Apparatus and methods for sealing a vascular puncture.

(54) Title: APPARATUS AND METHODS TO SEAL A VASCULAR PUNCTURE.

(54) Title: APPARATUS AND METHODS FOR SEALING A VASCULAR PUNCTURE.

(57) Summary

An apparatus for sealing a puncture through a vessel wall that includes a positioning assembly, a releasable sheath coupled to the positioning assembly, and a support member that can advance axially through the sheath. The positioning assembly includes a positioning element that is positioned on a distal portion of the positioning assembly and a sealant placed on a distal portion of the positioning assembly. The sheath guides the sealant and positioning assembly to the puncture of the vessel wall.

(57) Abstract

An apparatus for sealing a puncture through a vessel wall including a positioning assembly, a sheath releasably engaged with the positioning assembly, and a support member axially advanceable through the sheath. The positioning assembly includes a positioning element positioned at a distal portion of the positioning assembly and a sealant disposed at a distal portion of the positioning assembly. The sheath guides the sealant and positioning assembly to the puncture in the vessel wall.

YES

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IMPIC

Ib L «! I ·,: »iu> ·. i

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PATENT TITLE No. 354129

Headlines): ACCESSCLOSUREINC.

Home:

645 Clyde Ave., Mountain View, California, 94043, USA

Name: APPARATUS AND METHODS TO SEAL A VASCULAR PUNCTURE

Classification

CIP:

A61B17 / 08; A61 Β3Ζ / ρ3 ^ 1Μ25 / 10; A61M31 / 00; A61M37 / 00

Α61Β17 / βζ, αΑβ | 7 / ^ (? '1M31 / 00; A61M37 / 00

RONALD JHulgERtMARK: ANDY FISCELIW-SRAKÍDON FELL: SPO

CPC:

tional:

The patent of refere

Inventors):

In accordance with the article from the date of prese

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the | ^ implicity infectious ^ ent / 0 (87199 «Industrial.

Numei ^ e

MX / a / 2014Z0lÍ135

Validity;

Date of VI «i ^ iBient« (__

Ex Date

Who subscribes to this title I (Official Gazette of the Federation (01/25/2006, 06/05 / 2009,06 / 01/2010, Regulations of the Mexican Institute of articles 1^or. 3°, 4^or, 5th fraction V subsection a). * L 12/27/1999, amended on 10/10/2002, 07/29/2020 Deputy Generals, Coordinator, Divided Departmental Directors and other subordinates of the Mexican Institute of 04/08/1 2004 and 09/13/2007).

HE ZILVERSMIT; DAVID L.; RICHARD REPP; MARK iprorragables, told to antener vtgenteffos ^ erechos.

'¿4e the Industrial Property Law 999, 01/26/2004, 06/16/2005, so a), 4^or and 12th fractions I and III of 00 ^ 1 ^ / 07/2004, 07/28/2004 and 09/07/2007); tatdfe ^ exicano of Industrial Property (DOF Agreement that delegates powers to the Directors is, Divisional Deputy Directors, Coordinators OF 15/12/1999, amended on 02/04/2000, 07/29/2004,

This letter is signed with an advanced electronic signature (FIEL), based on articles 7 BIS 2 of the Industrial Property Law; 3 of its Regulations, and 1 section III, 2 section V, 26 BIS and 26 TER of the Agreement establishing the guidelines for the use of the Electronic Payment and Services Portal (PASE) of the Mexican Institute of Industrial Property, in the procedures indicated.

THE DIVISIONAL DIRECTOR OF PATENTS

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NAHANNY CANAL REYES

Original string:

NAHANNY MARISOL CANAL REYES | 00001000000403252793 | Administration Service

Tax | 1695 || MX / 2018/13349 | MX / a / 2014/011135 | PCT patent title | 1027 | RGZ | Page (s) 1 | z7uDaPyNNhT6bnvLerLjEJQPhMA =

Digital stamp:

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Arenal No 550 Piso 1, Pueblo Santa María Tepepan. Xochimilco, 16020, Mexico City.

(55) 53340700 www.gob.mx/iinpí

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--- shot down ιμΙ'οιι 155

IΚΡΙ

DEVICES AND METHODS FOR SEALING A PUNC ^^ tX ^^ LA ^ ...-

<img file="MX354129B_D0006.tif" />

FIELD OF THE INVENTION

The present invention relates generally to apparatus and methods for sealing functions in a body, and more particularly, to apparatus and methods for sealing a vascular puncture that extends through tissue within a blood vessel, and to apparatus and methods of delivering a plug, sealant, and / or other material in a percutaneous puncture that extends from a patient's skin to a blood vessel or other body lumen, eg, to seal the puncture.

BACKGROUND OF THE INVENTION

Apparatuses and methods are known for accessing a patient's vasculature percutaneously, eg, for carrying out a procedure within the vasculature, and for sealing the puncture that results after completion of the procedure. For example, a hollow needle can be inserted through a patient's skin and overlying tissue into a blood vessel. A guide wire can be passed through the needle lumen into the blood vessel, whereby the needle can be removed. Then an introducer sheath can be advanced over the guide wire into the vessel,

e.g .

<img file="MX354129B_D0007.tif" />

in conjunction with or subsequentus Tj'S ^^^^ dilators.

<img file="MX354129B_D0008.tif" />

A catheter or other device can be advanced through the introducer sheath and onto the guide wire to a position to perform a medical procedure. Therefore, the introducer sheath can facilitate access and / or introduction of different devices into the vessel, while minimizing trauma to the vessel wall and / or minimizing blood loss. Upon completion of the procedure, the introducer device (s) and sheath can be removed, leaving a puncture that extends between the skin and the vessel wall.

To seal the puncture, external pressure can be applied to the overlying tissue, eg, manually and / or using sandbags, until hemostasis occurs. This procedure, however, can be time consuming and expensive, requiring as much as an hour of the time of a medical professional. It is also uncomfortable for the patient, and may require the patient to remain immobilized in the operating room, catheter lab, or waiting area. Additionally, there is a risk of bruising from bleeding before hemostasis occurs.

Different apparatus and methods have been suggested to seal the vascular functions resulting from such patent procedures, such

<img file="MX354129B_D0009.tif" />

7,806,856, and the Publications of the

7,331,979 7,335,220, and

United States No. 2007/0231366, 2008/0082122, 2009/0088793,

2009/0254110, 2010/0168789, 2010/0274280, and 2010/0280546. Full disclosures of these references are expressly incorporated by reference in this document.

For example polymer, the MATRIX ™ product includes two synthetic polyethylene glycol powders (PEG, Polyethylene

Glycol) that were mixed with appropriate regulators injected into a femoral sheath at an arteriotomy site, as disclosed in the document by

States Patent

United No.

7,316,714. MYNX®

Vascular Closure Device is another system for sealing vascular punctures, eg, as disclosed in one or more of the references identified above, such as US Patent No. 7,335,220.

Consequently, apparatus and methods would be useful to seal a puncture through the tissue.

