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WO2025128753A1 - Régulation de différentiels de pression dans des dispositifs médicaux d'intervention - Google Patents

Régulation de différentiels de pression dans des dispositifs médicaux d'intervention Download PDF

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Publication number
WO2025128753A1
WO2025128753A1 PCT/US2024/059661 US2024059661W WO2025128753A1 WO 2025128753 A1 WO2025128753 A1 WO 2025128753A1 US 2024059661 W US2024059661 W US 2024059661W WO 2025128753 A1 WO2025128753 A1 WO 2025128753A1
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WO
WIPO (PCT)
Prior art keywords
sheath
lumen
medical device
leading edge
fluid
Prior art date
Legal status (The legal status 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 status listed.)
Pending
Application number
PCT/US2024/059661
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English (en)
Inventor
Andrew OLIVERIUS
Timothy MARASS
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St Jude Medical Cardiology Division Inc
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St Jude Medical Cardiology Division Inc
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Publication date
Application filed by St Jude Medical Cardiology Division Inc filed Critical St Jude Medical Cardiology Division Inc
Publication of WO2025128753A1 publication Critical patent/WO2025128753A1/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

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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
    • A61M25/0097—Catheters; Hollow probes characterised by the hub
    • 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
    • A61M25/06—Body-piercing guide needles or the like
    • A61M25/0662—Guide tubes
    • 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
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/02—Access sites
    • A61M39/06—Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof
    • 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
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/10—Tube connectors; Tube couplings
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14—Probes or electrodes therefor
    • A61B18/1492—Probes or electrodes therefor having a flexible, catheter-like structure, e.g. for heart ablation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00053—Mechanical features of the instrument of device
    • A61B2018/00214—Expandable means emitting energy, e.g. by elements carried thereon
    • A61B2018/0022—Balloons
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00053—Mechanical features of the instrument of device
    • A61B2018/00214—Expandable means emitting energy, e.g. by elements carried thereon
    • A61B2018/00267—Expandable means emitting energy, e.g. by elements carried thereon having a basket shaped structure
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/06—Measuring instruments not otherwise provided for
    • A61B2090/064—Measuring instruments not otherwise provided for for measuring force, pressure or mechanical tension
    • 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
    • A61M2025/0001—Catheters; Hollow probes for pressure measurement
    • A61M2025/0002—Catheters; Hollow probes for pressure measurement with a pressure sensor at the distal end
    • 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
    • A61M25/06—Body-piercing guide needles or the like
    • A61M25/0662—Guide tubes
    • A61M2025/0681—Systems with catheter and outer tubing, e.g. sheath, sleeve or guide tube

