WO2022221524A2 - Système, appareil et procédé de création de lumière - Google Patents

Système, appareil et procédé de création de lumière Download PDF

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Publication number
WO2022221524A2
WO2022221524A2 PCT/US2022/024803 US2022024803W WO2022221524A2 WO 2022221524 A2 WO2022221524 A2 WO 2022221524A2 US 2022024803 W US2022024803 W US 2022024803W WO 2022221524 A2 WO2022221524 A2 WO 2022221524A2
Authority
WO
WIPO (PCT)
Prior art keywords
balloon
tubular balloon
operating mode
tubular
tubules
Prior art date
Application number
PCT/US2022/024803
Other languages
English (en)
Other versions
WO2022221524A3 (fr
Inventor
Joseph R. Korotko
Raj RISWADKAR
William W. O'neill
Original Assignee
Accumed Radial Systems, Llc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from US17/379,423 external-priority patent/US20210346182A1/en
Application filed by Accumed Radial Systems, Llc filed Critical Accumed Radial Systems, Llc
Priority to CA3215474A priority Critical patent/CA3215474A1/fr
Priority to AU2022256478A priority patent/AU2022256478A1/en
Priority to JP2023563257A priority patent/JP2024514212A/ja
Publication of WO2022221524A2 publication Critical patent/WO2022221524A2/fr
Publication of WO2022221524A3 publication Critical patent/WO2022221524A3/fr
Priority to AU2022395016A priority patent/AU2022395016A1/en
Priority to PCT/US2022/050584 priority patent/WO2023091756A1/fr
Priority to CA3238444A priority patent/CA3238444A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A61M25/1006—Balloons formed between concentric tubes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/958—Inflatable balloons for placing stents or stent-grafts
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/962—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve
    • A61F2/966—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A61M25/104—Balloon catheters used for angioplasty
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2002/826—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents more than one stent being applied sequentially

Definitions

  • the invention is a system, apparatus and method for creating a space (collectively the “system”). More specifically, the system creates a lumen within a body to facilitate the use of a medical device, such as the use of a catheter in a blood vessel.
  • the term "lumen” means a "canal, duct, or cavity of a tubular organ.”
  • the system can facilitate catheterization by creating additional "working space” (i.e. the lumen) at a desired location within the body of a patient.
  • the additional space can be created by transitioning from a low-profile operating mode into a high-profile operating mode.
  • the term “catheter” refers collectively to a wide range of medical devices that are inserted into the body to (1) diagnose a medical condition; (2) treat a medical condition; (3) deliver nourishment; or (4) deliver medicine.
  • the term “catheter” is often used more specifically to refer to a tube inserted into the body of a patient for the purposes of (a) removing material from a location in the body of a patient and/or (b) delivering medicinal and/or nourishing material to a specific location within the body of a patient.
  • Catheters can be used in a variety of locations for a variety of purposes within the body of a patient. Catheterization procedures are commonly involved in the diagnosis and treatment of the cardiovascular system, the excretory system, and other similar systems of a patient.
  • Cardiovascular diseases are a serious health problem in the United States and elsewhere. About 1 in 3 deaths in the US is attributed to cardiovascular disease, which includes heart attacks and strokes. According to the World Health Organization (“WHO”), cardiovascular diseases are the number one cause of death in world. An estimated 17.3 million people died of cardiovascular diseases in 2008, a number that represents 30% of all deaths occurring in that year. According to WHO estimates, the number of deaths caused by cardiovascular diseases will reach 23.4 million by 2030.
  • WHO World Health Organization
  • CAD coronary artery disease
  • a variety of catheterization procedures are used in the prior art to diagnose and treat arterial disease.
  • a catheter In the context of cardiovascular disease, a catheter is often a long, thin, flexible, hollow intravascular tube used to access the cardiovascular system of the body. Catheterization is most commonly conducted through the radial artery in the wrist (transradial catheterization) or the femoral artery of the groin (transfemoral catheterization). Catheterization can also be conducted through the elbow, neck, and other parts of the body.
  • a wide variety of intravascular procedures can be used to address cardiovascular health issues in human beings.
  • PCI Percutaneous coronary intervention
  • Angioplasty is a medical procedure used to treat the narrowed coronary arteries of the heart.
  • a cardiologist feeds a deflated balloon or other similar device to the site of the blockage. The balloon can then be inflated at the point of blockage to open the artery.
  • a stent is often permanently placed at the site of blockage to keep the artery open after the balloon is deflated and removed.
  • Angioplasty has proven to be a particularly effective treatment for patients with medically refractory myocardial ischemia. Unfortunately, it is not always possible to position the catheter in the desired location for the purposes of an angioplasty procedure.
  • a method of performing angioplasty includes accessing an artery, inserting a tubular balloon into to the artery in a low-profile operating mode, the tubular balloon constrained in a generally helical shape, and forming a lumen within the generally helical shape by expanding the tubular balloon into a high-profile operating mode.
  • a system for forming a lumen includes a tubular balloon operable in a low-profile operating mode and a high-profile operating mode, and a matrix constraining the tubular balloon in a generally helical shape, the matrix comprising a weave.
  • the tubular balloon has a first diameter in a low-profile operating mode and a second diameter in a high-profile operating mode, and the second diameter is larger than the first diameter.
  • a system for forming a lumen includes a tubular balloon, the tubular balloon operable in a low-profile operating mode and a high-profile operating mode, and a matrix constraining the tubular balloon in a generally helical shape, the matrix comprising at least one thermally formed connection.
  • the tubular balloon has a first diameter in a low- profile operating mode and a second diameter in a high-profile operating mode, and the second diameter is larger than the first diameter.
  • Figure la is a block diagram illustrating an example of a system for creating a lumen.
  • Figure lb is a flow chart diagram illustrating an example of a process for creating a lumen.
  • Figure lc is an environmental diagram illustrating an example of an expansion component in a low-profile operating mode.
  • Figure Id is an environmental diagram illustrating an example of an expansion component in a high-profile operating mode.
  • Figure 2a is a hierarchy diagram illustrating an example of different embodiments of the system, including direct expansion embodiments and indirect expansion embodiments of the system.
  • Figure 2b is a hierarchy diagram illustrating an example of different embodiments of the system, including expansion component balloon embodiments and expansion component non-balloon embodiments.
  • Figure 2c is a hierarchy diagram illustrating an example of different types of balloons that can be utilized by the system.
  • Figure 3a is diagram illustrating a partial and close-up view of the tubular balloon expansion component illustrated in Figure 3b.
  • Figure 3b is a diagram illustrating an example of an axial view of the tubular balloon expansion component.
  • Figure 3c is a diagram illustrating an example of a top view of the tubular balloon expansion component.
  • Figure 3d is a diagram illustrating an example of a side view of the tubular balloon expansion component.
  • Figure 3e is a diagram illustrating an example of a cross-sectional view of a side view of the tubular balloon expansion component with an illustration of a space within the tubular balloon expansion component.
  • Figure 3f is a diagram illustrating an example of a partial and close-up view of the tubular balloon expansion component illustrated in Figure 3e.
  • Figure 3g is a perspective and partial diagram illustrating an example of a tubular balloon expansion component.
  • Figure 3h is a diagram illustrating an example of a front view of a pleated tubular expansion component, an example of a passive expansion component.
  • Figure 3i is a diagram illustrating an example of a perspective view of tubular balloon expansion component.
  • Figures 3j-m illustrate an example of the tubular balloon of Figures 3e-g.
  • Figure 4a is a flow chart diagram illustrating an example of a process for creating a lumen using a guide balloon embodiment of the system.
  • Figure 4b is an environmental diagram illustrating an example of a process step where the guide balloon is inserted.
  • Figure 4c is an environmental diagram illustrating an example of a process step where the guide balloon is inflated.