BRIEF DESCRIPTION OF ΙΛ INVENTION

The present application is directed to apparatus and methods for sealing a puncture in a body. More particularly, the present application is directed to apparatus and methods for vascular puncture extending within

IMPJC provide temporary or permanent hemostasis'J-TdKftl ^ ® iw '' ⁰¹ imhistw *. · - ·· ”· from a sanqui vessel and / or apparatus and methods for delivering a sealant and / or other material to a percutaneous puncture extending from a patient's skin to a blood vessel or other body lumen.

In accordance with an exemplary embodiment, an apparatus is provided for sealing a puncture that extends through tissue having an introducer sheath therein including a proximal end including an adapter, a distal end, and a extending lumen between them. Generally, the apparatus may include a positioning member that includes proximal and distal ends, and an expandable positioning element at the distal end although, a sealant that is worn at the distal end of the positioning element adjacent to the positioning element; a support member including proximal and distal ends, the distal end of the support member at the distal end of the positioning member adjacent to the sealant; and a sealant sleeve that is slidably positioned over the distal end of the support member, and that covers the sealant. The sleeve may include a portion abutting the introducer sheath adapter when the distal end of the positioning member is inserted into

<img file="MX354129B_D0010.tif" />

the introducer sheath to prevent

1'.gL? VS1kial · - ».. * · to the lumen of the introducer sheath such that when the positioning member advances into the lumen of the introducer sheath the sealant and the support member are exposed within the lumen of the introducer sheath, and further advancement of the positioning member causes the support member to direct the sealant distally through

<td>of the</td><td>lumen of</td><td>the</td><td>introducer sheath.</td><td></td><td></td><td></td>

<td></td><td colspan="2">Agree</td><td>with another modality,</td><td>it is provided</td><td>a</td><td>system</td>

<td>for</td><td>seal</td><td>a</td><td colspan="2">puncture that extends through</td><td>of</td><td>tissue</td>

<td>than</td><td>It includes</td><td>a</td><td>introducer sheath</td><td>that includes</td><td>a</td><td>extreme</td>

proximal including an adapter, a distal end, and a lumen extending therebetween; and a positioning member comprising proximal and distal ends, and an expandable positioning element at the distal end, the distal end of the positioning member dimensioned for insertion into the sheath and lumen adapter with the positioning element in a collapsed condition. A sealant can be carried on the distal end of the element. positioning adjacent to the positioning element, and a support member including proximal and distal ends can be brought into the positioning member such that the cleft end of the support member is positioned at the distal end of the positioning member adjacent to that of sealant can be placed so

<img file="MX354129B_D0011.tif" />

<img file="MX354129B_D0012.tif" />

distal end of the support member and cover the sealant.

The sleeve may include a portion abutting the introducer sheath adapter when the distal end of the positioning member is inserted into the introducer sheath to prevent the entire sleeve from entering the introducer sheath lumen such that when the positioning member advances into the introducer sheath lumen, the sealant and support member are exposed within the introducer sheath lumen, and further advancement of the positioning member causes the support member to direct the sealant distally through the introducer sheath lumen.

In accordance with yet another embodiment, a method is provided for sealing a puncture that extends through the tissue of a body lumen, the puncture having an introducer sheath therein. An elongated positioning member may be provided including proximal and distal ends, and a sleeve that at least partially surrounds a sealant and a distal end of a support member, the

<td>sleeve and sealant</td><td>placed</td><td>adjacent</td><td>yet</td><td>element</td><td>of</td>

<td>positioning in</td><td colspan="2">the distal end</td><td>of the</td><td>member</td><td>of</td>

<td>positioning. The</td><td>extreme</td><td>distal</td><td>of the</td><td>member</td><td>of</td>

positioning can be advanced

<img file="MX354129B_D0013.tif" />

lumen of the introducer sheath until it contacts the sheath adapter. The positioning member can be advanced further through the sheath lumen until the positioning element is positioned within the body lumen beyond a distal end of the introducer sheath, thereby causing the sleeve to slide over the support member to expose the sealant within the sheath lumen and advance the distal end of the support member within the introducer sheath lumen to direct the sealant through the introducer sheath lumen toward the distal end of the sheath. The introducer sheath can then be retracted to expose the sealant within the puncture.

In accordance with one embodiment, an apparatus for sealing a puncture is provided that includes an elongated positioning member that includes a proximal end and an expandable positioning element at a distal end thereof, and a cartridge that can be advanced along the positioning member from a proximal position adjacent the proximal end to a distal position. The cartridge may include a tubular member, a sealant placed within a lumen of the tubular member, eg, adjacent to a distal end of the tubular member, a lumen housing member

<img file="MX354129B_D0014.tif" />

end within the housing that support member s placed within that adjacent to the sealant, and a proximal of the tubular member.

A deployment mechanism is coupled to the tubular member includes one or more rack and pinion elements coupled to the proximal ends of the tubular member and support member. An actuator is provided in the housing that is coupled to the deployment mechanism such that, when activated, the tubular member is directed proximally and / or the support member is directed distally in a predetermined sequence. For example, the actuator may be activated to drive one or more rack and pinions to sequentially a) remove the tubular member relative to the sealant to expose the sealant from the lumen of the tubular member within a puncture and b) advance the support member to compress the sealant into the puncture. The retraction and advance time can be set based on the configuration of the deployment mechanism, eg, to delay the advance of the support member until the sealant is substantially exposed from the tubular member.

In accordance with another embodiment, a system is provided for sealing a puncture through tissue that generally includes an introducer sheath, a positioning member, and a cartridge.

<img file="MX354129B_D0015.tif" />

include a proximal end that includes a ^ adapted.ru.

distal end dimensioned for insertion into a puncture, and a lumen extending therebetween. The positioning member may include an elongated member including a proximal end and an expandable positioning element at a distal end thereof. The cartridge can be advanced along the positioning member from a proximal position to a distal position, and can include a tubular member including a sealant and a support member positioned within the lumen of the tubular member. A locking mechanism may be provided in the cartridge to engage the introducer sheath adapter when the tubular member is advanced to the distal position and enters the introducer sheath, eg, thereby engaging subsequent proximal movement of the tubular member and introducer sheath with each other.

In accordance with yet another embodiment, an apparatus is provided for sealing a puncture extending through tissue having an introducer sheath therein including a proximal end including an adapter, a distal end, and a extending lumen. between them. The apparatus may include a positioning member that includes proximal and 'idista 1 ends and msftiOT⁰ fí. ^ éinéftto · ..ddé expandable positioning at the distal end of the cartridge that can advance along the positioning member from a proximal position adjacent to the proximal end of the positioning member to a distal position.

The cartridge may include a sealant, a support member including a distal end positioned adjacent to the sealant, and a sleeve of sealant slidably positioned over the distal end of the support member and covering the sealant.

