WO2012015955A1 - Capteur de pression, ancrage de centrage, système et méthode de pose associés - Google Patents

Capteur de pression, ancrage de centrage, système et méthode de pose associés Download PDF

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Publication number
WO2012015955A1
WO2012015955A1 PCT/US2011/045583 US2011045583W WO2012015955A1 WO 2012015955 A1 WO2012015955 A1 WO 2012015955A1 US 2011045583 W US2011045583 W US 2011045583W WO 2012015955 A1 WO2012015955 A1 WO 2012015955A1
Authority
WO
WIPO (PCT)
Prior art keywords
implant
delivery system
sheath
assembly
implant delivery
Prior art date
Application number
PCT/US2011/045583
Other languages
English (en)
Inventor
Peter Hinchliffe
Harry Rowland
Michael Nagy
Reed Prior
Original Assignee
Endotronix, Inc.
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 Endotronix, Inc. filed Critical Endotronix, Inc.
Publication of WO2012015955A1 publication Critical patent/WO2012015955A1/fr
Priority to US16/727,230 priority Critical patent/US20200146562A1/en

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6846—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive
    • A61B5/6867—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive specially adapted to be attached or implanted in a specific body part
    • A61B5/6876—Blood vessel
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/02—Detecting, measuring or recording pulse, heart rate, blood pressure or blood flow; Combined pulse/heart-rate/blood pressure determination; Evaluating a cardiovascular condition not otherwise provided for, e.g. using combinations of techniques provided for in this group with electrocardiography or electroauscultation; Heart catheters for measuring blood pressure
    • A61B5/021—Measuring pressure in heart or blood vessels
    • A61B5/0215—Measuring pressure in heart or blood vessels by means inserted into the body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6846—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive
    • A61B5/6879—Means for maintaining contact with the body
    • A61B5/6882—Anchoring means

