 1 below.

[0077] I. Overview

[0078] The system can create a lumen within a patient's body that can be used to position a medical device, such as a catheter, that can potentially save the patient's life. The system can be described in terms of interacting entities, components, operating attributes, and processes.

[0079] A. Entity

[0080] As shown in FIG. 1a, system 100 is an interface between a health care provider 92 and a living body, or patient 90. The provider 92 is typically a physician, although nurses, paramedics, physician assistants, veterinarians, and other medical professionals can potentially function as provider 92 in certain circumstances. The patient 90 is typically a human, although other living bodies can comprise the patient 90 in certain circumstances. System 100 is a tool that the provider 92 can use to benefit the health status of the patient 90.

[0081] B. System

[0082] The purpose of the system 100 is to create sufficient "working space" (i.e., lumen 120) within the body of the patient 90 to allow for 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 even save the life of the patient 90.

[0083] C. Medical Devices and Procedures

[0084] 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, catheters of all kinds, stents, patient monitoring applications, and other similar invasive devices.

[0085] A catheter device is potentially any device that is inserted into the body of a patient 90. The term "catheter device" collectively refers 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 nutrition, or (4) deliver medication. The term "catheter device" is often used more specifically to refer to a tube that is inserted into the body of a patient 90 for the purposes of (a) removing a substance from a location within the body of the patient 90 and / or (b) delivering medicinal and / or nutritional substances to a specific location within the body of the patient 90. Catheters can be used in a variety of locations for a variety of purposes within the body of a patient 90. Catheterization procedures generally involve the diagnosis and treatment of the cardiovascular, excretory, and other systems of the patient 90.

[0086] The system 100 was originally conceived for the purpose of providing services to 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 angiography (PCA), chronic total occlusion (CTO), stenting, atherectomy, and embolic protection. The system 100 may be particularly useful in the context of transradial catheterization (catheterization in which the catheter first enters the patient 90 through the radial artery) because transradial catheterization typically involves catheterization devices that have a relatively small profile and a relatively sparse space to operate. The system 100, in its various embodiments, may also be used in a variety of settings, including cardiovascular care and treatment of entirely different conditions.

[0087] System 100 can also be used to deliver ingredients such as drugs, biologics, or excipients. For example, any portion of system 100, such as matrix 114 or tubular balloon 112 (described in more detail below), can be filled with an ingredient or encapsulated ingredients according to any known method. When system 100 is used intravascularly, contact between elements of system 100 releases the ingredient into the blood vessel.

[0088] The system 100 can also be used to temporarily improve blood perfusion in blood vessels that are tortuous or contain other obstacles, such as obstructions or occlusions.

[0089] System 100 can also be used to address a perforation or lesion in a blood vessel by being deployed at the perforation or lesion to apply pressure to the perforation or lesion to seal or reduce the size of the perforation or lesion and allow blood flow to continue through the vessel, as described in more detail below.

[0090] System 100 may also be used in conjunction with obtaining hemostasis at an access site. At the end of a catheterization procedure, when the last catheter or sheath is removed from the blood vessel (artery or vein), the hole in the blood vessel must be closed. Closing the hole in the blood vessel is called hemostasis. The hole in the blood vessel is called the access site. System 100 may be deployed at the access site to ensure continued perfusion through the blood vessel and act as a closure device, as described in more detail below. System 100 is deployed to cover the access site. This stops bleeding at the access site. With system 100 in place over the access site, the blood vessel is allowed to close naturally, or "self-heal." Once hemostasis at the access site is complete, system 100 may be removed. System 100 may be particularly advantageous for obtaining hemostasis at large caliber access sites, such as those for TAVR (Transcatheter Aortic Valve Replacement) procedures. In this example, system 100 may eliminate the need for surgical closure (suture closure) of the large caliber access site.

[0091] D. lumen

[0092] Lumen 120 is the space created within patient 90 by system 100. Lumen 120 is often referred to as a "duct, conduit, or cavity within a tubular organ." Lumen 120 is the "working space" within patient 90 in which medical device 80 is positioned. In many embodiments of system 100, lumen 120 is located within expansion component 110, which is at least substantially in the form of a hollow tube, and lumen 120 comprises a hollow core of expansion component 110.

[0093] E. Extension Components

[0094] The enhancement component 110 is a device that can exist in at least two operating modes 130 : a low profile operating mode 132 and a high profile operating mode 134 .

[0095] There are a wide variety of different embodiments of the extension component 110 that can be incorporated into a wide variety of different embodiments of the system 100. In many embodiments of the system 100, the extension component 110 can be converted from a high-profile mode of operation 134 back to a low-profile mode of operation 132 when the extension component 110 is no longer needed. In many embodiments, it may be easier for the provider 92 to remove the extension component 110 from the patient 90 when the extension component 110 is in the low-profile mode of operation 132.

[0096] The expansion components 110 can be categorized as direct versus indirect. Some embodiments of the system 100 utilize a balloon as the expansion component 110, while other embodiments of the system 100 utilize a non-balloon expansion component 110.

[0097] F. Operational Modes / States

[0098] The expansion component 110 can operate in two or more operating modes 130 (which may also be referred to as states 130). The low-profile operating mode 132 is typically the most convenient operating mode 130 for inserting 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 has been created and after the medical device 80 is properly positioned within the patient 90.

[0099] Some embodiments of the system 100 include one or more intermediate operating modes between the low profile operating mode 132 and the high profile operating mode 134 .

[0100] G. Process Flow Diagram

[0101] System 100 can be described as a series of process steps as well as an arrangement of interacting elements. FIG. 1b is a flow chart diagram illustrating an example of a method for creating lumen 120.

[0102] In step 200, the expansion component 110 is inserted into the patient 90. Different embodiments of the system 100 may include different types of expansion components 110 to create lumens 120 for different types of medical devices 80.

[0103] In step 202, the expandable component 110 is positioned within the patient 90. Different embodiments of the system 100 may include a variety of different locations within the patient 90.

[0104] In step 204, the operational mode 130 of the expansion component 110 is changed from a low-profile operational mode 132 to a high-profile operational mode 134 to create a lumen 120. The lumen 120 can serve as a "working space" for proper positioning and use of a medical device 80, such as a catheter.

[0105] In many embodiments, after the lumen 120 is created and the medical device 80 is properly positioned, the expansion component 110 is converted from the high-profile operating mode 134 back to the low-profile operating mode 132 to facilitate removal of the expansion component 110 from the body of the patient 90.

[0106] H. Operating environment

[0107] 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 situation should begin with identifying the desired medical device 80 to be used in the desired location. Next, an appropriate extension component 110 can be identified and selected.

[0108] 1c is an environmental diagram illustrating an example of the expansion component 110 in a low-profile mode of operation 132. The expansion component 110 is positioned at a desired location 88 within a blood vessel 91 of a patient 90.

[0109] FIG. 1d is an environmental diagram illustrating an example of an extended component 110 that has been converted (ie, extended) from a low-profile mode of operation 132 to a high-profile mode of operation 134.

[0110] I. Auxiliary Components

[0111] In many embodiments of the system 100, the expansion component 110 is only one component of many. For example, in the illustration of FIG. 1c and FIG. 1d, the expansion component 110 can interact with certain auxiliary components, such as a guide catheter 121 and a guide wire 122. In navigating various small blood vessels 91, various guide catheters 121 and guide wires 122 may be utilized to position the expansion component 110 at the desired location 88. While such components may be part of the system 100, the use of the auxiliary components varies greatly between different embodiments of the system 100. The system 100 may include virtually any prior art components useful to the provider 92 in addressing the needs of the patient 90.

[0112] II. Alternative Embodiments

[0113] Many features and inventive aspects of system 100 are illustrated in the drawings and described in the text of this application. However, a patent application cannot disclose all of the potential embodiments of an invention. In accordance with the provisions of the patent statutes, the principle and mode of operation of system 100 has been explained and illustrated in certain preferred embodiments. However, it should be understood that system 100 may be practiced otherwise than as specifically described and illustrated without departing from its spirit or scope.

[0114] The description of system 100 and various illustrations of system 100 should be understood to include all novel and non-obvious combinations of the elements described herein, and claims may be presented to any novel and non-obvious combinations of those elements in this or a later application. 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.

[0115] There are various categories that may be useful in describing various embodiments of the system 100.

[0116] A. Direct vs. Indirect

[0117] For all embodiments of the system 100, the expansion component 110 expands from a low-profile operating mode 132 to a high-profile operating mode 134 to create the lumen 120. In some embodiments of the expansion component 110, conversion between operating modes 130 is accomplished directly by the expansion component 110, while in other embodiments of the expansion component 110, conversion between operating modes is accomplished only indirectly by the expansion component 110.

[0118] 2a is a hierarchical diagram illustrating examples of a direct extension embodiment 101 and an indirect extension embodiment 102. The indirect extension embodiment 102 includes an extension component 110 that is extended or contracted by other components of the system 100. In contrast, the direct extension component 101 includes an extension component 110 that can change its operating mode 130 without using other components of the system 100.

[0119] Direct expansion embodiments 101 may include, but are not limited to, tubular balloon embodiments 103 and spiral balloon embodiments 104. Direct expansion embodiments 101 typically involve "inflating" a balloon with a substance, such as a liquid, to expand from a low profile operating mode 132 to a high profile operating mode 134. Some embodiments may utilize a gas, but it is often undesirable to risk inserting air or other gas bubbles into the blood vessel 91 of the patient 90.

