WO2019152622A1 - Nouveau dispositif de fil-guide, système et procédé - Google Patents

Nouveau dispositif de fil-guide, système et procédé Download PDF

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Publication number
WO2019152622A1
WO2019152622A1 PCT/US2019/016003 US2019016003W WO2019152622A1 WO 2019152622 A1 WO2019152622 A1 WO 2019152622A1 US 2019016003 W US2019016003 W US 2019016003W WO 2019152622 A1 WO2019152622 A1 WO 2019152622A1
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WO
WIPO (PCT)
Prior art keywords
guidewire
main body
patient
distal end
motion
Prior art date
Application number
PCT/US2019/016003
Other languages
English (en)
Inventor
Sagar SABLE
Original Assignee
Cedars-Sinai Medical Center
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
Application filed by Cedars-Sinai Medical Center filed Critical Cedars-Sinai Medical Center
Publication of WO2019152622A1 publication Critical patent/WO2019152622A1/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
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/09—Guide wires
    • 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
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/09—Guide wires
    • A61M2025/09125—Device for locking a guide wire in a fixed position with respect to the catheter or the human body

Definitions

  • the present disclosure generally relates to a guidewire. More specifically, the present disclosure relates to a guidewire used in devices such as catheters, sheaths, lines, and tubes, that is configured to not get retained inside the patient.
  • guidewires In healthcare, guidewires often become retained inside a patient, especially when the guidewire is used by individuals in training or physicians who are tired, distracted, or impaired otherwise. In these situations, the patient requires a second procedure - possibly more invasive in nature than the initial procedure requiring guidewire - in order to retrieve the retained guidewire.
  • guidewire in vivo to be used in devices (e.g., catheters, sheaths, lines, tubes, and the like) that is capable of expanding and collapsing beyond the diameter of the guidewire so that the guidewire does not get inadvertently retained inside the patient.
  • devices e.g., catheters, sheaths, lines, tubes, and the like
  • Such guidewire in combination with other devices may be used for insertion in, e.g., main pulmonary artery for enhance treatment of patients with heart and lung conditions.
  • a novel guidewire for use inside a patient includes a main body, a retractable end positioned at near or at a distal tip of the main body and is further configured to retract over (or under) the main body, a proximal tip of the main body that is configured to enter into the patient, and at least two coiled ends inside the guidewire, wherein the at least two coiled ends are configured to protrude out of the main body when the retractable end is retracted over the main body.
  • the end of the guidewire may include a retractable mechanism, which when retracted would expose the coiled ends of the inside wire that would then expand out.
  • the retractable mechanism may be configured to be broken and peeled away once the guidewire is in preferred or pre-determined place in vivo.
  • the retractable end, the at least two coiled ends, and the main body may be configured to be layered on top of each other.
  • the retractable end may further be configured to enter into the patient’s body.
  • the guidewire may include solid steel or nitinol core wires and solid core wire wrapped in a smaller wire coil or braid.
  • Coiled or braided wires offer a large amount of flexibility, pushability and kink resistance.
  • some of Boston Scientific’s guide wires use a nitinol tube with micro-cut slots instead of braided wire to improve torque control.
  • Nitinol wire, used by itself or braided with stainless steel, helps increase flexibility and allows the wire to spring back into shape after navigating a tortuous vessel segment.
  • the core materials may include at least one of: Stainless steel, Nitinol, TRITONTM alloy, or combination thereof.
  • Heraeus German company that produces some medical equipment also provides guidewires made of Platinum and Palladium, two metals (stainless steel proximal & Triton® distal), Tungsten and Gold-Plated Tungsten, steel, stainless steel mandrel, nitinol mandrel, stainless steel with nickel, Titanium, or a combination thereof.
  • the guidewire may be coated by a coating material.
  • the coating material may include nitinol (sleeve), PTFE, polymers such as polyurethane or polytetrafluoroethylene (PTFE), Silicone, variety of hydrophobic coatings, such as glidexTM, which is a mixture of polyolefin and iso-alkane, hydrophilic materials, polyurethane jacket with tungsten, anti -thrombogeni c/Heparin coating, hydrophobic coating, tetrafluoroethylene (TFE) coating, or a combination thereof.
  • the guidewire may be configured so that a motion applied to the guidewire may trigger the retractable end to retract over (or under) the main body.
  • the motion may include, e.g., twisting, pulling, pushing, squeezing, or any other pressure applied to the guidewire.
