WO2018217762A1 - Dispositifs et procédés de déploiement de dispositif de fermeture - Google Patents

Dispositifs et procédés de déploiement de dispositif de fermeture Download PDF

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Publication number
WO2018217762A1
WO2018217762A1 PCT/US2018/033907 US2018033907W WO2018217762A1 WO 2018217762 A1 WO2018217762 A1 WO 2018217762A1 US 2018033907 W US2018033907 W US 2018033907W WO 2018217762 A1 WO2018217762 A1 WO 2018217762A1
Authority
WO
WIPO (PCT)
Prior art keywords
tether
bioabsorbable member
compression
bioabsorbable
visual marker
Prior art date
Application number
PCT/US2018/033907
Other languages
English (en)
Inventor
Andrew James Denardo
Original Assignee
Morris Innovative, 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 Morris Innovative, Inc. filed Critical Morris Innovative, Inc.
Publication of WO2018217762A1 publication Critical patent/WO2018217762A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00004—(bio)absorbable, (bio)resorbable or resorptive
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
    • A61B2017/00646—Type of implements
    • A61B2017/00654—Type of implements entirely comprised between the two sides of the opening
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
    • A61B2017/00646—Type of implements
    • A61B2017/00659—Type of implements located only on one side of the opening
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
    • A61B2017/00672—Locating means therefor, e.g. bleed back lumen
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
    • A61B2017/0406—Pledgets

Definitions

  • the present disclosure relates to a device and a method for closing or sealing a puncture in a tubular tissue structure or the wall of a body cavity.
  • the puncture may be sealed with a bioabsorbable member comprising submucosal tissue, and/or an extracellular matrix-derived tissue, and/or a synthetic bioabsorbable material. More particularly, the present disclosure is directed to deployment of the bioabsorbable member.
  • a bioabsorbable member comprising submucosal tissue, and/or an extracellular matrix-derived tissue, and/or a synthetic bioabsorbable material is deployed in the blood vessel opening. Since the delivery and deployment of the bioabsorbable member at the puncture site is not generally visible to the practitioner, it may be challenging to consistently deploy the bioabsorbable member to the desired location.
  • the present disclosure relates to a device and a method for closing or sealing a puncture in a tubular tissue structure or the wall of a body cavity.
  • the puncture may be sealed with a bioabsorbable member comprising submucosal tissue, and/or an extracellular matrix-derived tissue, and/or a synthetic bioabsorbable material.
  • the present disclosure is directed to indicators or markers that provide a visual and/or tactile signal of proper placement and deployment of the bioabsorbable member.
  • a device for sealing a puncture site may comprise an elongated element having a distal portion insertable into the puncture site, a compressible bioabsorbable member releasably attached to the distal portion of the elongated element, a tether coupled to the bioabsorbable member such that proximal movement of the tether compresses the bioabsorbable member, and a deployment indicator associated with the tether, wherein proximal movement of the tether causes a visual and/or tactile change in the deployment indicator.
  • Some embodiments may comprise a second tether having a distal portion coupled to the bioabsorbable member and a proximal portion slidably coupled to the first tether by a first knot formed in the second tether.
  • the deployment indicator may include a first visual marker disposed on a proximal portion of the first tether, and the distance between the first knot and the first visual marker may correlate to compression of the bioabsorbable member.
  • the first visual marker may include a second knot formed in the proximal portion of the first tether.
  • the deployment indicator may include a second visual marker disposed on the second tether and distal to the first knot.
  • the bioabsorbable member When the first visual marker is located at or distal to the second visual marker, the bioabsorbable member may be compressed to a first compression level and when the first visual marker is located proximal to the second visual marker the bioabsorbable member may be compressed to a second compression level that is greater than the first compression level.
  • the first visual marker may include a portion of the first tether that is visually distinguishable from adjacent portions of the first tether.
  • the second visual marker may include a portion of the second tether that is visually distinguishable from adjacent portions of the second tether.
  • the deployment indicator may comprise a force meter, where a force measurement correlates to compression of the bioabsorbable member.
  • the deployment indicator may comprise a tension measurement instrument, where a tension measurement correlates to compression of the bioabsorbable member.
  • the tether may include a first portion fixedly coupled to the bioabsorbable member and a second portion slidably coupled to the bioabsorbable member, where the second portion may be slidably coupled to the first portion by a first knot formed in the second portion.
  • the deployment indicator may include a second knot formed in a proximal portion of the second portion such that a distance between the first knot and the second knot correlates to compression of the bioabsorbable member.
  • the sealing device may comprise an elongated element, a compressible bioabsorbable member releasably attached to a distal portion of the elongated element, a tether coupled to the
  • the method may comprise placing the distal portion of the elongated element and the attached bioabsorbable member into the anatomy of a patient, moving the tether proximally to compress to bioabsorbable member, and ceasing to move the tether proximally when the deployment indicator provides a visual and/or tactile indication that the bioabsorbable member has attained a desired level of compression in a desired portion of the anatomy of the patient.
  • the sealing device may further include a second tether having a distal portion coupled to the bioabsorbable member and a proximal portion slidably coupled to the first tether by a first knot formed in the second tether.
  • the deployment indicator may include a second knot formed in a proximal portion of the first tether such that the visual indication is a distance between the first knot and the second knot that is within a predetermined range of distances (e.g., from about 1 inch to about 1.5 inches).
  • the bioabsorbable member may be elongated and may be axially compressible, such that placing the distal portion of the elongated element may include placing the distal portion of the elongated element into a blood vessel of the patient, with a distal portion of the bioabsorbable member disposed in the lumen of the blood vessel. Moving the tether may include compressing the distal portion within the lumen of the blood vessel.
  • a device for sealing a puncture site in the wall of a body comprising an elongated element having a tissue wall contact exterior portion and having a length adapted to be inserted into the puncture site so that the length forms intravascular, intermediate and extracorporeal portions, and a bioabsorbable member releasably attached to the tissue wall contact exterior portion of the elongated element.
  • One embodiment of a device for sealing a puncture site in the wall of a body may comprise an elongated element having a distal portion insertable into the puncture site, a compressible bioabsorbable member releasably attached to the distal portion of the elongated element, a tether coupled to the distal portion of the bioabsorbable member such that proximal movement of the tether compresses the bioabsorbable member from a first configuration to a second configuration, and a deployment indicator associated with the tether, where proximal movement of the tether causes a visual and/or tactile change in the deployment indicator the compressible bioabsorbable member.
  • the compressible bioabsorbable member may have a proximal portion retained at a portion of the elongated element and a distal portion coupled to the proximal portion of the bioabsorbable member.
  • the bioabsorbable member may have a first configuration in which the distal portion is compressed to a first compression level and a second configuration in which the distal portion is compressed to a second compression level that is greater than the first compression level.
  • the tether may be a first tether
  • the device may comprise a second tether having a distal portion coupled to the bioabsorbable member and a proximal portion slidably coupled to the first tether by a first knot formed in the second tether.
  • the deployment indicator may include a first visual marker disposed on a proximal portion of the first tether, and a distance between the first knot and the first visual marker may indicate whether the bioabsorbable member is in the first configuration or the second configuration.
  • the deployment indicator may further include a second visual marker on the second tether at a distance from the first knot, and if the first visual marker is located between the second visual marker and the first knot, the bioabsorbable member is in the second configuration.
  • the distance between the second visual marker and the first knot may be about 1.5 inches.