[0120] The indirect expansion embodiment 102 may include, but is not limited to, a guide balloon embodiment 105 (wherein an expansion component 110 in the form of a cover 116 expands by being advanced over an inflated guide balloon 115), an insert component embodiment 106 (wherein an expansion component 110 in the form of a cover 116 expands by the insertion of an insert component 117 into the expansion component 110), and a sheath embodiment 107 (wherein a sheathed balloon 118 expands when it is no longer constrained by a sheath 119). The indirect expansion embodiment 102 utilizes other components of the system 100 to "inflate" to a high profile mode of operation 134 and "deflate" to a low profile mode of operation 132. The guide balloon embodiment 105 of the system 100 utilizes an expansion component 110 that is advanced over an inflated balloon to expand the expansion component 110. The insert component embodiment 106 of the system 100 utilizes an insert component 117 that is inserted into the expansion component 110 to expand the expansion component 110. The sheath embodiment 107 utilizes a sheath to constrain the expansion component 110 that would otherwise be in an expanded state.

[0121] B. Expandable Components Balloon vs. Non-Balloon

[0122] Just as different embodiments of system 100 may be categorized based on whether the expansion component 110 is expanded directly or indirectly, various embodiments of system 100 may also be categorized based on whether the expansion component 110 is a balloon of some kind (inflated 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.

[0123] FIG. 2b is a hierarchical diagram showing examples of both an expandable component balloon embodiment 108 and an expandable component non-balloon embodiment 109.

[0124] Examples of the expandable component balloon embodiment 108 may include, but are not limited to, the tubular balloon embodiment 103, the spiral balloon embodiment 104, and the sheath embodiment 107.

[0125] Examples of expansion component non-balloon embodiments 109 can include, but are not limited to, guide balloon embodiments 105 and insertion component embodiments 106.

[0126] C. Active vs. Passive Extension Components

[0127] Many of the differences in the various embodiments of the system 100 are defined by the differences in the different embodiments of the extension components 110. Two general categories of extension components 110 can be distinguished based on whether they are "active" or "passive."

[0128] 1. Active Extension Components / Active Devices

[0129] A balloon without a sheath

[0130] The embodiment of system 100 shown in Figures 3a-3g includes an inflatable balloon as the expansion component 110. That embodiment of system 100 has a balloon as the expansion component 110, which can be in either a low-profile state 132 or a high-profile state 134 (i.e., an expanded state). System 100 is transitioned between states 130 by inflating or deflating the expansion component 110 (i.e., the balloon). System 100 has "active" control via the inflation and deflation functions.

[0131] b. Balloon with sheath

[0132] An alternative embodiment of the 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 is self-expanding. The active control of the system 100 is through the use of a sheath 119 that covers the balloon. The device is in a low profile state 132 when the sheath 119 covers the self-expanding balloon. In this state 132, the system 100 can be inserted into the required location. The low profile state 132 facilitates insertion in a non-invasive manner. In this state 132, the system 100 can interact with other required devices, such as a 0.014 coronary guidewire and a guide catheter. Once the system 100 is properly positioned in the required location, the sheath 119 is retracted by the active control that allows the expansion component 110 to self-expand into an expanded high profile state 134. In the expanded high profile state 134, the system 100 can allow the performance of a medical procedure 81, including the insertion of other medical devices 80, such as a catheter device. This provides space 120 into which other devices may be inserted. When the expanded state 134 is no longer needed, the sheath 119 can be advanced over the balloon 118 using active control to transition the system 100 back to the low profile state 132.

[0133] Another potential alternative to achieve a self-expanding expansion component 110 is to use a material with spring characteristics. Many metals, such as stainless steel, have spring characteristics. Alternatively, a shape memory metal, such as Nitinol, may be used to achieve the self-expanding characteristics. It is envisioned that there may be other materials, either metallic or non-metallic, that may be used to achieve the self-expanding characteristics. These materials may be used to create a structure that functions as a "sheathed balloon" 118. In some embodiments, the sheathed balloon 118 may be similar to other types of balloons 111. In other embodiments, the sheathed balloon 118 may be a self-expanding braided structure 124.

[0134] 2. Passive Extension Components / Passive Devices

[0135] A passively controlled system is a system 100 that has two or more operating modes 130, where the system 100 is passively transitioned between states 130 instead of being actively transitioned between states 130.

[0136] a. Pleated extension component

[0137] One embodiment of passive control is a pleated expanding component 110 as shown in Figures 3h and 3i. The expanding component 110 of the system 100 would be made with pleats. The pleats would put the expanding component 110 in a low profile state 132. The expanding component 110 is small due to its pleated shape. When a different medical device 80 is inserted into the space 120 or the pleated expanding component 110, it would passively expand to a larger expanded state 134 to allow the other medical device 80 to pass through. The other medical device 80 would expand the pleats outwards to create a larger space 120 and a more expanded expanding component 110. In this embodiment, the system 100 would be passively transitioned between the two states 130 by the insertion of an assist device, rather than by active movement of the system 100 by an operator.

[0138] b. Elastic expansion component

[0139] An alternative embodiment of the passive control system 100 is an elastic expansion component 110. The elastic expansion component 110 would be made from an elastic or stretchable material. The expansion component 110 would be made in a low profile state 132. Its cross section would likely be circular, although other shapes such as oval are possible. When a different medical device 80 is inserted into the elastic expansion component 110, the device passively expands to a larger state to allow the other medical device to pass. The other medical device 80 causes the elastic expansion component 110 to form a larger space 120. In such an embodiment, the system 100 is passively transitioned between the two states 130, rather than being actively transitioned by an operator. The system 100 of this design can be made from a variety of materials, such as medical grade silicone or urethane.

[0140] D. Categories of Embodiments

[0141] As shown in both Figures 2a and 2b, various embodiments of the system 100 may be organized into categories. As shown in Figure 2c, many different embodiments of the system 100 may utilize some form of balloon 111. Some embodiments of the system 100 may utilize balloons 111 (i.e., tubular balloons 112 and spiral balloons 113) that have a non-inflated default state that requires inflation to transition from a low-profile mode of operation 132 to a high-profile mode of operation 134. Other embodiments of the system 100 use the balloon 111 (i.e., guide balloon 115 through which cover 116 is advanced) not as an expansion component, but as a mechanism for expanding the expansion component 110 from a low-profile mode of operation 132 to a high-profile mode of operation 134. Still other embodiments utilize balloons 111 (i.e., sheathed balloons 118) that have an inflated default state or that are self-inflating. The sheathed balloons 118 transition from a low-profile mode of operation 132 to a high-profile mode of operation 134 when removed from a 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.

[0142] System 100 can be implemented using (1) components that are integrated with other components of system 100 into a single standalone device, (2) non-integrated collections of components configured to function with specific supporting components, and (3) extended components 110 that are an order of magnitude integration between these two opposites.

[0143] As indicated by the various arrows in FIG. 1a, the system 100 can directly interact with both the patient 90 and the provider 92. Such a system 100 can be implemented in a wide variety of different alternative embodiments. Some embodiments of the system 100 can be a single stand-alone component, such as the expandable balloon 111. Other embodiments of the system 100 can include an arrangement of multiple components that can be permanently attached to one another or that can only be configured to cooperate temporarily with one another.

[0144] The system 100 may be used in conjunction with virtually any catheter device 80 and as part of virtually any catheterization procedure. It facilitates the catheterization procedure by aiding in the insertion of medical devices 80, such as various catheters and potentially other devices, into desired locations 80 within the body of a patient 90 that would otherwise be unreachable without the space 120 created by the system 100 transitioning from a low-profile operating environment 132 to a high-profile operating environment 134.

[0145] As an example, an angioplasty balloon catheter or a stent catheter may not otherwise be able to be placed at the desired location 88 where the occlusion is located. The system 100 can facilitate the insertion of a balloon or stent 123 (i.e., a catheter device) into the occlusion.

[0146] An advantage of the system 100 is that it can be inserted by itself into a required location where a medical device 80, such as a catheter, cannot be inserted by itself. The ability to be in either of the two states 130 allows the system 100 to have this advantage. Unlike a medical device 80, such as a catheterization device, which expands to remove an arterial blockage, the system 100 can be configured for the purpose of only expanding sufficiently to create a working space for the catheter device. The working 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 working space 120 to be inserted into their desired location 88. The working space 120 can create a safe passageway for the catheterization device 88 through a tortuous (serpentine) blood vessel 91 or past a stenosis that impinges on the blood vessel 91. The system 100 can temporarily straighten a tortuous blood vessel or expand a stenotic area.

[0147] The system 100 plays a supportive role for a medical device 80, such as a catheter. In cardiovascular catheterization, the system 100 is typically inserted into a coronary artery, or other artery or vein (collectively, "vessel" 91). The system 100 can be appropriately sized and configured to accomplish the desired task of creating additional space 120 for a desired catheter device at a desired location 88. The system 100 can have two or more states 130, including a low profile state 132 for device insertion and removal, and an expanded state 134 for coronary stabilization.

[0148] The original context in which the concept of system 100 was conceived was to facilitate percutaneous coronary intervention (PCI) procedures, or other similar intravascular procedures, however, system 100 may be configured for use with virtually any catheter device and any catheterization procedure.

[0149] The system 100 may 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 hydrophilic characteristics. It may be made using a variety of manufacturing methods such as extrusion, injection molding, thermoforming, thermal bonding, wire forming, laser manufacturing, or other manufacturing methods. It is made so that it can be appropriately packaged and sterilized. Possible sterilization methods would be electron beam irradiation, gamma irradiation, ethylene oxide (EO) gas sterilization, or nitrous oxide (NO2) gas sterilization.

[0150] 1. Tubular Balloon Embodiment

[0151] In the tubular balloon embodiment 103 of the system 100, the expansion component 110 is a tubular balloon 112. Figures 3a-3i relate to the tubular balloon embodiment 103 of the system 100.

[0152] 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 an uncompressed spring or other similar means. The tubular balloon 112 can have a burst rating of up to 27 atmospheres according to any known method of burst rating balloons.