  • the motion may be carried out via a mechanic means or device located on the guidewire.
  • a catheter sheath may be inserted along the guidewire once the guidewire is in place, wherein the at least two coiled ends may retract inside the main body when the catheter sheath passes over the at least two coiled ends.
  • the guidewire may be configured to be flushed in order to prevent clotting once placed in the patient’s body, such as, for example, a vein.
  • the guidewire includes a main body and an expandable end positioned at end of the main body and is further configured to balloon out upon a motion applied to the guidewire.
  • the main body may also balloon out when the expandable end is ballooned out.
  • the motion may include, e.g., twisting, pulling, pushing, squeezing, or any other pressure applied to the guidewire.
  • the motion may be carried out via a mechanic means or device located on the guidewire.
  • the expandable end may snap back and make the guidewire straight again upon application of another motion to the guidewire.
  • the another motion may include, e.g., untwisting, twisting, pulling, pushing, squeezing, or any other pressure applied to the guidewire.
  • the expandable end and the main body may be configured to be layered on top of each other.
  • the expandable end may be configured to enter into the patient’s body.
  • the guidewire includes a main body, wherein the main body further includes (a) a distal end positioned at end of the main body that is is further configured to be in expanded state, and (b) a proximal end positioned at the other end of the main body that is configured to enter inside the patient during, e.g., a surgical procedure.
  • the distal end may collapse when a sheath (or needle) catheter passes over the guidewire due to compression from the sheath catheter.
  • the distal end may expand again once the sheath catheter passes over the distal end.
  • the distal end may also collapse or expand further based on a motion applied to the guidewire.
  • the motion may include, e.g., twisting, untwisting, pulling, pushing, squeezing, or any other pressure applied to the guidewire.
  • the motion may be carried out via a mechanic means or device located on the guidewire.
  • the distal end and the main body may be configured to be layered on top of each other.
  • the distal end may be configured to enter into the patient’s body.
  • a method for securing a guidewire inside the patient includes placing a guidewire inside the patient, wherein the guidewire includes a main body and a distal end positioned near or at the end of the main body, applying a motion to the guidewire, wherein such motion is configured to cause the distal end to change its form, applying another motion to the guidewire which causes the guidewire to return to its original form.
  • the motion may include, e.g., twisting, untwisting, pulling, pushing, squeezing, or any other pressure applied to the guidewire.
  • the motion may be carried out via a mechanic means or device located on the guidewire.
  • the distal end and the main body may be configured to be layered on top of each other.
  • the distal end may be configured to enter into the patient’s body.
  • the change in form includes ballooning up, retracting the distal end inside (or on top of) the main body to expose at least two coils that balloon out, or any other changes to the form of the distal end and the main body.
  • a system for securing a guidewire inside the patient includes a guidewire; a hosted server; a database; a monitor computer; a memory containing machine readable medium including machine executable code having stored thereon instructions for performing a method disclosed herein; and a processor coupled to the memory, the processor configured to execute the machine executable code to cause the processor to: receive, from the guidewire, data output from the guidewire; and process and analyze the data to determine necessary pressure (or a motion) needed to cause the guidewire to change its form.
  • the guidewire may include a pressure sensor to determine when the guidewire has entered the predetermined or preferred location inside the patient, e.g., main pulmonary artery.
  • analyzing the data may include determining the necessary pressure to move the guidewire to the patient’s main pulmonary artery.
  • analyzing the data may include determining the necessary pressure to cause the guidewire to change its form.
  • the server and database may be connected to each other via at least one communication link.
  • the guidewire and the monitor computer may be coupled to the network via communication links.
  • the guidewire may be configured to be used by, for example, an authorized user of a patient to whom the guidewire is being used.
  • the data may then transferred immediately to the monitor computer, the hosted server, or the database for determining pressure needed to guide the guidewire to the predetermined location inside the patient (e.g., pulmonary artery).
  • the guidewire, the monitor computer, the hosted server, and the database may be configured to each include a computer-readable medium including a computer program that may be executed to carry out the processes disclosed herein.
  • the computer-readable medium may be configured to include a code section or code segment for performing each step disclosed herein.
  • the code may include an algorithm to determine pressure (or a motion) needed to cause the guidewire to change its form.
  • the code may further include an automatic instruction to be provided to the guidewire at a pre-determined location inside the patient (or a pre-determined pressure sensed by the guidewire) to change the form of the guidewire.