Definitions

  • the present disclosure relates generally to medical procedures that involve introducing interventional medical devices into a patient’s vasculature through an introducer.
  • the instant disclosure relates to devices and techniques that regulate pressure differentials that may arise when an interventional medical device is inserted into and moving through an introducer.
  • a variety of cardiovascular procedures such as electrophysiology (EP) mapping and ablation, delivery and implantation of implantable cardioverter defibrillator (ICD) leads, percutaneous transluminal coronary angiography (PTCA), angioplasty, and the like, require vascular access for corresponding interventional medical devices (e.g., EP catheters, ICD leads, PTCA balloon catheters, etc.).
  • interventional medical devices e.g., EP catheters, ICD leads, PTCA balloon catheters, etc.
  • Several techniques for introducing such devices into a patient’s vasculature such as the cut-down method and the Seidinger technique, are known.
  • the Seidinger technique involves surgically opening a vasculature of a patient with a relatively small incision and a needle, followed by inserting a guidewire into the vein or artery through the lumen of the needle. After removing the needle, an introducer (sometimes also referred to as a “sheath” or “introducer sheath”) can be inserted over the directing guidewire, followed by the advancement of the introducer along the guidewire into the vasculature until the distal end of the introducer reaches the target location of the vasculature or anatomical structure e.g., the heart) for an intended medical procedure.
  • an introducer sometimes also referred to as a “sheath” or “introducer sheath”
  • introducer can be inserted over the directing guidewire, followed by the advancement of the introducer along the guidewire into the vasculature until the distal end of the introducer reaches the target location of the vasculature or anatomical structure e.g.,
  • Steerable introducers such as the AgilisTM NxT steerable introducer (Abbott Laboratories; Abbott Park, IL), which can be advanced through the vasculature without the use of a guidewire, are also known.
  • the central lumen of the introducer establishes a safe passageway of access to the blood vessel or anatomical structure, thus allowing for repetitive insertion and withdrawal of various interventional medical devices into and from the patient’s vasculature.
  • introducers typically include a hub (or “cannula”) incorporating a hemostasis valve system at their proximal end.
  • the hemostasis valve system typically includes one or more valve gaskets contained within a housing.
  • the interventional medical device moves through the lumen of the introducer, it can create a plunger effect, where the pressure on one side of the leading edge of the interventional medical device differs from the pressure on the opposite side of the leading edge of the interventional medical device (in this context, the term “leading edge” refers to the distal end of the interventional medical device).
  • leading edge refers to the distal end of the interventional medical device.
  • the pressure ahead of the leading edge e.g, distal of the distal end of the interventional medical device
  • the pressure behind the leading edge e.g, proximal of the distal end of the interventional medical device.
  • the pressure ahead of the leading edge e.g. distal of the distal end of the interventional medical device
  • the pressure behind the leading edge e.g., proximal of the distal end of the interventional medical device
  • kits for access to a patient’s vasculature includes a sheath having a proximal end; a sheath hub attached to the proximal end of the sheath, the sheath hub including a housing, a proximal cap, and a hemostasis valve gasket disposed within the housing, wherein the proximal cap defines an aperture into the housing; and a straightener, wherein the straightener includes a transverse cross-sectional configuration that prevents advancement of the straightener through the aperture of the sheath hub to an extent sufficient to breach the hemostasis valve gasket.
  • the transverse cross-sectional configuration of the straightener may not be congruent to a shape of the aperture.
  • the aperture can include a circular aperture
  • the straightener can include a cylindrical body, and an outer diameter of the cylindrical body can exceed a diameter of the circular aperture.
  • the aperture can include a circular aperture
  • the straightener can include a frustoconical segment, a minimum outer diameter of the frustoconical segment can be smaller than a diameter of the circular aperture, and the outer diameter of the frustoconical segment can expand from the minimum outer diameter to an interfering outer diameter that is larger than the diameter of the circular aperture.
  • a sheath for vascular access includes: a shaft defining a lumen therethrough; a sheath hub attached to a proximal end of the shaft, the sheath hub comprising a hemostasis valve assembly; a pressure equalizer configured to equalize a pressure within the lumen ahead of a leading edge of an elongate medical device moving through the lumen with a pressure within the lumen behind the leading edge of the elongate medical device moving through the lumen without drawing air through the hemostasis valve assembly.