The sleeve may include a distal portion sized to enter the introducer sheath adapter when the cartridge advances to the distal position, and a proximal portion abutting the introducer sheath adapter to prevent the entire sleeve from entering the lumen of the introducer sheath. such that when the cartridge advances from the proximal to the distal position, the distal portion of the sleeve enters the lumen of the introducer sheath while the sleeve is stopped by the introducer sheath adapter and slides over the support member to expose the sealant within the lumen of the introducer sheath, and further advancement of the cartridge The distal position causes the support member to direct the sealant distally through the lumen of the introducer sheath.

V TX «T d ü /

T Jh i ¿¿'&amp; ÍAL

Certain aspects of this disclosed opr 'es'rátr¹ “'DirTg i dos to a device to seal a puncture through a vessel wall. The apparatus may include a positioning assembly that includes a positioning element positioned in a distal portion of the positioning assembly and a sealant positioned in a distal portion of the positioning assembly. The apparatus may include a releasable sleeve coupled with the positioning assembly. The apparatus may include a support member that can advance axially through the sheath.

Certain aspects of this disclosure are directed to an apparatus for sealing a puncture through a vessel wall. The apparatus may include a positioning assembly that includes a sealant placed in a distal portion of the

<td>assemble</td><td>of</td><td>positioning.</td>

<td>sheath to</td><td colspan="2">through which</td>

<td>assemble</td><td>of</td><td>positioning.</td>

<td>mango that</td><td>you</td><td>have a portion</td>

<td colspan="2">to move</td><td>with relationship </td>

<td>inside.</td><td>The</td><td>mango portion</td>

removably to the interior vaii can be docked

<td>The appliance can</td><td>include a</td>

<td colspan="2">can axially advance the</td>

<td>The appliance can</td><td>include a</td>

<td>external handle</td><td>configured</td>

<td>A portion of</td><td>accommodation</td>

<td colspan="2">outer can be docked</td>

<td>and / or the portion of</td><td>accommodation</td>

removably with the positioning assembly.

<img file="MX354129B_D0016.tif" />

Any of the devices, character! Stic ^ s ^ ffiS ^ odosT ^ 'or processes that are disclosed in the specif include in any of the modalities. For example, the positioning assembly may include a sealant sleeve that at least partially surrounds the sealant. The sheath may include an adapter portion configured to receive the sealant sleeve. An inside diameter of the sheath may be less than an outside diameter of the sealant sleeve. The sealant can include a first portion of sealant distal to a second portion of sealant. The first portion of sealant may be different from the second portion of sealant.

In certain aspects, the apparatus may include a positioning element configured to move between an unexpanded state and an expanded state. The positioning element can be positioned on a distal portion of the positioning assembly and / or adjacent to the positioning element.

In certain aspects, the handle may include a first actuator configured to decouple the movement of the outer handle portion and the inner handle portion. The handle may include a second actuator configured to advance a support member through the sheath. For example, the pod may include a rack and pinion. The pinion can be linked configured to cause certain aspects, the handle can be configured to retract lMW-^; to the second ¿© 'S'ÉWthdor and move

In including a third actuator the positioning element through the sealant. The third actuator may be slidable relative to the inner housing portion.

Certain aspects of this disclosure are directed to a method of sealing a puncture through a vessel wall. The method may include advancing a sheath over a guide wire. The method may include removing the guide wire. The method may include advancing a positioning assembly through the sheath such that the positioning element enters the vessel. The positioning assembly may carry a sealant placed on a distal portion of the positioning assembly. The method may include retracting the sheath to expose the sealant out of the cup. In certain aspects, advancing the positioning assembly may include transferring the sealant from a sealant sleeve to the sheath.

Any of the apparatus, features, methods, or processes disclosed in the specification can be included in any of the modalities of the method. For example, the method may include expanding the positioning element within the vessel. The method may include retracting the positioning element proximally to seat the positioning element with Xjg¿k> ®ie^e5ap3Te3 ^^Iof the glass. The method may include releasably coupling the positioning assembly and the sheath. The method may include releasing the positioning assembly from the sheath. The method may include advancing a support member to tamp down the sealant. The method may include releasing the positioning assembly from the support member. The method may include retracting the positioning element through the sealant, leaving the sealant in place. The method may include advancing a dilated through the sheath.

Other aspects and features of the present invention will become apparent from consideration of the following description taken in conjunction with the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

It will be appreciated that the exemplary apparatus shown in the drawings are not necessarily drawn to scale, with an emphasis rather on illustrating the different aspects and features of the modalities illustrated.

Figure 1A is a side view of an exemplary embodiment of an apparatus for delivering a puncture sealant through tissue, including a positioning member and a movable cartridge impi '':

MilΤ.; &lt;Σ-ΑΓ · &lt;Ο about eí^fc’^,ása ¥ ® ^ to ^ ** of · positioning that includes the sealant.

<img file="MX354129B_D0017.tif" />

Figure IB is an exploded perspective view of the apparatus of Figure 1A.

Figure 2A is a side view of the apparatus of Figures 1A and IB showing a sealant and support member (in dashed lines) within an outer tubular member of the cartridge.

Figure 2B is a cross sectional view of an exemplary embodiment of a housing that can be provided at the proximal end of the cartridge of Figures 1A-2A, showing a deployment mechanism therein for deploying the sealant from the cartridge.

Figure 3 is a cross sectional view of an alternate embodiment of a deployment mechanism that can be provided within a cartridge housing, as shown in Figures 1A-2A, including a slider actuator and discontinuous teeth in a pinion of the deployment mechanism.

Figure 3A is a cross-sectional view of another alternative embodiment of a deployment mechanism, including a support member that is indirectly coupled to the deployment mechanism.

•• -hj

The Figure is a sectional view of yet another alternative deployment modality, which includes a push button actuator.

Figure 4A is a detail of a pinion drive arrangement that can be included in the deployment mechanism of Figure 4.

The Figure is a cross sectional view of yet another alternative embodiment of a deployment mechanism, which includes a lever actuator.

Figures 6A and 6B are partial side cross-sectional views of another embodiment of a positioning member that includes a self-retracting assembly to automatically retract the positioning member when activated.

Figures 7A-7C are side views of an alternative embodiment of a positioning member that includes a retraction lock that limits movement of the positioning member relative to a cartridge (only a first cartridge rack is shown for clarity only).

Figures 8A-8C are partial side cross-sectional views of yet another embodiment of an apparatus that includes a positioning member and a cartridge carrying a sealant that includes a self-retracting mechanism to retract the cartridge member.

positioning

INi F in relation to

<img file="MX354129B_D0018.tif" />

Figures 9A and 9B are details showing a collapsed positioning element being retracted through the sealant exposed inside a cartridge.

Figures 10A-10G are cross-sectional views of a patient's body showing a method of sealing a puncture using the apparatus of Figures 1A-2B.

Figure 11 is a cross-sectional view of a patient's body showing another embodiment of a cartridge for delivering a sealant within a puncture including a collapsible distal region.

Figure 12 is a side view of another embodiment of an apparatus for sealing a puncture through tissue that includes a positioning member, and a cartridge movable on the positioning member that includes a sealant sleeve slidable on a sealant and member of support.