  • the first visual marker includes a second knot formed in the proximal portion of the first tether.
  • the deployment indicator may include a second visual marker disposed on the second tether and distal to the first knot, such that when the first visual marker is located at or distal to the second visual marker, the bioabsorbable member is in the first configuration, and when the first visual marker is located proximal to the second visual marker, the bioabsorbable member is in the second configuration.
  • the first visual marker may include a portion of the first tether that is visually distinguishable from adjacent portions of the first tether
  • the second visual marker may include a portion of the second tether that is visually distinguishable from adjacent portions of the second tether.
  • the deployment indicator may include indicia on the elongated element and a visual marker on the tether, and a location of the visual marker relative to the indicia indicates whether the bioabsorbable member is in the first configuration or the second configuration.
  • the indicia may mark a range of relative positions between the indicia and the visual marker within which the bioabsorbable member is in the second configuration. For example, the range of relative positions may have a length of about 1.5 inches.
  • the tether includes a first portion fixedly coupled to the bioabsorbable member and a second portion slidably coupled to the bioabsorbable member, where the second portion may be slidably coupled to the first portion by a first knot formed in the second portion.
  • the deployment indicator may include a second knot formed in a proximal portion of the second portion, where a distance between the first knot and the second knot indicates whether bioabsorbable member is in the first configuration or the second configuration.
  • the deployment indicator may include a force meter, where a force measurement may correlate to compression of the bioabsorbable member, and/or a tension measurement instrument, where a tension measurement may correlate to compression of the bioabsorbable member.
  • the compressible bioabsorbable member includes submucosal tissue, or ECM-derived tissue, or synthetic bioabsorbable material.
  • the proximal portion of a bioabsorbable member may include a cuff disposed around the outer circumference of the elongated element and the distal portion of the bioabsorbable member may include a ribbon that extends distally from the cuff.
  • the ribbon may include a plurality of openings along its length, and the tether may be threaded through the plurality of openings, and when the bioabsorbable member is in the second configuration, the ribbon may be compressed by proximal tensioning of the tether.
  • the elongated element of any of the devices described herein may include a lumen and an access hole connected to the lumen, and when the bioabsorbable member is in the first configuration, the distal portion of the bioabsorbable member may be located within the lumen, and when the bioabsorbable member is in the second configuration, the distal portion may extend out of the lumen through the access hole.
  • the device may further comprise a retaining wire located within the lumen of the elongated element and threaded through the proximal portion of the bioabsorbable member.
  • Some embodiments may further comprise a safety tether that is fixedly coupled to the proximal portion of the bioabsorbable member.
  • a device for sealing a puncture site may comprise an elongated element having a distal portion insertable into the puncture site, a compressible bioabsorbable member releasably attached to the distal portion of the elongated element, a compression tether movably coupled to the bioabsorbable member such that proximal movement of the compression tether compresses the bioabsorbable member, and a safety tether fixedly coupled to the bioabsorbable member and slidably coupled to the compression tether.
  • the compression tether may include a first visual marker
  • the safety tether may include a second visual marker
  • the first visual marker may be movable relative to the second visual marker.
  • the first visual marker may be a knot and the second visual marker may be a loop through which the compression tether is threaded.
  • a compression level of the bioabsorbable member may be indicated by a location of the first visual marker relative to the second visual marker.
  • the second visual marker may further include indicia representing a distance that corresponds to a pre-determined compression level of the bioabsorbable member.
  • the pre-determined compression level of the bioabsorbable member may be a compression level that substantially seals a puncture site. In some embodiments, the distance may be about 1.5 inches.
  • the sealing device may comprise an elongated element, a compressible bioabsorbable member releasably attached to a distal portion of the elongated element, a tether coupled to the bioabsorbable member, and a deployment indicator associated with the tether.
  • the method may comprise placing the distal portion of the elongated element and the attached bioabsorbable member into the anatomy of a patient, moving the tether proximally to compress to bioabsorbable member, and ceasing to move the tether proximally when the deployment indicator provides a visual and/or tactile indication that the bioabsorbable member has attained a desired level of compression in a desired portion of the anatomy of the patient.
  • the tether may be a first tether
  • the sealing device may further include a second tether having a distal portion coupled to the bioabsorbable member and a proximal portion slidably coupled to the first tether by a first knot formed in the second tether.
  • the deployment indicator may include a second knot formed in a proximal portion of the first tether, and the visual indication is a distance between the first knot and the second knot that is within a pre-determined range of distances.
  • the pre-determined range of distances may be from about 1 inch to about 1.5 inches.
  • bioabsorbable member may be elongated and is axially compressible, and the placing may include placing the distal portion of the elongated element into a blood vessel of the patient, with a distal portion of the bioabsorbable member disposed in the lumen of the blood vessel, and the moving may include compressing the distal portion within the lumen of the blood vessel.
  • a method of sealing a puncture site in tissue comprises the steps of providing an elongated element having a bioabsorbable member disposed on the exterior thereof, the elongated element being configured to be introduced into a body with the bioabsorbable member disposed thereon; and providing a deposit member that allows the bioabsorbable member to be left within a body when the elongated element is removed from the body.
  • a method of sealing a puncture site in the wall of a body cavity comprises the step of providing an access device having an elongated element having a lumen therein and a tissue wall contact exterior portion and having a
  • bioabsorbable member releasably disposed on the tissue wall contact exterior portion of the elongated element; placing the access device in contact with tissue; locating an instrument within the lumen of the elongated element; releasing the bioabsorbable member from the elongated element; and removing the elongated element from contact with tissue while allowing the bioabsorbable member to remain in contact with the tissue.
  • FIG. 1 is a schematic illustration of a vascular introducer and closure device, according to an embodiment.
  • FIGS. 2A to 21 illustrate an introducer and closure device according to an embodiment.
  • FIGS. 3 A to 3C illustrate various placements of a compressed bioabsorbable member at a puncture site.
  • FIGS. 4A to 4B illustrate various embodiments of an introducer and closure device.
  • FIG. 5 shows a graft sheet and tether attached thereto, according to an embodiment.
  • FIG. 6A depicts one variation of an introducer element, graft sheet and graft sheet compression tether, according to an embodiment.
  • FIG. 6B is a close up view of the introducer element, graft sheet and compression tether of FIG. 6A.
  • FIGS. 6C and 6D are close up views of the graft sheet (bioabsorbable member) and compression tether configurations, respectively.
  • FIG. 7A illustrates a graft sheet disposed through a puncture site in an uncompressed configuration
  • FIG. 7B illustrates the graft sheet in a compressed configuration
  • FIG. 7C depicts another embodiment of a device with the graft sheet in a compressed configuration
  • FIG. 8 depicts examples of force-curves that correlate with compression levels of the graft sheet (bioabsorbable member).
  • FIG. 9 illustrates a method of use of a vascular introducer and closure device according to an embodiment.
  • the present disclosure is related to devices and methods for sealing a puncture in a tubular tissue structure, such as a blood vessel, or in the wall of a body cavity, with submucosal tissue, another extracellular matrix-derived tissue, or a synthetic bioabsorbable material capable of supporting the growth of endogenous connective tissue in vivo resulting in remodeling of endogenous connective tissue at the puncture site and in formation of a static seal.