  • Figure 4d is an environmental diagram illustrating an example of a process step where the expansion component in the form of a cover is advanced over the inflated guide balloon in order to expand the cover from a low-profile state into a high-profile state.
  • Figure 4e is an environmental diagram illustrating an example of a process step where the cover is positioned as desired within the body of the patient to create a lumen at the desired location.
  • Figure 4f is an environmental diagram illustrating an example of a process step where the guide balloon is deflated and removed, creating a lumen within the cover.
  • Figure 4g is an environmental diagram illustrating an example of a process step where a stent catheter is inserted through the space created by the cover.
  • Figure 5a is a flow chart diagram illustrating an example of a process for creating a lumen using an insertion component embodiment of the system.
  • Figure 5b is an environmental diagram illustrating an example of a process step where the cover is inserted into the body of the patient.
  • Figure 5c is an environmental diagram illustrating an example of a process step where an insertion component is inserted into the cover (a type of expansion component) positioned within the body of the patient to expand the distal section of the expansion component and to create the desired lumen at the desired location.
  • Figure 5d is an environmental diagram illustrating an example of a process step where a stent catheter is inserted through the cover.
  • Figure 6a is a flow chart diagram illustrating an example of a process for creating a lumen using a sheathed balloon embodiment of the system.
  • Figure 6b is an environmental diagram illustrating an example of a process step where a sheath covers the sheathed balloon during insertion the sheathed balloon.
  • Figure 6c is an environmental diagram illustrating an example of a process step where the sheath and the sheathed balloon within the sheath are positioned as desired within the body of the patient.
  • Figure 6d is an environmental diagram illustrating an example of a process step where the sheath is withdrawn. This causes the balloon to self-expand because it is no longer constrained by the sheath, triggering the creation of the additional working space (i.e. lumen) within in the body of the patient.
  • additional working space i.e. lumen
  • Figure 6e is an environmental diagram illustrating an example of how the expanded sheathed balloon can create or enhance the lumen at the desired location within the body of the patient.
  • Figure 6f is an environmental diagram illustrating an example of a process step where the stent catheter is inserted into the patient through the working space created by the presence of the balloon in a high-profile operating mode.
  • Figure 6g is an environmental diagram illustrating an example of a process step where the sheath is advanced to collapse the balloon for removal.
  • Figure 7a is a diagram illustrating a perspective view of a helix and matrix configuration that includes a tubular balloon constrained in the shape of a helix by a weave functioning as a matrix.
  • Figure 7b is a diagram illustrating an example of a side view of the helix and matrix configuration of Figure 7 a.
  • Figure 7c is a diagram illustrating an example of an axial view of the helix and matrix configuration of Figures 7a and 7b.
  • Figure 7d is a diagram illustrating an example of a perspective section view of the helix and matrix configuration of Figures 7a-7c.
  • Figure 7e is a diagram illustrating an example of close-up view of the illustration in Figure 7d.
  • Figure 7f is a hierarchy diagram illustrating an example of different components and component configurations that can be utilized in a helix balloon embodiment of the system.
  • Figures 8a-f show an example helix balloon with tubules.
  • Figures 9a-c show an example tubular balloon with connection(s).
  • the invention is a system, apparatus and method for creating a space (collectively the “system”). More specifically, the system creates a lumen within a body to facilitate the use of a medical device, such as the use of a catheter in a blood vessel.
  • a medical device such as the use of a catheter in a blood vessel.
  • the term "lumen” means a "canal, duct, or cavity of a tubular organ.”
  • the additional space can be created by transitioning from a low-profile operating mode into a high-profile operating mode.
  • the additional space can enable the use of other medical devices by overcoming the problems of conventional access such as vessel tortuosity or insignificant stenoses.
  • the system enables a balloon angioplasty catheter or stent catheter can be inserted through the passageway or tunnel of the lumen past the access problems and onto the desired location.
  • the system can create a lumen in the body of a patient. That lumen can be used to position a medical device, such as a catheter, that can potentially save the life of the patient.
  • a medical device such as a catheter
  • the system can be described in terms of interacting entities, components, operational attributes, and processes.
  • a system 100 is an interface between a healthcare provider 92 and a body of a living organism, i.e. a patient 90.
  • the provider 92 is typically a physician, although nurses, paramedics, physician assistants, veterinarians, and other health care professionals can potentially act as providers 92 in certain contexts.
  • the patient 90 is typically a human being, but other organisms can constitute patients 90 in certain contexts.
  • the system 100 is a tool that the provider 92 can use to benefit the health status of the patient 90.
  • the purpose of the system 100 is to create "working space" (i.e. a lumen 120) within the body of the patient 90 sufficient to enable the positioning and use of a medical device 80 such as a catheter within the body of the patient 90.
  • the system 100 can be implemented in a wide variety of different ways. The system 100 can be used to improve the health of the patient 90 and to even save the life of the patient 90.
  • a wide variety of different medical devices 80 and medical procedures 81 can benefit from the lumen 120 created by the system 100.
  • Examples of potentially useful medical devices 80 include but are not limited to all types of catheters, stents, patient monitoring applications, and other similar invasive devices.
  • a catheter device is potentially any device inserted into the body of a patient 90.
  • the term “catheter device” refers collectively to a wide range of medical devices that are inserted into the body to (1) diagnose a medical condition; (2) treat a medical condition; (3) delivery nourishment; or (4) deliver medicine.
  • the term “catheter device” is often used more specifically to refer to a tube inserted into the body of a patient 90 for the purposes of (a) removing material from a location in the body of a patient 90 and/or (b) delivering medicinal and/or nourishing material to a specific location within the body of a patient 90.
  • Catheters can be used in a variety of locations for a variety of purposes within the body of the patient 90. Catheterization procedures are commonly involved in the diagnosis and treatment of the cardiovascular system, the excretory system, and other systems of a patient 90.
  • the system 100 was originally conceived for the purpose of serving providers 92 involved in providing medical procedures 81 such as coronary vascular procedures. Examples of such procedures include but are not limited to Percutaneous Coronary Intervention (PCI), Percutaneous Coronary Angiogram (PCA), Chronic Total Occlusions (CTO), Stent implantation, Atherectomy, and Embolic Protection.
  • PCI Percutaneous Coronary Intervention
  • PCA Percutaneous Coronary Angiogram
  • CTO Chronic Total Occlusions
  • Stent implantation Atherectomy, and Embolic Protection.
  • the system 100 can be particularly useful in the context of transradial catheterizations (catheterizations in which the catheter initially enters the body of the patient 90 through the radial artery) because transradial catheterizations typically involve catheterization devices with a relatively smaller profile and relatively sparse space in which to operate.
  • the system 100 in its varying embodiments can also be used in a variety of contexts that involve cardiovascular care and the treatment of wholly different conditions.
  • a lumen 120 is a space created within the patient 90 by the system 100.
  • the lumen 120 is often referred to as a "canal, duct, or cavity within a tubular organ".
  • the lumen 120 is the "working space" within the patient 90 in which the medical device 80 is positioned.
  • the lumen 120 is located within the expansion component 110 and the expansion component 110 is at least substantially in the form a hollow tube, with the lumen 120 comprising the hollow core of the expansion component 110.
  • An expansion component 110 is the device capable of existing in at least two operating modes 130, a low-profile operating mode 132 and a high-profile operating mode 134.
  • expansion components 110 can transform from a high- profile operating mode 134 back into a low-profile operating mode 132 when the expansion component 110 is no longer needed.
  • Expansion components 110 can be categorized as direct vs. indirect. Some embodiments of the system 100 utilize balloons as expansion components 110 while other embodiments of the system 100 utilize non-balloon expansion components 110.
  • the expansion component 110 can operate in two or more operating modes 130 (which can also be referred to as states 130.
  • the low-profile operating mode 132 is typically the most convenient operating mode 130 in which to insert the expansion component 110 into the patient 90 prior to creating the lumen 120.