[0153] 2. Spiral Balloon Embodiment

[0154] In a spiral balloon embodiment 104 of system 100, expansion component 110 is a spiral balloon 113, i.e., a tubular balloon 112 constrained by a matrix 114 to form at least a substantially spiral shape. Figures 7a-7e show an example of a spiral balloon embodiment 104.

[0155] Just like the tubular balloon embodiment 103, the spiral balloon embodiment 104 can utilize a wide variety of different inflation mechanisms.

[0156] The spiral balloon embodiment 104 may be highly desirable due to the impact of the matrix 114, which can selectively increase the stiffness of the expansion component 110 so that it can be inserted into locations 88 that a tubular balloon 112 without the matrix 114 cannot reach. As shown in FIG. 2c, the spiral balloon 113 may be implemented as a conventional inflatable balloon, but can also be implemented as a self-expanding spiral component 141 or as a mechanically expanding spiral component 142.

[0157] FIG. 7g illustrates another exemplary spiral balloon 113'. The spiral balloon 113 described above has a generally circular cross-section and is wound to define a generally circular lumen 120. In the example of FIG. 7g, the spiral balloon 113' has a triangular or generally triangular cross-section and is wound to define a generally triangular lumen 120'. The triangular cross-section provides certain advantages, such as improved compactness, when the spiral balloon 113' is folded into a low-profile operating mode 132. These advantages are the same as those described below for the triangular tubular balloon 112' and shown in FIGS. 3n-3p.

[0158] 3.Sheath embodiment

[0159] The sheath embodiment 107 of the system 100 uses a balloon 111 that does not require inflation to transition from the low-profile mode of operation 132 to the high-profile mode of operation 134. Figures 6a-6g relate to the sheath embodiment 107 of the system 100. The sheathed balloon 118 transitions from the low-profile mode of operation 132 to the high-profile mode of operation 134 when it is removed from the constraining sheath 119. The sheathed balloon 118 can be returned to the low-profile mode of operation 132 by being positioned back within the sheath 119.

[0160] As shown in FIG. 2c, the sheathed balloon 118 may be implemented as a braided balloon 124.

[0161] 4. Guide Balloon Embodiment

[0162] Guide balloon embodiment 105 of system 100 includes an expansion component 110 that is not a balloon 111. Rather, expansion component 110 is a cover 116 that advances over a preceding inflated balloon, i.e., guide balloon 115. Figures 4a-g show examples of guide balloon embodiment 105 of system 100.

[0163] 5. Insert Component Embodiments

[0164] The insertion component embodiment 106 of the system 100 does not require the use of any type of balloon 111 in the expansion / deflation process. In the insertion component embodiment 106 of the system 100, an insertion component 117 is inserted into the expansion component 110 to expand the expansion component 110 from a low-profile operating mode 132 to a high-profile operating mode 134. The expansion component 110 in the insertion component embodiment 106 of the system 100 can be a cover 116, such as another catheter. The insertion component embodiment 106 is shown in Figures 5a-5d.

[0165] III. Tubular Balloon Embodiments

[0166] Some embodiments of the system 100 utilize a single tubular balloon 112 that functions as the expansion component 110 to facilitate a transition between a low-profile state 132 and a high-profile state 134 that can create a lumen 120 for an applicable medical device 80, such as a balloon angioplasty catheter or stent 123, at a desired location 88 within the patient's 90 body.

[0167] A "working space" or lumen 120 is created within the tubular balloon 112 by expansion of the tubular balloon 112 into a high profile operating mode 134. An example of a different type of expansion component 110 may include an inflatable balloon 112 having a "donut hole" space (see Figures 3a-i).

[0168] As discussed above, some embodiments of the system 100 can be configured to expand / contract using different techniques and different component configurations. In some embodiments of the system 100, expansion of the system 100 is achieved via an expansion component 110 that is part of the system 100. In other embodiments, expansion of the system 100 is achieved by expansion of a separate component / device within the system 100 that is expanded and then used to expand or enable expansion of the system 100. For example, removal of the sheath 119 can cause expansion of the sheathed balloon 118 in the sheath embodiment 107 of the system 100 (see FIGS. 6a-6g).

[0169] The tubular balloon 112 can be implemented in a wide variety of different ways. Some embodiments of the tubular balloon 112 as the expansion component 110 can inflate the tubular balloon 112 using an inflation tube 150 connected to a valve 151 on the tubular balloon 112. The valve 151 acts as a connector and may optionally include a flow control mechanism in some examples.

[0170] The tubular balloon 112 can be inflated using air, other forms of gas, water, and other forms of liquids or fluids. The tubular balloon 112 can also be inflated using mechanical means, such as a spring. Some embodiments of the tubular balloon 112 may include a self-inflating balloon 111.

[0171] In tubular balloon embodiments 103 that require active inflation, the valve 151 is typically positioned at a proximal end of the balloon 112, such as the "tail" end of the balloon 112. The valve 151 is connected to an inflation tube 150. The tube 150 extends longitudinally to the inflatable lumen 120. The inflatable lumen is at a distal end, which would be like the "tip" end. The overall length is about 100-120 cm (39.4-47.2 inches). The inflatable balloon 112 is about 35 mm (1.38 inches). The inflation tube 150 is about 65-85 cm (25.6-33.5 inches) in some embodiments of the system 100. The system 100 may be configured to have a low profile state 132, which is a deflated or folded state. The low profile diameter size will be small enough to fit the required arterial location and to interact with other medical devices 80 used during the procedure. The low profile diameter size will be approximately 0.030 to 0.060 inches (0.76 to 1.52 mm).

[0172] Figure 3a illustrates a close-up partial view of the system 100 of Figure 3b. A partial example of an inflatable balloon 112 is shown with associated lumen 120 and tube 150 to facilitate inflation / deflation.

[0173] 3b illustrates 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" in the center of the expandable component 110.

[0174] FIG. 3c illustrates an example of a top view of the system 100.

[0175] FIG. 3d illustrates an example of a side view of the system 100.

[0176] FIG. 3e illustrates an example of a cross-sectional side view of system 100, showing lumen 120 within system 100.

[0177] FIG. 3f shows an enlarged partial view of FIG. 3e.

[0178] As shown in FIGS. 3e-g, in some examples, the tubular balloon 112 has a double-walled structure including an inner wall 400 and an outer wall 402. A space 404 is defined between the inner wall 400 and the outer wall 402. The space 404 is configured to receive a fluid via the inflation tube 150, as described above. Once the space 404 is filled with fluid, the tubular balloon 112 is expanded to a high-profile operating mode 134, in which 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.

[0179] The tubular balloon 112 has two opposing ends 112a / 112b. The valve 151 can be located at one end 112a or at a different location along the length of the tubular balloon 112. If the valve 151 is at one of the opposing ends 112a, the other of the opposing ends 112 can be sealed or otherwise closed to maintain fluid pressure in the space 404 when the tubular balloon 112 is in a high profile mode of operation. If the valve 151 is at a different location along the length of the tubular balloon 112, both of the ends 112a / 112b of the tubular balloon 112 can be sealed or otherwise closed.

[0180] As mentioned above, the inflation tube 150 may include a connector 251 at the end opposite the valve 151, as shown in FIG. 3j. The connector 251 may be configured to mate with a syringe or fluid line, as known in medical applications, to communicate fluid to / from the tubular balloon 112.

[0181] The tubular balloon 112 may be straight, as shown in Fig. 3j, or curved, as shown in Fig. 3k. The tubular balloon 112 may be inflexible (e.g., rigid) and therefore fixed in a straight / curved shape. In another example, the tubular balloon 112 may be semi-flexible or flexible (e.g., flexible) and may alternate between straight and curved shapes.

[0182] The tubular balloon 112 can have flat ends 112a / 112b, as shown in FIG. 3j. The flat ends have a plane that is parallel, coaxial, or collinear with the axis A of the tubular balloon 112. In another example, shown in FIG. 3l and FIG. 3m, the tubular balloon 112 can have angled ends 112a / 112b. One or both ends can be angled. The angled ends have a plane that is angled with respect to the axis A.

[0183] In another example shown in Figures 3n-3p, the tubular balloon 112' has a triangular or approximately triangular cross-section. Accordingly, the lumen 120 also has a triangular or approximately triangular cross-section. The triangular cross-section allows the tubular balloon 112' to be folded more compactly into a low-profile operating mode 132 as compared to the cylindrical tubular balloon 112 described above, and may have certain manufacturing advantages.

[0184] 3o, the triangular cross-section may include indentations or depressions 405 on one, two, or three sides of the triangle. The indentations or depressions 405 further assist the tubular balloon 112' in folding into a compact, low-profile operating mode 132 by providing fold points to facilitate folding of the tubular balloon 112'.

[0185] FIG. 3p illustrates the folded tubular balloon 112' in the low-profile mode of operation 132. As shown, when folded, each of the three points of the triangular cross section are essentially flat and form leaflets 407 that fold circumferentially about the axis of the tubular balloon 112'. This further contributes to the compact nature of the tubular balloon 112' when in the low-profile mode of operation 132. Additionally, the tubular balloon 112' has a small lumen 120' even in the low-profile mode of operation 132. This small lumen 120' can receive a guidewire 122, as described in more detail below.

[0186] Either tubular balloon 112 / 112' may be fabricated, in one example, by blow molding. In some examples, tubular balloon 112' may be fabricated in a cylindrical shape like tubular balloon 112 and then pressed, molded, or otherwise formed into a triangular shape.

[0187] In some examples shown in FIGS. 9a-9c, 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 wall 400 and the outer wall 402 at the connections 406. The connections 406 can provide additional structural integrity to the tubular balloon 112. The connections 406 also prevent the inner wall 400 from folding into the lumen 120 when the tubular balloon 112 is in a high-profile operating mode 134. In other words, the connections 406 act against pressure 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.

