WO2018081008A1 - Méthode et appareil servant à mesurer la longueur d'une lésion anatomique vasculaire - Google Patents

Méthode et appareil servant à mesurer la longueur d'une lésion anatomique vasculaire Download PDF

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Publication number
WO2018081008A1
WO2018081008A1 PCT/US2017/057894 US2017057894W WO2018081008A1 WO 2018081008 A1 WO2018081008 A1 WO 2018081008A1 US 2017057894 W US2017057894 W US 2017057894W WO 2018081008 A1 WO2018081008 A1 WO 2018081008A1
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WO
WIPO (PCT)
Prior art keywords
lumen
catheter
lesion
dual
dual lumen
Prior art date
Application number
PCT/US2017/057894
Other languages
English (en)
Inventor
Ali Aboufares
Original Assignee
Ali Aboufares
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 Ali Aboufares filed Critical Ali Aboufares
Priority claimed from US15/790,752 external-priority patent/US11471071B2/en
Publication of WO2018081008A1 publication Critical patent/WO2018081008A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/103—Detecting, measuring or recording devices for testing the shape, pattern, colour, size or movement of the body or parts thereof, for diagnostic purposes
    • A61B5/107—Measuring physical dimensions, e.g. size of the entire body or parts thereof
    • A61B5/1072—Measuring physical dimensions, e.g. size of the entire body or parts thereof measuring distances on the body, e.g. measuring length, height or thickness
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/103—Detecting, measuring or recording devices for testing the shape, pattern, colour, size or movement of the body or parts thereof, for diagnostic purposes
    • A61B5/107—Measuring physical dimensions, e.g. size of the entire body or parts thereof
    • A61B5/1076—Measuring physical dimensions, e.g. size of the entire body or parts thereof for measuring dimensions inside body cavities, e.g. using catheters