  • the low-profile operating mode 132 is also typically the most convenient operating mode 130 in which the provider 92 can remove the expansion component 110 after the lumen 120 is created and after the medical device 80 has been positioned correctly within the patient 90.
  • Some embodiments of the system 100 will involve one or more intermediate operating modes between the low-profile operating mode 132 and the high-profile operating mode 134.
  • Figure lb is a flow chart diagram illustrating an example of a method for creating a lumen 120.
  • the expansion component 110 is inserted within the patient 90.
  • Different embodiments of the system 100 can involve different types of expansion components 110 to create lumen 120 for different types of medical devices 80.
  • the expansion component 110 is positioned within the patient 90.
  • Different embodiments of the system 100 can involve a wide variety of different locations within the body of the patient 90.
  • the operating mode 130 of the expansion component 110 is changed from a low-profile operating mode 132 into a high-profile operating mode 134 in order to create a lumen 120. It is the lumen 120 that serves as the "working space" for the proper positioning and use of the medical device 80, such as a catheter.
  • the expansion component 110 is transformed back from a high-profile operating mode 134 into a low-profile operating mode 132 to facilitate the removal of the expansion component 110 from the body of the patient 90.
  • the system 100 can be implemented in a wide variety of different operating environments and locations. The process of determining which embodiment of the system 100 is best suited for a particular context should begin with identifying the desired medical device 80 to be used at the desired location. The appropriate expansion component 110 can then be identified and selected.
  • Figure lc is an environmental diagram illustrating an example of an expansion component 110 in a low-profile operating mode 132.
  • the expansion component 110 is being positioned to a desired location 88 within a blood vessel 91 in the patient 90.
  • Figure Id is an environmental diagram illustrating an example of an expansion component 110 that has been transformed (i.e. expanded) from a low-profile operating mode 132 into a high-profile operating mode 134.
  • the expansion component 110 is but one component of many.
  • the expansion component 110 can interfaces with certain ancillary components, such as a guide catheter 121 and a guide wire 122.
  • ancillary components such as a guide catheter 121 and a guide wire 122.
  • a guide catheter 121 and a guide wire 122 may be utilized to position the expansion component 110 to the desired location 88.
  • Such components may be part of the system 100, but the use of ancillary components will vary widely between different embodiments of the system 100.
  • the system 100 can include virtually any prior art component useful to the provider 92 in addressing the needs of the patient 90.
  • the expansion component 110 expands from a low-profile operating mode 132 into a high-profile operating mode 134 to create a lumen 120.
  • the transformation between operating modes 130 is accomplished directly by the expansion component 110 while in other embodiments of the expansion component 110, the transformation between operating modes is accomplished only indirectly by the expansion component 110.
  • Figure 2a is a hierarchy diagram illustrating examples of direct expansion embodiments 101 as well as indirect expansion embodiments 102.
  • Indirect expansion embodiments 102 involve expansion components 110 that expand or shrink due to other components of the system 100.
  • direct expansion components 101 involve expansion components 110 that can change operating modes 130 without the use of other components of the system 100.
  • Direct expansion embodiments 101 can include but are not limited to a tubular balloon embodiment 103 and a helix balloon embodiment 104. Direct expansion embodiments 101 typically involve "inflating" a balloon with a substance such as liquid to expand from a low-profile operating mode 132 into a high-profile operating mode 134. Some embodiments may utilize a gas, but it is often not desirable to risk inserting bubbles of air or other gases in the blood vessels 91 of patients 90.
  • Indirect expansion embodiments 102 can include but are not limited to a guide balloon embodiment 105 (where an expansion component 110 in the form of a cover 116 expands by advancing upon an inflated guide balloon 115), an insertion component embodiment 106 (where an expansion component 110 in the form of a cover 116 expands through the insertion of an insertion component 117 into the expansion component 110), and a sheath embodiment 107 (where the sheathed balloon 118 inflates when no longer constrained by the sheath 119). Indirect expansion embodiments 102 utilize other components of the system 100 to "inflate" to a high-profile operating mode 134 and to "deflate" to a low-profile operating mode 132.
  • Guide balloon embodiments 105 of the system 100 use an expansion component 110 that is advanced over an inflated balloon to expand the expansion component 110.
  • Insertion component embodiments 106 of the system 100 use a insertion component 117 that is inserted into the expansion component 110 to expand the expansion component 110.
  • Sheath embodiments 107 utilize a sheath to constrain an expansion component 110 that would otherwise exist in an expanded state.
  • the various embodiments of the system 100 can also be categorized on the basis of whether the expansion component 110 is some type of balloon (which inflates using air, some other gas, some form of liquid or fluid, or through the use of mechanical means) or whether the expansion component 110 is not a balloon.
  • Figure 2b is a hierarchy diagram illustrating examples of both expansion component balloon embodiments 108 and expansion component non-balloon embodiments 109.
  • expansion component balloon embodiments 108 can include but are not limited to tubular balloon embodiments 103, helix balloon embodiments 104, and sheath embodiments 107.
  • expansion component non-balloon embodiments 109 can include but are not limited to guide balloon embodiments 105 and insertion component embodiments 106.
  • the embodiment of the system 100 illustrated in Figures 3a-3g involves an inflatable balloon as the expansion component 110. That embodiment of the system 100 has a balloon as the expansion component 110 that can be in either a low-profile state 132 or a high-profile state 134 (i.e. an expanded state).
  • the system 100 is transitioned between states 130 by inflating or deflating the expansion component 110 (i.e. the balloon).
  • the system 100 has an “active” control through the inflation and deflation feature.
  • An alternate embodiment of an active control system 100 is a self-expanding balloon with a sheathed balloon 118 as the expansion component 110.
  • the system 100 would have a balloon that self-expands.
  • Active control of the system 100 is through the use of a sheath 119 that covers the balloon.
  • the device is in the low-profile state 132 when the sheath 119 covers the self-expanding balloon. In this state 132 the system 100 can be inserted to the required location.
  • the low-profile state 132 will facilitate insertion in an atraumatic manner.
  • the system 100 will be able to interface with other necessary devices, such as a 0.014 coronary guide wire and a guide catheter.
  • the sheath 119 When the system 100 is properly positioned at the required location, the sheath 119 is retracted by active control which allows the expansion component 110 to self-expand to the expanded high-profile state 134.
  • the system 100 can enable the performance of medical procedures 81 involving the insertion of other medical devices 80 such as a catheter device. It will provide a space 120 through which other devices can be inserted.
  • the sheath 119 can be advanced over the balloon 118 with active control and transition the system 100 back to the low-profile state 132.
  • Another potential alternative means to achieve a self-expanding expansion component 110 is to use materials with a spring feature. Many metals have a spring feature, such as stainless steels. Alternately, shape memory metals such as Nitinol could be used to achieve a self-expanding feature. It is envisioned that there may be other materials, either metals or non-metals, which could be used to achieve a self-expanding feature. These materials can be used to make a structure that serves as a “sheathed balloon” 118. In some embodiments, the sheathed balloon 118 can be similar to other types of balloons 111. In other embodiments, the sheathed balloon 118 can be a self-expanding braid structure 124.
  • a passive control system is a system 100 that has two or more operating modes 130, and the system 100 is passively transitioned between the states 130 instead of actively transitioned between states 130.
  • a passive control is a pleated expansion component 110 as illustrated in Figures 3h and 3i.
  • the expansion component 110 of the system 100 would be made with pleats.
  • the pleats cause the expansion component 110 to have a low-profile state 132.
  • the expansion component 110 is small because of its pleated shape.
  • the other medical device 80 will force the pleats to expand outward to form a larger space 120 and a more expanded expansion component 110.
  • the system 100 is passively transitioned between the two states 130 by the insertion of the assisted device, not the active operation of the system 100 by the operator.