Definitions

  • This application relates to a medical implantable pressure sensor device, centering and anchoring mechanism, delivery system and more particularly to a method for delivering and positioning the pressure sensor into the human body.
  • Delivery systems and centering anchoring devices are currently being used in medical procedures to guide and position devices from a remote site to a target site within a body.
  • a guidewire is introduced into an artery or vein.
  • the guidewire is then advanced through the vascular system to the target site where the vascular implant is to be positioned.
  • the guidewire then functions as a rail for the advancement of the delivery system.
  • a target vascular site is the right pulmonary artery and middle lobe vessel.
  • the delivery system and centering/anchoring mechanism for the delivery system lacks certain critical features, the surgical procedure may not be able to be performed. That is, for example, in some instances, the anatomy is quite tortuous and if the delivery system is not able to negotiate this tortuous anatomy the procedure may not be possible.
  • the physician is left to select generally available off the shelf accessories such as sheaths and wires to deliver the implant as best he can.
  • an implant delivery system comprising a sheath and dilator assembly for placement over a guidewire.
  • an implant delivery system comprises a sheath containing an implant, a retention rod and a suture loop attached at their proximal end to a handle assembly.
  • the implant, with centering/anchoring mechanism compressed for delivery, may be housed within the distal outer sheath.
  • the handle assembly retracts the outer sheath using a button through the handle body to deliver the implant.
  • the suture is cut by the suture release knob once the implant has been confirmed to be in the desired location with the centering/anchoring mechanism fully deployed.
  • the delivery system sheath is made from an extruded plastic material such as, for example, Pebax®, and may have a reinforcement placed within the wall to reduce kink-ability.
  • the retention rod and handle may also be made from plastic.
  • the handle body has two halves.
  • the sheath may have a marker band at the distal end for visualization under fluoroscopy.
  • This marker band may be made from gold or any other similar material.
  • the centering/anchoring mechanism may be made from super-elastic nitinol or any other similar material.
  • the sheath may have a smoothly tapered distal tip to transition smoothly from the dilator.
  • a stop may be provided to limit relative movement of the sheath and delivery system when the delivery system is inserted into the sheath, such that a distalmost end of the delivery system sheath may not be able to extend past a distalmost end of the sheath. Thus allowing the sheath with a marker band to clearly identify the distal most point of the system.
  • the sheath has an inner diameter of about 4 mm and the delivery system fits within it.
  • the present invention also provides a method of delivering a vascular implant into a body, the method comprising at least one of the following steps: a) Negotiating the vascular anatomy with a guidewire and locating the tip of the guidewire in the desired target location. In a particular embodiment, from the femoral vein to the right middle lobe pulmonary artery.
  • a dilator/sheath system comprising a sheath disposed onto a dilator that accepts a guidewire, the guidewire size may be about, as a non-limiting example .035 inches; c) Advancing the dilator/sheath system into the vascular system from a remote site wherein the sheath and dilator may be locked together;
  • the marker band may be able to indicate and confirm correct positioning.
  • the sheath may be maintained in a fixed position relative to the patient while the dilator and guidewire are removed from the sheath.
  • a reference pressure measurement may be taken by connecting appropriate equipment to the side arm at the proximal end of the sheath. This measurement may be taken while the sheath is maintained in a fixed position relative to the patient, but may also be taken at any other desired time.
  • the delivery system While the sheath is maintained in a fixed position relative to the patient the delivery system is introduced into the sheath and advanced within the sheath until the distal ends align, this may be confirmed by the sheath locking into the delivery system sheath hub at the proximal end.
  • the implant While the sheath and delivery system are maintained in a fixed position relative to the patient the implant may be visually and electronically checked for correct positioning and function.
  • the button may be depressed and/or withdrawn in a proximal direction retracting the sheath and sheath of the delivery system, exposing the implant and deploying the implant and centering/anchoring mechanism.
  • the implant While the sheath and delivery system may be maintained in a fixed position the implant may be checked for function and position electronically and visually. If the implant is not where the operator desires, it may be re-sheathed, one or more times, by moving the button in the distal direction, collapsing the centering/anchoring mechanism.
  • the implant may be released by pulling the suture release knob. This may cut at least one end of the suture loop allowing the suture to become lose, releasing the implant.
  • Figure 1 illustrates a perspective view of the sheath/dilator system of the present invention showing the dilator locked together with the sheath over a guidewire.
  • Figure 2 illustrates a perspective view of the delivery system with button and suture release knob.
  • Figure 2 A illustrates a close up cross-sectional view of the distal end of the delivery system showing the implant secured to the end of the retention rod with the suture loop (the implant is shown without centering and anchoring features for simplicity).
  • Figure 3 illustrates an anatomical view illustrating the delivery system of the present invention being inserted through the femoral vein for subsequent advancement through the vascular system, e.g. to the right pulmonary artery (the delivery system handle is not shown for simplicity).
  • Figure 4 illustrates an exploded view of the delivery system of Figure 2 (the implant assembly is not shown for simplicity).
  • Figure 5 illustrates a perspective view of the delivery system and sheath locked together prior to implant deployment (shown out of the body for clarity).