  • a tubular tissue structure such as a blood vessel, or in the wall of a body cavity
  • An access or sealing device may include an elongated element, a compressible bioabsorbable member releasably attached to the elongated element, a tether coupled to the bioabsorbable member, and a deployment indicator associated with the tether such that movement of the tether causes a visual and/or tactile change in the deployment indicator.
  • FIG. 1 schematically depicts one variation of an access or sealing device comprising an elongated element 102, a bioabsorbable member 106 releasably attached to a distal portion 104 of the elongated element, a tether 108 that is coupled to the bioabsorbable member 106, and a deployment indicator 110 associated with the tether 108.
  • the tether 108 may attached to the proximal portion 107 and/or distal portion 105 of the bioabsorbable member 106.
  • the tether 108 may be coupled to the distal portion 105 of the bioabsorbable member 106 such that proximally withdrawing the tether 108 (e.g., in the direction of arrow A) compresses the distal portion 105 against the proximal portion 107 of the bioabsorbable member 106.
  • the configuration of the deployment indicator 110 may signal to the clinician whether the bioabsorbable member 106 is placed at the desired location and/or whether the distal portion 105 of the bioabsorbable member has been sufficiently compressed against the proximal portion 107 of the bioabsorbable member.
  • the indicator 110 may provide a visual signal and/or tactile signal of the deployment location and state of the bioabsorbable member.
  • the device and method of the present disclosure can be used to seal a puncture in a tubular tissue structure, such as a blood vessel, or in the wall of a body cavity, that has been created intentionally or unintentionally during a surgical procedure or non-surgically (e.g., during an accident).
  • Punctures made intentionally include vascular punctures made in various types of vascular, endoscopic, or orthopaedic surgical procedures, such as in coronary and in peripheral arteries and veins (e.g., subclavian vein or jugular vein).
  • a puncture in the wall of any body cavity or region such as: the peritoneum (for pleural drainage), the perineum (for perineal drainage), the meninges, including the dura (for accessing cerebral spinal fluid, such as for device/therapeutics delivery and/or drainage of excess CSF), the gallbladder, urinary bladder, renal collecting system, and hepatobiliary drainage regions.
  • Procedures in conjunction with which the access and closure devices may be used may include angiographic examination, angioplasty, laser angioplasty, valvuloplasty, atherectomy, stent deployment, rotablator treatment, aortic prosthesis implantation, intraortic balloon pump treatment, pacemaker implantation, any intracardiac procedure, electrophysiological procedures, interventional radiology, and various other diagnostic, prophylactic, and therapeutic procedures such as dialysis and procedures relating to percutaneous extracorporeal circulation.
  • FIG. 2A illustrates an introducer 200 adapted for catheterization, exemplary of the type of introducer element that may be used in accordance with the present disclosure.
  • an introducer 200 adapted for use in catheterization procedures is illustrated in FIG. 2A, it is understood that the present disclosure is applicable to any type of introducer element used to provide access to the lumen of a tubular tissue structure, such as a blood vessel, or to a body cavity.
  • the present disclosure is applicable to an introducer element such as a needle, a cannula, a guide wire, an introducer element adapted for dialysis, a trocar, or any other introducer element used to access the lumen of a tubular tissue structure or a body cavity.
  • FIG. 1 illustrates an introducer 200 adapted for catheterization, exemplary of the type of introducer element that may be used in accordance with the present disclosure.
  • an introducer 200 adapted for use in catheterization procedures is illustrated in FIG. 2A, it is understood that the present disclosure is applicable to any type of introducer element used to
  • FIG. 2F depicts one embodiment of a kit 250 comprising an introducer and closure device 252 (such as any of the embodiments described herein), an obturator 254, a pre-dilator 256, a guide wire 258 and a dilator 260.
  • An introducer 200 as depicted in FIG. 2A can be used when performing catheterization procedures in coronary and peripheral arteries and veins BV.
  • a catheter is introduced into the vascular system by first penetrating the skin S, underlying muscle tissue MT, and the blood vessel BV with a needle, and a guide wire 202 may be inserted through the lumen of the needle and may enter the blood vessel. Subsequently, the needle may be withdrawn and the introducer 200 may be fed over the guide wire 202 and pushed through skin S and through the vessel wall to enter the vessel BV.
  • the guide wire 202 may be removed and a catheter may be inserted into the lumen of the introducer 200 and advanced through the vascular system until the working end of the catheter is positioned at a predetermined location.
  • the guide wire 202 may be left in place throughout the procedure and the introducer 200 may be removed before the guide wire 202 is removed.
  • the catheter is withdrawn.
  • the introducer 200 may also be removed and the opening through which, for example, introducer 200 was inserted must be sealed as quickly as possible once the procedure is completed.
  • the present disclosure may be employed, for example, to rapidly seal a puncture site in a blood vessel upon completion of a catheterization procedure.
  • the introducer 200 illustrated in FIG. 2A is an exemplary embodiment and has a user distal end 204 for insertion into blood vessel BV and a user proximal end 206.
  • the introducer 200 may include a dilator 208 and a sheath 210 which extends axially over the dilator 208.
  • a sheath cap 214 may be disposed axially over a portion of sheath 210 and a valve cap 222 may be connected to sheath cap 214 and to a side port tube 216.
  • a biodegradable member or sheet 212 may be coupled to the introducer 200 and the sheath 210.
  • the dilator 208 may include a section having a decreased diameter (not shown) as compared to other sections of the dilator. The section having a decreased diameter may help to provide clearance within the sheath 210 for a flexible portion 213 of the sheet 212 when the flexible portion 213 is disposed within the sheath 210 as discussed below.
  • An introducer may also include three-way valve 218 connected to an end of the side port tube 216, and syringe connector 220, adapted for the attachment of a syringe to the introducer 200 and connected to valve cap 222.
  • the biodegradable member or sheet 212 of the introducer may include submucosal tissue or another extracellular matrix-derived tissue or a synthetic bioabsorbable material extending axially over a portion of sheath 210.
  • sheet 212 of submucosal tissue or another extracellular matrix-derived tissue or a synthetic bioabsorbable material includes cuff section 224 that extends axially over a portion of sheath 210.
  • Sheet 212 further includes flexible section 213 at a user distal end 226 that is disposed within sheath 210 prior to deployment.
  • sheath 210 includes an access hole 228 that receives flexible section 213 therein while allowing cuff section 224 to remain outside and around sheath 210.
  • Distal end 226 of sheath 210 is inserted into tubular tissue structure S, such as a blood vessel, and user proximal end 230 remains outside of the punctured vessel wall.
  • Proximal end 230, cuff 224, of the sheet 212 extends axially over a portion of the introducer 200 as depicted in FIG. 2A.
  • FIG. 2D is an exploded view of one embodiment of an introducer and closure device.
  • the device may include an introducer 200 including a bleed-back port at a distal portion (such as is depicted in FIG. 2B) and a skive and retaining hole 217 for a retaining wire 211 and for release of the flexible section 213.
  • a proximal portion of the introducer 200 may include a valve cap 231 and a hemostasis valve 233.
  • the sheet or bioabsorbable member 212 may be coupled to a compression tether 236.
  • the proximal portion of the tether 236 may be coupled (e.g., clamped) to a suture tab 235 and tab insert 237.
  • the proximal portion handle portion of the introducer may also have a port that is coupled to a flush tube 239 that is in communication with three-way valve 218.
  • the device may also include a retaining wire 211, which may include a wire cap 241 and plug 243 that clamp the wire 211 at a proximal portion to facilitate manipulation by an operator.