  • An alternate embodiment of a passive control system 100 is an elastic expansion component 110.
  • the elastic expansion component 110 would be made of elastic or stretchable materials.
  • the expansion component 110 would be made in the low-profile state 132. Its cross section is likely to be a round shape, but other shapes are possible, such as elliptical.
  • the system 100 is passively transitioned between the two states 130 instead of actively transitioned by the operator.
  • a system 100 of this design could be made from a variety of materials, such as medical grade silicones or urethanes.
  • the various embodiments of the system 100 can be organized into categories. As illustrated in Figure 2c, many different embodiments of the system 100 can utilize some form of a balloon 111. Some embodiments of the system 100 can utilize a balloon 111 with a default state of uninflated that require inflation to transition from a low-profile operating mode 132 into a high-profile operating mode 134 (i.e. the tubular balloon 112 and the helix balloon 113). Other embodiments of the system 100 use the balloon 111 not as the expansion component but as a mechanism for expanding the expansion component 110 from a low-profile operating mode 132 into a high-profile operating mode 134 (i.e. the guide balloon 115 on which a cover 116 is advanced).
  • Still other embodiments utilize a balloon 111 that has a default state of inflated or that self-inflates (i.e. a sheathed balloon 118).
  • a sheathed balloon 118 transitions from a low-profile operating mode 132 into a high- profile operating mode 134 when it is removed from the constraining sheath 119.
  • the sheathed balloon 118 can be returned to the low-profile operating mode 132 by being positioned back within the sheath 119.
  • the system 100 can be implemented using expansion components 110 that are (1) integrated into a single stand-alone device with other components of the system 100; (2) a non- integrated collection of components configured to function with certain supporting components; (3) a magnitude of integration that falls between these two polar opposites.
  • the system 100 can directly interact with both the patients 90 and providers 92.
  • Such a system 100 can be implemented in a wide variety of different alternative embodiments.
  • Some embodiments of the system 100 can be single stand-alone components, such as an expandable balloon 111.
  • Other embodiments of the system 100 can involve configurations of multiple components which may be permanently attached to each other, or merely configured to temporarily act in concert with each other.
  • the system 100 can be used in conjunction with virtually any catheter device 80 and as part of virtually any catheterization procedure. It facilitates a catheterization procedure by aiding the insertion of medical devices 80 such as various catheters and potentially other devices to the desired location 80 in the body of the patient 90 that cannot otherwise be reached without the space 120 created by the system 100 transitioning from a low-profile operating environment 132 into a high-profile operating environment 134.
  • an angioplasty balloon catheter or a stent catheter may not otherwise able to be placed in the desired location 88 where the blockage is located.
  • the system 100 can facilitate inserting the balloon or stent 123 (i.e. the catheter device) to the blockage.
  • the advantage of the system 100 is that it can be inserted to required locations by itself that medical devices 80 such as catheters cannot be inserted by themselves.
  • the ability to exist in either of two states 130 enables the system 100 to have this advantage.
  • the system 100 can be configured for the purpose of merely expanding sufficiently to create operating space for the catheter device.
  • the operating space 120 is in the form of a lumen or passageway created by the expanded state of the system 100. Other catheterization devices can pass through the operating space 120 in order to be inserted to their desired location 88.
  • the operating space 120 can create safe passage for catheterization devices 88 through tortuous (serpentine) vessels 91 or past stenoses that impinge vessels 91.
  • the system 100 may temporarily straighten out tortuous vessels or dilate stenosed areas.
  • the system 100 works in a supportive role with respect to a medical device 80, such as catheter.
  • the system 100 is typically inserted into coronary arteries, or other arteries or veins (collectively “vessels” 91).
  • the system 100 can be appropriately sized and constructed to accomplish the desired task of creating an additional space 120 for the desired catheter device at the desired location 88.
  • the system 100 can have two or more states 130, with a low-profile state 132 for insertion and removal of the device, and an expanded state 134 for coronary stabilization.
  • PCI percutaneous coronary intervention
  • the system 100 can be configured for use with virtually any catheter device and any catheterization procedure.
  • the system 100 can be made from biocompatible medical grade materials, such as polymers (plastics) and metals.
  • the system 100 may be made from materials or have coatings that give it additional features. It may have a hydrophilic feature. It can be made using various manufacturing methods, such as extrusion, injection molding, thermal forming, thermal bonding, wire forming methods, laser manufacturing methods or other manufacturing methods. It will be made in such a way that it can be properly packaged and sterilized. Likely sterilization methods would be e-beam radiation, gamma radiation, ethylene oxide (EO) gas sterilization or nitrous oxide (N02) gas sterilization.
  • EO ethylene oxide
  • N02 nitrous oxide
  • the expansion component 110 is a tubular balloon 112.
  • Figures 3a - 3i pertain to tubular balloon embodiments 103 of the system 100.
  • the tubular balloon 112 can be inflated with air, other forms of gas, water, and other forms of liquids or fluids.
  • the tubular balloon 112 can be inflated with mechanical means such as a spring that is uncompressed or other similar means.
  • the expansion component 110 is a helix balloon 113, i.e. a tubular balloon 112 that is constrained by a matrix 114 to form an at least substantially helical shape.
  • Figures 7a-7e illustrate examples of helix balloon embodiments 104.
  • helix balloon embodiments 104 can utilize a wide variety of different inflating mechanisms.
  • Helix balloon embodiments 104 can be highly desirable because of the impact of the matrix 114, which can selectively increase the rigidity of the expansion component 110 so that it can be inserted into locations 88 that a tubular balloon 112 without a matrix 114 will not be able to reach.
  • helix balloons 113 can be implemented as conventional inflatable balloons, but also as a self-expanding helix component 141 or as a mechanically-expanding helix component 142.
  • a sheath embodiment 107 of the system 100 uses a balloon 111 that does not require inflation to transition from a low-profile operating mode 132 into a high-profile operating mode 134.
  • Figures 6a-6g pertain to sheath embodiments 107 of the system 100.
  • a sheathed balloon 118 transitions from a low-profile operating mode 132 into a high-profile operating mode 134 when it is removed from the constraining sheath 119.
  • the sheathed balloon 118 can be returned to the low-profile operating mode 132 by being positioned back within the sheath 119.
  • a sheathed balloon 118 can be implemented as a braid balloon 124.
  • a guide balloon embodiment 105 of the system 100 involves an expansion component 110 that is not a balloon 111. Rather, the expansion component 110 is a cover 116 that is advanced over a preceding inflated balloon, i.e. a guide balloon 115.
  • Figures 4a-4g illustrated examples of guide balloon embodiments 105 of the system 100.
  • Insertion component embodiments 106 of the system 100 need not use any kind of balloon 111 in the expansion/shrinkage processes.
  • an insertion component 117 is inserted into the expansion component 110 to cause the expansion component 110 to expand from a low-profile operating mode 132 into a high-profile operating mode 134.
  • the expansion component 110 in an insertion component embodiment 106 of the system 100 can be a cover 116, such as another catheter. Insertion component embodiments 106 are illustrated in Figures 5a-5d.
  • Some embodiments of the system 100 will utilize a single tubular balloon 112 to serve as the expansion component 110 to facilitate the transition between a low-profile state 132 and a high-profile state 134 that can create a lumen 120 for the applicable medical device 80, such as a balloon angioplasty catheter or stent 123, at the desired location 88 in the body of the patient 90.
  • a single tubular balloon 112 to serve as the expansion component 110 to facilitate the transition between a low-profile state 132 and a high-profile state 134 that can create a lumen 120 for the applicable medical device 80, such as a balloon angioplasty catheter or stent 123, at the desired location 88 in the body of the patient 90.
  • the "working space" or lumen 120 created by the expansion of a tubular balloon 112 into a high-profile operating mode 134 is created within the tubular balloon 112.