  • the algorithm may include at least one of: probability algorithm, machine learning algorithm, or combination thereof.
  • Another aspect of the present disclosure discloses a computer readable storage medium tangibly embodying a computer readable program code having computer readable instructions which, when implemented, cause a computer to carry out the steps as described herein.
  • Another aspect of the present disclosure discloses a non-transitory machine readable medium having stored thereon instructions for performing a method including machine executable code which when executed by at least one machine, causes the machine to carry out the steps as disclosed herein.
  • Yet another aspect of the present disclosure discloses a computer readable storage medium tangibly embodying a computer readable program code having computer readable instructions which, when implemented, cause a computer to carry out the steps of a method as described herein.
  • a guidewire for use inside a patient’s body including: a main body; a retractable end positioned at the end of the main body; and at least two coiled ends inside the main body,
  • the main body includes (a) a distal end that is configured to stay outside the patient’s body and (b) a proximal end that is configured to enter the patient, wherein the retractable end is configured to retract over the main body, and wherein the at least two coiled ends are configured to protrude out of the main body when the retractable end is retracted.
  • Embodiment 2 The guidewire of embodiment 1, wherein the two coiled ends are configured to form an umbrella shape when the two coiled ends protrude out of the distal end once the retractable end is retracted over the main body towards the proximal end and away from the distal end, thereby having the two coiled ends retain the distal end of the guidewire outside the patient’s body.
  • Embodiment 3 The guidewire of embodiment 1, wherein the retractable end is configured to be broken and peeled away once the guidewire is in preferred or pre-determined place inside the patient.
  • Embodiment 4. The guidewire of embodiment 1, wherein the retractable end includes a biodegradable material.
  • Embodiment 5 The guidewire of embodiment 1, wherein the guidewire includes a solid steel core wires and solid core wire wrapped in a smaller wire coil or braid, wherein the coiled or braided wires offer a flexibility, pushability, and kink resistance.
  • Embodiment 6 The guidewire of embodiment 1, wherein the guidewire includes nitinol core wires and solid core wire wrapped in a smaller wire coil or braid, wherein the coiled or braided wires offer a flexibility, pushability, and kink resistance.
  • Embodiment 7 The guidewire of embodiment 5, wherein the core materials include at least one of: stainless steel, Nitinol, TRITONTM alloy, or a combination thereof.
  • Embodiment 8 The guidewire of embodiment 1, wherein a motion applied to the guidewire is configured to trigger the retractable end to retract over the main body.
  • Embodiment 9 The guidewire of embodiment 7, wherein the motion includes at least one of: twisting, untwisting, pushing, squeezing, or any combination thereof.
  • Embodiment 10 The guidewire of embodiment 7, wherein the motion is carried out via mechanical means located on the guidewire.
  • Embodiment 11 The guidewire of embodiment 1, wherein a catheter sheath is configured to be inserted along the guidewire once the guidewire is in place, wherein the at least two coiled ends are configured to retract inside the main body when the catheter sheath passes over the at least two coiled ends.
  • Embodiment 12 The guidewire of embodiment 1, wherein the guidewire is configured to be flushed in order to prevent clotting once placed in the patient’s body.
  • Embodiment 13 The guidewire of embodiment 8, wherein the guidewire includes at least one wire that that is connected to the retractable end and the proximal end of the main body away from the retractable end, wherein the motion applied to the proximal end of the main body is configured to transmit a torque from the proximal end of the main body to the retractable end via the at least one wire to cause the retractable end to retract over the main body away from the distal end and towards the proximal end.
  • Embodiment 14 A guidewire for use inside the patient including: a main body; and an expandable end positioned at a distal end of the main body and is further configured to balloon out upon a motion applied to the guidewire, wherein the distal end is located at or near a portion of the main body that is configured to stay outside the patient, and wherein the main body includes a proximal end on an opposite end of the distal end and is configured to enter inside the patient.
  • Embodiment 15 The guidewire of embodiment 14, wherein the main body is configured to balloon out when the expandable end is ballooned out.
  • Embodiment 16 The guidewire of embodiment 14, wherein the motion includes at least one of: twisting, pulling, pushing, squeezing, or any other pressure applied to the guidewire.
  • Embodiment 17 The guidewire of embodiment 14, wherein the motion may be carried out via a mechanic means or device located on the guidewire.