  • the pressure equalizer includes a fluid inlet through a wall of the shaft, wherein the fluid inlet is positioned distally of the hemostasis valve assembly and behind the leading edge of the elongate medical device moving through the lumen.
  • a fluid reservoir which can include a low-friction syringe filled with a fluid or a reservoir constructed of a flexible material (e.g., a saline bag), is optionally coupled to the fluid inlet.
  • the pressure equalizer includes an irrigation flow controller configured to adjust a flow rate of an irrigation fluid into the lumen through the sheath hub distal of the hemostasis valve assembly.
  • the irrigation flow controller may be configured to adjust the flow rate of the irrigation fluid responsive to a rate of change in position of the elongate medical device relative to the sheath.
  • a first position sensor may be coupled to the elongate medical device
  • a second position sensor may be coupled to the sheath
  • the rate of change in position of the elongate medical device relative to the sheath may be determined using an output of the first position sensor and an output of the second position sensor.
  • the irrigation flow controller may be configured to adjust the flow rate of the irrigation fluid responsive to a measured pressure difference between the pressure within the lumen ahead of the leading edge of the elongate medical device and the pressure within the lumen behind the leading edge of the elongate medical device.
  • a first pressure sensor can be positioned within the lumen ahead of the leading edge of the elongate medical device
  • a second pressure sensor can be positioned within the lumen behind the leading edge of the elongate medical device
  • the measured pressure difference can be measured using an output of the first pressure sensor and an output of the second pressure sensor.
  • the instant disclosure also provides a method of regulating pressure differentials across a leading edge of an elongate medical device moving through a lumen of a sheath.
  • the method includes: facilitating introduction of a fluid behind the leading edge of the elongate medical device as it moves through the lumen to equalize a pressure within the lumen ahead of the leading edge of the elongate medical device with a pressure within the lumen behind the leading edge of the elongate medical device, wherein the fluid is not air drawn into the lumen through a hemostasis valve assembly coupled to a proximal end of the sheath.
  • One contemplated approach to facilitating introduction of a fluid behind the leading edge of the elongate medical device includes forming a fluid inlet into the lumen, wherein the fluid inlet is positioned distally of the hemostasis valve assembly and behind the leading edge of the elongate medical device moving through the lumen. It is desirable for the fluid inlet to be positioned at a point along the sheath that will be within a patient’s vasculature during use of the sheath.
  • Another contemplated approach to facilitating introduction of a fluid behind the leading edge of the elongate medical device includes coupling a fluid reservoir to the fluid inlet.
  • the fluid reservoir includes a low-friction syringe or a reservoir constructed of a flexible material (e.g., a saline bag).
  • a sheath for vascular access.
  • the sheath includes: a shaft defining a lumen therethrough; a sheath hub attached to a proximal end of the shaft, the sheath hub including a hemostasis valve assembly; a flush chamber between the hemostasis valve assembly and the lumen of the shaft, the flush chamber including an outlet port; a first valve between the flush chamber and the lumen of the shaft; and a second valve positioned at the outlet port of the flush chamber, the second valve comprising a one-way valve oriented to permit fluid outflow from the flush chamber.
  • Figure 1 is a side, partially cut-away view illustration of the Seidinger technique for vascular access.
  • Figure 2 is a cross-sectional view of a representative introducer comprising a hub within which an integral hemostasis valve system is disposed.
  • Figures 3 A through 3C depict the use of a straightener to collapse the distal end of an electrophysiology catheter for introduction through an introducer.
  • Figure 4 is a schematic illustration of the interaction between a straightener according to aspects of the instant disclosure and an introducer.
  • Figure 5A illustrates negative pressure transients that may arise as an interventional medical device is advanced through an introducer.
  • Figure 5B illustrates negative pressure transients that may arise as an interventional medical device is withdrawn from an introducer.
  • Figure 6 depicts passive approaches to pressure equalization to mitigate negative pressure transients.
  • Figure 7 depicts active approaches to pressure equalization to mitigate negative pressure transients.