  • expansion components 110 can include inflatable balloons 112 with a “donut hole” space (see Figures 3a-3i),
  • some embodiments of the system 100 can be configured to expand/contract using different technologies and different component configurations.
  • the expansion of the system 100 is achieved through an expansion component 110 that is part of the system 100.
  • the expansion of the system 100 is achieved by the expansion of a separate component/device in the system 100 that is expanded, and used to then expand or allow for the expansion of the system 100.
  • the removal of a sheath 119 can trigger the expansion of the sheathed balloon 118 in a sheath embodiment 107 of the system 100 (see Figures 6a - 6g).
  • Tubular balloons 112 can be implemented in a wide variety of different ways. Some embodiments of tubular balloons 112 as expansion components 110 can use an inflation tube 150 connected to a valve 151 on the tubular balloon 112 to inflate the tubular balloon 112.
  • the valve 151 acts as a connector, and in some examples, can optionally include flow control features.
  • Tubular balloons 112 can be inflated using air, other forms of gases, water, and other forms of liquids or fluids. Tubular balloons 112 can also be inflated using mechanical means such as springs. Some embodiments of tubular balloons 112 can involve a balloon 111 that self-inflates.
  • the valve 151 is typically positioned at the proximal end of the balloon 112, which would be like the ‘tail’ end of the balloon 112.
  • the valve 151 is connected to an inflation tube 150.
  • the tube 150 runs longitudinally to the inflatable lumen 120.
  • the inflatable lumen is at the distal end, which would be like the ‘business’ end.
  • the overall length is approximately 100-120cm (39.4-47.2 inches).
  • the inflatable balloon 112 is approximately 35mm (1.38 inches).
  • the inflation tube 150 is approximately 65-85cm (25.6-33.5 inches) in some embodiments of the system 100.
  • the system 100 can be constructed to have a low-profile state 132, which would be a deflated or collapsed state.
  • the low-profile diameter size would be small enough to fit into the required arterial locations and to interface with other medical devices 80 used during the procedure.
  • the low-profile diameter size would be approximately 0.030-0.060 inch (0.76- 1.52mm).
  • Figure 3a is a diagram illustrating a partial and close-up view of the system 100 in Figure 3b.
  • a partial example of the inflatable balloon 112 is illustrated along with the accompanying lumen 120 and the tube 150 that facilitates inflation/deflation.
  • Figure 3b is a diagram illustrating an example of an axial view of the system 100.
  • the lumen 120 created by the system 100 is in the form of a “donut hole” at the center of the expansion component 110.
  • Figure 3c is a diagram illustrating an example of a top view of the system 100.
  • Figure 3d is a diagram illustrating an example of a side view of the system 100.
  • Figure 3e is a diagram illustrating an example of a cross-sectional view of a side view of the system 100 with an illustration of a lumen 120 within the system 100.
  • Figure 3f illustrates a close-up and partial view of Figure 3e.
  • the tubular balloon 112 has a dual- wall construction that includes an inner wall 400 and an outer wall 402.
  • a space 404 is defined between the inner and outer walls 400/402.
  • the space 404 is configured to receive fluid via the inflation tube 150 as discussed above.
  • the tubular balloon 112 is expanded into the high profile operating mode 134 where the tubular balloon 112 has a cylindrical shape that defines the lumen 120.
  • the inflation tube 150 is in fluid communication with the space 304 via the valve 151.
  • the tubular balloon 112 has two opposed ends 112a 112b.
  • the valve 151 could be located at one end 112a or could be at a different location along the length of the tubular balloon 112. If the valve 151 is at one of the opposed ends 112a, then the other of the opposed ends 112 could be sealed or otherwise closed off to maintain fluid pressure within the space 404 when the tubular balloon 112 is in the high profile operating mode. If the valve 151 is at a different location along the length of the tubular balloon 112, then both of the ends 112a 112b of the tubular balloon 112 could be sealed or otherwise closed off.
  • the inflation tube 150 may include a connector 251 at an opposite end from the valve 151, shown in Figure 3j.
  • the connector 251 can be configured to mate with a syringe or fluid line as would be known for medical applications in order to communicate fluid to/from the tubular balloon 112.
  • the tubular balloon 112 could be straight, as shown in Figure 3j, or curved, as shown in Figure 3k.
  • the tubular balloon 112 could be noncompliant (e.g., rigid), and therefore fixed in the straight/curved shape.
  • the tubular balloon 112 is semi-compliant or compliant (e.g., flexible), and can alternate between the straight and curved shapes.
  • the tubular balloon 112 could have flat ends 112a l 12b as shown in Figure 3j.
  • a flat end has a plane that is parallel, coaxial, or colinear to an axis A of the tubular balloon 112.
  • the tubular balloon 112 could have angled ends 112a 112b. One or both ends could be angled. Angled ends have a plane that is angled with respect to the axis A.
  • the tubular balloon 112 includes one or more connections 406 where the inner wall 400 is connected to the outer wall 402 such that there is no space 404 between the inner and outer walls 400/402 at the connection 406.
  • the connection 406 can provide additional structural integrity to the tubular balloon 112.
  • the connection 406 also prevents the inner wall 400 from collapsing into the lumen 120 when the tubular balloon 112 is in the high profile operating mode 134. In other words, the connection 406 acts against the pressure forces exerted on the inner wall 400 when the space 404 is filled with fluid.
  • the tubular balloon 112 may include one or more connections 406.
  • connection 406 could be made in a variety of ways.
  • the connection 406 could be made by bonding the inner and outer walls 400/402 together using any known adhesive that is suitable for the material of the inner and outer walls 400/402 and for medical applications.
  • Any known material that is suitable for medical applications could be used for the tubular balloon 112, however, some non-limiting examples include PET (polyethylene terephthalate), nylons, engineered nylons, polyamides, polyurethanes, nylon elastomers, and other thermoplastic elastomers.
  • the connection 406 could be made by fusing the inner and outer walls 400/402 together using a thermal bonding technique such as laser welding or any other known technique that is suitable for the material of the inner and outer walls 400/402 and for medical applications.
  • connection 406 is a point or dot.
  • the connection 406 does not extend across a substantial radial or circumferential extent of the tubular balloon 112.
  • the tubular balloon 112 can include one or more point or dot connections 406.
  • the point or dot connections 406 could be distributed on the tubular balloon 112 in any pattern such as circumferential or axial rows, or any other pattern.
  • connection 406 is a line or rib that extends along a circumferential or axial extent of the tubular balloon 112.
  • the connections 406 extend along less than the entire axial or circumferential extent of the tubular balloon 112 in order to maintain a single common space 404 throughout the entire tubular balloon 112 for receiving the fluid from the inflation tube 150 as discussed above.
  • the tubular balloon includes multiple ribs that extend along a majority, e.g,. greater than 50% but less than 100%, of the circumferential extent of the tubular balloon 112.
  • the rib or line connections 406 could be evenly spaced along the axial extent of the tubular balloon 112 as shown in Figures 9b-c, though other arrangements/distributions are also contemplated.
  • Some embodiments of the system 100 anticipate that a guide balloon 115 is used in conjunction with the system 100.
  • the guide balloon 115 can help position the system 100 within the body of the patient 90.
  • Figure 4a is a flow chart diagram illustrating an example of a process for enhancing catheterization performed by a guide balloon embodiment 105 of the system 100.
  • the guide balloon 115 is inserted into the body of the patient 90.
  • Figure 4b is an environmental diagram illustrating an example of a process step where the guide balloon 115 is inserted.
  • a guide catheter 121 or similar medical device 80 can be inserted to the femoral or radial artery, and the guide catheter will be advanced until it accesses the right or left coronary ostium.
  • the ostium is the start of the coronary artery. It is where the artery branches off the aorta.
  • a guide wire 122 will be inserted through the guide catheter 121 and into the coronary artery beyond the point where treatment is to be conducted.