  • the retaining wire 211 may be coupled to the cuff section 224 of the bioabsorbable member, as described below.
  • FIG. 2E depicts one embodiment in which the cuff section 224 of sheet 212 may be held in place and/or coupled on sheath 210, for example, by a retaining wire 21 1 or other line attached thereto and to sheath cap 214 or valve cap 222.
  • the retaining wire 211 may be slidably disposed through an opening in the cuff section 224 and a retaining hole 217 in the sheath 210.
  • the flexible section 213 of the sheet 212 may be disposed through an access hole 228 in the sheath 210.
  • FIG. 2H depicts a side view of the sheath 210 without the sheet 212 and
  • FIG. 21 depicts a cross-sectional view of the sheath 210.
  • the retaining hole 217 and the access hole 228 may be slits, slots, or openings in a side wall portion of the sheath 210.
  • the access hole 228 may be a slit in the side wall of the sheath
  • the retaining hole 217 may be an opening on a flap of sidewall formed by the slit.
  • the opening on the cuff section 224 may be positioned over the retaining hole 217, which may facilitate threading the retaining wire 211 through both the cuff section and the sheath so that the sheet 212 is coupled to the sheath 210.
  • the cuff section 224 may be located on an outer surface of the sheath 210 while the flexible section 213 may be located within the lumen of the sheath 210 through the access hole 228. That is, the flexible section 213 may extend from the cuff section 224 through the access hole 228 and into the sheath lumen.
  • the retaining wire 211 may be withdrawn at the user proximal end so that the sheet may be decoupled from the sheath.
  • the device may optionally include a safety tether 221 that is attached to the cuff via a lock stitch 223.
  • the safety tether 221 may include a knot that is slidably coupled to a compression tether (e.g., tether 236).
  • a bleed-back port 234 may be located in the sheath (and/or introducer), distal to the cuff section, as depicted in FIG. 2B.
  • the bleed-back port 234 may be an opening in the sheath (and/or introducer), located from about 5 mm to about 7 mm distal to the cuff section 224 and/or the access hole 228 (e.g., the bleed- back port may be located at a leading portion of the sheath so that it enters a vessel ahead of the bioabsorbable member).
  • the sheath is disposed over a dilator (e.g., the sheath 210 may extend axially over the dilator 208)
  • the portion of the dilator that is in proximity to and/or disposed over the bleed-back hole may be ground down such that blood flow through the bleed-back hole to the user proximal end 206 is not obstructed.
  • blood flows into the bleed-back port back to a proximal portion of the device (e.g., user proximal end 206).
  • a certain length of the flexible section 213 e.g., ribbon
  • blood flow from the port to the user proximal end may indicate that about two-thirds (e.g., about 13 mm) of the ribbon is within the vessel lumen.
  • cuff section 224 is prevented from being pushed along introducer 200 when the user inserts introducer 200 through, for example, a vessel wall with his hand in contact with sheet 212 or from friction provided by skin S, muscle MT, or other encountered anatomy.
  • Introducer 200 is inserted into the anatomy until cuff section 224 abuts the wall of vessel BV, or other desired structure, as shown in FIG. 2A.
  • Such abutment provides increased resistance and tactile feedback indicating that cuff 224 is positioned at vessel BV.
  • the retaining wire 211 may be removed to permit relative movement between sheet 212 (including cuff 224) and sheath 210.
  • sheet 212 is permitted to move relative to sheath 210, sheath 210 is further advanced into vessel BV. During the moving of sheath 210, sheet 212 is held in place via the abutment of cuff section 224 against the wall of vessel BV. Such relative movement results in flexible portion 213 being extracted from within (e.g., exiting from) sheath 210 through access hole 228 until flexible portion 213 is fully outside of sheath 210 and within vessel BV.
  • the sheet 212 has a second tether 236 attached at or near to the proximal end 230 of the sheet 212.
  • Tether 236 e.g., compression tether
  • Tether 236 is attached to sheet 212, at or near proximal end 230 of sheet 212 and extends axially downwards through flexible portion 213 towards distal end 226 of sheet 212 and then back up through flexible portion 213 towards proximal end 230.
  • Tether 236 is threaded through sheet 212 at many places.
  • FIG. 2E depicts one embodiment where a compression tether is threaded or woven throughout and along the length of the flexible portion 213.
  • the tether 236 may be threaded or woven distally (e.g., through a first set of openings) and then threaded or woven proximally (e.g., through a second set of openings).
  • the density of the threading (e.g., the number of tether loops across the length of the flexible portion) may be determined at least in part on the relative length of the tether 236 and the length of the flexible portion 213.
  • a bioabsorbable member with higher density threading may increase the thickness of the compressed flexible portion as compared to a bioabsorbable member with lower density threading.
  • proximal end 238 of tether 236 is pulled to gather distal end 226 of sheet 212 in the puncture site or on the inside of the vessel wall (see FIG. 2G). Subsequent retracting of sheath 210 leaves gathered sheet 212 to form a plug at the puncture site of the vessel wall.
  • Sheet 212 may have any combination of tethers 236 and retaining tethers, or may lack one or more types of tethers.
  • the sheet 212 may lack a retaining tether.
  • tether 236 is used to gather the sheet 212 in the puncture site and against the inside of the vessel wall.
  • Tethers with different functions may have different indicia disposed thereon, such as different colors, so that the user can easily identify the tether with the desired function.
  • tethers with different functions may have different caps attached to the externally exposed ends so that the tether with the desired function can be easily identified.
  • the tethers are made of resorbable thread and the tethers can be attached to the sheet 212 by any suitable means.
  • the tethers can be tied to the sheet 212, hooked to the sheet 212 by using hooks, barbs, etc.
  • an access and/or closure device may include a safety tether, which may be fixedly attached to the biodegradable member so that the biodegradable member may be retrieved in the event of mis-delivery.
  • the access or sealing device described herein may be used to access blood vessels and/or vascular structures that cannot be directly visualized by the clinician. That is, during an access and/or closure procedure, the distal portion of the introducer as well as the bioabsorbable member (e.g., cuff or proximal portion, ribbon or distal portion) are located below the surface of the patient's skin and are not visible to the clinician. In particular, the position of the bioabsorbable member and its configuration with respect to the blood vessel may be difficult to determine or confirm.
  • the bioabsorbable member e.g., cuff or proximal portion, ribbon or distal portion
  • FIGS. 3A-3C schematically depict three examples of bioabsorbable member deployment locations.
  • An access or sealing device may include an introducer 300 and a bioabsorbable member 304.
  • the bioabsorbable member 304 may have a proximal portion or cuff 306 and a distal portion or ribbon 308.
  • a compression tether 310 may be coupled to the bioabsorbable member 304.
  • the introducer 300 has been inserted through skin S and into blood vessel BV through blood vessel wall BVW.
  • the distal portion of the introducer 300 is located within the blood vessel lumen BVL.
  • FIG. 3A depicts one variation of a desired placement scenario, where the proximal portion or cuff 306 of the bioabsorbable member is located outside of the blood vessel lumen BVL, disposed along the outer surface of the blood vessel wall BVW, and the distal portion or ribbon 308 is located within the blood vessel lumen BVL.
  • the ribbon 308 has been compressed (i.e., by pulling the compression tether 310 proximally), and may be disposed along the inner surface of the blood vessel wall BVW.