Definitions

  • the present invention generally relates to the field of medical devices and more particularly, is directed to a method and apparatus for measuring the length of a vascular anatomic lesion.
  • cardiovascular system is responsible for circulating blood throughout the body via the heart, arteries and veins, delivering oxygen and nutrients to organs and cells, especially the brain, and carrying their waste products away. More than any other system, the body will not tolerate a malfunctioning cardiovascular system for very long. Many of the ailments that affect the cardiovascular system require a surgical intervention. For example, a catheter containing medications or miniature instruments is often inserted into a blood vessel for treatment and/or analysis of lesions or other damaged tissue. In such cases, accurate measurements of anatomic lesion length are of paramount importance.
  • Figure 1 illustrates a lesion formed in a straight, or linear, portion of a blood vessel
  • Figure 2 illustrates a lesion formed in a curved, or non-linear, portion of a blood vessel
  • Figure 3 is an elevation view of one embodiment of a device for measuring the length of lesions in accordance with the present invention
  • Figure 4 illustrates the marking measurement used to determine the length of a lesion in the embodiment of Figure 3;
  • Figures 5 - 7 illustrate the construction of a device for measuring the length of a lesion in accordance with the present invention
  • Figure 8 illustrates the progression of use of the measuring device of the present invention
  • Figure 9 illustrates in more detail the measurement marking scale of the measuring device of the present invention.
  • Figures 10 and 11 illustrate a computer control system for the measuring device of the present invention.
  • the present invention is a dual lumen plastic catheter intended for use in, for example, the coronary and/or the peripheral vasculature.
  • Other uses and applications include the genitourinary system (e.g., ureter and pulmonary stents and like).
  • the catheter houses two lumens in parallel for a short distance then continues as a single lumen proximally to the outside of the body.
  • the first lumen is a rapid exchange (RX) delivery lumen and is designed to accommodate a 0.014 inch (0.36 mm) guidewire which allows the catheter to be advanced from outside the human body to the specific blood vessel.
  • the first lumen may also be sized to accommodate other guidewire sizes that are known in the art, such as 0.018 inch and 0.035 inch guidewires.
  • the second lumen is an over-the-wire (OTW) that accommodates a 0.023 inch (0.58 mm) wire, or "ruler". The second lumen is longer that the first lumen and extends to become the catheter itself.
  • a “marker” is placed at distal end of the lesion.
  • the “marker” is a radio- opaque band that represents a fusion point on the catheter tip.
  • the fusion point is the overlap of the radiopaque catheter distal tip and the inner ruler distal tip. In accordance with the present invention, this is considered the baseline state.
  • the operator pulls back the "ruler" within the catheter while observing the partial marker move proximally under continuous X-ray fluoroscopy. Once the desired lesion length/distance is achieved, the operator records the distance displaced on the ruler (from the outside) at the hub using a graduated millimeter marking millimeter (or inch) marking printed on the ruler along its length.
  • Such a system allows the exact measurement of the lesion as the distance measured after the pull-back is the anatomic lesion length.
  • Figure 1 illustrates a representative coronary artery 1 takeoff from an aorta 2.
  • a lipid plaque, or lesion 3 is shown in a mid- segment of artery 1.
  • lesion length is defined by the distance between points A and B, as shown in Figure 1.
  • lesion 3 is in an area of artery 1 that is essentially straight or linear.
  • the operator dilates the blood vessel at that location using a balloon/stent equal to or a bit longer than the distance A-B.
  • the classic teaching is to treat normal-to-normal vessel thus extending a few millimeters on each end of A and B.
  • Figure 2 illustrates a lesion 21 that is in an area of vessel 22 that is not straight on, in other words, non-linear.
  • the length A - B of lesion 21 may be the same as lesion 3 shown in Figure 1.
  • the non-linearity of vessel 22 in the area of lesion 21 leads to errors in visual estimates of its length as inferred from a 2-D image of a 3-D structure.
  • FIG 3 illustrates of the lesion length measuring tool (LLT) of the present invention.
  • LLT lesion length measuring tool
  • a regular guidewire 999 of variable diameter ranging between 0.014 inch to 0.035 inch is introduced in a hollow vascular structure in the usual manner.
  • Catheter 10 Over guidewire 999, and in a monorail fashion, a catheter 10 is introduced and placed at the target lesion to be studied.
  • Catheter 10 has proximal hub 21 that is an extension of catheter 10.
  • Hub 21 is a female/receiving bolt, or similar fastening device, that accommodates another smaller diameter catheter 41 in its center.
  • a male screw 31 is provided at the proximal end of inner catheter 41 that can fit tightly into hub 21.
  • Figure 4 represents the relationship between the catheters in two different states.
  • Catheter 11 represents one of the lumens that constitute catheter 10.
  • Catheter 11 has a closed tip on its distal end. In the "baseline state" as shown in Figure 4-B, catheter 41 is screwed all the way in with the hubs 21-31 in full contact.
  • catheter 41 In the "pull-back" state as shown in Figure 4- A, which represents the unscrewing of male screw 31 from hub 21, catheter 41 when exposed has millimeter marks engraved on it similar to a measuring ruler. The zero mark is at the hub 31 and the ruler runs in an ascending numbers fashion distally into catheter 11. In another embodiment, the reference marks run in a descending order. Whether the reference marks are ascending or descending, it is important that they be consistently spaced so that they can be used to indicate distance.
  • FIG. 5 is a detailed view of the distal end of catheter 10.
  • catheter 10 is comprised of two lumens 11 and 12 of variable diameters.
  • Lumen 12 is a short lumen that extends typically 10-20 cm in length starting distally.
  • Lumen 12 also accommodates guidewire 999 which is the initial instrument introduced in the vessel.
  • Lumen 11 accommodates catheter 41, which is the "ruler" in accordance with the present invention.
  • Figure 6 illustrates the "baseline” state.
  • catheter 41 inside lumen 11 is advanced all the way in (distally) such that the tip of catheter 41 is at the tip of catheter 10.
  • This position represents a fusion point at the tip of catheter 10 which also serves as a radiopaque marker.
  • This marker 51 is comprised of the tip of catheter 41 and the tip of catheter 10 and has a circumferential radiopaque band 20.
  • Catheter 41 is radiopaque along its length.
  • Figure 7 illustrates the "pull-back" state.
  • hubs 21-31 are disunited and catheter 41 is pulled out by pulling out on hub 31, there is a coaxial displacement of catheter 41 proximally.
  • the distance between the two points is the pull-back or lesion length measurement distance.
  • FIG 8 illustrates the operation of the device of the present invention as follows:
  • FIG. 10 illustrates a further embodiment of the present invention.
  • a measuring sensor 101 is provided within hub 21.
  • hub 31 is adjacent to hub 21, indicating that catheter 41 has not been withdrawn to any degree
  • measuring sensor 101 returns an electrical signal 102 indicating that distance 103 is 0.
  • measuring sensor 101 When hub 31 is fully extended away from hub 21, and distance 103 is at its maximum, measuring sensor 101 returns an electrical signal indicating the maximum travel of catheter 41. For those intermediate distances between 0 and the maximum travel of catheter 41, measuring sensor 101 returns real time signals corresponding to distance 103 at all points in time.
  • Control Unit 1100 illustrated in Figure 11.
  • Control Unit 1100 includes a CPU 1101.
  • the CPU is used for executing computer software instructions as is known in the art.
  • CPU 1101 is coupled to a number of other elements via a signal and data bus 1102 as is also known in the art. These elements include ROM (Read Only Memory) 1104 which may be used to store computer software instructions, RAM 1105 (Random Access Memory) which also may be used to store computer software instructions, I/O Interface 1106 which may be used to interface CPU 1101 to elements and/or functions that are external to CPU 1101, and Non Volatile Memory 1103 which may be used to store computer software instructions as well.
  • ROM Read Only Memory
  • RAM 1105 Random Access Memory
  • I/O Interface 1106 which may be used to interface CPU 1101 to elements and/or functions that are external to CPU 1101
  • Non Volatile Memory 1103 which may be used to store computer software instructions as well.
  • I/O Interface 1106 is used to interface CPU HOlto elements or functions that are external to the CPU. These external elements might include Keyboard 1107, Visual Display 1108, Pointing Device 1109, such as a mouse or touch pad, and Network Interface 1110.
  • ROM 1104 Depending on the tasks to be performed by CPU 1101, its computer software instructions might be divided into two or more separate and distinct categories which are stored in separate portions of ROM 1104, RAM 1105 and/or Non Volatile Memory 1103.
  • a basis set of low level operating instructions known in the art as firmware, might be stored in, for example, ROM 1104. These low level rudimentary instructions provide the necessary instructions for how the controller communicates with the other computer hardware. Such instructions are necessary for the controller to perform any useful work, regardless of the application for which the device is to be used.
  • the computer instruction set that is executed by CPU 1101 to perform the particular tasks required of Control Unit 1100 is often called “application software” and operationally "sits" on top of the firmware.
  • the application software is stored in RAM 1105.
  • the application software could also be stored in ROM 1104 or in Non Volatile Memory 1103.
  • Network interface 1110 allows Control Unit 1100 to be connected to the Internet, or to other networks, such as local area or wide area networks. Such a network connections allows client computers Client - 1 to Client - n to connect the Control Unit 1100.
  • measuring signal 102 is coupled to Control Unit 1100.
  • application software 1105 is programed to received and displayed a visual image on Visual Display 1108 which indicates the precise distance that catheter 41 has traveled and its location.
  • Visual Display 1108 can be implemented in the form of a conveniently placed computer monitor that will give the surgeon a much easier to view indication of the location of the catheter at any point in time.
  • Network Interface 1110 allows client computers to observe and monitor the procedure remotely.