  • the guide balloon 115 of the system 100 will be inserted over top of the guide wire 122 and through the guide catheter 121 into the artery.
  • FIG. 4c is an environmental diagram illustrating an example of a process step where the guide balloon 115 is inflated.
  • the guide balloon 115 is inflated after it is properly positioned. It can be inflated pneumatically with a gas such as air or hydraulically with a liquid. It is most likely to be inflated which a 50-50 mixture of sterile saline and contrast media. It may be inflated to lower pressures of 1-4 atmospheres or higher pressures up to 16 atmospheres.
  • the inflated outside diameter of the guide balloon 115 may be less than, equal to, or greater than the diameter of the artery.
  • the guide balloon 115 may temporarily straighten any tortuous areas of the artery, either completely or partially.
  • FIG. 4d is an environmental diagram illustrating an example of a process step where the cover
  • the expansion component 110 which is the core component of the system 100, is inserted over top of the guide balloon 115 and through the guide catheter 121.
  • the expansion component 110 may be either a self-expanding design or a fixed diameter design.
  • the guide balloon 115 outside diameter and the expansion component 110 inside diameter will be specifically designed for an optimum interface.
  • the interface may be a slip fit design, a line-to-line fit design, or an interference design. The interface design will aid insertion of the expansion component 110 and make insertion as atraumatic as possible to eliminate or prevent arterial wall damage.
  • Figure 4e is an environmental diagram illustrating an example of a cover 116 expanded over a guide balloon 115.
  • the guide balloon 115 serves the important task to eliminate or prevent arterial wall damage from the leading edge of the expansion component 110 while it is being inserted, even though the leading edge may be design with its own atraumatic tip. To this end, the guide balloon 115 may intentionally be longer than the expansion component 110. It may be two times or more than the length of the expansion component 110.
  • Figure 4f is an environmental diagram illustrating an example of a process step where the guide balloon 115 is deflated and removed.
  • the guide balloon 115 is deflated and removed after the expansion component 110 is properly positioned.
  • the expansion component 110 may be designed to maintain straightening of the artery after the guide balloon 115 is removed.
  • the expansion component 110 may be either a self-expanding design or a fixed diameter design for this embodiment of the system 100.
  • the expansion component 110 will create space 120 in the artery in the form of a lumen.
  • Other devices 80 can pass through the space 120 created by the system 100 when it is in the high-profile expanded state 134, such as an angioplasty balloon, a stent catheter, or some other form of similar medical device 80.
  • Figure 4g is an environmental diagram illustrating an example of a process step where a stent 123 is inserted through the space 120 created by the system 100.
  • the system 100 is removed from the artery when it is not needed anymore.
  • the artery would regain its natural shape.
  • This embodiment of the system 100 would interface with the other catheterization devices 80 used during the procedure, such as the guide wire 122, guide catheter 121, balloon catheters and stent 123.
  • Figure 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 a cover 116.
  • the insertion component 117 can be attached to the guide catheter 121.
  • FIG. 5b is an environmental diagram illustrating an example of a process step where the cover 116 is inserted into the body of the patient 90.
  • a guide catheter 121 will be inserted to the femoral or radial artery, and the catheter 121 will be advanced until it accesses the right or left coronary ostium.
  • the ostium is the start of the coronary artery. It is where the artery branches off the aorta.
  • a guide wire 122 will be inserted through the guide catheter 121 and into the coronary artery beyond the point where treatment is to be conducted.
  • the cover 116 will often be an integral part of the guide catheter 121.
  • the cover 116 can be connected to the distal end of the guide catheter 121 as pat of the manufacturing process for those components.
  • FIG. 5c is an environmental diagram illustrating an example of a process step where an insertion component 117 is inserted into the cover 116 positioned within the body of the patient 90 to expand the distal section of the cover 116.
  • An insertion component 117 would be inserted into the inside the entire length of the connected expansion component 110 (i.e. the cover 116) and guide catheter 121. As it is inserted it will expand the expansion component 110 (i.e. the cove 116) to the high-profile state 134.
  • FIG. 5d is an environmental diagram illustrating an example of a process step at 326.
  • the nested structure of the high-profile state 134 expansion component 110 and the insertion component 117 will create space 120 through which other medical devices 80 can be inserted, such as an angioplasty balloon catheter or a stent catheter 123.
  • the expansion component 110 i.e. the cover 116 of the system 100 and insertion component 117 will be removed when they are not needed anymore.
  • the expansion component 110 of this embodiment can be made with shape memory materials, a braid construction, a pleated design or any other expandable design structure.
  • Shape memory materials can be metallic or non-metallic. Nitinol is one possible metallic material that could be used.
  • the expansion component 110 could be made from Nitinol and the memorized shape would be the low-profile state 132. This memorized low- profile state 132 would enable the connected expansion component 110 and guide catheter 121 to be inserted into the coronary artery past the ostium, tortuous areas and any stenoses.
  • the insertion component 117 would be used to actively transition the expansion component 110 from the low-profile state 132 to the high-profile state 134.
  • Non-metallic shape memory polymers could also be used to construct the expansion component 110 and accomplish the same result.
  • a braid structure could be used to construct the cover 116.
  • the braid would be made to the size of the low-profile state 132.
  • the woven mesh pattern of the braid has space in the interstices between its wires. This would allow it to expand to the high-profile state 134 when the insertion component 117 is inserted.
  • a pleated design could be used to make the cover 116.
  • the pleated design would be made to the size of the low-profile state 132.
  • the insertion component 117 would unfold the pleats, when it is inserted, allowing it to transition to the high-profile state 134.
  • Figure 6a is a flow chart diagram illustrating an example of a process of enhancing catheterization performed by a sheath covered embodiment 107 of the system 100.
  • expansion component 110 of the system 100 is self-expanding.
  • the sheath 119 allows for the expansion component 110 to exist in a low-profile mode 132 by constraining the expansion component 110.
  • the expansion component 110 (such as a sheathed balloon 118) expands into a high-profile operating mode 134.
  • the self-expanding feature can be made with self-expanding materials, such as a braid structure.
  • the braid structure is cylindrical in shape.
  • the wall of the cylinder is constructed of the woven mesh of the braid.
  • the ends of the cylinder are open.
  • the braid would be designed with space in its weave pattern, which would allow the braid structure to exist in either the high-profile self-expanded state 134 or the low-profile state 132.
  • FIG. 6b is an environmental diagram illustrating an example of a process step where a sheath 119 covers the system 100 during insertion.
  • the expansion component 110 could be compressed to a low- profile state 132 and inserted into a sheath 119.
  • the sheath 119 would cover the expansion component 110 keeping it in the low-profile state 132.
  • the expansion component 110 and sheath 119 would be inserted through the guide catheter 121 and into the artery 91 as one unit.
  • the system 100 is positioned within the body of the patient 90.
  • Figure 6c is an environmental diagram illustrating an example of a process step where the sheath 119 and system 100 are positioned as desired within the body of the patient 90.
  • the expansion component 110 and sheath 119 would have an appropriate low-profile size, strength, and flexibility to be inserted past any tortuous areas or stenosis [00196]
  • Figure 6d is an environmental diagram illustrating an example of a process step where the sheath 119 is withdrawn; causing the system 100 to self-expand and triggering the creation of the additional working space 120 within in the body of the patient 90 for the purposes of catheterization.
  • the sheath 119 is removed after the system 100 is properly positioned.
  • the expansion component 110 will automatically deploy because of its self-expanding feature.
  • the expansion component creates space 120 in the artery.
  • Figure 6e is an environmental diagram illustrating an example of how the expanded system 100 can straighten out an artery within the body of the patient 90.
  • the expansion component 110 may partially or completely straighten any artery tortuosity. The straightening effect would be transient.