[0188] The connection 406 can be made in a variety of ways. For example, the connection 406 can be made by bonding the inner wall 400 and the outer wall 402 together using any known adhesive suitable for the materials of the inner wall 400 and the outer wall 402 and medical applications. Any known material suitable for medical applications can be used for the tubular balloon 112, but some non-limiting examples include PET (polyethylene terephthalate), nylon, engineering nylon, polyamide, polyurethane, nylon elastomers, and other thermoplastic elastomers. In another example, the connection 406 can be made by fusing the inner wall 400 and the outer wall 402 together using a thermal bonding technique such as laser welding, or any other known technique suitable for the materials of the inner wall 400 and the outer wall 402 and medical applications.

[0189] In the example of Fig. 9a, the connections 406 are points or dots. In other words, the connections 406 do not extend over a substantial radial or circumferential extent of the tubular balloon 112. The tubular balloon 112 may include one or more point-like or dot-like connections 406. The point-like or dot-like connections 406 may be distributed on the tubular balloon 112 in any pattern, such as a circumferential or axial row, or any other pattern.

[0190] In another example shown in Figures 9b-9c, the connections 406 are lines or ribs that extend along the 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 to maintain a single common space 404 throughout the tubular balloon 112 for receiving fluid from the inflation tube 150, as described above. In the particular example of Figures 9b-9c, the tubular balloon includes multiple ribs that extend along a majority of the circumferential extent of the tubular balloon 112, e.g., greater than 50% to less than 100%. The ribs or line connections 406 may be evenly spaced along the axial extent of the tubular balloon 112, as shown in Figures 9b-9c, although other arrangements / distributions are contemplated.

[0191] IV. Guide Balloon Embodiments

[0192] Some embodiments of the system 100 contemplate that a guide balloon 115 is used in conjunction with the system 100. The guide balloon 115 can aid in positioning the system 100 within the patient 90.

[0193] FIG. 4 a is a flow chart diagram illustrating an example of a process for enhancing catheterization performed by the guide balloon embodiment 105 of the system 100 .

[0194] In step 302, the guide balloon 115 is inserted into the patient 90. FIG. 4b is an environmental diagram showing an example of the process step in which the guide balloon 115 is inserted. At the start of a coronary catheterization procedure, a guide catheter 121 or similar medical device 80 can be inserted into the femoral or radial artery, and the guide catheter is advanced until it accesses the right or left coronary ostium. The coronary ostium is the beginning of the coronary artery. This is where the artery branches off from the aorta. A guide wire 122 is inserted through the guide catheter 121 into the coronary artery past where treatment is to be performed. The guide balloon 115 of the system 100 is inserted over the guide wire 122 and through the guide catheter 121 into the artery. The guide balloon 115 is in a deflated state while being inserted. It is inserted past any tortuous areas or stenosis.

[0195] Returning to FIG. 4a, in step 304, the guide balloon 115 is inflated. FIG. 4c is an environmental diagram showing an example of a process step in which the guide balloon 115 is inflated. The guide balloon 115 is inflated after being properly positioned. It can be inflated pneumatically with a gas such as air, or hydraulically with a liquid. It will most likely be inflated with a 50:50 mixture of sterile saline and contrast. It can be inflated to lower pressures of 1-4 atmospheres or higher pressures up to 16 atmospheres. The inflated outer diameter of the guide balloon 115 can be less than, equal to, or greater than the diameter of the artery. The guide balloon 115 can temporarily straighten any tortuous areas of the artery, either fully or partially.

[0196] Returning to FIG. 4a, in step 306, the cover 116 is advanced over the guide balloon 115. FIG. 4d is an environmental diagram illustrating an example of a process step in which the cover 116 is advanced over the inflated guide balloon 115. The expansion component 110, the core component of the system 100, is inserted over 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 or fixed diameter design. When the expansion component 110 exits the distal end of the guide catheter 121, it follows the top of the inflated guide balloon 115. The outer diameter of the guide balloon 115 and the inner diameter of the expansion component 110 are specially designed for an optimal interface. This interface may be a slip fit, a line fit, or an interference design. The interface design aids in the insertion of the expansion component 110 and makes the insertion as atraumatic as possible to eliminate or prevent damage to the arterial wall.

[0197] FIG. 4e is an environmental view showing an example of the cover 116 expanded over the guide balloon 115. The guide balloon 115 performs the important task of eliminating or preventing damage to the arterial wall from the leading edge of the component 110 while it is being inserted, even though the leading edge was designed with its own atraumatic tip. For this purpose, the guide balloon 115 may be intentionally longer than the expanding component 110. It may be more than twice the length of the expanding component 110.

[0198] Returning to FIG. 4a, in step 308, the guide balloon 115 is deflated. FIG. 4f is an environmental view illustrating one example of a process step in which 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 keep the artery straight after the guide balloon 115 is removed.

[0199] Returning to FIG. 4a, in step 310, the guide balloon 115 is removed. The expansion component 110 may be either a self-expanding or fixed diameter design in this embodiment of the system 100. The expansion component 110 creates a space 120 within the artery in the form of a lumen. Other devices 80, such as an angioplasty balloon, a stent catheter, or some other form of similar medical device 80, can pass through the space 120 created by the system 100 when the system is in the high-profile expanded state 134.

[0200] In step 312, a stent 123 is positioned through the system 100. Figure 4g is an environmental diagram illustrating an example process step in which a stent 123 is inserted through the space 120 created by the system 100.

[0201] The system 100 is removed from the artery when it is no longer needed. The artery will resume its natural shape. This embodiment of the system 100 will interact with other catheterization devices 80 used during the procedure, such as a guidewire 122, a guide catheter 121, a balloon catheter, and a stent 123.

[0202] V. Insert Component Embodiments

[0203] 5a 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 the cover 116. In some embodiments, the insertion component 117 can be attached to a guide catheter 121.

[0204] In step 322, the cover 116 attached to the guide catheter 121 is inserted into the patient 90. FIG. 5b is an environmental diagram showing an example of the process step in which the cover 116 is inserted into the patient 90. At the start of a typical coronary catheterization procedure, the guide catheter 121 is inserted into the femoral or radial artery, and the catheter 121 is advanced until it accesses the right or left coronary ostium. The coronary ostium is the beginning of the coronary artery. This is where the artery branches off from the aorta. The guide wire 122 is inserted through the guide catheter 121 and into the coronary artery beyond where treatment is to be performed. In this embodiment of the expanding component 110 in the form of a cover 116, the cover 116 is often an integral part of the guide catheter 121. The cover 116 can be connected to the distal end of the guide catheter 121 as part of the manufacturing process of these components.

[0205] Returning to FIG. 5a, in step 324, the insertion component 117 is inserted into the cover 116. FIG. 5c is an environmental diagram illustrating an example of a process step in which the insertion component 117 is inserted into the cover 116 positioned within the patient 90 to expand a distal portion of the cover 116. The insertion component 117 will be inserted inside the entire length of the connected expansion component 110 (i.e., cover 116) and guide catheter 121. Once inserted, it expands the expansion component 110 (i.e., cover 116) to a high-profile state 134.

[0206] Returning to Figure 5a, in step 326, the stent catheter 123 is inserted through the insertion component 117 and into the patient 90. Figure 5d is an environmental diagram illustrating one example of the process steps in step 326. The nesting of the expansion component 110 in the high profile state 134 and the insertion component 117 creates a space 120 into which another medical device 80, such as an angioplasty balloon catheter or stent catheter 123, may be inserted.

[0207] The extension component 110 (ie, the cover 116) and the insert component 117 of the system 100 are removed when they are no longer needed.

[0208] The expansion component 110 of this embodiment may be made of a shape memory material, a braided construction, a pleated design, or any other expandable design.

[0209] The shape memory material can be metallic or non-metallic. Nitinol is one possible metallic material that can be used. The expanding component 110 can be made from Nitinol and the memorized shape would be a low profile state 132. This memorized low profile state 132 would allow the connected expanding component 110 and guide catheter 121 to be inserted into the coronary artery across the coronary ostium, tortuous areas, and any stenosis. The insertion component 117 would be used to actively transition the expanding 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 expanding component 110 and achieve the same result.

[0210] A braided structure may be used to construct the cover 116. The braid would be sized to a low profile state 132. The woven mesh pattern of the braid has spaces in the interstices between its wires. This would allow it to expand to a high profile state 134 when the insert component 117 is inserted.

[0211] A pleated design may be used to create the cover 116. The pleated design would be sized for a low profile state 132. An insert component 117 would unfold the pleats when inserted, allowing them to transition to a high profile state 134.

[0212] VI. Sheathed Balloon Embodiment

[0213] 6a is a flow chart diagram illustrating an example of a process for enhancing catheterization performed by a sheathed embodiment 107 of the system 100. In this category of embodiments, the expansion component 110 of the system 100 is self-expanding. The sheath 119 constrains the expansion component 110, thereby allowing the expansion component 110 to exist in a low-profile mode 132. When the expansion component 110 is released from the sheath 119, the expansion component 110 (e.g., the sheathed balloon 118) expands to a high-profile operating mode 134.

[0214] The self-expanding feature may be created using a self-expanding material, such as a braided structure. The braided structure is cylindrical in shape. The walls of the cylinder are made up of a woven mesh of braids. Both ends of the cylinder are open. The braid is designed with spaces in its weaving pattern that will allow the braided structure to exist in either a high-profile self-expanding state 134 or a low-profile state 132.

[0215] In step 350, the system 100 with the sheath 119 (and encapsulated expansion component 110, such as sheathed balloon 118) is inserted into the patient 90. FIG. 6b is an environmental diagram illustrating an example of a process step in which the sheath 119 covers the system 100 during insertion. The expansion component 110 may be compressed to a low-profile state 132 and inserted into the sheath 119. The sheath 119 will cover the expansion component 110 and keep it in the low-profile state 132. The expansion component 110 and sheath 119 will be inserted as a unit into the artery 91 through the guide catheter 121.