Figure 12A is a cross-sectional detail of the distal end of the cartridge of Figure 12.

Figures 13A-13C are cross-sectional views of a patient's body showing a method of sealing a puncture using the apparatus of Figure 12.

Figure 14 is a partial cross-sectional side view of an exemplary embodiment of a sheath uptake that can be provided in a sealant.

i VAT \ appliance ^ paassa ^ 'efitregar

<img file="MX354129B_D0019.tif" />

Figures 15A and 15B are partial side cross-sectional views of another exemplary embodiment of a sheath that can be provided in an apparatus that includes a bleed port.

Figures 16A and 16B are perspective and side views, respectively, of another embodiment of an apparatus for delivering a sealant in a puncture through the tissue.

Figure 16C is a side view of the apparatus of the

Figures 16A and 16B with a portion of an outer housing removed to show internal components of the apparatus.

Figure 16D is a perspective view of another introducer sheath and dilator assembly that can be used in cooperation with the apparatus of Figures 16A-16C.

Figures 17A-17F illustrate a method of delivering a sealant to an arteriotomy site.

Figures 18A, 18A-1, 18B, and 18B-1 illustrate a mechanism for controlling fluid flow through an infiltration line.

Figures 19A, 19A-1, 19B, and 19B-1 illustrate another mechanism for controlling fluid flow through an infiltration line.

<img file="MX354129B_D0020.tif" />

i

<img file="MX354129B_D0021.tif" />

Figures 19C-19D illustrate yet another mechanism for controlling fluid flow through infiltration.

Figures 19E-19F illustrate yet another mechanism for controlling fluid flow through an infiltration line.

Figures 20A, 20A-1, 20B, and 20B-1 illustrate yet another mechanism for controlling fluid flow through an infiltration line.

Figures 21A-21B illustrate a mechanism for controlling the movement of an outer housing relative to an inner housing.

Figures 22A-22B illustrate another mechanism for controlling the movement of an outer housing relative to an inner housing.

Figures 23A-23B illustrate yet another mechanism for controlling the movement of an outer housing relative to an inner housing.

Figures 24A-24C illustrate a locking mechanism to prevent actuation of a support member.

Figures 25A-25B illustrate a mechanism for advancing a support member.

Figures 26A-26B illustrate another mechanism for advancing a support member.

Figures to restrict positioning.

Figures a sealant to a

I .M r 'Λ. >

¹

INCUSA

27A-27B illustrate a retraction lock the movement of an assembly of

28A-28F illustrate another method of delivering arteriotomy site.

Figures 29A-29B illustrate an apparatus for delivering a sealant to an arteriotomy that includes an inflation indicator.

Figures 30A-30D illustrate one embodiment of a dilated configured to fit a sheath.

Figures 31A-31C illustrate another embodiment of a dilated configured to fit a sheath.

Figures 32A, 32B-32D-1 illustrate a mechanism for coupling a positioning assembly and a sheath.

Figure 33 illustrates another mechanism for coupling a positioning assembly and a sheath.

Figures 34A-34I illustrate a method of delivering a sealant to an arteriotomy site.

DETAILED DESCRIPTION OF THE INVENTION

Turning to the drawings, Figures 1A-2B show an exemplary embodiment of an apparatus 10 for sealing a puncture through tissue that generally includes a positioning member 14 and a cartridge or shuttle 16 that is carried NSvrw · &lt;.... .,._;^Lon the positioning member 14 to deliver a ^ ^ S'efiador ”** 2 into a puncture (not shown). ¹ ET car tu cno 16 may include an elongated tubular member 20 carrying sealant 2 therein, a tube or support member 30 adjacent to sealant 2 within tubular member 20, and a handle or housing 23 coupled to and / or carried by tubular member 20 and / or support member 30.

As shown in Figures 1A-2A, cartridge 16 may initially be provided in a proximal position, eg, where the sealant is spaced proximally away from an expandable positioning element 46 in the positioning member 14. All of the Cartridge 16 can be advanced from the proximal position to a distal position, e.g., as shown in Figures 10A-10C, to advance the sealant 2 into a puncture and / or toward the positioning element 46. In certain aspects, the relative lengths of the positioning member 14 and the cartridge 16 may be such that the sealant 2 is placed adjacent to the positioning element 46 in an initial position, eg, such that the entire cartridge 16 is not advanced from a proximal to a distal position, eg, similar to apparatus 210 shown in Figures 8A-8C and / or apparatus 710 shown in Figures 16A and 16B, and as further described elsewhere in this document.

'V ·?>

·/’

As the picture shows

2B, include a deployment mechanism within coupled to tubular member 20 and support member 30.

As described below, deployment mechanism 60 should be configured to direct tubular member 20 and / or support member 30 axially relative to housing 23, and consequently relative to sealant 2 and / or positioning member 14 , eg, to deploy and / or compress sealant 2.

Optionally, apparatus 10 (or any of the other embodiments herein) may be part of a system, eg, which may also include a delivery, access, procedure, introducer, or other sheath 80 (not shown). , see, eg, Figures 10A-10F). Introducer sheath 80 may be a conventional sheath 80, eg, as shown in Figures 10A-10F, or it may be a custom sheath, such as sheath 780 shown in Figure 16C, eg. eg, which includes features of bleeding and / or sheath blockage, as described below.

Optionally, apparatus 10 and / or system may include one or more other components.

eg, a guidewire needle, and / or other instrument to create a puncture, a source of inflation medium, and / or a source of additional sealing compound (not shown), eg, to provide a team

<img file="MX354129B_D0022.tif" />

for a medical procedure.

i iVi riw ixni rae ss * '^ct '*'?

^or &lt;c.U; r. you-v.

Generally, as best seen in 1 to _Figujua. ^^ 2 / l_fc...- Q.1. Tubular member 20 may include a proximal end 22 that extends into and / or engages housing 23 and / or deployment mechanism 60, a distal end 24 dimensioned for insertion into an introducer and / or puncture sheath (not shown ), and a lumen 26 that extends between the proximal and distal ends 22, 24. Tubular member 20 can be substantially rigid, semi-rigid, or flexible, eg, such that tubular member 20 can be advanced through an introducer sheath or otherwise within a puncture through tissue. Distal end 24 may terminate in a tapered, rounded, or blunt distal tip. Optionally, similar to others

<td>described modalities</td><td colspan="2">later,</td><td colspan="2">the distal end</td><td> 24</td>

<td>can end in a</td><td>tip</td><td>distal</td><td>folding,</td><td>divisible,</td><td>or</td>

<td>deformable (not shown</td><td> ) ·</td><td></td><td></td><td></td><td></td>

<td colspan="2">With additional reference</td><td>at</td><td>Figures</td><td>2A and 2B,</td><td>the</td>

Support member 30 may be an elongated tubular body dimensioned to be slidably received within lumen 26 of tubular member 20. Support member 30 may include a proximal end 32 that extends inwardly and / or engages the housing 23 and / or deployment mechanism 60, and a distal end 34 positioned proximal to the sealing distal end

2, for keeping other

<img file="MX354129B_D0023.tif" />

«,

4 of the. tubular member and / or adyS'ótlf ^ ea (example, to facilitate hao acToy / o form sealant 2 within a puncture,

eg, when the tubular member 20 as described retracts during use, later. Support member 30 may also include a lumen (not shown) extending between proximal and distal ends 32, 34, eg, to slidably accommodate and receive positioning member 14 therethrough.