  • Figure 8 is a perspective view of an exemplary steerable introducer according to additional aspects of the instant disclosure.
  • Figure 9 is a partially cut-away view of the handle of the steerable introducer of Figure 8 that makes various internal features thereof visible.
  • the instant disclosure provides apparatus and methods for regulating pressure differentials that may arise during introduction and/or withdrawal of an interventional medical device via an introducer sheath.
  • aspects of the disclosure will be described with reference to the introduction of an interventional medical device into a patient’s vasculature. Those of ordinary skill in the art, however, will appreciate that the instant teachings may be applied to good advantage in other contexts.
  • Figure 1 depicts the introduction of various medical devices, including guidewire 10, cardiovascular introducer 18, and dilator 14, into a blood vessel 16 using the Sei dinger technique.
  • various medical devices including guidewire 10, cardiovascular introducer 18, and dilator 14, into a blood vessel 16 using the Sei dinger technique.
  • the ordinarily-skilled artisan will be familiar with the Seidinger technique, it need not be described in further detail herein.
  • those of ordinary skill in the art will be familiar with other approaches to introducing medical devices into blood vessel 16, including the use of steerable introducers.
  • cardiovascular introducer 18 includes an introducer sheath 12, a hub 20, a hemostasis valve system 30, and a side-port fluid tubing 22 with an associated stopcock assembly 24.
  • hub 20 includes a cap 28 and a housing 26 circumferentially sealed together, within which an integral hemostasis valve system 30 (including, by way of example only, two hemostasis valve gaskets 30a, 30b) is disposed at its proximal end.
  • Side-port fluid tubing 22 and associated stopcock assembly 24 are also coupled to hub 20 or housing 26 to enable the introduction of medical fluids (e.g, saline) through cardiovascular introducer 18 or introducer sheath 12 for an intended clinical procedure.
  • medical fluids e.g, saline
  • FIG. 2 is a cross-sectional view of cardiovascular introducer 18 incorporating an integral hemostasis valve system 30 within a circumferentially-sealed hub 20.
  • hub 20 Various details of hub 20, including housing 26 and cap 28, will be familiar to those of ordinary skill in the art; thus, hub 20 will only be described herein to the extent necessary to understand the instant disclosure.
  • cap 28 defines an aperture 29 into housing 26 (e.g, an opening through which various interventional medical devices may be inserted through hub 20, into introducer sheath 20, and thus into blood vessel 16.
  • cap 28 Contained within circumferentially sealed housing 26 by cap 28 are one or more hemostasis valve gaskets, such as a first (or proximal) valve gasket 30a and a second (or distal) valve gasket 30b as described in international patent application publication no. WO 2022/245598, which is hereby incorporated by reference as though fully set forth herein.
  • first and second valve gaskets 30a, 30b may be collectively referred to as a hemostasis valve system 30.
  • FIGs 3A-3C illustrate the use of a straightener 32 to prepare an electrophysiology catheter 34 for insertion into cardiovascular introducer 18 through hub 20.
  • electrophysiology catheter 34 includes a shaft 36 and a basket electrode 38 surrounding a balloon 40 at the distal end thereof.
  • this particular configuration of the distal end of electrophysiology catheter 34 is merely illustrative, such that the teachings herein can be applied to good advantage in connection with any complex distal shape of electrophysiology catheter 34 (e.g, various curves and spirals, paddle shapes, and the like).
  • basket electrode 38 and balloon 40 can be collapsed into a lower-profile, generally cylindrical shape similar to that of shaft 36.
  • This lower-profile shape may be more conducive to inserting electrophysiology catheter 34 into cardiovascular introducer 18 through hub 20, as shown in Figure 3C, by mitigating the difficulty that would attend inserting basket electrode 38 into aperture 29 in the expanded configuration shown in Figure 3A.
  • Figure 4 schematically depicts the interaction between straightener 32 and hub 20 of cardiovascular introducer 18.
  • straightener 32 includes a transverse cross- sectional configuration that prevents advancement of straightener 32 through aperture 29 of cap 28 to an extent sufficient to breach hemostasis valve system 30 (e.g., it will not go far enough to penetrate valve gasket 30a, 30b).
  • the transverse cross-section of straightener 32 can be configured to be non-congruent to the shape of aperture 29.
  • the transverse cross-sectional configuration of straightener 32 can have a different shape than aperture 29.
  • straightener 32 includes a cylindrical body, and therefore has a generally circular transverse cross-sectional configuration.