Abstract

L'invention concerne un cathéter double lumière pourvu d'une échelle de mesure. Le cathéter selon l'invention comprend une paire de lumières, dont l'une est conçue pour recevoir une échelle de mesure servant à mesurer la longueur d'une lésion à l'intérieur du corps. Le cathéter comporte également un orifice de visualisation permettant à l'utilisateur de visualiser l'échelle de mesure et de déterminer la longueur de la lésion.
PCT/US2017/057894 2016-10-24 2017-10-23 Méthode et appareil servant à mesurer la longueur d'une lésion anatomique vasculaire WO2018081008A1 (fr)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US201662412007P 2016-10-24 2016-10-24
US62/412,007 2016-10-24
US15/790,752 2017-10-23
US15/790,752 US11471071B2 (en) 2017-10-23 2017-10-23 Method and apparatus for measuring the length of a vascular anatomic lesion

Publications (1)

Publication Number Publication Date
WO2018081008A1 true WO2018081008A1 (fr) 2018-05-03

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2023034406A1 (fr) * 2021-08-31 2023-03-09 Accumed Radial Systems, Llc Étrier de micro-cathéter

Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6068635A (en) * 1998-03-04 2000-05-30 Schneider (Usa) Inc Device for introducing an endoprosthesis into a catheter shaft
WO2002047549A1 (fr) * 2000-07-13 2002-06-20 Wilson Cook Medical, Inc. Système de marquage pour instrument médical
US6613002B1 (en) * 1999-06-05 2003-09-02 Wilson-Cook Medical Incorporated System of indicia for a medical device
US20050143770A1 (en) * 2003-07-31 2005-06-30 Carter Matthew P. Distal wire stop
US20120095319A1 (en) * 2007-04-16 2012-04-19 C. R. Bard, Inc. Guidewire-Assisted Catheter Placement System
US8206370B2 (en) * 2006-04-21 2012-06-26 Abbott Laboratories Dual lumen guidewire support catheter
US20150119702A1 (en) * 2013-10-24 2015-04-30 Suman K. Mulumudi Devices and methods for measuring anatomic regions

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6068635A (en) * 1998-03-04 2000-05-30 Schneider (Usa) Inc Device for introducing an endoprosthesis into a catheter shaft
US6613002B1 (en) * 1999-06-05 2003-09-02 Wilson-Cook Medical Incorporated System of indicia for a medical device
WO2002047549A1 (fr) * 2000-07-13 2002-06-20 Wilson Cook Medical, Inc. Système de marquage pour instrument médical
US20050143770A1 (en) * 2003-07-31 2005-06-30 Carter Matthew P. Distal wire stop
US8206370B2 (en) * 2006-04-21 2012-06-26 Abbott Laboratories Dual lumen guidewire support catheter
US20120095319A1 (en) * 2007-04-16 2012-04-19 C. R. Bard, Inc. Guidewire-Assisted Catheter Placement System
US20150119702A1 (en) * 2013-10-24 2015-04-30 Suman K. Mulumudi Devices and methods for measuring anatomic regions

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2023034406A1 (fr) * 2021-08-31 2023-03-09 Accumed Radial Systems, Llc Étrier de micro-cathéter

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