  • the bioabsorbable member 304 may be located as depicted in FIG. 3A, but the ribbon 308 may not be sufficiently compressed.
  • FIGS. 3B-3C depict variations of scenarios where the bioabsorbable member was not properly deployed within the blood vessel wall BVW (e.g., where the distal portion is located within the blood vessel lumen BVL and the proximal portion is located outside of the blood vessel lumen BVL).
  • FIG. 3B depicts a scenario where the introducer 300 was not advanced far enough into the blood vessel, resulting in the deployment of the bioabsorbable member 304 entirely (or nearly entirely) outside the blood vessel lumen.
  • the cuff 306 is located too far from the blood vessel wall such that when the ribbon 308 is compressed, it contacts the cuff 306 instead of the inner surface of the blood vessel wall.
  • FIG. 3C depicts a scenario where the introducer 300 was advanced too far into the blood vessel, resulting in the deployment of the bioabsorbable member 304 entirely (or nearly entirely) inside the blood vessel lumen.
  • the cuff 306 may be located entirely within the vessel lumen or may span the vessel wall such that part of the cuff is in the lumen and part of the cuff is outside the lumen (e.g., the cuff may be located within the thickness of the vessel wall, and/or disposed along the inner surface of the vessel wall).
  • the ribbon 308 When the ribbon 308 is compressed, it contacts the cuff 306 instead of the inner surface of the blood vessel wall.
  • the bioabsorbable member 304 is not sufficiently secured to the vessel wall at the puncture site such that the bioabsorbable member could effectively plug or obstruct the puncture opening.
  • FIG. 3C there is an additional risk of the bioabsorbable member dislodging from the vessel wall into the vessel lumen and possibly obstructing blood flow through the vessel.
  • any of the access or sealing devices described herein may include a bioabsorbable member deployment indicator that is configured to provide a visual and/or tactile signal to the clinician that may indicate the location of the bioabsorbable member and the compression state of the bioabsorbable member.
  • an access or sealing device may include a force measurement instrument coupled to the one or more tethers associated with deployment and/or compression of the bioabsorbable member, where the force measurements may correspond with certain configurations and/or locations of the bioabsorbable member relative to the blood vessel.
  • Force or tension measurement instruments such as a force gauge (e.g., spring-based and/or pointer-and-scale gauges), may be coupled to a proximal portion of the tether(s). Such measurements may quantify tactile feedback (e.g., resistance when pulling the tether(s) proximally), which may help facilitate consistent deployment of the bioabsorbable member.
  • a force gauge e.g., spring-based and/or pointer-and-scale gauges
  • tactile feedback e.g., resistance when pulling the tether(s) proximally
  • the deployment indicator may include features and/or structures associated with (e.g., coupled to, located on, attached to, integral with) one or more of the tethers, and may include, for example, knots, tags, bands, regions having thicker tether diameters and/or tether textures (e.g., smooth regions, rough regions, variable coatings, etc.), regions having visual indicia such as high-contrast markings, varying color markings, alphanumeric markings, etc.
  • a deployment indicator may include features and/or structures on the elongated portion of the access or sealing device that is external to the patient.
  • a deployment indicator may include indicia on the shaft of the introducer, including, but not limited to, length interval markings, hash or tick marks, various colored or high-contrast markings along the length of the shaft. Movement of a compression tether (i.e., a tether that is coupled to the bioabsorbable member such that movement of the tether causes compression of the bioabsorbable member) relative to the introducer shaft may be gauged using one or more visual markers on the compression tether and the shaft.
  • a deployment indicator may include a marker on the compression tether and indicia on the shaft of the introducer, where the position of the marker relative to the indicia represents (e.g., is a proxy for) the compression state and/or location of the bioabsorbable member.
  • the compression tether (and/or other tethers) may be mechanically engaged with the introducer shaft. This may facilitate the ease and/or consistency of interpreting the relative motion between the compression tether and the introducer shaft, and/or may help reduce entanglements between the tether(s) and/or shaft.
  • FIG. 4A depicts one embodiment of an access or sealing device 400.
  • the device 400 may include an elongated element or shaft 402 and a bioabsorbable member 404 releasably attached to a distal portion of the shaft 402.
  • the device 400 may be similar or identical to any of the other access or sealing devices described above.
  • the device 400 may further include a compression tether 408 coupled to the bioabsorbable member such that proximal movement of the tether (i.e., toward the clinician) compresses the bioabsorbable member 404.
  • the device 400 may optionally include a second tether or safety tether 406 coupled to the bioabsorbable member 404.
  • the safety tether 406 may be fixedly secured to the bioabsorbable member 404 (e.g., to a cuff or proximal portion) such that proximal movement of the tether 406 acts to remove the bioabsorbable member from the patient in the event of mis-delivery or misplacement. Proximal movement of the safety tether may not compress the bioabsorbable member as much as proximal movement of the compression tether (if at all).
  • the device 400 may further include one or more deployment indicators associated with various components of the device, as represented by the boxes with dotted lines (410, 420, 430).
  • the device 400 may include an indicator 410 having one or more structures or features associated with the one or more tethers.
  • the indicator 410 may include a first knot (or marker) on the compression tether 408 and a second knot (or marker) on the safety tether 406, and the distance between the two knots (or markers) is correlated to a compression level and/or location of the bioabsorbable member 404.
  • the device 400 may alternatively or additionally include an indicator 420 having one or more structures or features associated with the one or more tethers and one or more features associated with the shaft 402 of the device 400.
  • the indicator 420 may include a knot on the compression tether 408 and markings (e.g., hash marks, interval marks, colored lines, etc.) on the shaft 402, and the relative positioning between the knot and the markings correlate to compression levels and/or locations of the bioabsorbable member 404.
  • the distance between a marker on the compression tether and a marker on the safety tether and/or shaft of the introducer may correlate with a compression level of the bioabsorbable member.
  • a distance that correlates with an ideal or desired compression level and a range of distances that correlates with an acceptable range of compression levels around the ideal compression level, or within which the ideal compression level may be expected to be achieved.
  • This distance may be referred to as a desired compression distance, and this range of distances may be referred to as a desired compression range, or a zone of confidence.
  • the desired compression distance may vary depending on a variety of factors, including patient parameters and/or closure device parameters or configurations.
  • factors that may affect the distance between the markers that may correlate with an ideal or desired compression level of the bioabsorbable member may include the thickness of the wall of the vessel (or body lumen), the length of the ribbon portion of the bioabsorbable member that has been deployed into the lumen of the vessel (or body lumen), the weave or threading pattern of the compression tether in the ribbon, the relative length of the compression tether woven into the ribbon and the length of the ribbon (e.g., the ratio of the compression tether length and the ribbon length), angle of penetration of the device into the vessel (or body lumen), and/or the thickness of the ribbon when in a compressed configuration.
  • the desired compression range that may encompass the compression distance that may correlate with an ideal or desired compression level in an introducer and closure device (such as the devices depicted in FIGS. 2A-2F) deployed to a femoral artery having a wall thickness between about 2 mm to about 4 mm may be about 1 inch to about 1.5 inches.
  • the distance between the markers, i.e. desired compression range, that may encompass the compression distance that may correlate with a desired compression range may be less than about 1 inch.
  • the distance between the markers i.e. desired compression range may be more than about 1.5 inches. That is, the greater the thickness of the vessel wall, the greater the distance between the markers that may encompass the compression distance that correlates with an ideal or desired compression level.