Support member 30 can be substantially rigid, semi-rigid, and / or substantially flexible, eg, with sufficient column strength to allow proximal movement of tubular member 20 relative to sealant 2 without changing support member 30 and / or to allow distal end 34 of support member 30 to advance to compress sealant 2 within a puncture, eg, by pushing from the proximal end! 32 by means of the mechanism

<td>of</td><td>display 60 like</td><td>more described</td><td>ahead.</td><td></td><td></td>

<td></td><td>As it is shown in</td><td>dotted on the</td><td>Figure 2A,</td><td>the</td><td>sealant</td>

<td> 2</td><td colspan="2">can be placed inside the</td><td>lumen 26</td><td>of the</td><td>member</td>

<td colspan="2">tubular 20 next</td><td>to the extreme</td><td>distal</td><td> 24,</td><td>e.g.,</td>

immediately adjacent and / or surrounded by the distal tip. Lumen 26 may be dimensioned such that tubular member 20 and sealant 2 are slideable relative to one another.

<img file="MX354129B_D0024.tif" />

IMPI

INSTITUTO MEX5CAKO to the other, eg, to allow the member ^ * to retract proximally relative to the sell'iaete »]? ·· ^¹¹ and / or support myombr · »30, as described below. In an exemplary embodiment, sealant 2 may include a first proximal, or main, section 2a that is formed from lyophilized hydrogel, and a second, distal, or tipped section 2b (not shown, see, eg, FIG. 11) which is formed from a plurality of non-lyophilized and / or non-crosslinked precursors, eg, formed as a solid mass or solid plug, melted or otherwise bonded to and extending distally from the first section, e.g., as disclosed in United States application document Serial No. 13 / 354,278, filed on January 19, 2012, the full disclosure of which is expressly incorporated or referenced herein.

Sealant 2 can include one or more biocompatible, bioabsorbable, and / or expandable materials, such as a lyophilized hydrogel. The sealant 2 may have a solid or hollow cylindrical shape, a laminated sheet shape, a disc shape, or other shapes or cross sections, such as elliptical, triangular, square, conical, disc, polygonal shapes. For example, sealant 2 can be formed from a solid material that includes a lumen (not shown) that extends between the proximal ends and

<img file="MX354129B_D0025.tif" />

distal to it. The lumen can

PI 1 create. (Lé iNDu; rwAL - * · a sheet of material around a mandrel, by molding, _ pqr.

drilling or otherwise removing material from an already formed solid material, and the like.

The lumen may be dimensioned such that the positioning member or other instrument (not shown) can slide or otherwise pass through sealant 2, as described in the references identified with Serial No. 13 / 354,278, the full disclosures of which are expressly incorporated by reference in this document.

In some embodiments, sealant 2 can be formed from a biocompatible and / or bioabsorbable hydrogel, eg, polyethylene glycol (PEG, Polyethylene Glycol). For example, the hydrogel can include a lyophilized PEG polymer that includes hydrolytically degradable chemical groups, eg, that includes a network of macro porous polymer, that can capture fluid and expand when exposed to an aqueous environment. The magnitude of expansion or swelling (pre to post hydration) can be significant, eg, about two to ten times (2X-10X) its freeze-dried size based on volume. Additionally or alternatively, sealant 2 may include pro-thrombotic material, eg, including one or more biological pro-thrombotics, such as collagen, fibrin, ά π- -τ '' · »-

Β Λ LAI ¡1 zd .. · .β ¡,¹ γ ν · - “- 'Ιν

ΙΗ5Τ: ~ ”· .Ό MEXICAN V. ' · ~ '' '> X- Ί carboxymethyl cellulose, oxidized cellulose, algin'§tf¿S ^; - ¿d) elía.ti¿ÜP,^{; i}'' or other synthetic protein-based material, such as polyglycolic acids (PGAs, Polyglycolic Acids), polylactides (PLAs, Plylactides), polyvinyl alcohol, and the like.

Optionally, sealant 2 can include one or more therapeutic and / or pharmaceutical agents, eg, to promote healing, prevent infection and / or other adverse medical events, and the like. Such agents can be embedded in the sealant material and / or applied as one or more coatings or layers. Additionally or alternatively, sealant 2 can be substantially homogeneous, or can include one or more different materials at one or more locations. For example, in some embodiments, sealant 2 may include a carrier or core having first and second hydrogel precursors placed therein in a non-reactive state, which can provide an adherent coating when sealant 2 is exposed to an aqueous environment .

Turning to Figure 2B, housing 23 may include an actuator 62 coupled to deployment mechanism 60 therein, eg, to selectively direct tubular member 20 and / or support member 30 to expose and / or compress the sealant 2. In an exemplary embodiment, deployment mechanism 60 may include one or more rack and pinion elements causing

T /..i 1; t-'cyí át. - / &lt;'♦ · K coupled together in an arrangement ^ hd ^ féfiíclo.

that the tubular member 20 and member retract in and / or advance in a predetermined sequence.

as shown in Figure 2B, the deployment mechanism may include a first rack attached to proximal end 22 of tubular member 20, a second rack attached to proximal end 32 of support member

30, and a pinion coupled between the first and second racks

64,

66.

In an exemplary embodiment, proximal ends 22 may be attached to racks 64, 66, eg, by providing stems (not shown) in racks 64, 66 that are received within proximal ends 22, 32, and / or by bonding, fusion, sonic welding at proximal ends 22, 32 to the stems or directly to the racks 64, 66.

The pinion 68 can be fixed translationally relative to the housing 23, eg, such that the pinion 68 is free to rotate about a fixed axis to the housing 23 without substantial translational movement along or through an axis longitudinal 11 of the apparatus 10. The racks 64, 66 can be slidably mounted within the housing 23, eg, along rails, rails, grooves, and the like 70, 72, such that the racks 64, 66 can be slid inside of the accommodation

IMPI /

INSTITUTE V, lonqitudajnaa¡ <> wáai .ς can be limited by —nrmmTmtinMiim IIH 1 ~ m 'Μ' ιί-ΓΙιι e ⁴ of the actuator 62 or substantially parallel to the movement of the racks 64, rails and / or by the movement interaction with the pinion 68, eg, to limit the distance that the tubular member 20 and support member 30 move.