  • the system 100 is withdrawn the artery would regain its natural shape
  • FIG. 6f is an environmental diagram illustrating an example of a process step where the stent catheter 123 is inserted into the patient 90 through the working space 120 created by the presence of the system 100 in a high-profile operating mode 134.
  • Other devices can pass through the space 120 created by the system 100 when it is in the high-profile expanded state 134, such as an angioplasty balloon catheter or stent 123.
  • FIG. 6g is an environmental diagram illustrating an example of a process step where the sheath 119 is advance to collapse the system 100 for removal.
  • the system 100 can be removed when it is not needed any more.
  • the sheath 119 is advanced over the expansion component 110 causing it to collapse to the low-profile state 132, and then the expansion component 110 and sheath 119 are removed together as one unit.
  • An alternate embodiment of this form of the system 100 uses a self-expanding braid structure 124 to serve as the sheathed balloon 118.
  • the construction of the braid 124 can be designed to provide optimum performance.
  • Braid 124 characteristics such as number of wires, shape of wire, wire material, pitch, uniform pitch, variable pitch and weave pattern can be chosen to obtain the desired performance. More or less wires, and wire material, can affect strength and flexibility of the component. Round wires or flat wires can affect wall thickness. Pitch and weave pattern can affect expansion strength and profile size.
  • Stainless Steel or Nitinol are likely materials for the braid 124 wire, however other metals or non-metals can possibly be used.
  • Stainless Steel can be formulated with ‘spring’ characteristics enabling it to self-expand.
  • Nitinol is a metallic alloy of nickel and titanium. It is in a class of metals known as ‘shape memory’.
  • a nitinol -based expansion component can be made with a shape memory of the high-profile expanded state 134, enabling it to self- expand. There are also shape memory polymers that can be used to construct the expansion component.
  • the braid 124 can be covered with an inner and outer liner to make it atraumatic and prevent arterial wall damage.
  • the inner and outer liners would expand and collapse with the system 100.
  • the sheath 119 may have an atraumatic tip to aid insertion and eliminate or reduce damage to the artery wall.
  • the expansion component 110, sheath 119 or both items could have radio-opaque features so they can be visualized with fluoroscopic imaging.
  • This embodiment of the system 100 can interface with the other catheterization devices used during the procedure, such as the guide wire 122, guide catheter 121, balloon catheters, stent 123, as well as other medical devices 80.
  • Helix balloon embodiments 104 of the system 100 are similar to tubular balloon embodiments 103 of the system 100, except that in a helix balloon embodiment 104 of the system 100, the balloon 111 is constrained and shaped by a matrix 114 the configures the shape of the balloon 111 into a helix balloon 113.
  • the helix balloon 113 is defined by multiple turns 213 of the tubular balloon 112, which forms a helix shape.
  • a helix balloon 113 can change operating modes 130 in precisely the same ways using the same technologies and principles of chemistry and physics.
  • the tubular balloon 112 could have a dual-wall construction, as described above, or could have another construction such as a continuous tube.
  • FIG. 8a-f An example helix balloon 113 is shown in Figures 8a-f (discussed in more detail below).
  • the helix balloon 113 is defined between opposed ends 113a/l 13b and along an axis A.
  • the axis A can be straight, as in Figure 8a, or curved, as in Figure 8b.
  • the helix balloon 113 may be compliant or flexible to enable bending, or may be rigidly fixed in a straight or bent shape.
  • an inflation tube 150 is configured to mate with the tubular balloon 112 at a valve 151 as discussed above.
  • the inflation tube 150 fluidly connects a space 212 within the tubular balloon 112 with a fluid source (not shown). Therefore, fluid such as saline can be provided or removed from the tubular balloon 112 to cause the helix balloon 113 to deflate or expand between the low profile operating mode 132 and the high profile operating mode 134 as discussed above.
  • the valve 151 could be located at an end of the tubular balloon 112 that corresponds to one of the opposed ends 113a/l 13b of the helix balloon 113 or could be at a different location along the length of the helix balloon 113. If the valve 151 is at one of the opposed ends 113a, then the other end of the tubular balloon 112 (e.g., the end of the tubular balloon 112 that corresponds to the other of the opposed ends 113b) could be sealed or otherwise closed off to maintain fluid pressure within the space 212 when the helix balloon 113 is in the high profile operating mode 134. If the valve 151 is at a different location along the length of the helix balloon 113, then both of the ends of the tubular balloon 112 could be sealed or otherwise closed off.
  • the inflation tube 150 may include a connector 251 at an opposite end from the valve 151.
  • the connector 251 can be configured to mate with a syringe or fluid line line as would be known for medical applications in order to communicate fluid to/from the tubular balloon 112.
  • the matrix 114 maintains the helical shape of the helix balloon 113 in all operating modes 130.
  • the matrix 114 can be implemented in a wide variety of different embodiments, including but not limited to a weave 145, a bonding agent 146, a thermally formed connection 147, a matrix cover 148, and a flange 149.
  • the cross sectional shape of the helix balloon 113 can be maintained differently in different operating modes 130. For example, the cross section of the helix balloon 113 would otherwise be round in an inflated state (high- profile operating mode 134) and flat in a deflated state (low-profile operating mode 132).
  • the matrix 114 can maintain the helical shape in both states.
  • the matrix 114 needs both flexibility and strength to properly perform its function.
  • the matrix 114 can include a medicinal component 126, a mechanism or configuration of mechanisms that enable medicinal capabilities to the system 100.
  • the medicinal component 126 may include diagnosis or treatment of a medical condition, or delivery of medicine or nutrient.
  • the matrix 114 may contain vaso-active agents to cause vasoconstriction or vasodilation, depending on what may be required. Such an agent may be transient or longer lasting.
  • Nitric oxide is an example of a vaso-active agent that can dilate a vessel, which would make the vessel bigger (larger diameter) until the agent wears off.
  • the matrix 114 may contain any of the class of drug coatings that prevent intimal hyperplasia. Intimal hyperplasia often is a physiologic response to an angioplasty procedure resulting in restenosis of the treated area, which in layman’s terms is a clogged stent 123.
  • a weave 145 can be a configuration of one or more threads 144 that can contain the balloon 111 in the shape of a helix balloon 113.
  • the weave 145 can use as many or as few threads 144 as desired. In many embodiments, between 10-12 threads 144 uniformly distributed about the helix balloon 113 is a particular desirable configuration.
  • the weave 145 would wrap around the helix balloon 113 as the helix balloon 113 makes consecutive passes of the helical shape.
  • a chemical means to constrain the shape of the helix balloon 113 can be made from a bonding agent 146 that is applied to a balloon 111 to secure its shape as a helix balloon 113.
  • a bonding agent 146 can be used by itself or with other components to maintain the helical shape of the helix balloon 113. Consecutive passes of the helical shape can be bonded to adjacent passes.
  • a wide variety of bonding agents including but not limited to adhesive glues or silicone can be used as possible bonding agents 146.
  • the bonding agent 146 may be applied using dip coating techniques.
  • a wide range of thermal forming techniques known in the prior art can be used to connect adjacent passes of the helical shape together.
  • the aggregate configuration of thermally formed connections 147 can by itself or in conjunction with other components, constitute the matrix 114.
  • a matrix cover 148 is a relatively thin sheet or a collection of thin sheets that overlay the balloon 111 to shape it into a helix balloon 113.
  • the matrix cover 148 can contain the helix balloon 113 and maintain its helical shape.
  • the matrix cover 148 can be made from a fabric or other similar material suitable for the particular location 88 in the patient 90.
  • the matrix cover 148 can cover a single pass of the helical shape, multiple passes or all passes.
  • the matrix cover 148 can be used by itself or in conjunction with other components to constitute the matrix 114.
  • the matrix cover 148 may be applied using dip coating techniques as well as other plausible manufacturing methods.