  • increasing the density of the compression tether weave in the ribbon of the bioabsorbable member e.g., increasing the ratio of the compression tether length and the ribbon length
  • the desired compression range may be from about 1 in to about 1.5 in for a device where the ratio of the compression tether length threaded/woven through the ribbon to the ribbon length is from about 2: 1 to about 10: 1, while in other embodiments, the desired compression range may be from about 0.5 in to about 0.8 in for a device where the ratio of the compression tether to ribbon length is from 11 : 1 to about 20: 1.
  • the visual feedback from the relative position of the markers on the tethers and/or shaft described above may be used in conjunction with tactile feedback (e.g., manual resistance to further proximal withdrawal and/or data readings from a force measurement device) by the clinician to determine whether a desired compression level has been attained.
  • the compression of the ribbon may be reflected in the excursion of the markers on the tethers.
  • the clinician may proximally withdraw the compression tether until encountering a resistance to further proximal withdrawal. Upon detecting this resistance, the clinician may then refer to the positions of the markers to determine whether they are in a desires compression range or zone of confidence.
  • the clinician may determine whether a full or desired level of compression has been achieved, and/or whether the bioabsorbable member is in the desired location with respect to the lumen and lumen wall (e.g., bioabsorbable member spans the wall such that a proximal portion or cuff is outside of the lumen against the outer wall and a distal portion or ribbon is inside of the lumen).
  • bioabsorbable member spans the wall such that a proximal portion or cuff is outside of the lumen against the outer wall and a distal portion or ribbon is inside of the lumen.
  • the compression tether may signal to the clinician that the bioabsorbable member has not been properly deployed across the lumen wall, and that the bioabsorbable member may be entirely inside or entirely outside of the lumen (i.e., there is no lumen wall between the cuff and the ribbon).
  • the desired compression range e.g., outside of the zone of confidence and/or less than the desired compression distance
  • the desired compression distance may be adjusted in accordance with the wall thickness of the targeted body lumen.
  • the desired compression distance may be greater for introducer and closure devices intended for deployment in body lumens with thicker walls.
  • an indicator may denote a range of acceptable compression marker distances to accommodate a variety of wall thicknesses and body lumens.
  • an indicator may comprise a visual marker having a length that corresponds to a range of compression marker distances that would indicate an acceptable level of ribbon compression for a variety of wall thicknesses.
  • the device 400 may include an indicator 430 having one or more force measurement instruments (e.g., force meters) coupled to the compression tether 408 and where force measurements/readings correlate to compression levels and/or locations of the bioabsorbable member 404.
  • the indicator 430 may include a force meter coupled to a proximal end of the compression tether 408.
  • a force or tension measurement instrument may help quantify a tactile feedback signal, such as resistance experienced by the clinician when withdrawing the tether(s) proximally.
  • one or more of the tethers may include retainer tabs (e.g., loops, hooks, and/or handles sized and shaped for finger manipulation) attached to the proximal end of the tethers.
  • the proximal handle of the device may include markings or indicia and/or hooks, loops, slots that engage with the retainer tabs of the tethers. Such retainer tabs, markings and/or indicia may help to reduce tether tangling and/or facilitate the proper operation of the device.
  • an access or sealing device may include a single tether where a first portion of the tether is attached to a proximal portion or cuff of the bioabsorbable member and a second portion of the tether is threaded through a distal portion or ribbon of the bioabsorbable member.
  • the first portion of the tether may act as a safety tether described above, where proximal movement or pulling of the first portion of the tether may remove the bioabsorbable member from the patient in the event of mis-placement or mis-delivery.
  • the second portion of the tether may act as a compression tether as described above, where proximal movement of the tether compresses the bioabsorbable member.
  • the first portion may terminate a first end of the tether and the second end may terminate at a second end of the tether, and the device may further include retainer tabs, markings, and/or indicia to identify the tether ends.
  • the first portion of the tether may extend from a first end to the cuff of the bioabsorbable member where it is secured by a knot to the cuff.
  • the tether may then continue along the ribbon of the bioabsorbable member and the second portion of the tether may be threaded throughout the ribbon, eventually looping back toward the cuff and then proximally to the second end of the tether. Pulling the second end of the tether (e.g., moving it proximally) may transmit a proximally-directed forward to the ribbon, thereby compressing it against the cuff.
  • FIG. 5 depicts one embodiment of an access or sealing device including a deployment indicator having a first visual marker located on a compression tether and a second visual marker located on a safety tether.
  • the longitudinal distance between the first and second visual markers may correlate with compression levels of the ribbon of the bioabsorbable member.
  • the first visual marker may be a first knot on the compression tether
  • the second visual marker may be a second knot on the safety tether.
  • the first and second knots may be fixed to the compression tether and safety tether.
  • FIG. 5 depicts one embodiment of a bioabsorbable member 500 and a deployment indicator including a first knot 510 fixed to a compression tether 508 and a second knot 512 on a safety tether 506 that slidably couples the compression tether 508 to the safety tether 506.
  • a first knot 510 fixed to a compression tether 508
  • a second knot 512 on a safety tether 506 that slidably couples the compression tether 508 to the safety tether 506.
  • the compression tether 508 slides through an opening of the second knot 512 on the safety tether 506, and the first knot 510 also moves proximally towards the second knot 512.
  • the safety tether 506 may be fixedly coupled to a proximal portion 505 of the bioabsorbable member 500, at the cuff 502, such that proximally moving the safety tether 506 withdraws the bioabsorbable member 500 from the patient.
  • the compression tether 508 may be coupled to a distal portion 503 of the ribbon 504 of the bioabsorbable member, and threaded along the length of the ribbon proximally toward the cuff 502 and then continue toward a proximal end (optionally terminating at a tab 514).
  • Visual inspection of the distance between the first knot and the second knot of the deployment indicator may provide information regarding the compression level of the ribbon.
  • a distance 509 between the first knot 510 and the second knot 512 may indicate the level of compression of the ribbon 504.
  • the compression level of the ribbon 504 may be considered adequate for sealing or closing the vessel puncture.
  • the safety tether 506 may optionally include indicia (e.g., tags, bands, regions having larger diameters and/or differing textures, high-contrast markings, varying color markings, alphanumeric markings, etc.) that denote a distance of about 1.0 inch to about 1.5 inches from the second knot 512 so that a clinician can readily identify whether the desired distance 509 (and thus, ribbon compression) has been attained.
  • a distance 509 of greater than about 1.5 inches may indicate that the ribbon 504 is under-compressed. Releasing a bioabsorbable member that is under- compressed may result in a leaky (not fluid-tight) or incomplete puncture closure.
  • a distance 509 that is less than about 1.0 inch may indicate that the ribbon 504 is over-compressed and/or that the ribbon 504 is contacting the cuff 502, with no intervening vessel wall. This may indicate that the bioabsorbable member was incorrectly deployed, for example, such that the cuff and the ribbon are both outside of the vessel lumen (e.g. FIG. 3B) or that the cuff and ribbon are both inside of the vessel lumen (e.g. FIG. 3C).
  • a deployment indicator may include a first visual marker on the first portion of the tether and a second visual marker on the second portion of the tether, where the first and second visual markers may be any of the knots described above.
  • FIGS. 6A-6D depict one embodiment of an access or sealing device comprising a bioabsorbable member deployment indicator.