  • Embodiment 18 The guidewire of embodiment 14, including at least one wire that that is connected to the proximal end of the main body away from the expandable end, wherein the motion applied to the proximal end of the main body is configured to transmit a torque from the proximal end of the main body to the expandable end via the at least one wire to cause the expandable end to expand.
  • Embodiment 19 The guidewire of embodiment 14, wherein the expandable end is configured to snap back and make the guidewire straight again upon application of another motion to the guidewire.
  • Embodiment 20 The guidewire of embodiment 19, wherein the another motion includes at least one of: untwisting, twisting, pulling, pushing, squeezing, or any other pressure applied to the guidewire.
  • Embodiment 21 The guidewire of embodiment 14, wherein the expandable end and the main body are configured to be layered on top of each other.
  • Embodiment 22 The guidewire of embodiment 14, wherein the distal end is configured to collapse when a sheath catheter passes over the guidewire due to compression from the sheath catheter.
  • Embodiment 23 The guidewire of embodiment 21, wherein the distal end is configured to expand again once the sheath catheter passes over the distal end and is inserted inside the patient’s body.
  • FIG. 1 depicts a side view of an example of a guidewire that is constructed in accordance with the principles of the present disclosure.
  • FIG. 2 depicts a side view of another example of a guidewire that is constructed in accordance with the principles of the present disclosure.
  • FIG. 3 depicts side view of yet another example of a guidewire that is constructed in accordance with the principles of the present disclosure.
  • FIG. 4 depicts an example of a method for using the guidewire that is constructed in accordance with the principles of the present disclosure.
  • FIG. 5 depicts an example of a guidewire being used in construction in accordance with the principles of the present disclosure.
  • FIG. 6 depicts an example of a system for deploying a guidewire in accordance with the principles of the present disclosure.
  • the term “comprising” or “comprises” is used in reference to compositions, methods, and respective component(s) thereof, that are useful to an embodiment, yet open to the inclusion of unspecified elements, whether useful or not. It will be understood by those within the art that, in general, terms used herein are generally intended as“open” terms (e.g., the term“including” should be interpreted as“including but not limited to,” the term“having” should be interpreted as“having at least,” the term“includes” should be interpreted as “includes but is not limited to,” etc.).
  • patient and“subject” are used interchangeably herein. These terms are intended to include all animal subjects, including mammals. Human patients/subjects are intended to be within the scope of the patients/subjects treated using the various embodiments of the inventive systems, apparatuses and methods described herein.
  • wireless transmitter means at least one of microwave, Infrared or RF module or a cellular/wireless modem and is configured to transmit data.
  • the term“coupled” means at least either a direct electrical connection between the connected items or an indirect connection through one or more passive or active intermediary devices.
  • the term“circuit” means at least either a single component or a multiplicity of components, either active and/or passive, that are coupled together to provide a desired function.
  • the term“signal” as used herein may include any meanings as may be understood by those of ordinary skill in the art, including at least an electric or magnetic representation of current, voltage, charge, temperature, data or a state of one or more memory locations as expressed on one or more transmission mediums, and generally capable of being transmitted, received, stored, compared, combined or otherwise manipulated in any equivalent manner.
  • Terms such as“providing,”“processing,”“supplying,”“determining,”“calculating” or the like may refer at least to an action of a computer system, computer program, signal processor, logic or alternative analog or digital electronic device that may be transformative of signals represented as physical quantities, whether automatically or manually initiated.
  • a “computer,” as used in this disclosure, means any machine, device, circuit, component, or module, or any system of machines, devices, circuits, components, modules, or the like, which are capable of manipulating data according to one or more instructions, such as, for example, without limitation, a processor, a microprocessor, a central processing unit, a general purpose computer, a cloud, a super computer, a personal computer, a laptop computer, a palmtop computer, a mobile device, a tablet computer, a notebook computer, a desktop computer, a workstation computer, a server, or the like, or an array of processors, microprocessors, central processing units, general purpose computers, super computers, personal computers, laptop computers, palmtop computers, mobile devices, tablet computers, notebook computers, desktop computers, workstation computers, servers, or the like.
  • A“server,” as used in this disclosure, means any combination of software and/or hardware, including at least one application and/or at least one computer to perform services for connected clients as part of a client-server architecture.
  • the at least one server application may include, but is not limited to, for example, an application program that can accept connections to service requests from clients by sending back responses to the clients.
  • the server may be configured to run the at least one application, often under heavy workloads, unattended, for extended periods of time with minimal human direction.