[0216] Returning to Figure 6a, in step 352, the system 100 is positioned within the patient 90. Figure 6c is an environmental diagram illustrating one example of a process step in which the sheath 119 and system 100 are desirably positioned within the patient 90. The expansion component 110 and sheath 119 will have an appropriate low profile size, strength, and flexibility to be inserted across any tortuous areas or strictures.

[0217] Returning to FIG. 6a, in step 352, the sheath 119 is withdrawn. FIG. 6d is an environmental view illustrating an example process step in which the sheath 119 is withdrawn, causing the system 100 to self-expand and creating additional working space 120 within the patient 90 for catheterization purposes. The sheath 119 is removed after the system 100 is properly positioned. The expanding component 110 automatically deploys due to its self-expanding characteristics. The expanding component creates space 120 within the artery.

[0218] Returning to FIG. 6a, in step 354, the system 100 is expanded to the high-profile state 134. FIG. 6e is an environmental diagram illustrating one example of how the expanded system 100 can straighten an artery within the body of a patient 90. The expansion component 110 may partially or completely straighten any arterial bends. The straightening effect will be temporary. Once the system 100 is withdrawn, the artery will resume its natural shape.

[0219] Returning to Figure 6a, in step 356, a stent catheter 123 is inserted through the system 100. Figure 6f is an environmental diagram illustrating an example process step in which the stent catheter 123 is inserted into the patient 90 through the working space 120 created by the presence of the system 100 in the high-profile operating mode 134. Other devices, such as an angioplasty balloon catheter or stent 123, can pass through the space 120 created by the system 100 when in the high-profile expanded state 134.

[0220] Returning to FIG. 6a, in step 358, the sheath 119 is advanced to collapse the system 100 for removal. FIG. 6g is an environmental diagram illustrating an example process step in which the sheath 119 is advanced to collapse the system 100 for removal. The system 100 can be removed when it is no longer needed. The sheath 119 is advanced over the expansion component 110, causing it to collapse to a low-profile state 132, and then the expansion component 110 and sheath 119 are removed together as a unit.

[0221] An alternative embodiment of this form of the system 100 uses a self-expanding braided structure 124 that functions as the sheathed balloon 118. The structure of the braid 124 can be designed to provide optimal performance. The properties of the braid 124, such as number of wires, wire shape, wire material, pitch, uniform pitch, variable pitch, and braid pattern, can be selected to obtain desired performance. More or fewer wires and wire material can affect the strength and flexibility of the component. Round or flat wires can affect wall thickness. Pitch and braid pattern can affect expansion strength and profile size.

[0222] Stainless steel or Nitinol are likely materials for the braid 124 wires, but other metals or nonmetals may possibly be used. Stainless steel can be formulated with "spring" properties that allow it to self-expand. Nitinol is a metal alloy of nickel and titanium. It is a type of metal known as "shape memory." Nitinol-based expanding components can be made with shape memory of a high profile expanded state 134, allowing it to self-expand. There are also shape memory polymers that can be used to construct the expanding components.

[0223] The braid 124 may be covered with inner and outer liners to make it atraumatic and prevent damage to the arterial wall. The inner and outer liners will expand and collapse with the system 100.

[0224] The sheath 119 may have an atraumatic tip to aid in insertion and to eliminate or reduce trauma to the arterial wall.

[0225] The expansion component 110, the sheath 119, or both articles can have radiopaque features so that they can be visualized with fluoroscopic imaging.

[0226] This embodiment of the system 100 can interact with other catheterization devices used during the procedure, such as guidewires 122 , guide catheters 121 , balloon catheters, stents 123 , as well as other medical devices 80 .

[0227] VII. Spiral Balloon Embodiment

[0228] The spiral balloon embodiment 104 of system 100 is similar to the tubular balloon embodiment 103 of system 100, except that in the spiral balloon embodiment 104 of system 100, the balloon 111 is constrained and shaped by a matrix 114 that configures the shape of the balloon 111 into a spiral balloon 113. The spiral balloon 113 is defined by multiple turns 213 of the tubular balloon 112 that form a spiral shape.

[0229] A. Spiral balloon

[0230] Just as the tubular balloon 112 can be inflatable, self-inflating, or mechanically expandable, the helical balloon 113 can change operation modes 130 in exactly the same ways, using the same techniques and principles of chemistry and physics. The tubular balloon 112 can have a double-walled structure, as described above, or can have another structure, such as a continuous tube.

[0231] An exemplary spiral balloon 113 is shown in Figures 8a-8f (described in more detail below). The spiral balloon 113 is defined along an axis A between opposing ends 113a / 113b. The axis A may be straight, as in Figure 8a, or curved, as in Figure 8b. The spiral balloon 113 may be soft or flexible to allow bending, or may be rigidly fixed in a straight or curved shape.

[0232] In one example shown in FIG. 8f (described in more detail below), the inflation tube 150 is configured to mate with the tubular balloon 112 at the valve 151, as described above. In this manner, the inflation tube 150 fluidly connects the space 212 within the tubular balloon 112 with a fluid source (not shown). Thus, a fluid, such as saline, can be supplied or removed from the tubular balloon 112 to contract or expand the spiral balloon 113 between the low-profile operating mode 132 and the high-profile operating mode 134, as described above. The valve 151 can be located at an end of the tubular balloon 112 corresponding to one of the opposing ends 113a / 113b of the spiral balloon 113, or can be at a different location along the length of the spiral balloon 113. If the valve 151 is at one of the opposing ends 113a, the other end of the tubular balloon 112 (e.g., the end of the tubular balloon 112 corresponding to the other of the opposing ends 113b) may be sealed or otherwise closed to maintain fluid pressure in the space 212 when the spiral balloon 113 is in the high profile operating mode 134. If the valve 151 is at a different location along the length of the spiral balloon 113, both ends of the tubular balloon 112 may be sealed or otherwise closed.

[0233] As mentioned above, the inflation tube 150 may include a connector 251 at the end opposite the valve 151. The connector 251 may be configured to mate with a syringe or fluid line, as known in medical applications, to communicate fluid to / from the tubular balloon 112.

[0234] It should be understood that the discussion herein regarding the spiral balloon 113 is equally applicable to the spiral balloon 113' shown in FIG. 7g and described above.

[0235] B. Matrix

[0236] A mechanism or configuration of mechanisms that maintains the balloon 111 in the shape of a spiral balloon 113. The matrix 114 maintains the spiral shape of the spiral balloon 113 in all operating modes 130. The matrix 114 may be implemented in a wide variety of different embodiments, including but not limited to braids 145, bonding agents 146, thermally formed connections 147, matrix covers 148, and flanges 149. The cross-sectional shape of the spiral balloon 113 may be maintained differently in different operating modes 130. For example, the cross-section of the spiral balloon 113 would otherwise be circular in the inflated state (high profile operating mode 134) and flat in the deflated state (low profile operating mode 132). The matrix 114 may maintain the spiral shape in both states. The matrix 114 requires both flexibility and strength to properly perform its function.

[0237] The matrix 114 may include a medicinal component 126, which is a mechanism or configuration of mechanisms that allows medicinal capabilities for the system 100. The medicinal component 126 may include diagnosis or treatment of a medical condition, or delivery of a medicinal or nutrient. The matrix 114 may include a vasoactive agent to cause vasoconstriction or vasodilation, depending on what may be needed. Such agents may be temporary or may last longer. Nitric oxide is an example of a vasoactive agent that can dilate blood vessels, which will make them larger (larger in diameter) until the agent wears off. The matrix 114 may include any type of drug coating that prevents intimal hyperplasia. Intimal hyperplasia is often a physiological response to an angioplasty procedure, resulting in restenosis of the treated area, which generally speaking is clogging of the stent 123.

[0238] 1. Braiding

[0239] The weave 145 can be a configuration of one or more threads 144 that can encapsulate the balloon 111 in the shape of the spiral balloon 113. The weave 145 can use as many or as few threads 144 as desired. In many embodiments, 10-12 threads 144 evenly distributed around the spiral balloon 113 is a particularly desirable configuration. The weave 145 will wrap around the spiral balloon 113 as it makes a continuous pass of the spiral shape.

[0240] 2. Binder

[0241] A chemical means to constrain the shape of the helical balloon 113. The matrix 114 can be made of a binder 146 that is applied to the balloon 111 to fix its shape as a helical balloon 113. The binder 146 can be used by itself or with other components to maintain the helical shape of the helical balloon 113. Successive passes of the helical shape can be bonded to adjacent passes. A wide variety of binders can be used as possible binders 146, including but not limited to adhesives or silicones. The binder 146 may be applied using a dip coating technique.

[0242] 3. Thermally formed connections

[0243] Constraints on the helical balloon 113 are implemented by application of heat. A wide range of thermoforming techniques known in the art can be used to connect adjacent paths of the helical shape to one another. The collective arrangement of thermally formed connections 147 can comprise the matrix 114 by itself or in conjunction with other components.

[0244] 4. Matrix coating

[0245] The matrix cover 148 is a relatively thin sheet or collection of thin sheets that covers the balloon 111 and forms it into a spiral balloon 113. The matrix cover 148 can contain the spiral balloon 113 and maintain its spiral shape. The matrix cover 148 can be made from a fabric or other similar material suitable for a particular location 88 within the patient 90. The matrix cover 148 can cover a single pass, multiple passes, or all passes of the spiral shape. The matrix cover 148 can be used alone or in conjunction with other components to make up the matrix 114. The matrix cover 148 can be applied using dip coating techniques and other reasonable manufacturing methods.