  • Figure 6 illustrates a perspective view of the implant with centering anchor components attached.
  • Figure 7 illustrates a perspective view of the implant showing an alternate embodiment of the centering anchor components attached.
  • Figure 8 illustrates a perspective view of an alternate embodiment of the implant showing an alternate embodiment of the centering anchor component attached.
  • the medical device delivery system comprises an implant delivery system 10 having multiple components, movable with respect to one another to deliver and release the implant.
  • the implant delivery system 10 as shown in Figures 2, 3, 4 and 5, comprises a sheath/dilator assembly 20.
  • the system 10 comprises an implant and anchor assembly 30, as shown in Figures 2A, 6-8, the anchor design is not shown in Figure 2A for clarity.
  • proximal refers to closer to the user and the term “distal” refers to further from the user.
  • the implant delivery system 10 comprises a sheath 11, integral or attached, to a sheath lock feature 11 A.
  • the sheath may house the implant and/or anchor assembly 30, at its distal end.
  • the retention rod 12 is assembled to the upper and lower housings 13 A and 13B and inserted into the sheath 11. Thus, it also acts to limit distal movement of the implant assembly 30 when the sheath 11 is being retracted.
  • a suture loop 14 is threaded through two lumens of the retention rod 12 to secure the implant assembly 30 until ready to release.
  • a suture release knob 15 may be positioned across one leg of a suture loop 14 within the upper and lower handle halves 13A and 13B, in preparation of cutting at least one suture to release the implant assembly 30 when desired, as illustrated in Figure 4.
  • a button 16 may engage the sheath lock feature 11A through the handle half 13 A that enables the retraction and deployment of an implant and anchor assembly 30 that may be guided in a button track 17.
  • Figure 1 illustrates an embodiment with the sheath/dilator assembly 20 designed to be inserted into the body wherein an embodiment for insertion is shown in Figure 3.
  • the sheath/dilator assembly comprises a sheath 21 integral with or attached to a marker band 25, a hub 22 and a side arm 23.
  • a dilator 24 may be located inside a sheath 21, when being inserted into the body.
  • the dilator 24 may have, but is not limited to, a conical tip or a cylindrical tip.
  • the dilator 24 may be designed to receive, as a non-limiting example, about a 0.035 inch guidewire.
  • the guidewire may be comprised of a size ranging from about 0.010 inch to about 0.075 inch.
  • Figure 3 illustrates a non- limiting embodiment where the sheath/dilator is advanced over a guidewire into the femoral vein 40, up the vena cava 41, into the right atrium 42, into the right ventricle 43, up into the pulmonary artery 44 and then, in an embodiment, into the right pulmonary artery.
  • the sheath/dilator if desired, may then be advanced on into the middle lobe pulmonary artery 46.
  • a dilator 24 and guidewire 26 may be removed.
  • an implant delivery system 10 may be inserted.
  • the proximal end of the second sheath engages the sheath lock feature 11 A, locking the two sheaths together (See Figure 5).
  • a button 16 is retracted proximally in a button track 17 in a handle housing
  • a button 16 can be advanced distally to recapture the implant assembly 30. It is also possible to rotate the implant 30 to achieve optimum rotational orientation, based on fluoroscopic markings on the implant or RF interrogation of the implant. Once a final position has been achieved and confirmed a suture release knob 15 can be deployed cutting at least one suture leg of a suture loop 14 releasing an implant assembly 30.
  • the implant assembly may comprise an anchor design, not limited to the examples below, used to anchor and/or center an implant in a host vessel.
  • an implant assembly 30 has a first anchor design 32 shown in Figure 6, comprising at least one expandable feature with integral atraumatic pads 33 and at least one hook 34 attached to or integral with an implant 31.
  • the first anchor design may be used to center an implant in a host vessel.
  • Figure 7 shows an implant assembly 30 having a second anchor design 35 comprising at least one expandable feature with integral atraumatic pads 33 and at least one hook 34 attached to or integral with an implant 31.
  • the second anchor design may be used to center an implant in a host vessel.
  • Figure 8 shows the implant assembly 30 having a third anchor design 36 composed of at least one spring loaded expandable feature attached to or integral with an implant 31.
  • the third anchor design may be used to center an implant in a host vessel.
  • the suture loop 14 may engage the third anchor design 36 to enable retention prior to release.
  • the implant 31 may be a sensor such as, but not limited to, a wireless sensor, a pressure sensor, a wireless pressure sensor, a chemical sensor, a wireless chemical sensor, a blood glucose sensor, a wireless blood glucose sensor, and other sensor implants.
  • a sensor such as, but not limited to, a wireless sensor, a pressure sensor, a wireless pressure sensor, a chemical sensor, a wireless chemical sensor, a blood glucose sensor, a wireless blood glucose sensor, and other sensor implants.
  • an implant anchoring and centering mechanism may be made from, but is not limited to, nitinol or other similar materials and designed to be released into vessels with sizes of, but not limited to, between about 3 and 20 mm in diameter, about 5 and 15 mm in diameter, about 7 and 13 mm in diameter, or about 9 and 11 mm in diameter.
  • a sensor without the need for fluoroscopic guidance.
  • Pressure sensors are routinely temporarily implanted without fluoroscopy via a balloon floated delivery device.
  • An example of such a delivery device is a Swan-Ganz catheter.
  • a Swan-Ganz catheter may be modified with a detachable sensor implant that may be left behind prior to retracting the Swan-Ganz catheter.
  • a wireless tracking device external to the body may be used.
  • a balloon may be floated into the pulmonary artery using standard techniques.
  • a wireless tracking device is capable of following the flotation of the device from outside the body.
  • the wireless tracking device may use RF energy, ultrasound energy, or other means to interrogate the position of the sensor during delivery of the sensor.