  • the server may include a plurality of computers configured, with the at least one application being divided among the computers depending upon the workload. For example, under light loading, the at least one application can run on a single computer. However, under heavy loading, multiple computers may be required to run the at least one application.
  • the server, or any if its computers, may also be used as a workstation.
  • A“database,” as used in this disclosure, means any combination of software and/or hardware, including at least one application and/or at least one computer.
  • the database may include a structured collection of records or data organized according to a database model, such as, for example, but not limited to at least one of a relational model, a hierarchical model, a network model or the like.
  • the database may include a database management system application (DBMS) as is known in the art.
  • the at least one application may include, but is not limited to, for example, an application program that can accept connections to service requests from clients by sending back responses to the clients.
  • the database may be configured to run the at least one application, often under heavy workloads, unattended, for extended periods of time with minimal human direction.
  • A“communications network,” as used in this disclosure, means a wired and/or wireless medium that conveys data or information between at least two points.
  • the wired or wireless medium may include, for example, a metallic conductor link, a radio frequency (RF) communication link, an Infrared (IR) communication link, telecommunications networks, an optical communication link, internet (wireless and wired) or the like, without limitation.
  • the RF communication link may include, for example, WiFi, WiMAX, IEEE 802.11, DECT, 0G, 1G, 2G, 3G, 4G, 5G or future cellular standards, Bluetooth, Bluetooth Low Energy, NFC, ultrasound, induction, laser (or similar optical transmission) and the like.
  • A“computer-readable storage medium,” as used in this disclosure, means any medium that participates in providing data (for example, instructions) which may be read by a computer. Such a medium may take many forms, including non-volatile media, volatile media, and transmission media. Non-volatile media may include, for example, optical or magnetic disks, flash memory, and other persistent memory. Volatile media may include dynamic random access memory (DRAM). Transmission media may include coaxial cables, copper wire and fiber optics, including the wires that comprise a system bus coupled to the processor. Transmission media may include or convey acoustic waves, light waves and electromagnetic emissions, such as those generated during radio frequency (RF) and infrared (IR) data communications.
  • RF radio frequency
  • IR infrared
  • Computer-readable media include, for example, a floppy disk, a flexible disk, hard disk, magnetic tape, any other magnetic medium, a CD-ROM, DVD, any other optical medium, punch cards, paper tape, any other physical medium with patterns of holes, a RAM, a PROM, an EPROM, a FLASH-EEPROM, any other memory chip or cartridge, a carrier wave as described hereinafter, or any other medium from which a computer can read.
  • the computer-readable medium may include a“Cloud,” which includes a distribution of files across multiple (e.g., thousands of) memory caches on multiple (e.g., thousands of) computers.
  • sequences of instruction may be delivered from a RAM to a processor, (ii) may be carried over a wireless transmission medium, and/or (iii) may be formatted according to numerous formats, standards or protocols, including, for example, WiFi, WiMAX, IEEE 802.11, DECT, 0G, 1G, 2G, 3G or 4G cellular standards, Bluetooth, or the like.
  • A“network,” as used in this disclosure means, but is not limited to, for example, at least one of a local area network (LAN), a wide area network (WAN), a metropolitan area network (MAN), a personal area network (PAN), a campus area network, a corporate area network, a global area network (GAN), a broadband area network (BAN), a cellular network, the Internet, the cloud network, or the like, or any combination of the foregoing, any of which may be configured to communicate data via a wireless and/or a wired communication medium.
  • These networks may run a variety of protocols not limited to TCP/IP, IRC, SSL, TLS, UDP, or HTTP.
  • a system, a device, and a method uses a guidewire that is configured to not be lost or retained inside the patient’s body.
  • FIG. 1 illustrates an example of a guidewire 100 that is constructed in accordance with the principles of the present disclosure.
  • the guidewire includes a main body 10, a retractable end 20 positioned at end of the main body 10 and is further configured to retract over (or under) the main body 10 away from the distal end 25 of the main body 10, and at least two coiled ends 30 inside the guidewire 100, wherein the at least two coiled ends 30 are configured to protrude out of the main body 10 when the retractable end 20 is retracted over the main body 100.
  • the guidewire 100 also includes a proximal end (not shown) that is configured to enter the patient and is on the opposite end of the distal end 25 that remains outside the patient as the distal end 25 goes through a modification to retain the guidewire 100 from being inadvertently lost or stuck inside the patient during, e.g., a surgical procedure.