  • FIG. 6A depicts an access or sealing device 600 that includes an introducer or sheath 602, a bioabsorbable member 604 releasably coupled to a distal portion of the sheath 602, a compression tether 604 and a safety tether 606.
  • a distal portion 603 of the compression tether 604 may be coupled to the bioabsorbable member 604 (e.g., as depicted in FIG. 5) and a proximal portion 605 of the compression tether 604 may be coupled to an optional tab or retainer 614.
  • the compression tether 608 may be slidably coupled to the safety tether 606 via a knot 612 on the safety tether 606.
  • the knot 612 may be at a fixed location on the safety tether 606, but may have an opening that is large enough for the compression tether 608 to move and slide through the knot 612.
  • FIG. 6C is a close-up view of one example of how the safety tether 606 is attached to the proximal portion or cuff 616 of the bioabsorbable member 604 and how the compression tether is attached to the distal portion or ribbon 618 (in a compressed
  • FIGS. 6B and 6D depict one embodiment of a deployment indicator 620, which may include a (second) knot 610 disposed on the compression tether 608 and the safety tether (first) knot 612, where a distance 609 between the second knot 610 and the first knot 612 correlates to a compression level of bioabsorbable member (e.g., the compression level of the distal portion or ribbon).
  • a clinician may visually determine whether the distance 609 is within the desired compression range (e.g., at a desired compression distance).
  • the compression tether 608 is proximally moved such that the distance 609 is zero (i.e., the second knot 610 contacts the first knot 612) without encountering tactile resistance, this may indicate that the ribbon portion has compressed against the cuff. This may occur, for example, if the bioabsorbable member was mis- deployed (e.g., the cuff and ribbon are both inside the lumen or outside of the lumen, as depicted in FIGS. 3B-3C) and/or if the lumen wall has slipped out from between the cuff and the ribbon, and/or if the puncture has enlarged such that the lumen wall is no longer between the cuff and the ribbon. In light of these visual and tactile indications, the clinician may wish to remove the bioabsorbable member.
  • visual deployment indicators may include other types of visual landmarks.
  • a visual deployment indicator may include one or more tags, bands, regions having larger diameters and/or differing textures, high-contrast markings, varying color markings, alphanumeric markings, labels, and the like.
  • Such visual indicators or features may be associated with the tether(s) and/or the shaft and/or the handle and/or the retaining tabs of the access or sealing device and may facilitate visual inspection of the relative movement and/or position of the marker(s) on the compression tether against the other tethers and/or the shaft.
  • FIGS. 7A-7B depict the use of one variation of a deployment indicator comprising one or more visual indicia in an access or sealing procedure.
  • Access or sealing device 700 may include a shaft or introducer (not shown for clarity), a bioabsorbable member 704 having a proximal cuff 701 and a distal ribbon 705, a compression tether 708 fixedly attached to the ribbon and slidably coupled to the cuff, and a safety tether 706 attached to the cuff.
  • a deployment indicator may include visual marker 710 on the compression tether 708, a knot 712 on the safety tether that slidably couples the compression tether with the safety tether, and optionally, a marker zone 711 that extends along a length of the safety tether that is distal to the knot 712.
  • the visual marker 710 and/or the marker zone 711 may include regions or lengths having larger diameters and/or differing textures, high-contrast markings, varying color markings, alphanumeric markings, labels, and the like.
  • the distance 709 between the knot 712 and the marker zone 71 1 may represent the desired distance between the visual marker 710 that would indicate a desired level of compression of the ribbon 705.
  • the length of the marker zone 71 1 may represent a range of ribbon compression levels that may be acceptable for sealing a vessel wall puncture. For example, if compression tether 708 is moved proximally such that the sliding marker 710 is located within the length of the marker zone
  • a clinician would know that the ribbon is at an acceptable compression level for sealing the puncture. This is scenario is depicted in FIG. 7B. If the sliding marker 710 is located at about a distance 709 from the knot 712, the clinician would know that the ribbon 705 is at a maximum desired compression level.
  • the distance 709 may be from about 0.5 inch to about 1.0 inch and the length of the marker zone 711 may be from about 0.25 inch to about 0.75 inch, e.g., about 0.5 inch.
  • the distance 709 i.e., location of the marker zone 711 relative to the knot 712
  • the length of the marker zone 711 may vary based on the wall thickness of the targeted body lumen, the weave density of the compression tether over the length of the ribbon, and other factors described previously. For example, in procedures where the introducer and closure device is deployed across a thicker vessel wall (e.g., about 4 mm to about 5 mm thick arterial wall), proximally pulling the compression tether 708 such that the sliding marker 710 is just within the distal portion of the marker zone 711 may indicate an appropriate level of ribbon compression.
  • proximally pulling the compression tether 708 such that the sliding marker 710 is in the middle of or toward the proximal portion of the marker zone 711 may indicate an appropriate level of ribbon compression.
  • the 711 may provide an indication of the length of the ribbon that has been deployed into the vessel lumen.
  • the ribbon may have a length of about 2 cm and an ideal or desired
  • bioabsorbable member deployment may include deploying at least about two-thirds (i.e., about 1.33 cm) of the ribbon into the lumen of the vessel such that when the ribbon is compressed, sufficient ribbon material is compressed against the wall puncture to close the puncture against the cuff.
  • Bioabsorbable members for deployment in body lumens with thicker walls may have a longer ribbon portion, for example, about 3 cm or more (e.g., from about 3 cm to about 6 cm) while bioabsorbable members for deployment in body lumens with thinner walls may have a shorter ribbon portion, for example, less than about 2 cm.
  • the sliding marker 710 may include indicia that may facilitate precise alignment or positioning of the sliding marker within the marker zone 711.
  • the marker zone 711 may also include indicia (e.g., in the middle of the marker zone length) to provide a further reference marker as to the movement of the compression tether relative to the safety tether.
  • a deployment indicator may include a force meter, and the force or tension measurements may correlate with various compression levels of the bioabsorbable member (e.g., ribbon or distal portion of the bioabsorbable member).
  • FIG. 8 depicts an example of a force-displacement plot, which represents the static release force (measured in grams or pounds) as a function of tether displacement (measured in mm).
  • Curve 800 represents the static force as a function of compression tether displacement when the ribbon has been over-compressed (e.g., as depicted in FIGS.
  • curve 810 represents the static force as a function of compression tether displacement when the ribbon has attained a suitable level of compression (e.g., as depicted in FIG. 3A), and curve 820 represented the static force as a function of compression tether
  • a certain amount of slack may be provided on the compression tether.
  • about 76 mm of slack has been provided on the compression tether so that it may be moved proximally from about 6 mm to about 82 mm with little or no increase in the static release force.
  • the compression tether begins to compress the ribbon, which exerts a force on the compression tether that opposes the proximally-directed force.
  • the tether travel length at which the static force rapidly increases may indicate whether the ribbon is under ideal compression or is over- or under- compressed.
  • This force-displacement plot may vary depending on the threading pattern of the tether in the ribbon (which may result in a multiplicative effect where a proximal withdrawal of the compression tether by a distance X results in a compression of aX (where a is a scaling factor).
  • FIG. 9 depicts one variation of method of sealing a puncture site using a sealing device that includes a deployment indicator, such as any of the devices described above.