Generally, the racks 64, 66 and the pinion 68 can include cooperating teeth that interact with each other in such a way that the movement of the elements causes the desired movement in the other elements. For example, as shown, the pinion 68 includes teeth 69, substantially dimensioned and evenly spaced around their outer circumference, and the racks 64, 66 include similar teeth 65, 67 that extend substantially continuously along their lengths . In some embodiments, the deployment mechanism may include multiple sprockets (not shown) coupled between the racks 64, 66, eg, with different tooth or diameter configurations, eg, to provide different translation rates of the first and second zippers 64, 66, if desired.

In the embodiment shown in Figure 2B, actuator 62 may be a slider button directly coupled to first rack 64. Actuator 62 may be slidable within a slot (not shown) in the

JL A «Λ. Λ. - ·. ; .-hee ..: ·· 'Mexican institute

BE THE PROPERTY £ ^; , · Accommodation 23, thus allowing «gysT &amp; ecWftá ^ OT to be directed from a first position 'U dlBtHT, * sample, until

Optionally, a second or proximal position (not shown).

the slot or housing 23 may include gaps or other locking features (not shown) to releasably secure the actuator accordingly the deployment mechanism 60, the tubular member 20, and / or support member 30) in one 'or more positions desired, eg, distal and proximal positions.

When the actuator is activated, the deployment mechanism 60 can cause the first rack 64 to be proximally directed, thereby retracting the tubular member 20 proximally. Due to cooperating teeth 65, 67, 69, movement of the first rack 64 may cause the pinion 68 to rotate, which in turn may cause the second rack 66 to advance distally and thereby advance the member support 30 distally. Therefore, actuator 62 and deployment mechanism 60 shown in Figure 2B can substantially simultaneously cause tubular member 20 to retract proximally and support member 30 advance distally to deploy sealant 2, as further described. ahead. In this arrangement, the relative movement of the tubular member 20 and the support member 30 can be one31

<img file="MX354129B_D0026.tif" />

MEXICAN INSTiTUTC a-uno, that is, the tubular member 20 is r ^ t ¿&amp; ú \) Ía''Saiéffta distance than the support member 30 svan ?? - Teeth can be provided in discontinuous and / or non-uniform arrangements, if desired, eg, to create predetermined delays in movement between tubular member 20 and support member 30 and / or different rates of retraction and advance. For example, Figure 3 shows an alternative embodiment in which zippers 64a, 66a,

<td>me</td><td>sprocket 68a</td><td colspan="2">include the</td><td>teeth 65a,</td><td>67a, 69a</td><td>not</td>

<td>are</td><td>continuous.</td><td>By</td><td>example,</td><td>the pinion</td><td>68th se</td><td>can</td>

<td colspan="2">provide with</td><td>the</td><td>teeth</td><td>69th that</td><td colspan="2">extend only</td>

partially around the outer surface or multiple sets of teeth 69a (only one set is shown for simplicity) that are spaced from each other around the circumference of the pinion 68a.

In an exemplary embodiment, racks 64a, 66a may include a substantially continuous set of teeth 65a, 67a, with teeth 65a on first rack 64a coupled with a corresponding first set of teeth 69a on pinion 68a when actuator is provided 62a in its initial distal position. In this position, teeth 67a on second rack 66a may not engage any teeth on pinion 68a. Therefore, when actuator 62a is initially activated

2 T Λ &lt;Ό] Γ<img file="MX354129B_D0027.tif" /> ί'Λ .. LX íNsmV * · 'the first zipper 64a ^B 'mbazejíspe ·

<img file="MX354129B_D0028.tif" />

immediately, thus retracting _ &lt;= ;,], τηί, οτϊΐ^ΚΐΓΛΆ·- immediately. As actuator 62a and first rack 64a move, pinion 68a can be rotated until a second set of teeth 69a (not shown) on pinion 68a engages teeth 67a on second rack 66a. Further movement of actuator 62a may consequently cause second rack 66a to move, thereby advancing support member 30 distally.

By providing one or more regions without teeth 69a on pinion 68a, advancement of support member 30 can be delayed by a desired time or distance after retraction of tubular member 20 begins. For example, this delay may allow sealant 2 to be partially or completely exposed from distal end 24 of tubular member 20 before support member 30 begins to advance to compress sealant 2, which can reduce the risk of sealant 2 is compressed and jammed within the tubular member 20.

If desired, the size and / or spacing of teeth 65a, 67a on racks 64a, 66a may be different from one another, eg, to cause different translation distances as actuator 62 is activated.

<img file="MX354129B_D0029.tif" />

³³ IMPI

U'PtGANG 'INSTITUTE · * &lt;· ·. '&lt;&lt;

For example, a second pinion can be fitted between the pinion 68a and the second rack 6 (? A new. ± ej ^ £ xa. ^ Ua .... different diameter and / or configuration of teeth corresponding to teeth 67a in second rack 66a, which may cause support member 30 to advance a greater or lesser distance than tubular member 20 retracts as actuator 62 is activated.

In some embodiments, the advancement of the support member can be delayed by indirectly coupling the proximal end 32 of the support member 30 to the second rack 66. For example, as shown in Figure 3A, the second rack 66a 'may include a stem or other extension 79a 'partially extending within distal end 32 of support member 30, eg, to support proximal end 32 of substantial lateral movement. The stem 79a 'may be dimensioned to slide within the support member 30 while still accommodating the positioning member (not shown) therethrough. Alternatively, another support (not shown) may be provided within housing 23a 'that supports the proximal end 32 of support member 30 from lateral movement while allowing axial movement. Therefore, in the initial position, the proximal end 32 of the support member 30 may be spaced distally away from the second rack 66a '.

I-γ »/ T -r» Tí '> 1 -'. I fú ¡NSTirurr *. -r - i. Zippers 64a,

66a ', and pinion 68a may include substantially continuous cooperating teeth shown), similar to the embodiment of Figure 2B, such that, when actuator 62a is activated, both racks

64a, 66a 'can be moved immediately due to pinion 68a. Because the proximal end 22 of the tubular member 20 is directly coupled to the first zipper 64a, the first zipper 64a can immediately begin to retract the tubular member 20. Although the second rack 66a 'also begins to advance immediately, the support member 30 does not initiate movement until the second rack 66a' contacts or otherwise engages the proximal end 32 of the support member 30. Therefore, movement of support member 30 can be delayed until tubular member 20 has been retracted, eg, by the offset distance of proximal end 32 of support member 30 from second rack 66a '.

Although a slider button is shown in Figures 2B and 3 for actuator 62, 62a, it will be appreciated that other actuators may be provided in housing 23, 23a '. For example, turning to Figure 4, another embodiment of a housing 23b is shown that includes a deployment mechanism 60b that includes first and second zippers 64b, 66b

IMPIOUS?

attached to one or more sprockets (tNDUATUV. 'l. · ». &lt;* is shown - the proximal ends

22, 32 of a tubular member 20 and support member 30, generally similar to those of the

Figure 3. Unlike the modality of Figure

3, actuator 62b includes a push button actuator that can be pressed at least partially within the housing

23b to activate deployment mechanism 60b. As best seen in Figure 4A, actuator 62b includes an arrow 74b that slidably mounts to housing 23b, eg, along a rail, slot, or other guide (not shown).