  • the at least two coiled ends 30 may form an umbrella-like shape when they protrude out of the main body lOm which causes the at least two coiled ends 30 be stuck outside the patient’s body by anchoring the at least two coiled ends 30 on a sheath (or a port) as shown in, e.g., FIG.
  • the guidewire 100 may be configured so that a motion (e.g., twisting, pulling, pushing, squeezing, or any other pressure) applied to the guidewire 100 may trigger the retractable end 20 to retract over (or under) the main body 10.
  • a motion e.g., twisting, pulling, pushing, squeezing, or any other pressure
  • the guidewire may include at least one wire (or another connecting means) that is connected to the retractable end 20 and opposing end of the main body (away from the retractable end), wherein the motion applied to the distal end 25 of the main body (or anywhere on the guidewire) is configured to transmit a torque from the opposing end of the main body 10 to the retractable end 20 via the at least one wire to cause the retractable end 20 to retract over (or under) the main body 10 away from the main body 10.
  • the at least one wire may be placed inside the guidewire 100 or outside the guidewire 100.
  • FIG. 2 illustrates another example of a guidewire 200 that is constructed in accordance with the principles of the present disclosure.
  • the guidewire 200 includes a main body 10 and an expandable end (distal end) 25 positioned at end of the main body and is further configured to balloon out upon a motion applied to the guidewire 200.
  • the motion may include, e.g., twisting, pulling, pushing, squeezing, or any other pressure applied to the guidewire.
  • the expandable end 25 may snap back and make the guidewire 200 straight again upon application of another motion to the guidewire.
  • the another motion may include, e.g., untwisting, twisting, pulling, pushing, squeezing, or any other pressure applied to the guidewire.
  • the motion may also include insertion of a catheter over the guidewire 200.
  • the expandable end 25 may include at least two components 35 that are configured to be connected to at least one wire (or another connecting means) that is connected to the each component and opposing end of the main body 10 (away from the expandable end), wherein the motion applied to the opposing end of the main body 10 (or anywhere on the guidewire) is configured to transmit a torque from the opposing end of the main body to the at least two components 35 via the at least one wire to causing the at least two components 35 to expand, thereby expanding the expandable end 25.
  • the at least one wire may be placed inside the guidewire or outside the guidewire.
  • the guidewire 200 Upon the expansion of the expandable end 25, the guidewire 200 will be held in place outside the patient’s body as it will not pass through the sheath (as shown in, e.g., FIG. 5). In this state, the expandable end 25 will be retained outside the patient’s body by the expanded two components 35.
  • FIG. 3 illustrates yet another example of a guidewire 300 being deployed inside the patient in accordance with the principles of the present disclosure.
  • the guidewire 200 includes a main body 10 and a distal end 25 positioned at end of the main body 10 and outside the patient’s body, and is further configured to be in expanded state, wherein the distal end 25 may collapse when a sheath (or needle) catheter 45 passes over the guidewire 300 due to compression from the sheath catheter.
  • the distal end 25 may expand again once the sheath catheter 45 passes over the distal end 25.
  • the distal end 25 may also collapse or expand further based on a motion (e.g., twisting, untwisting, pulling, pushing, squeezing, or any other pressure) applied to the guidewire.
  • the distal end 25 may be deployed outside the patient’s body such that a portion of the guidewire 300 (e.g., the primal end 25 in expanded state)
  • FIG. 4 illustrates an example of a method for securing a guidewire inside the patient in accordance with the principles of the present disclosure.
  • the method includes placing a guidewire inside the patient, wherein the guidewire includes (a) a main body, (b) a distal end positioned near or at the end of the main body, and (c) a proximal end positioned near or at the opposing end of the main body, wherein the proximal end is configured to enter the patient and the distal end is configured to remain outside the patient (S401), applying a motion to the guidewire, wherein such motion is configured to cause the distal end to change its form (S402), and applying another motion to the guidewire which causes the guidewire to return to its original form (S403).
  • changing the form of the distal end makes it so that the distal end 25 is retained outside the patient’s body as to prevent the guidewire from being inadvertently stuck or lost inside the patient.
  • the change in the distal end 25 may include, e.g., ballooning out the guidewire, deploying a set of coils, and deploying an adhesive means that allow the distal end 25 to remain outside the patient’s body as shown in, e.g., FIG. 5.
  • FIG. 5 depicts in detail an example of a guidewire 500 being used in construction in accordance with the principles of the present disclosure.