  • the outer diameter of straightener 32 can, however, exceed the diameter of a circular aperture 29, which prevents straightener 32 from being inserted into hub 20 far enough to breach hemostasis valve system 30.
  • straightener 32 can include a frustoconical segment 42.
  • the minimum outer diameter of frustoconical segment 42 may be small enough to pass through a circular aperture 29.
  • the outer diameter of frustoconical segment 42 expands from this point, however, to an interfering outer diameter that is larger than the diameter of a circular aperture 29, which stops straightener 32 from further insertion.
  • electrophysiology catheter 34 can be advanced forward, across hemostasis valve system, and through introducer sheath 12 to the desired destination within the patient’s vasculature.
  • aspects of the instant disclosure relate to a pressure equalizer that is configured to mitigate negative pressure transients by allowing the pressure within the lumen of introducer sheath 12 on opposite sides of the distal end of electrophysiology catheter 34 as it moves within introducer sheath 12 to equalize without a fluid crossing hemostasis valve system 30.
  • various pressure equalizers will be described with reference to ameliorating negative pressure transients that occur behind (that is, proximally of) the distal end of electrophysiology catheter 34 as it is advanced through introducer sheath 12 (e.g., the scenario illustrated in Figure 5A).
  • Those of ordinary skill in art will understand how to adapt the ensuing teachings herein to ameliorate negative pressure transients that arise during withdrawal of electrophysiology catheter 34 from introducer sheath 12 (e.g., the scenario illustrated in Figure 5B)
  • the pressure equalizer facilitates introduction of a fluid, other than a fluid drawn across hemostasis valve system 30, into the lumen 62 of introducer sheath 12.
  • a fluid other than a fluid drawn across hemostasis valve system 30, into the lumen 62 of introducer sheath 12.
  • one or more fluid inlets into lumen 62 such as vent holes 60 formed in the wall of introducer sheath 12, may be provided.
  • Vent holes 60 may be placed distally of hemostasis valve system 30, but proximal of the distal end of electrophysiology catheter 34 moving through lumen 62.
  • vent holes 60 are positioned more than about 1 inch away from distal vent holes 56, such as about 3 inches away from distal vent holes 56, in a proximal direction.
  • a fluid reservoir 66 may be coupled to supply a fluid, such as saline, through vent holes 60 to ameliorate negative pressure transients that arise behind the moving distal end of electrophysiology catheter 34. It is contemplated that a low-friction syringe or a fluid container constructed of a flexible material, such as a saline bag, can be used as fluid reservoir 66.
  • irrigation flow controller 70 is coupled to fluid reservoir 66 to control the delivery of fluid from reservoir 66 to lumen 62 through side-port fluid tubing 22.
  • irrigation flow controller 70 can control the flow of irrigant into cardiovascular introducer 18.
  • flow controller 70 is configured to adjust the flow rate of irrigant into cardiovascular introducer 18 in response to a rate of change in position of electrophysiology catheter 34 relative to introducer sheath 12, thus allowing the irrigant flow rate to be matched to the rate of insertion of electrophysiology catheter 34.
  • electrophysiology catheter 34 and introducer sheath 12 may each carry one or more position sensors (e.g., electrodes and/or magnetic coils) to enable the relative positions thereof to be determined by an electroanatomical mapping system 72 (e.g., Abbott Laboratories’ EnSite PrecisionTM Cardiac Mapping System).
  • the position information determined by electroanatomical mapping system 72 may be input to flow controller 70 and used by flow controller 70 to increase or decrease the irrigant flow rate to mitigate negative pressure transients according to the rate of insertion of electrophysiology catheter 34 through introducer sheath 12.
  • flow controller 70 could equally well be integrated into the electroanatomical mapping system as into a stand-alone controller as shown in Figure 7.
  • flow controller 70 is configured to adjust the flow rate of irrigant into cardiovascular introducer 18 in response to measured pressure differentials on opposite sides of the moving distal end of electrophysiology catheter 34.
  • two pressure sensors 74a, 74b may be provided within lumen 62, with one positioned relatively near the proximal end of lumen 62 (to measure pressure proximally of the moving distal end of electrophysiology catheter 34) and the other positioned relatively near the distal end of lumen 62 (to measure pressure distally of the moving distal end of electrophysiology catheter 34).
  • Flow controller 70 can use the differential between the pressures measured by sensors 74a, 74b to increase or decrease the irrigant flow rate to mitigate negative pressure transients.
  • flow controller 70 is configured to mitigate negative pressure in excess of about 4 psi (e.g., it is configured to increase or decrease the irrigant flow rate to ensure that the pressure differential between sensors 74a, 74b does not exceed about 4 psi).