[0246] 5. Flanges

[0247] The flanges 149 are rims, collars, or rings that secure the balloon 111 in the shape of the spiral balloon 113. The cross section of the spiral balloon 113 can have one or more flanges 149. Adjacent paths of the spiral shape can be connected to one another by flanges 149. The connected flanges 149 in an assembly can form the matrix component 114. The flanges 149 can be connected using braids 145, bonding agents 146, thermally formed connections 147, matrix covers 148, and / or potentially other means.

[0248] 6. Canaliculus

[0249] 8a-8e, the matrix component 114 includes tubules 200 disposed circumferentially about the spiral balloon 113. The tubules 200 extend parallel to the axis A of the spiral balloon 113 between adjacent turns 213a, 213b of the spiral balloon 113 to help constrain the spiral balloon 113 in a helical shape and maintain the lumen 120, as will become apparent from the following description.

[0250] The canaliculus 200 can be made of the same material as the spiral balloon 113 or a different material than the spiral balloon 113. Any known material suitable for medical applications can be used, but some non-limiting examples include PET (polyethylene terephthalate), nylon, engineering nylon, polyamide, polyurethane, nylon elastomers, and other thermoplastic elastomers. The canaliculus 200 can be non-compliant (e.g., rigid), semi-compliant, or flexible (e.g., flexible). Similarly, the spiral balloon 113 can be non-compliant (e.g., rigid), semi-compliant, or flexible (e.g., flexible). The canaliculus 200 and the spiral balloon 113 can have the same, similar, or different flexibility.

[0251] Each tubule 200 extends between opposing ends 202a / 202b, one of which contacts a first turn 213a of the spiral balloon 113 and the other of which contacts a second turn 213b adjacent to the first turn 213a.

[0252] The canaliculus 200 may be integral with the spiral balloon 113 or may be a separate structure attached to the spiral balloon 113 according to any known method appropriate to the materials of the canaliculus 200 and the spiral balloon 113 and the medical application. In either example, the canaliculus 200 is a hollow structure having a space 204. The space 204 is in fluid communication with the space 212 of the tubular balloon 112 such that the canaliculus expands with the spiral balloon 113 when the spiral balloon 113 is expanded from the low profile mode of operation 132 to the high profile mode of operation 134, as described above. The canaliculus 200 and the spiral balloon 113 may have a burst rating of up to about 27 atmospheres according to any known method of burst rating balloons. In this manner, the canaliculi 200 assists in maintaining the lumen 120 by providing structural support for the spiral balloon 113 preventing the spiral balloon 113 from collapsing into the lumen 120 when the spiral balloon 113 is in the high profile operating mode 134.

[0253] As shown in Figures 8a-8b, the canaliculi 200 are spaced apart from each other by a distance x. The canaliculi 200 have a length y defined as the distance between the ends 202. The length y corresponds to the distance between adjacent turns 213a / 213b of the spiral balloon 113 (known as the pitch of the helix). In the example of Figures 8a-8f, the distance x is constant, meaning that the canaliculi 20 are evenly spaced around the circumference of the spiral balloon 113. However, in other examples, the distance x may be variable, meaning that the canaliculi 200 have a different circumferential distribution around the spiral balloon 113. The distances x and y may be selected to provide flexibility to the spiral balloon 113 when it is in the high profile operating mode 134. For example, an area of ​​the spiral balloon 113 that requires flexing may have fewer canaliculi 200 so as not to impede the movement of the spiral balloon 113 relative to other areas in that local area.

[0254] The tubules 200 have a diameter d (FIG. 8e), which in one example is the same as the diameter of the tubular balloon 112 that is helically constrained to form the helical balloon 113. In other examples, the diameter d of the tubules 200 can be different than the diameter of the tubular balloon 112.

[0255] 7. Inner support

[0256] In one example shown in Figures 10a-b, the matrix component 114 includes an inner support 300 disposed inside the spiral balloon 113 created by the tubular balloon 112. The inner support 300 is attached to the inner surface 213c of the spiral balloon 113, e.g., the surface 213c that faces the lumen 120 when in the high-profile mode of operation 134. The inner support 300 can be non-compliant (e.g., rigid), semi-compliant, or flexible (e.g., flexible). Similarly, the spiral balloon 113 can be non-compliant (e.g., rigid), semi-compliant, or flexible (e.g., flexible). The inner support 300 and the spiral balloon 113 can have the same, similar, or different flexibility. In some examples, the inner support 300 is perforated, e.g., formed from a mesh.

[0257] When the helical balloon 113 is expanded from the low-profile mode of operation 132 to the high-profile mode of operation 134, as described above, the inner support 300 has a generally cylindrical shape and supports the helical balloon 113 in a helical shape to maintain the lumen 120. The inner support 300 also maintains the distance y (known as the pitch of the helix) between adjacent turns 213a / 213b of the helical balloon 113. In some instances, the distance y is zero or near zero, meaning that adjacent turns 213a / 213b of the helical balloon 113 are in contact with one another. In other instances, the distance y is greater than zero.

[0258] The inner support 300 may be made from any medical grade biocompatible material, such as, by way of non-limiting example, PET (polyethylene terephthalate), nylon polymer, or thermoplastic polyurethane. In a particular example, the inner support 300 is made from a "thin film" material having a thickness on the order of tenths of a millimeter. The inner support 300 may be made from the same material as the tubular balloon 112 or a different material.

[0259] 10a-b, the inner support 300 is continuous and forms a continuous generally cylindrical shape, for example, when the helical balloon 113 is in a high profile mode of operation 134. In other examples, the inner support 300 is discontinuous and includes several strips of material, such as the discontinuous outer support including multiple strips 350a / 350b described below.

[0260] The inner support 300 is attached to the spiral balloon 113 such that the inner support 300 is not detached from the spiral balloon 113 when the spiral balloon 113 is used as described herein. For example, the tubular balloon 112 can be attached to the inner support 300 by any suitable adhesive known in the art for the tubular balloon 112 / inner support 300 materials that are also biocompatible. In other examples, the tubular balloon 112 can be attached to the inner support 300 by thermal bonding, such as heat welding, RF (radio frequency) welding, ultrasonic welding, laser welding, etc. The attachment may be continuous, for example, along the entire inner surface 213c of the spiral balloon 113, or discontinuous, for example, only at certain points along the inner surface 213c.

[0261] 8.Outer support

[0262] In one example shown in Figures 11a-11b, the matrix component 114 includes an outer support 350. The outer support 350 can be used with the inner support 300 described above or by itself. The outer support 350 can be similar to the inner support 300, except that it is attached to the outer surface 213d of the spiral balloon 113. Like the inner support 300, the outer support 350 can be made from any medical grade biocompatible material, such as, by way of non-limiting example, PET (polyethylene terephthalate), nylon polymer, or thermoplastic polyurethane. In certain examples, the outer support 350 is made from a "thin film" material having a thickness on the order of tenths of a millimeter. The outer support 350 can be made from the same material as the tubular balloon 112 or a different material. In some examples, the outer support 350 is perforated, for example, formed from a mesh.

[0263] The outer support 350 can be attached to the spiral balloon 113 by adhesive or thermal bonding, as described above with respect to the inner support 300, such that the outer support 350 is not detached from the spiral balloon 113 when the spiral balloon 113 is used as described herein. In one example, the attachment can be by a number of connectors 352, as shown in the example of Figures 11a-11b. The connectors 352 can be filaments or threads similar to the threads 144 described above. In another example, the connectors 352 can be strips of material, either the same material as the outer support 350 or a different material than the outer support 350. The connectors 352 form loops that wrap around the turns 213a / 213b of the spiral balloon 113, connecting the turns 213a / 213b to the outer support 350. The connectors 352 can be connected to the outer support 350 and the spiral balloon 113 by any of the attachment methods described herein, such as adhesive or thermal bonding. In one example, there may be a connector 352 on each turn 213a / 213b, while in other examples, only some of the turns 213a / 213b have connectors 352. Additionally, there may be several connectors spaced circumferentially around the outer surface 213d such that a particular turn 213a / 213b has multiple connectors 352. In all cases, there are enough connectors 352 to maintain the helical shape of the helical balloon 113 and lumen 120 in the high-profile mode of operation 134.

[0264] The outer support 350 can be continuous, such that it forms a continuous, generally cylindrical shape when the spiral balloon 113 is in the high-profile mode of operation 134, as shown in FIGS. 11a-11b. In other examples, the outer support can be discontinuous and include multiple strips or segments 350a / 350b, as shown in FIGS. 12a-12b. Several strips 350a / 350b can be circumferentially disposed around the outer surface 213d of the spiral balloon 113. In some examples, the strips 350a / 350b have end portions 354 that fold over the ends 113a / 113b of the spiral balloon 113 and into the inner surface 213c of the spiral balloon 213.

[0265] 12c, the spiral balloon 113 can have a flattened profile at the outer surface 213d such that the cross section of the 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, if an inner support 300 is used, the flattened profile can additionally or alternatively be on the inner surface 213c.

[0266] 12d, both an inner support 300 and an outer support 350 are used. In this example, the inner support 300 / outer support 350 may be joined to one another between successive turns 213a / 213b of the helical balloon 113.

[0267] 13a-c show a mandrel 375 that can be used to assemble the spiral balloon 113 with the outer support 350. The mandrel 375 includes threads 377 that define a space 379 configured to receive the tubular balloon 112 to form the spiral balloon 113. The tubular balloon 112 is wound into the space 377, and then the outer support 350 is placed on the mandrel 375 along with the tubular balloon 112. The mandrel 375 locates the tubular balloon 112 relative to the outer support 350 for attachment by any of the methods described above. In instances where a connector 352 is used, the connector 352 can be placed on the mandrel 375 prior to winding the tubular balloon 112 into the space 377. In certain instances, the mandrel 375 has a notch or groove 381 configured to receive the connector 352.