Abstract

L'invention concerne un système de pose de dispositif médical. Le système de pose d'implant selon l'invention comprend un ensemble gaine et dilatateur destiné à être placé sur un fil-guide. Dans un exemple, le système selon l'invention comprend une gaine contenant un implant, une tige de rétention et une boucle de suture fixées par leur extrémité proximale sur un ensemble manche. L'implant, pourvu du mécanisme de centrage/ancrage comprimé pour la pose, peut être contenu dans la gaine externe distale. L'ensemble manche rétracte la gaine externe au moyen d'un bouton, à travers le corps de manche, pour poser l'implant. La suture est coupée par le bouton de relâchement de suture une fois que l'implant se trouve bien en place à l'endroit souhaité, avec le mécanisme de centrage/ancrage pleinement déployé.
PCT/US2011/045583 2010-07-27 2011-07-27 Capteur de pression, ancrage de centrage, système et méthode de pose associés WO2012015955A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
US16/727,230 US20200146562A1 (en) 2011-07-27 2019-12-26 Sensor delivery system and method

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US36811010P 2010-07-27 2010-07-27
US61/368,110 2010-07-27

Related Parent Applications (1)

Application Number Title Priority Date Filing Date
US15/213,712 Continuation-In-Part US10638955B2 (en) 2011-06-30 2016-07-19 Pressure sensing implant

Related Child Applications (2)

Application Number Title Priority Date Filing Date
PCT/US2013/059769 Continuation WO2014070316A1 (fr) 2011-07-27 2013-09-13 Capteur de pression, ancrage, système de placement et procédé
US14/428,551 Continuation US10206592B2 (en) 2012-09-14 2013-09-13 Pressure sensor, anchor, delivery system and method

Publications (1)

Publication Number Publication Date
WO2012015955A1 true WO2012015955A1 (fr) 2012-02-02

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PCT/US2011/045583 WO2012015955A1 (fr) 2010-07-27 2011-07-27 Capteur de pression, ancrage de centrage, système et méthode de pose associés

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WO (1) WO2012015955A1 (fr)

Cited By (17)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2014070316A1 (fr) * 2012-09-14 2014-05-08 Endotronix, Inc. Capteur de pression, ancrage, système de placement et procédé
US9867552B2 (en) 2011-06-30 2018-01-16 Endotronix, Inc. Implantable sensor enclosure with thin sidewalls
US10226218B2 (en) 2011-06-30 2019-03-12 Endotronix, Inc. Pressure sensing implant
US10638955B2 (en) 2011-06-30 2020-05-05 Endotronix, Inc. Pressure sensing implant
US10806352B2 (en) 2016-11-29 2020-10-20 Foundry Innovation & Research 1, Ltd. Wireless vascular monitoring implants
US10806428B2 (en) 2015-02-12 2020-10-20 Foundry Innovation & Research 1, Ltd. Implantable devices and related methods for heart failure monitoring
US10993669B2 (en) 2017-04-20 2021-05-04 Endotronix, Inc. Anchoring system for a catheter delivered device
US20210153813A1 (en) * 2019-11-21 2021-05-27 Bardy Diagnostics, Inc. Insertable physiological monitor injector tool
US11039813B2 (en) 2015-08-03 2021-06-22 Foundry Innovation & Research 1, Ltd. Devices and methods for measurement of Vena Cava dimensions, pressure and oxygen saturation
US11103146B2 (en) 2005-06-21 2021-08-31 St. Jude Medical Luxembourg Holdings Ii S.A.R.L. (“Sjm Lux 11”) Wireless sensor for measuring pressure
US11206992B2 (en) 2016-08-11 2021-12-28 Foundry Innovation & Research 1, Ltd. Wireless resonant circuit and variable inductance vascular monitoring implants and anchoring structures therefore
US11564596B2 (en) 2016-08-11 2023-01-31 Foundry Innovation & Research 1, Ltd. Systems and methods for patient fluid management
US11622684B2 (en) 2017-07-19 2023-04-11 Endotronix, Inc. Physiological monitoring system
US11701018B2 (en) 2016-08-11 2023-07-18 Foundry Innovation & Research 1, Ltd. Wireless resonant circuit and variable inductance vascular monitoring implants and anchoring structures therefore
US11779238B2 (en) 2017-05-31 2023-10-10 Foundry Innovation & Research 1, Ltd. Implantable sensors for vascular monitoring
US11896365B2 (en) 2011-06-30 2024-02-13 Endotronix, Inc. MEMS device for an implant assembly
US11944495B2 (en) 2017-05-31 2024-04-02 Foundry Innovation & Research 1, Ltd. Implantable ultrasonic vascular sensor

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US6699186B1 (en) * 2000-03-10 2004-03-02 Remon Medical Technologies Ltd Methods and apparatus for deploying and implantable biosensor
WO2005018507A2 (fr) * 2003-07-18 2005-03-03 Ev3 Santa Rosa, Inc. Système et procédés d'annuloplastie mitrale activés à distance
WO2008091409A1 (fr) * 2007-01-25 2008-07-31 Boston Scientific Limited Endoscope avec endoprothèse préchargée ou pré-chargeable
WO2008098255A2 (fr) * 2007-02-09 2008-08-14 Taheri Laduca Llc Appareil et procédé de déploiement d'un dispositif implantable à l'intérieur du corps