  • FIG. 8 depicts a steerable introducer 80, such as the AgilisTM NxT steerable introducer mentioned above.
  • a steerable introducer 80 such as the AgilisTM NxT steerable introducer mentioned above.
  • Those of ordinary skill in the art will be familiar with steerable introducers and will appreciate that such devices typically include various features in common with cardiovascular introducer 18 discussed above, such as introducer sheath 12, hub 20 (including hemostasis valve system30 therein), side-port tubing 22, and stopcock assembly 24.
  • Handle 82 typically includes one or more actuators, such as knob 84, that, when actuated (e.g., rotated about the longitudinal axis of handle 82), deflect the distal end of introducer sheath 12 to facilitate navigation of introducer sheath 12 through a patient’s vasculature.
  • actuators such as knob 84
  • Figure 9 is a partial cut-away view of handle 82 to show various internal features thereof.
  • a flush chamber 86 within handle 82 Flush chamber 86 is proximally accessible through hemostasis valve system 30 and is distally in fluid communication with lumen 62 of introducer sheath 12.
  • a one-way valve 88 which has its outlet outside of handle 82, is also in fluid communication with flush chamber 86.
  • An additional valve 90 such as a ball valve, is disposed between flush chamber 86 and lumen 62 of introducer sheath 12.
  • an interventional medical device such as electrophysiology catheter 34, is inserted through hub 20 and into handle 82 with valve 90 closed. With the distal end of electrophysiology catheter 34 positioned within flush chamber 86, flush chamber 86 is filled with a flushing fluid (e.g., saline) via stopcock assembly 34 and side-port tubing 22.
  • a flushing fluid e.g., saline
  • flush chamber 86 Once flush chamber 86 is purged of any other fluids, the flushing fluid will begin to exit one-way valve 88 (the flushing fluid is prevented from exiting the proximal end of flush chamber 86 by hemostasis valve system 30 and from exiting the distal end of flush chamber 86 by valve 90).
  • the practitioner can then open valve 90 and advance electrophysiology catheter 34 into lumen 62 of sheath 12 and further into the patient’s vasculature. In this manner, the combination of flush chamber 86 and valve 90 operates in a manner similar to an airlock.
  • a kit for access to a patient’s vasculature comprising: a sheath having a proximal end; a sheath hub attached to the proximal end of the sheath, the sheath hub comprising a housing, a proximal cap, and a hemostasis valve gasket disposed within the housing, wherein the proximal cap defines an aperture into the housing; and a straightener, wherein the straightener includes a transverse cross-sectional configuration that prevents advancement of the straightener through the aperture of the sheath hub to an extent sufficient to breach the hemostasis valve gasket.
  • Clause 2 The kit according to clause 1, wherein the transverse cross-sectional configuration of the straightener is not congruent to a shape of the aperture.
  • Clause 3 The kit according to clause 2, wherein: the aperture comprises a circular aperture; the straightener comprises a cylindrical body; and an outer diameter of the cylindrical body exceeds a diameter of the circular aperture.
  • Clause 4 The kit according to clause 2, wherein: the aperture comprises a circular aperture; the straightener comprises a frustoconical segment; a minimum outer diameter of the frustoconical segment is smaller than a diameter of the circular aperture; and the outer diameter of the frustoconical segment expands from the minimum outer diameter to an interfering outer diameter that is larger than the diameter of the circular aperture.
  • a sheath for vascular access comprising: a shaft defining a lumen therethrough; a sheath hub attached to a proximal end of the shaft, the sheath hub comprising a hemostasis valve assembly; a pressure equalizer configured to equalize a pressure within the lumen ahead of a leading edge of an elongate medical device moving through the lumen with a pressure within the lumen behind the leading edge of the elongate medical device moving through the lumen without drawing air through the hemostasis valve assembly.
  • Clause 6 The sheath according to clause 5, wherein the pressure equalizer comprises a fluid inlet through a wall of the shaft, wherein the fluid inlet is positioned distally of the hemostasis valve assembly and behind the leading edge of the elongate medical device moving through the lumen.
  • Clause 7 The sheath according to clause 6 or 7, further comprising a fluid reservoir coupled to the fluid inlet.
  • Clause 8 The sheath according to clause 7, wherein the fluid reservoir comprises a low-friction syringe filled with a fluid.
  • Clause 9 The sheath according to any of clauses 5 to 8, wherein the pressure equalizer comprises an irrigation flow controller configured to adjust a flow rate of an irrigation fluid into the lumen through the sheath hub distal of the hemostasis valve assembly.