Actuator 62b can be directed from a first outer position, as shown, to a second inner position (not shown) further into housing 23b. Pinion 68b includes shaft 76b and shaft 74b and shaft 76b includes cooperating teeth 75b, 77b that interact to cause rotation of pinion 68b when actuator 62b is activated. The relative size of the outside diameter of teeth 77b on axis 7 6b and teeth 69b on pinion 68b can be set to provide a desired advantage, eg, such that a relatively small displacement of actuator 62b can cause a greater displacement of the tubular member 20 and / or support member 30 (or vice versa).

For example, similar to the first zipper 64b may be such that the first zipper

20) immediately retracts when

ΙΜΡΙ '^&lt;Λ·''

MEXICAN INSTITUTE moda 1 i dade s^TC couple

64b (and the tubular member initially activates the actuator 62b. The second rack 66b may not be coupled to the pinion 68b until a predetermined delay, such that the advance of the support member 30 is delayed by a desired time or distance after retraction of the tubular member 20. Alternatively, if desired, mechanism for other delays or accommodations may be provided using deployment 60b, eg, delaying retraction of tubular member 20 by a predetermined time and / or causing advancement of support member 30 before initiate retraction of tubular member 20 by providing a discontinuous region of teeth

69b on pinion 68b that do not engage teeth 65b on first rack 64b until actuator 62b is partially depressed.

Moving on to the Figure

5, another exemplary form of accommodation is shown.

23c including a deployment mechanism 60c including first and second zippers

64c,

66c attached to a pinion 68c the proximal ends

22, of a tubular member and support member

30, generally similar to the previous modalities.

Actuator 62c may include a lever

T 7 * Λ 77 7 ''

117-1 .ik r.

KSTiTUTO V 'que ^ trQQésfAisie' p-wede to rotate or otherwise direct from a distal to a second or proximal position pj- mn go to μ _ J í '-λ -¹ (not shown) Actuator 62c may include an arrow 74c that engages pinion 68c such that rotation of actuator 62c causes rotation of pinion 68c. In certain respects, one or more additional sprockets can be coupled between the sprocket

68c and zippers 64c, 66c, eg, to provide increased mechanical advantage and / or translation of zippers

64c, 66c based on distance the lever travels

62c.

Similar to the previous modalities, the first rack 64c can be coupled to the pinion 68c such that the first rack 64c (and tubular member 20) retracts immediately when the actuator is initially activated

62c. The second rack 66c may not engage the pinion 68c until a predetermined delay, such that the advance of the support member 30 is delayed after the retraction of the tubular member 20. If desired, other delays or accommodations can be provided using the deployment mechanism 60c, similar to the other modalities in this document.

Optionally, any of - these deployment mechanisms 60-60c may include features that limit the movement of actuator 62-62c and / or lasi-WS ^

64c, 66-66c. For example, with reference to the modality of the

Figure

2B (as an example only), the first rack and / or rail 70 may include one or more ratchets or other unidirectional features allow the first rack 64 to move freely proximally from the distal position to the proximal position, but prevent movement distal.

Similar features can be coupled to actuator 62 and / or pinion 68 that allow the actuator and / or pinion to move only in one direction, eg, to allow retraction of tubular member 20 but not allow tubular member Advance distally subsequently. Therefore, once the tubular member 20 is being retracted to at least partially expose the sealant to them, the tubular member may not advance distally back through the sealant 2, which may otherwise clog and / or damage the sealant.

2.

Also alternatively, one or more locking features may be provided (not on the positioning member 14,

eg, to limit movement of tubular member 20 and / or support member 30, as described below.

Optionally, any of the modalities in this document may include other desired features in housing 23. For example,

IMfri-.x>

how it was shown

INDUSTKIAL ---- sizing can be provided to slidably receive positioning member 14 therethrough. The member can be aligned with the second rack 66 and / or the proximal end 32 of the support tube 30 to slidably accommodate the cartridge 10 on the positioning member

14, as described elsewhere in this document. Additionally or alternatively, a spring mechanism 78a may be provided around the day member 78 and / or otherwise coupled between the deployment mechanism 60 and the positioning member 14. For example, a compression spring 78a may be provided between a stop on the first rack 64 and an adapter 48 on the positioning member 14 to automatically facilitate and / or retract the positioning member 14 during a procedure, as described elsewhere. part of this document.

Additionally or alternatively, housing 23 may include a sheath pickup assembly within a sleeve 23a, similar to other embodiments herein. Optionally, housing 23 may also include one or more retainers or other features (not shown) for coupling cartridge 16 to positioning member 14, eg, for releasably coupling housing 23 to adapter 48 shown in the

<img file="MX354129B_D0030.tif" />

Figur ^ g ^^ or itícusmu

<img file="MX354129B_D0031.tif" />

Dome Se '

<img file="MX354129B_D0032.tif" />

described later and in the references incorporated by reference in this document. Additionally or alternatively, housing 23 may include a trigger lock (not shown) which may be coupled to deployment mechanism 60, eg, to prevent movement of actuator 62 and / or deployment mechanism 60 until I know

<td>release the lock</td><td>, how I know</td><td>describes</td><td>later.</td><td></td>

<td>Coming back</td><td>at</td><td>Figures</td><td>1A-2A, the</td><td>member of</td>

<td>positioning</td><td>14 can</td><td>include</td><td>usually</td><td>a member</td>

<td>elongated 40 that</td><td colspan="2">includes one end</td><td>proximal 42,</td><td>an extreme</td>

distal 44, and an occlusion or positioning element 46 at the distal end 44. The positioning element 46 may be an expandable member, such as a balloon, a wire mesh structure, an expandable frame, and the like, eg ., dimensioned to advance through an introducer sheath when collapsed, as disclosed in the references incorporated by reference herein. Positioning member 46 may be selectively expandable, eg, using an inflation medium source, such as a syringe, a pull wire, and / or another actuator (not shown) operable from proximal end 42 of the member positioning 14.

<img file="MX354129B_D0033.tif" />

For example, as shown, positioning may be a balloon 46, and the member. Positioning 14 may include a tubular body 40 that includes a lumen (not shown) extending between the proximal and distal ends 42, 44 and communicating with an interior of the balloon 46. In some embodiments, the positioning member 14 may include an inflation media source, such as a syringe 148, that can communicate with an interior of adapter 48 via inflation line 48c or otherwise coupled to adapter 48 at proximal end 42 of positioning member 14. Optionally, the positioning member 14 can include an internal pull wire (not shown) that causes the balloon 46 to shorten during expansion and extend during collapse. Exemplary modalities of positioning members 14 including usable balloons are disclosed in United States Publication Nos. 2004/0249342, 2004/0267308, 2006/0253072, and 2008/0009794. Full disclosures of these references are expressly incorporated by reference in this document.