  • the guidewire 500 includes a main body 10 and an expandable end (distal end) 25 positioned at end of the main body and is further configured to balloon out upon a motion applied to the guidewire 500.
  • the expandable end 25 may expand and snap back and make the guidewire 200 straight again upon application of a motion to the guidewire.
  • the another motion may include, e.g., untwisting, twisting, pulling, pushing, squeezing, or any other pressure applied to the guidewire.
  • the motion may also include insertion of a catheter 45 over the guidewire 200.
  • the expandable end 25 may include at least two components 35 that are configured to be connected to at least one wire (or another connecting means) that is connected to the each component and opposing end of the main body 10 (away from the expandable end), wherein the motion applied to the opposing end of the main body 10 (or anywhere on the guidewire) is configured to transmit a torque from the opposing end of the main body to the at least two components 35 via the at least one wire to causing the at least two components 35 to expand, thereby expanding the expandable end 25.
  • the at least one wire may be placed inside the guidewire or outside the guidewire.
  • the expandable end 25 may include at least two coils that are configured to project out of the expandable end 25 upon a motion and/or movement of the retractable end 20 (as shown in, e.g., FIG. 1). Upon the expansion of the expandable end 25 or projection of the at least two coils, the guidewire 200 will be held in place outside the patient’s body as it will not pass through a sheath 55.
  • a health care professional may (a) insert a needle (not shown) having a sheath (or port) 55 into the patient’s body, (b) insert the guidewire through the inserted sheath 55 which is configured to partly protrude outside the patient’s body while having a portion of the sheath 55 inside the patient’s body as to facilitate an insertion of, e.g., a catheter, (c) exert a motion to activate the guidewire thereby changing the guidewire’ s form (e.g., expand, deploy coil, and the like) so that changed form of the guidewire prevents the distal end 25 of the guidewire from being pulled inside the sheath 55 as to retain the guidewire outside the patient’s body, and (d) insert the catheter 45 over the guidewire and into the patient’s body via the sheath 55.
  • a needle not shown
  • the guidewire insert the guidewire through the inserted sheath 55 which is configured to partly protrude outside the patient’s body while having a portion of the sheath 55 inside the
  • the diameter of the distal end 25 is configured to be greater than the diameter of the sheath 55 so that the distal end 25 does not fit through the sheath 55 and remains outside the patient’s body.
  • the sheath 55 may include a diameter of, e.g., 1.5 French in neonates and pediatrics to 9.5-10 French in adults requiring larger bore access.
  • a health care professional may (a) insert a needle into the patient’s body, (b) insert the guidewire through the needle into the patient’s body to a predetermined (or desired) location, (c) remove the needle, (d) expand and/or change the guidewire’ s form such that the portion of the guidewire outside the patient’s body changes in form such that the diameter of the outside portion is greater than the diameter of the skin’s opening as to not fit inside the patient’s skin, thereby preventing the guidewire from inadvertently lost inside the patient, (e) insert a catheter having a sheath (or a port) through the needle into the patient’s body which compresses the expanded (or changed) portion of the guidewire while the catheter passes through the expanded portion, (f) having the sheath remaining on surface of the patient’s skin where the guidewire and catheter are inserted into the patient’s body while having the expanded portion remain above or on top of the sheath outside the patient’s body, thereby preventing the
  • FIG. 6 depicts an example of a system 600 for deploying a guidewire in accordance with the principles of the present disclosure.
  • the system 600 includes providing a guidewire 610 and receiving and carrying out wireless transmission of instructions, such as, for example, begin an insertion of the guidewire into the patient via, e.g., percutaneous technique, measure a pressure needed to guide the guidewire to a predetermined location inside the patient (e.g., main pulmonary artery) and change the guidewire 6l0’s form (e.g., expand, contract, and the like) in order to secure the guidewire inside the patient’s body.
  • instructions such as, for example, begin an insertion of the guidewire into the patient via, e.g., percutaneous technique, measure a pressure needed to guide the guidewire to a predetermined location inside the patient (e.g., main pulmonary artery) and change the guidewire 6l0’s form (e.g., expand, contract, and the like) in order to secure the guidewire inside the patient’s body.
  • the system includes a guidewire 610, a network 620, a monitor (e.g., a system manager) computer (or computing device) 630, a hosted server (or computer) 640, and a database 650, all of which may be coupled to each other via communication links 660.