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6699186B1 (en) * 2000-03-10 2004-03-02 Remon Medical Technologies Ltd Methods and apparatus for deploying and implantable biosensor
WO2005018507A2 (fr) * 2003-07-18 2005-03-03 Ev3 Santa Rosa, Inc. Système et procédés d'annuloplastie mitrale activés à distance
WO2008091409A1 (fr) * 2007-01-25 2008-07-31 Boston Scientific Limited Endoscope avec endoprothèse préchargée ou pré-chargeable
WO2008098255A2 (fr) * 2007-02-09 2008-08-14 Taheri Laduca Llc Appareil et procédé de déploiement d'un dispositif implantable à l'intérieur du corps

Cited By (27)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US11103146B2 (en) 2005-06-21 2021-08-31 St. Jude Medical Luxembourg Holdings Ii S.A.R.L. (“Sjm Lux 11”) Wireless sensor for measuring pressure
US11890082B2 (en) 2005-06-21 2024-02-06 Tc1 Llc System and method for calculating a lumen pressure utilizing sensor calibration parameters
US11684276B2 (en) 2005-06-21 2023-06-27 Tc1, Llc Implantable wireless pressure sensor
US11179048B2 (en) 2005-06-21 2021-11-23 St. Jude Medical Luxembourg Holdings Ii S.A.R.L. (“Sjm Lux 11”) System for deploying an implant assembly in a vessel
US11103147B2 (en) 2005-06-21 2021-08-31 St. Jude Medical Luxembourg Holdings Ii S.A.R.L. (“Sjm Lux 11”) Method and system for determining a lumen pressure
US11589773B2 (en) 2011-06-30 2023-02-28 Endotronix, Inc. MEMS device for an implant assembly
US11896365B2 (en) 2011-06-30 2024-02-13 Endotronix, Inc. MEMS device for an implant assembly
US9867552B2 (en) 2011-06-30 2018-01-16 Endotronix, Inc. Implantable sensor enclosure with thin sidewalls
US11707230B2 (en) 2011-06-30 2023-07-25 Endotronix, Inc. Pressure sensing implant
US10638955B2 (en) 2011-06-30 2020-05-05 Endotronix, Inc. Pressure sensing implant
US10433764B2 (en) 2011-06-30 2019-10-08 Endotronix, Inc. Implantable sensor enclosure with thin sidewalls
US10226218B2 (en) 2011-06-30 2019-03-12 Endotronix, Inc. Pressure sensing implant
US11547320B2 (en) 2011-06-30 2023-01-10 Endotronix, Inc. Implantable sensor enclosure with thin sidewalls
WO2014070316A1 (fr) * 2012-09-14 2014-05-08 Endotronix, Inc. Capteur de pression, ancrage, système de placement et procédé
US10206592B2 (en) 2012-09-14 2019-02-19 Endotronix, Inc. Pressure sensor, anchor, delivery system and method
US10806428B2 (en) 2015-02-12 2020-10-20 Foundry Innovation & Research 1, Ltd. Implantable devices and related methods for heart failure monitoring
US10905393B2 (en) 2015-02-12 2021-02-02 Foundry Innovation & Research 1, Ltd. Implantable devices and related methods for heart failure monitoring
US11039813B2 (en) 2015-08-03 2021-06-22 Foundry Innovation & Research 1, Ltd. Devices and methods for measurement of Vena Cava dimensions, pressure and oxygen saturation
US11564596B2 (en) 2016-08-11 2023-01-31 Foundry Innovation & Research 1, Ltd. Systems and methods for patient fluid management
US11206992B2 (en) 2016-08-11 2021-12-28 Foundry Innovation & Research 1, Ltd. Wireless resonant circuit and variable inductance vascular monitoring implants and anchoring structures therefore
US11701018B2 (en) 2016-08-11 2023-07-18 Foundry Innovation & Research 1, Ltd. Wireless resonant circuit and variable inductance vascular monitoring implants and anchoring structures therefore
US10806352B2 (en) 2016-11-29 2020-10-20 Foundry Innovation & Research 1, Ltd. Wireless vascular monitoring implants
US10993669B2 (en) 2017-04-20 2021-05-04 Endotronix, Inc. Anchoring system for a catheter delivered device
US11779238B2 (en) 2017-05-31 2023-10-10 Foundry Innovation & Research 1, Ltd. Implantable sensors for vascular monitoring
US11944495B2 (en) 2017-05-31 2024-04-02 Foundry Innovation & Research 1, Ltd. Implantable ultrasonic vascular sensor
US11622684B2 (en) 2017-07-19 2023-04-11 Endotronix, Inc. Physiological monitoring system
US20210153813A1 (en) * 2019-11-21 2021-05-27 Bardy Diagnostics, Inc. Insertable physiological monitor injector tool

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