  • Clause 10 The sheath according to clause 9, wherein the irrigation flow controller is configured to adjust the flow rate of the irrigation fluid responsive to a rate of change in position of the elongate medical device relative to the sheath.
  • Clause 11 The sheath according to clause 10, further comprising: a first position sensor coupled to the elongate medical device; and a second position sensor coupled to the sheath, wherein the rate of change in position of the elongate medical device relative to the sheath is determined using an output of the first position sensor and an output of the second position sensor.
  • Clause 12 The sheath according to clause 9, wherein the irrigation flow controller is configured to adjust the flow rate of the irrigation fluid responsive to a measured pressure difference between the pressure within the lumen ahead of the leading edge of the elongate medical device and the pressure within the lumen behind the leading edge of the elongate medical device.
  • Clause 13 The sheath according to clause 12, further comprising: a first pressure sensor positioned within the lumen ahead of the leading edge of the elongate medical device; and a second pressure sensor positioned within the lumen behind the leading edge of the elongate medical device, wherein the measured pressure difference is measured using an output of the first pressure sensor and an output of the second pressure sensor.
  • Clause 14 A method of regulating pressure differentials across a leading edge of an elongate medical device moving through a lumen of a sheath, comprising: facilitating introduction of a fluid behind the leading edge of the elongate medical device as it moves through the lumen to equalize a pressure within the lumen ahead of the leading edge of the elongate medical device with a pressure within the lumen behind the leading edge of the elongate medical device, wherein the fluid is not air drawn into the lumen through a hemostasis valve assembly coupled to a proximal end of the sheath.
  • Clause 15 The method according to clause 14, wherein facilitating introduction of a fluid behind the leading edge of the elongate medical device comprises forming a fluid inlet into the lumen, wherein the fluid inlet is positioned distally of the hemostasis valve assembly and behind the leading edge of the elongate medical device moving through the lumen.
  • Clause 16 The method according to clauses 15, wherein the fluid inlet is positioned at a point along the sheath that will be within a patient’s vasculature during use of the sheath.
  • Clause 17 The method according to any of clauses 15 to 16, wherein facilitating introduction of a fluid behind the leading edge of the elongate medical device comprises coupling a fluid reservoir to the fluid inlet.
  • Clause 18 The method according to clause 17, wherein the fluid reservoir comprises a low-friction syringe.
  • Clause 19 The method according to clause 17 or 18, wherein facilitating introduction of a fluid behind the leading edge of the elongate medical device comprises providing an irrigation flow controller configured to adjust a flow rate of an irrigation fluid from the fluid reservoir into the lumen through the fluid inlet.
  • Clause 20 The method according to clause 19, wherein the irrigation flow controller is configured to adjust the flow rate of the irrigation fluid responsive to a rate of change in position of the elongate medical device relative to the sheath.
  • Clause 21 The method according to clause 19, wherein the irrigation flow controller is configured to adjust the flow rate of the irrigation fluid responsive to a measured pressure difference between the pressure within the lumen ahead of the leading edge of the elongate medical device and the pressure within the lumen behind the leading edge of the elongate medical device.
  • a sheath for vascular access comprising: a shaft defining a lumen therethrough; a sheath hub attached to a proximal end of the shaft, the sheath hub comprising a hemostasis valve assembly; a flush chamber between the hemostasis valve assembly and the lumen of the shaft, the flush chamber including an outlet port; a first valve between the flush chamber and the lumen of the shaft; and a second valve positioned at the outlet port of the flush chamber, the second valve comprising a one-way valve oriented to permit fluid outflow from the flush chamber.
  • flow controller 70 can simply increase the irrigant flow rate to a constant high rate of between about 20 ml/min and about 60 ml/min during insertion and/or withdrawal of electrophysiology catheter 34.
  • All directional references e.g., upper, lower, upward, downward, left, right, leftward, rightward, top, bottom, above, below, vertical, horizontal, clockwise, and counterclockwise
  • Joinder references e.g., attached, coupled, connected, and the like
  • Joinder references are to be construed broadly and may include intermediate members between a connection of elements and relative movement between elements. As such, joinder references do not necessarily infer that two elements are directly connected and in fixed relation to each other.