[0268] 9. Clip

[0269] In one example shown in Figures 14a-14g, the matrix component 114 includes one or more clips 500. As best seen in Figure 14a, which shows the clip 500 in a flattened or unfolded state, and Figure 14d, which shows a perspective view of the clip 500 in a folded state, each clip 500 includes a central leaf 502, first and second receiving leaves 504a / 504b on either side of the central leaf 502, and first and second folded leaves 506a / 506b adjacent each of the receiving leaves 504a / 504b. A hinge point 505 separates the central leaf 502 from the first and second receiving leaves 504a / 504b and separates the first and second receiving leaves 504a / 504b from the first and second folded leaves 506a / 506b. The hinge point 505 may include a groove that allows the clip 500 of the clip to fold at the hinge point 505, as described in more detail below. However, other means of creating the hinge point 505 are also contemplated. The receiving leaf 504a / 504b includes an opening 508 configured to receive successive turns 213a / 213b of the spiral balloon 113. The opening 508 is sized to fit the diameter of the tubular balloon 112. The opening 508 can be centrally located along the length of the receiving leaf 504a / 504b (described in more detail below) or can be located closer to the central leaf 502 than the folded leaf 506a / 506b. The clip 500 has a width W that corresponds to the number of openings 508 / number of turns 213a / 213b of the spiral balloon 113 configured to be received within the clip 500.

[0270] As best seen in FIG. 14g, the clip 500 is positioned such that the successive turns 213a / 213b of the spiral balloon 113 are received within the opening 508 and the central leaf 502 rests along the outer surface of the spiral balloon 113. For example, a tubular balloon 112 may be wound within the clip 500 to form the spiral balloon 113. The folded leaf 506a / 506b is folded toward the central leaf 502, as best seen in FIG. 14e and FIG. 14g, thereby trapping the successive turns 213a / 213b of the spiral balloon 113 between the central leaf 502 and the folded leaf 506a / 506b to maintain the spiral shape. In the folded state, the folded leaf 506a / 506b is on the inner surface / lumen 120 side of the spiral balloon 113. The folding leaves 506a / 506b are disposed at an angle of approximately 90 degrees relative to the receiving leaves 504a / 504b, which in their folded state are disposed at an angle of approximately 90 degrees relative to the central leaf 502.

[0271] As best seen in FIG. 14a, the central leaf 502 has a length Lc, the receiving leaves 504a / 504b have a length Lr, and the folding leaves 506a / 506b have a length Lf. In certain instances, Lc is greater than Lr, and Lr is greater than Lf. Generally, Lr is greater than the diameter D of the tubular balloon 112. For example, Lr may be up to about 50% greater than the diameter of the tubular balloon.

[0272] The length Lf of the folded leaves 506a / 506b can be selected so that they touch each other in the folded state. In another example, the folded leaves 506a / 506b have a length Lf such that they overlap each other in the folded state, as shown in Figure 14f. In yet another example, the folded leaves 506a / 506b have a length Lf such that they do not touch or overlap each other in the folded state, as shown in Figures 14b and 14d.

[0273] As shown in the examples of Figures 14a and 14c, respectively, the matrix component 114 may include one clip 500 or multiple clips 500 spaced circumferentially about the spiral balloon 113. Although two clips 500 are shown in Figure 14c, more clips may be used in other examples.

[0274] 14f, matrix component 114 includes a cylindrical support 510 that surrounds the portion of spiral balloon 113 that is received within opening 508. Support 510 may be more rigid than spiral balloon 113 and may help maintain the helical shape of spiral balloon 113 as well as provide mechanical protection to spiral balloon 113. Support 510 may be separate from clip 500 or may be integral.

[0275] Clip 500 may be made from a flexible, semi-flexible, or non-flexible biocompatible polymeric material, such as PET (polyethylene terephthalate), Pebax®, nylon, polyurethane, or combinations thereof. In a particular example, clip 500 is made from a polymeric material that is about 0.06-0.1 mm thick.

[0276] 10.Band Connector

[0277] In one example shown in Figures 15a-15c, the matrix component 114 includes one or more band connectors 550. Each band connector 550 surrounds two or more successive turns 213a / 213b to maintain the helical shape of the spiral balloon 113. For example, as shown in the example of Figure 15c, three band connectors 550 may be used. In this particular example, the three band connectors 550 are evenly spaced around the circumference of the spiral balloon, e.g., each band connector 550 is separated from an adjacent band connector by about 120 degrees. However, other arrangements are contemplated.

[0278] Each band connector 550 is a rectangular flexible, semi-flexible, or inflexible sheet configured to be folded over successive turns 213a / 213b of the spiral balloon 113 into the folded state shown in Figs. 15a-15b. The band connectors 550 may 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. 15b) that may be about 0.05-0.02 mm in some examples. This folding creates overlapping portions 552 where the ends 554a / 554b of the band connectors overlap and are secured to each other to provide a folded state in which the band connectors 550 maintain the shape of the spiral balloon 113. This securing may be by adhesive bonding, heating, welding, bonding, or pressure.

[0279] In the exemplary band connector 550 that is non-flexible, it may be formed from multiple separate pieces that are assembled and connected together by locking mechanisms or bonding / other connection methods appropriate for the materials.

[0280] 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 that is greater than about 3 mm in some examples. The length of the sheet in the unfolded state is selected to provide a folded length L and a folded width W, taking into account the length Lo of the overlapping portion 552. For example, the width W can be selected so that the folded band connector 550 fits around a diameter D of the tubular balloon 112, as shown in FIG. 15b. Thus, the width W is equal to D+2t. In a particular example, the width W is about 0.5-2 mm. The length L is selected to enclose a desired number of consecutive turns 213a / 213b of the spiral balloon 113. Thus, the length L is equal to about n*D+2*t, where n is the number of consecutive turns 213a / 212b around which the band connector 550 is wrapped. In some examples, n is 3-5.

[0281] In some examples, overlapping band connectors 550 may be used. For example, for a set of ten turns 213a / 213b of a spiral balloon, turns 2-5 may be covered by one band connector 550, turns 4-7 may be covered by another band connector 550, and so on. Thus, the band connectors 550 may be interleaved / overlapping along the axial length and circumference of the spiral balloon 113. In some examples, the band connectors 550 may be connected to one another, such as by any of the connection methods described above for the overlapping portions 552.

[0282] 16a-b show a mandrel 575 that can be used to assemble the spiral balloon 113 with the band connector 550. The mandrel 575 includes threads 577 that define a space 579 configured to receive the tubular balloon 112 to form the spiral balloon 113. The mandrel includes at least one groove 581 configured to receive a portion 550a of the band connector. The tubular balloon 112 is then wrapped within the space 577 over the portion 550a of the band connector. Next, as shown in FIG. 16b, a second portion 550b of the band connector is folded into a folded state around the spiral balloon 113 and joined to the first portion 550a at the overlapping portion 552, for example, as described above.

[0283] The mandrel 575 of Figures 16a-b can also be used to assemble the spiral balloon 113 with the clip 500 described above. In one example, the central leaf 502 of the clip 500 can be placed into the groove 581 of the mandrel 575, and the folded leaves 504a / 504b are positioned so that the tubular balloon 112 can be wrapped through the opening 508 and onto the central leaf 502, within the space 577. The folded leaves 504a / 504b can then be moved into a folded position, such as that shown in Figure 14d, and in some examples may be held in the folded position by a thin strip of tape or other material.

[0284] 11. Co-extruded restraints

[0285] In one example shown in Figures 17a-17b, the matrix component 114 includes multiple restraints on adjacent turns 213a / 213b of the spiral balloon 113. The restraints are tabs 600 extending from the turns 213a / 213b of the spiral balloon. One or both of the tabs 600 have a length L that is greater than half the distance y between adjacent turns 213a / 213b of the spiral balloon 113 (known as the pitch of the helix). Thus, the tabs 600 overlap each other at overlapping portions 602. The length L can be about 0.5 mm to 2 mm in some examples. The width W can also be about 0.5 mm to 2 mm. The overlapping tabs 600 can have the same or different widths W. The thickness of the tabs can be about 0.05 mm to 0.02 mm in some examples.

[0286] Tab 600 is joined at overlapping portions 602 to constrain turns 213a / 213b of helical balloon 113. Joining may be by any known method appropriate to the material of tab 600, such as adhesive, welding, pressure, etc.

[0287] Several tabs 600 may be formed at predetermined distances along the spiral balloon 113 such that when the spiral balloon 113 is wound to define a lumen 120 having a desired diameter, the tabs 600 of successive turns 213a / 213b overlap one another. For example, when the spiral balloon 113 is wound in a spiral shape, the tabs 600 may be spaced 120 degrees apart 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 spiral balloon 113 such that when the spiral balloon 113 is wound, the tab 600 overlaps itself at the overlap 602 between adjacent turns 213a / 213b.

[0288] 17c, in some examples, the tabs 600 include a lip 604 at a distal end of the tabs 600. The lips 604 of adjacent tabs 600 interact with one another at the overlapping portion 602 to improve bonding / joining of the tabs 600. In this example, the tabs 600 may be aligned with one another or offset from one another to facilitate engagement of the lips 604, as shown in FIG.

[0289] Tab 600 is co-extruded with spiral balloon 113. That is, tab 600 is formed as spiral balloon 113 is being formed and is therefore integral with spiral balloon 113. Tab 600 can be the same or a different material as tubular balloon 112. Tab 600 may comprise, for example, PET (polyethylene terephthalate), nylon, engineering nylon, polyamide, polyurethane, nylon elastomers, and other thermoplastic elastomers.