  • Method 900 may include placing 902 an access or sealing device having an introducer or shaft, a releasable bioabsorbable member and a compression tether coupled to the bioabsorbable member into a tubular anatomy (e.g., blood vessel) of a patient and confirming 904 that a proximal portion (e.g., cuff) of the bioabsorbable member is located outside of the lumen of the tubular anatomy and a distal portion (ribbon) of the bioabsorbable member is located inside the lumen of the tubular anatomy.
  • a proximal portion e.g., cuff
  • confirming proper placement may include monitoring blood flow through the introducer and/or any shafts, valves, or dilators of the access or sealing device.
  • a bleed-back port may be located on the shaft from about 5 mm to about 7 mm distal to the cuff of the bioabsorbable member.
  • a bleed-back port may be located in the introducer or shaft, about 7 mm distal to the cuff such that bleed-back observed at a proximal end of the device indicates that at least a portion (e.g., about two-thirds or more) of the ribbon is located within the lumen of the vessel.
  • confirming proper placement or deployment of the bioabsorbable member may include observing the curl and tension of the one or more tethers (e.g., compression tether and/or safety tether and/or retaining tether).
  • the operator may advance the sheath of the introducer and closure device forward (e.g., distal to the operator and toward the vessel wall) to determine whether the cuff is positioned at the wall puncture, outside of the vessel lumen. If the cuff of a bioabsorbable member is located outside of the vessel wall, advancing the sheath will cause the compression and safety tethers to curl at the point of entry on the patient's skin.
  • the cuff may be located partially or entirely within the vessel lumen, which may require removal by the operator.
  • the compression tether and/or safety tether may each comprise proximal tabs and/or may be coupled by a ligature or lasso to facilitate operator manipulation and retention at the proximal end.
  • Some variations of access or sealing devices may include a safety tether, which may be removed 906 after the placement of the bioabsorbable member has been confirmed 904.
  • the method 900 may then include releasing the distal portion (e.g., ribbon) of the bioabsorbable member from the introducer or shaft. After the ribbon has been released, method 900 may include compressing 910 the ribbon. Compressing 910 the ribbon may include moving 910a the compression tether proximally and ceasing 910b tether movement when a deployment or compression indicator provides a visual and/or tactile indication that the ribbon has attained a desired level of compression or the bioabsorbable member has been improperly placed or deployed (e.g., FIGS. 3B-3C).
  • a deployment or compression indicator provides a visual and/or tactile indication that the ribbon has attained a desired level of compression or the bioabsorbable member has been improperly placed or deployed (e.g., FIGS. 3B-3C).
  • the method 900 may include retrieving 910c the bioabsorbable member.
  • the method 900 may also include advancing device through the access or sealing device to perform a procedure within the lumen of the tubular anatomy.
  • Steps 910 and 912 may be reversed; that is, ribbon compression may take place before the procedure or after the procedure.
  • the compression tether may optionally 914 be moved proximally, and the sealing device may be withdrawn 916. Withdrawing 916 the sealing device may optionally include proximally moving the compression tether occasionally. This may help to maintain some tension on the tether and stabilize the bioabsorbable member at its deployment location.
  • method 900 may include cutting 918 the compression tether. Steps that are optional to method 900 are enclosed in boxes with dotted outlines.
  • inventive embodiments are presented by way of example only and that, within the scope of the appended claims and equivalents thereto, inventive embodiments may be practiced otherwise than as specifically described and claimed.
  • inventive embodiments of the present disclosure are directed to each individual feature, system, article, material, kit, and/or method described herein.
  • inventive concepts may be embodied as one or more methods, of which an example has been provided.
  • the acts performed as part of the method may be ordered in any suitable way. Accordingly, embodiments may be constructed in which acts are performed in an order different than illustrated, which may include performing some acts simultaneously, even though shown as sequential acts in illustrative embodiments.
  • the phrase "at least one,” in reference to a list of one or more elements, should be understood to mean at least one element selected from any one or more of the elements in the list of elements, but not necessarily including at least one of each and every element specifically listed within the list of elements and not excluding any combinations of elements in the list of elements.
  • This definition also allows that elements may optionally be present other than the elements specifically identified within the list of elements to which the phrase "at least one" refers, whether related or unrelated to those elements specifically identified.
  • At least one of A and B can refer, in one embodiment, to at least one, optionally including more than one, A, with no B present (and optionally including elements other than B); in another embodiment, to at least one, optionally including more than one, B, with no A present (and optionally including elements other than A); in yet another embodiment, to at least one, optionally including more than one, A, and at least one, optionally including more than one, B (and optionally including other elements); etc.

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  • Life Sciences & Earth Sciences (AREA)
  • Biomedical Technology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Engineering & Computer Science (AREA)
  • Cardiology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
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  • Surgical Instruments (AREA)

Abstract

L'invention concerne des dispositifs et des procédés pour sceller une perforation dans une structure de tissu tubulaire ou la paroi d'une cavité corporelle. La perforation est scellée avec un élément bioabsorbable comprenant un tissu sous-muqueux, et/ou un tissu dérivé de matrice extracellulaire et/ou un matériau synthétique bioabsorbable. L'élément bioabsorbable a une partie manchette et une partie ruban couplée à la manchette et s'étendant à partir de celle-ci. Une première partie d'une amarre est couplée à la partie manchette et une seconde partie de l'amarre est couplée à la partie ruban de telle sorte que le retrait de la seconde partie de l'amarre comprime la partie ruban contre la partie manchette. Un indicateur fournit une représentation visuelle et/ou tactile du degré de compression du ruban.
PCT/US2018/033907 2017-05-22 2018-05-22 Dispositifs et procédés de déploiement de dispositif de fermeture WO2018217762A1 (fr)

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Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20070276433A1 (en) * 2006-05-23 2007-11-29 St. Jude Medical Puerto Rico B.V. Puncture closure apparatuses, sealing plugs, and related methods
US20120158044A1 (en) * 2010-12-17 2012-06-21 Boston Scientific Scimed, Inc. Tissue puncture closure device
US20120283770A1 (en) * 2009-08-31 2012-11-08 St. Jude Medical Puerto Rico Llc Compressible arteriotomy locator for vascular closure devices and methods
US20140277113A1 (en) * 2013-03-15 2014-09-18 Cook Medical Technologies Llc Vascular closure device suture tension limiting and indication mechanism
US20160367368A1 (en) * 2014-03-10 2016-12-22 Tendyne Holdings, Inc. Devices and methods for positioning and monitoring tether load for prosthetic mitral valve
US20170100113A1 (en) * 2012-12-21 2017-04-13 Essential Medical, Inc. Vascular locating systems and methods of use

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20070276433A1 (en) * 2006-05-23 2007-11-29 St. Jude Medical Puerto Rico B.V. Puncture closure apparatuses, sealing plugs, and related methods
US20120283770A1 (en) * 2009-08-31 2012-11-08 St. Jude Medical Puerto Rico Llc Compressible arteriotomy locator for vascular closure devices and methods
US20120158044A1 (en) * 2010-12-17 2012-06-21 Boston Scientific Scimed, Inc. Tissue puncture closure device
US20170100113A1 (en) * 2012-12-21 2017-04-13 Essential Medical, Inc. Vascular locating systems and methods of use
US20140277113A1 (en) * 2013-03-15 2014-09-18 Cook Medical Technologies Llc Vascular closure device suture tension limiting and indication mechanism
US20160367368A1 (en) * 2014-03-10 2016-12-22 Tendyne Holdings, Inc. Devices and methods for positioning and monitoring tether load for prosthetic mitral valve

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