Landscapes

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

Abstract

L'invention concerne des dispositifs permettant de réduire à un minimum le passage d'air à travers une valve hémostatique de l'introducteur lorsqu'un dispositif médical est inséré à travers celui-ci. Un kit comprend une gaine (12) et un moyeu de gaine (20) fixé à l'extrémité proximale de la gaine. Le moyeu de gaine comprend un boîtier (26), un capuchon proximal (28) qui délimite un orifice (29) dans le boîtier, et un joint d'étanchéité (30) de valve hémostatique à l'intérieur du boîtier. Le kit comprend également un redresseur (32) ayant une section transversale qui empêche l'avancement du redresseur par l'orifice du moyeu de gaine suffisamment loin pour rompre le joint d'étanchéité. La gaine peut également comprendre un égaliseur de pression conçu pour égaliser une pression à l'intérieur de la lumière de gaine devant un bord d'attaque du dispositif médical se déplaçant à travers celle-ci avec une pression à l'intérieur de la lumière de gaine derrière le bord d'attaque du dispositif médical se déplaçant à travers celle-ci sans aspirer de l'air à travers l'ensemble valve hémostatique.
PCT/US2024/059661 2023-12-15 2024-12-11 Régulation de différentiels de pression dans des dispositifs médicaux d'intervention Pending WO2025128753A1 (fr)

Applications Claiming Priority (2)

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US202363610636P 2023-12-15 2023-12-15
US63/610,636 2023-12-15

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WO2025128753A1 true WO2025128753A1 (fr) 2025-06-19

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Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20110208284A1 (en) * 2010-02-25 2011-08-25 Biotronik Ag Protective sleeve for a medical device, system comprising a protective sleeve and a medical device, and a method for the production thereof
US20150320539A1 (en) * 2012-06-28 2015-11-12 Qvanteq Ag Packaging and transfer system for an implant application
JP6325931B2 (ja) * 2014-07-25 2018-05-16 テルモ株式会社 カテーテル、保護シース及びカテーテルシステム
US20210290386A1 (en) * 2015-08-20 2021-09-23 Edwards Lifesciences Corporation Loader and retriever for transcatheter heart valve, and methods of crimping transcatheter heart valve
WO2022245598A1 (fr) 2021-05-21 2022-11-24 St. Jude Medical, Cardiology Division, Inc. Joint de valve, et valves hémostatiques et unités de canule l'incorporant

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20110208284A1 (en) * 2010-02-25 2011-08-25 Biotronik Ag Protective sleeve for a medical device, system comprising a protective sleeve and a medical device, and a method for the production thereof
US20150320539A1 (en) * 2012-06-28 2015-11-12 Qvanteq Ag Packaging and transfer system for an implant application
JP6325931B2 (ja) * 2014-07-25 2018-05-16 テルモ株式会社 カテーテル、保護シース及びカテーテルシステム
US20210290386A1 (en) * 2015-08-20 2021-09-23 Edwards Lifesciences Corporation Loader and retriever for transcatheter heart valve, and methods of crimping transcatheter heart valve
WO2022245598A1 (fr) 2021-05-21 2022-11-24 St. Jude Medical, Cardiology Division, Inc. Joint de valve, et valves hémostatiques et unités de canule l'incorporant

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