[0290] 13. Strips with flaps

[0291] In one example shown in Figures 18a-18c, the matrix component 114 includes a strip 700 having a series of flaps 702 that correspond to the turns 213a / 213b of the spiral balloon 113. The flaps 702 wrap around the turns 213a / 213b of the spiral balloon, connecting the strip 700 to the spiral balloon 113 and constraining the spiral balloon 113 to the spiral, as shown in Figures 18b-18c. The strip 700 may be long enough to span the axial length of the wrapped spiral balloon 113 in some examples. In other examples, the strip 700 spans only some of the turns 213a / 213b of the spiral balloon 113. More than one strip 700 may be used. In a particular example, the matrix component 114 includes three strips 700 arranged at approximately 120 degrees from each other around the circumference of the spiral balloon 113.

[0292] Each of the flaps 702 has a length L and a width W (FIG. 18a) of about 0.5 mm to about 2 mm. The thickness of the flap may be about 0.05 mm to 0.2 mm. The length L is longer than the circumference of the tubular balloon 112 such that when the flap 702 wraps around each turn 213a / 213b, it overlaps with itself at the overlap portion 704. The flap 702 can be secured to itself at the overlap portion 704 and / or to the tubular balloon 112 by any suitable method, such as by adhesive, welding, pressure, etc.

[0293] Mandrel 375 of Figures 13a-13c can be used to assemble spiral balloon 113 with strip 700. The strip is positioned so that flap 702 corresponds to space 379. Flap 702 extends over space 379. Tubular balloon 112 is wrapped within space 379 over flap 702. Flap 702 is then wrapped around windings 213a / 213b and attached as described above.

[0294] The strip 700 can be the same or a different material as the tubular balloon 112. The strip 700 may include, for example, PET (polyethylene terephthalate), nylon, engineering nylon, polyamide, polyurethane, nylon elastomers, and other thermoplastic elastomers.

[0295] 12. Scalloped Restraints

[0296] In one example shown in Figures 19a-19c, the matrix component 114 includes a scalloped restraint 800. The scalloped restraint 800 includes two scalloped strips 802a / 802b, each having a hemispherical profile and preformed with scallops 804 that correspond to the curvature of the tubular balloon 112. The scalloped strips 802a / 802b are positioned such that the tubular balloon 112 is sandwiched between them, helically restraining the spiral balloon 113. The scalloped strips 802a / 802b are joined at the interface 806 between each successive turn 213a / 213b of the spiral balloon by any suitable method, such as adhesive, welding, pressure, etc.

[0297] The scalloped restraint 800, in some examples, can be long enough to span the axial length of the wound spiral balloon 113. In other examples, the scalloped restraint 800 spans only some of the turns 213a / 213b of the spiral balloon 113. More than one scalloped restraint 800 may be used. In a particular example, the matrix component 114 includes three scalloped restraints 800 positioned approximately 120 degrees from one another around the circumference of the spiral balloon 113.

[0298] The scalloped restraint 800 can be the same or a different material as the tubular balloon 112. The scalloped restraint 800 may include, for example, PET (polyethylene terephthalate), nylon, engineering nylon, polyamide, polyurethane, nylon elastomers, and other thermoplastic elastomers.

[0299] The scalloped strips 802a / 802b each have a width W (FIGS. 19b-19c) of about 0.5 mm to about 2 mm. The thickness of the scalloped strips 802a / 802b may be about 0.05 mm to 0.2 mm.

[0300] Mandrel 375 of Figures 13a-13c can be used to assemble spiral balloon 113 with scalloped restraint 800. One of scalloped strips 802a is placed onto mandrel 375 such that scallops 804 fit within space 379. Tubular balloon 112 is wrapped within space 379 over scalloped strip 802a. The other of scalloped strip 802b is then placed onto spiral balloon 113 and scalloped strips 802a / 802b are joined at the joint.

[0301] In some examples, the scalloped strips 802a / 802b can be joined into a single long strip that can be folded over itself to provide two opposing scalloped strips 802a / 802b (similar to the band connector 500 described above).

[0302] C. Working Example

[0303] 7a illustrates a perspective view of a helix 113 and matrix 114 configuration that includes a tubular balloon constrained in the shape of a helix by braids 145 that act as matrix 114. The inner central lumen 120 of the helix is ​​0.058 inches, which is created by wrapping the tubular balloon 112 around a mandrel and is secured by matrix 114. Twelve threads 144 with a diameter of 0.002 inches form the matrix 114.

[0304] FIG. 7b shows an example of a side view of the helix 113 and matrix 114 configuration of FIG. 7a.

[0305] 7c shows an example of a planar front view of the helix 113 and matrix 114 configuration of FIGS. 7a and 7b. As shown, twelve threads are evenly spaced around the helical balloon 113.

[0306] FIG. 7d shows an example of a perspective cross-sectional view of the spiral 113 and matrix 114 configuration of FIGS. 7a-7c.

[0307] FIG. 7e illustrates an example of an exemplary expanded view of FIG. 7d.

[0308] FIG. 7f is a hierarchical diagram showing various examples of different spiral balloons 113 and matrix components 114. As shown in the figure with dotted lines, the matrix 114 is an optional component, although it is often highly desirable. As shown, the spiral balloon 113 can be implemented as a self-expanding spiral component 141, a mechanically expandable spiral component 142, and an inflatable spiral balloon 113 shown in FIGS. 7a-7e. As shown, the matrix 114 can be implemented as a braid 145, a binder 146, a thermally formed connection 147, and a matrix cover 148. As mentioned above, the matrix 114 may include a pharmaceutical ingredient 126.

[0309] VIII. Glossary / Index

[0310] Table 1 below is a table linking element numbers, element names, and element descriptions. [Table 1] TIFF2025507239000003.tif237160TIFF2025507239000004.tif237160TIFF2025507239000005.tif238158TIFF20255072390 00006.tif236160TIFF2025507239000007.tif236157TIFF2025507239000008.tif238159TIFF2025507239000009.tif199161

Claims

1. 1. A system for creating a lumen, comprising: a generally helically wound balloon having an inner surface and an outer surface; 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; Equipped with The balloon has a first diameter in a low profile mode of operation and the generally helical shape has a second diameter in a high profile mode of operation, the second diameter being greater than the first diameter.

2. The system of claim 1 , wherein the support has a generally cylindrical shape and is continuous.

3. The system of claim 1 , wherein the support is discontinuous, the support comprising one or more strips.

4. The system of claim 3 , wherein the one or more strips are attached to the outer surface of the generally spiral shape.

5. The system of claim 4 , wherein at least one or more strips include end portions that are folded onto the inner surface of the generally spiral shape.

6. The system of claim 1 , wherein the support is attached to the at least one of the inner and outer surfaces of the generally helical shape by a connector.

7. The system of claim 1 , wherein the support is a thin film.

8. The system of claim 1 , wherein the support is perforated.

9. The system of claim 1 , wherein the support includes a first support on the inner surface of the generally helical shape and a second support on the outer surface of the generally helical shape.

10. 1. A system for creating a lumen, comprising: a generally helically wound balloon having an inner surface and an outer surface; at least one clip constraining the balloon in the generally helical shape, the at least one clip including a central leaf and first and second receiving leaves on either side of the central leaf, the first and second receiving leaves each including a first opening and a second opening, the first opening receiving a first turn of the generally helical shape and the second opening receiving a second turn of the generally helical shape; Equipped with The balloon has a first diameter in a low profile mode of operation and the generally helical shape has a second diameter in a high profile mode of operation, the second diameter being greater than the first diameter.

11. The system of claim 10 , wherein the central leaf rests along an outer surface of the generally helical shape.

12. 11. The system of claim 10, further comprising first and second folded leaves adjacent the first and second receiving leaves, respectively, the first and second folded leaves configured to fold toward the central leaf, thereby trapping the first and second turns of the generally spiral shape.

13. 11. The system of claim 10, further comprising at least one cylindrical support surrounding at least a portion of the first and second turns of the helical balloon received within the first or second opening of the receiving portion.

14. 1. A system for creating a lumen, comprising: a generally helically wound balloon having an inner surface and an outer surface; at least one band connector constraining the balloon in the generally helical shape, the at least one band connector encircling at least two successive turns of the generally helical shape; Equipped with The balloon has a first diameter in a low profile mode of operation and the generally helical shape has a second diameter in a high profile mode of operation, the second diameter being greater than the first diameter.

15. The system of claim 14 , wherein the system includes three band connectors, each of the three band connectors being evenly circumferentially spaced about the generally spiral shape.

16. 15. The system of claim 14, wherein the at least one band connector is folded about the at least two successive turns of the generally spiral shape such that first and second opposing ends of the at least one band connector overlap one another at overlapping portions.

17. 17. The system of claim 16, wherein the first and second opposing ends of the at least one band connector are secured to one another at the overlapping portion by an adhesive, by a thermal bond, or by a pressure bond.

18. 1. A method of creating a lumen in an artery, comprising: inserting a balloon into the artery in a low profile mode of operation, the balloon having an inner surface and an outer surface and a support attached to at least one of the inner surface and the outer surface; forming the lumen within the generally helical shape by expanding a tubular balloon into a high profile operating mode in which the inner surface of the generally helical shape defines a lumen and the support constrains the balloon to the generally helical shape; A method comprising:

19. 1. A method of creating a lumen in an artery, comprising: inserting a balloon into the artery in a low profile mode of operation, the balloon having an inner surface and an outer surface; forming the lumen by expanding the balloon into a high profile operating mode, the inner surface defining a lumen and at least one clip constraining the balloon into a generally helical shape, the at least one clip including a central leaf and first and second receiving leaves on either side of the central 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 the second opening receiving a second turn of the generally helical shape; A method comprising:

20. 1. A method of creating a lumen in an artery, comprising: inserting a balloon into the artery in a low profile mode of operation, the balloon having an inner surface and an outer surface; forming the lumen by expanding the balloon into a high profile operating mode in which the inner surface defines the lumen and at least one band connector constrains the balloon into a generally helical shape, the at least one band connector encircling at least two successive turns of the generally helical shape; A method comprising:

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