  • a flange 149 is a rim, collar, or ring that secures the balloon 111 into the shape of a helix balloon 113.
  • the cross-section of the helix balloon 113 can have one or more flanges 149. Adjacent passes of the helical shape can be connected together by the flange 149.
  • the connected flanges 149 in the aggregate can form the matrix component 114.
  • Flanges 149 can be connected using a weave 145, a bonding agent 146, a thermally formed connection 147, a matrix cover 148, and/or potentially other means.
  • the matrix component 114 includes tubules 200 arranged circumferentially around the helix balloon 113.
  • the tubules 200 run parallel to the axis A of the helix balloon 113 between adjacent turns 213a, 213b of the helix balloon 113 in order to constrain the helix balloon 113 in the helical shape and assist in maintaining the lumen 120 as will become apparently from the below description.
  • the tubules 200 can be made of the same material as the helix balloon 113 or a different material than the helix balloon 113. Any known material that is suitable for medical applications could be used, however, some non-limiting examples include PET (polyethylene terephthalate), nylons, engineered nylons, polyamides, polyurethanes, nylon elastomers, and other thermoplastic elastomers.
  • the tubules 200 can be non-compliant (e.g., rigid), semi- compliant, or compliant (e.g., flexible).
  • the helix balloon 113 can be non-compliant (e.g., rigid), semi-compliant, or compliant (e.g., flexible).
  • the tubules 200 and helix balloon 113 can have the same, similar, or difference compliance.
  • Each tubule 200 spans between opposed ends 202a 202b.
  • One of the ends 202a meets a first turn 213a of the helix balloon 113 and the other of the ends 202b meets a second turn 213b adjacent the first turn 213a.
  • the tubules 200 can be integral with the helix balloon 113 or can be separate structures that are attached to the helix balloon 113 according to any known method suitable for the material(s) of the tubules 200 and helix balloon 113 and for medical applications.
  • the tubules 200 are hollow structures having a space 204.
  • the space 204 is in fluid communication with the space 212 of the tubular balloon 112 so that the tubules inflate with the helix balloon 113 when the helix balloon 113 is expanded from the low-profile operating mode 132 to the high-profile operating mode 134 as described above.
  • the tubules 200 and helix balloon 113 can have a burst rating of up to about 27 atm according to any known method of burst rating balloons. In this way, the tubules 200 assist in maintaining the lumen 120 when the helix balloon 113 is in the high-profile operating mode 134 by providing structural support for the helix balloon 113 that impedes collapsing of the helix balloon 113 into the lumen 120.
  • the tubules 200 are spaced apart from one another by a distance x.
  • the tubules 200 have a length y defined as the distance between ends 202.
  • the length y corresponds to a distance between adjacent turns 213a/213b of the helix balloon 113 (which is known as the pitch of a helix).
  • the distance x is constant, meaning the tubules 20 are evenly spaced about the circumference of the helix balloon 113.
  • the distance x could be variable, meaning the tubules 200 have a different circumferential distribution around the helix balloon 113.
  • the distances x and y can be selected to provide flexibility in the helix balloon 113 when it is in the high-profile operating mode 134. For instance, areas of the helix balloon 113 that require bending could have less tubules 200 so as not to impede the movement of the helix balloon 113 in that localized area and with respect to other areas.
  • the tubules 200 have a diameter d ( Figure 8e) that is in one example the same as the diameter of the tubular balloon 112 that is constrained in a helix to form the helical balloon 113. In other examples, the diameter d of the tubules 200 can be different from the diameter of the tubular balloon 112.
  • Figure 7a is a diagram illustrating a perspective view of a helix 113 and matrix 114 configuration that includes a tubular balloon constrained in the shape of a helix by a weave 145 functioning as a matrix 114.
  • the central lumen 120 inside the helix is 0.058 inches, which is created by wrapping the tubular balloon 112 around a mandrel and secured by the matrix 114. Twelve threads 144 that are 0.002 inches in diameter form the matrix 114.
  • Figure 7b is a diagram illustrating an example of a side view of the helix 113 and matrix 114 configuration of Figure 7a.
  • Figure 7c is a diagram illustrating an example of a planar front view of the helix 113 and matrix 114 configuration of Figures 7a and 7b. As illustrated in the figure, the 12 threads are uniformly spaced around the helix balloon 113.
  • Figure 7d is a diagram illustrating an example of a perspective section view of the helix 113 and matrix 114 configuration of Figures 7a-7c.
  • Figure 7e is a diagram illustrating an example of a close-up view of the illustration in Figure 7d.
  • Figure 7f is a hierarchy diagram illustrating various examples of different helix balloon 113 and matrix components 114.
  • the matrix 114 is an optional component although often a highly desirable one.
  • a helix balloon 113 can be implemented as a self-expanding helix component 141, a mechanically-expanding helix component 142, as well as the inflatable helix balloon 113 illustrated in Figures 7a-7e.
  • the matrix 114 can be implemented as a weave 145, a bonding agent 146, a thermally formed connection 147, and a matrix cover 148.
  • the matrix 114 can include a medicinal component 126.
  • Table 1 is a chart linking together element numbers, element names, and element descriptions.

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
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  • Public Health (AREA)
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  • Endoscopes (AREA)

Abstract

L'invention concerne un système de création d'une lumière comprenant un ballonnet tubulaire comportant une paroi interne et une paroi externe, et un espace délimité entre la paroi interne et la paroi externe ; une valve ; et un tube de gonflage en communication fluidique avec l'espace par l'intermédiaire de la valve. Le ballonnet tubulaire a un premier diamètre dans un mode d'utilisation à profil bas et un second diamètre dans un mode d'utilisation à profil élevé. Le second diamètre est supérieur au premier diamètre. Le ballonnet tubulaire se transforme du mode d'utilisation à profil bas au mode d'utilisation à profil élevé par réception d'un fluide par l'intermédiaire du tube de gonflage. L'invention divulgue également un système de création d'une lumière.
PCT/US2022/024803 2021-04-14 2022-04-14 Système, appareil et procédé de création de lumière WO2022221524A2 (fr)

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CA3215474A CA3215474A1 (fr) 2021-04-14 2022-04-14 Systeme, appareil et procede de creation de lumiere
AU2022256478A AU2022256478A1 (en) 2021-04-14 2022-04-14 Systems for creating a lumen
JP2023563257A JP2024514212A (ja) 2021-04-14 2022-04-14 管腔を形成するためのシステム、装置及び方法
AU2022395016A AU2022395016A1 (en) 2021-11-19 2022-11-21 Systems for creating a lumen
PCT/US2022/050584 WO2023091756A1 (fr) 2021-11-19 2022-11-21 Systèmes de création d'une lumière
CA3238444A CA3238444A1 (fr) 2021-11-19 2022-11-21 Systemes de creation d'une lumiere

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US202163174718P 2021-04-14 2021-04-14
US63/174,718 2021-04-14
US17/379,423 2021-07-19
US17/379,423 US20210346182A1 (en) 2013-10-26 2021-07-19 System, apparatus, and method for creating a lumen

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US4909252A (en) * 1988-05-26 1990-03-20 The Regents Of The Univ. Of California Perfusion balloon catheter
JP2514087Y2 (ja) * 1990-05-25 1996-10-16 幸三 牧田 離脱式両端逆止弁付きバル―ン
US5985307A (en) * 1993-04-14 1999-11-16 Emory University Device and method for non-occlusive localized drug delivery
US6231551B1 (en) * 1999-03-01 2001-05-15 Coaxia, Inc. Partial aortic occlusion devices and methods for cerebral perfusion augmentation
US8808237B2 (en) * 2010-04-26 2014-08-19 Joseph Michael Thielen Expandable perfusion balloon
US10201688B2 (en) * 2011-03-10 2019-02-12 Western New England University Biopsy spacer device and method of operation

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