  • a monitor e.g., a system manager
  • the hosted server 640 and database 650 may be connected to each other and/or the network 620 via one or more communication links 660.
  • the guidewire 610 and the monitor computer 630 may be coupled to the network 620 via communication links 660.
  • the guidewire 610 may include a main body and a distal end, wherein the distal end is configured to change its form based on pre-determined settings, active motion applied on the guidewire, or a command from the system.
  • the guidewire 610, the monitor computer 630, the hosted server 640, and the database 650 may each include a controller that carries out the method as disclosed herein.
  • the guidewire 610 may be used by, for example, an authorized user (e.g., doctor, nurse, or the like) of a patient to whom guidewire 610 is being inserted.
  • an authorized user e.g., doctor, nurse, or the like
  • the guidewire collects necessary data from the patient (e.g., location of the guidewire 610, required pressure to get the guidewire 610 to a desired location inside the patient, and the like)
  • said data may then transferred immediately to the monitor computer, the hosted server, or the database for screening (or analysis) to detect various information, e.g., medical conditions in otherwise asymptomatic patient, pressure needed to place (or guide) the guidewire to, e.g., the main pulmonary artery, or timing to activate a command (or a motion) to change the form of the guidewire 610 once the guidewire 610 is placed at the desired location in vivo so that the distal end of the guidewire is retained outside the patient and the guidewire is not stuck or lost inside the patient.
  • the guidewire 610, the monitor computer 630, the hosted server 640, and the database 650 may each include a computer-readable medium including a computer program that may be executed to carry out the processes disclosed herein.
  • the computer-readable medium may include a code section or code segment for performing each step disclosed herein.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Biophysics (AREA)
  • Pulmonology (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Media Introduction/Drainage Providing Device (AREA)

Abstract

La présente invention concerne un fil-guide destiné à être utilisé à l'intérieur du corps d'un patient. Le fil-guide comprend un corps principal; une extrémité rétractable positionnée à l'extrémité du corps principal; et au moins deux extrémités enroulées à l'intérieur du corps principal, le corps principal comprenant (a) une extrémité distale qui est configurée pour rester à l'extérieur du corps du patient et (b) une extrémité proximale qui est configurée pour entrer dans le patient, l'extrémité rétractable étant configurée pour se rétracter sur le corps principal, et les au moins deux extrémités enroulées étant configurées pour faire saillie hors du corps principal lorsque l'extrémité rétractable est rétractée.
PCT/US2019/016003 2018-02-02 2019-01-31 Nouveau dispositif de fil-guide, système et procédé WO2019152622A1 (fr)

Applications Claiming Priority (2)

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US201862625892P 2018-02-02 2018-02-02
US62/625,892 2018-02-02

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN114917460A (zh) * 2022-06-09 2022-08-19 江苏理工学院 一种组织复位支撑装置

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4281660A (en) * 1978-10-18 1981-08-04 Tugumasa Fujiwara Method for fixing pervenous electrode in atrial pacing and device therefor
US20080015508A1 (en) * 2006-07-07 2008-01-17 Wilson-Cook Medical, Inc. Telescopic wire guide
US20090105653A1 (en) * 2007-10-17 2009-04-23 Gardia Medical Ltd Guidewire stop
US20110218520A1 (en) * 2008-10-31 2011-09-08 Daniela Andrich Catheterisation device
WO2018222952A1 (fr) * 2017-06-01 2018-12-06 Duke University Dispositifs de retenue de fil-guide destinés à être utilisés avec des cathéters, procédés et kits associés

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4281660A (en) * 1978-10-18 1981-08-04 Tugumasa Fujiwara Method for fixing pervenous electrode in atrial pacing and device therefor
US20080015508A1 (en) * 2006-07-07 2008-01-17 Wilson-Cook Medical, Inc. Telescopic wire guide
US20090105653A1 (en) * 2007-10-17 2009-04-23 Gardia Medical Ltd Guidewire stop
US20110218520A1 (en) * 2008-10-31 2011-09-08 Daniela Andrich Catheterisation device
WO2018222952A1 (fr) * 2017-06-01 2018-12-06 Duke University Dispositifs de retenue de fil-guide destinés à être utilisés avec des cathéters, procédés et kits associés

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN114917460A (zh) * 2022-06-09 2022-08-19 江苏理工学院 一种组织复位支撑装置
CN114917460B (zh) * 2022-06-09 2023-07-04 江苏理工学院 一种组织复位支撑装置

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