Additionally or alternatively, the positioning member may include one or more additional features to limit facilitating movement of the positioning member 14, eg, relative to other components of the apparatus

10. By

Q j ιΟΙΐΐρ · 1 · «· shown in Figures 7A-7C, the positioning member may include a retraction lock 114 within housing 23 (not shown for simplicity), which can limit the movement of positioning member 14 with relation to the first rack 64. The retraction lock

114 it can be axially fixed relative to the tubular body of the positioning member 14 and can have a larger outer dimension than an opening 61 in the first rack 64 (which can otherwise accommodate the positioning member 14 and / or support member 30 (not shown) moving axially relative to first rack 64). For example, the retraction lock 114 may be a member of the tubular body 40, eg.

interference fit, override r

<td>United</td><td>to</td>

<td>. by</td><td>means, medium</td>

<td>Union</td><td>with</td>

of one or more of an adhesive, fusion, sonic welding, and the like.

<td>The apparatus</td><td colspan="2">10 can be provided</td><td>with</td><td>a</td><td>blocking</td><td>of</td>

<td>retraction 114</td><td>located</td><td>as shown</td><td>in</td><td>the</td><td>Figure</td><td>7A,</td>

<td colspan="2">eg with the cartridge</td><td>16 in position</td><td>than</td><td>I know</td><td>shows</td><td>in</td>

<td>Figures 1A-</td><td>-2A. In</td><td colspan="2">some modalities,</td><td>the</td><td colspan="2">lengths</td>

<td>relative of</td><td>Body</td><td>tubular 40</td><td>of the</td><td colspan="2">member</td><td>of</td>

<td>positioning</td><td>14 and the</td><td>tubular member</td><td colspan="2">20 of</td><td>cartridge</td><td> 16</td>

3

IMPI Fíq ÍNSTrrvTc- ml'X'can⁴- '»v¹ - A-i-m.

L't H rfC? IEOAil and may be such that sealant 2 (not shown, ^lN^ é^rí ^ piSa · ^; ·? '' 'Figure 2A) is placed immediately adjacent expandable 46 'CS'nfaT' rftí'lSribTb '*, that is, in such a way that advancement of cartridge 16 is not necessary during the procedure, as described elsewhere in this document and in the references incorporated by reference in this document.

In some embodiments, the positioning member 14 cannot be retracted proximally relative to the cartridge

<td>due</td><td>to the</td><td>blocking</td><td>of</td><td>retraction</td><td>114 I know</td><td>lean on</td><td>the</td>

<td>first</td><td colspan="2">zipper</td><td> 64</td><td>inside of the</td><td>accommodation</td><td>23. By</td><td>the</td>

<td>so much,</td><td>the</td><td>blocking</td><td>of</td><td>retraction</td><td>114 can</td><td>to prevent</td><td>the</td>

unwanted proximal movement of the positioning member

14, eg, during preparation or other manipulation before apparatus 10 is used to seal a puncture.

As shown in Figure 7B, when the actuator 62 of the deployment mechanism 60 (not shown) is activated to retract the first rack 64 (and the tubular member 20, also not shown), the retraction lock 114 may be spaced a distance corresponding 115A of the first rack 64. Thereafter, if the positioning member 14 is retracted, eg, manually or automatically during a sealing procedure, as described elsewhere in this document, the distance that the positioning member 14 can retract is limited by the distance 115B, this is until the blocking of

<img file="MX354129B_D0034.tif" />

again at the first zip 64, like,

Figure 7C.

Additionally or alternatively, the positioning member 14 may include a self-retracting assembly 140 that can be used to automatically retract the positioning member 14 during use. For example, Figures 6A and 6B show an exemplary embodiment of a self-retracting assembly 140 attached or otherwise coupled to a positioning member 14 ', which is generally similar to other positioning members described elsewhere in this document and in the applications incorporated by reference in this document.

Alternatively, the features of the self retracting assembly 114 can be incorporated directly into the adapter 48 'of the positioning member 14' (not shown).

Generally, self-retracting assembly 140 includes a housing 142 that includes a chamber 53 within which a piston 14 can be slidably positioned. Chamber 143 can be substantially sealed between piston 144 and adapter 48 ', p eg by the same piston 144 and / or other seals 144a, so that fluid and / or pressure from chamber 143 can be introduced or evacuated without leakage

5 substantial

The piston

144 can be

<img file="MX354129B_D0035.tif" />

<img file="MX354129B_D0036.tif" />

<img file="MX354129B_D0037.tif" />

tubular 40 'of the positioning member ^ 14', jcuej., adjacent to the proximal end 42 'of the tubular body 40',

eg, by one or more of an interference fit, adhesive bonding, melting, sonic welding, and the like.

In addition, a fluid / pressure line 146 communicates with

<td colspan="2">camera 143,</td><td>eg coupled to</td><td>the</td><td>inflation line</td><td>48c '</td>

<td>That</td><td>communicates</td><td>with a syringe</td><td>(not</td><td>shown), similar</td><td>to</td>

<td>That</td><td>shows</td><td>in Figure 1A,</td><td>the</td><td>what can be the</td><td>same</td>

<td>j eringa</td><td>That</td><td colspan="2">used to inflate</td><td colspan="2">and collapse the member</td>

expandable 46 'of positioning member 14'. The fluid / pressure line 146 may include a flow control switch 146a to selectively open and close the fluid / pressure line 146 during use, eg, such that chamber 144 communicates with the syringe only when switch 146a is open.

Before use, the positioning member 14 'may be provided with the piston 144 in the distal position shown in Figure 6A. As shown, in this position, the proximal end 42 of the tubular body 40 is generally extended and / or straight. To secure piston 144 and proximal end 42 in this position, switch 146a can be opened and fluid can be introduced into chamber 143, thereby closing switch 136a.

When you want to retract the member of

<img file="MX354129B_D0038.tif" />

14 ', eg after unfolding or exposing

<img file="MX354129B_D0039.tif" />

the expandable member 46 may collapse, eg, by evacuating fluid via inflation line 48c 'similar to other modalities, with switch 146a in the closed position. Once the expandable member 46 collapses, switch 56a can be opened, and the fluid to be evacuated from chamber 143 via fluid / pressure line 146, eg, using the same syringe or syringe different from the one used to collapse the expandable member 46.

This evacuation may cause piston 144 to slide proximally into housing 142 toward the adapter.

48 ', as shown in Figure 26B, thereby pulling expandable member 46 proximally, eg, through sealant 2 and / or into tubular member 20 (not shown), similar to the process shown in Figures 9A and 9B. As piston 144 moves proximally within housing 142, it can cause proximal end 42 of tubular body 40 to gather and / or otherwise collapse within chamber 143, also as shown in Figure 6B.

In some embodiments, other self-retracting features may be provided in the positioning member 14, eg, similar to the spring mechanism

7 Τ í \ AD? ...

Ιΐ'ίΟ A p

BtmTinvM & xiCAwo. » : '' ·> 1

78a shown in Figure 2B. For example ^ w ^^ w ^ i ^ urgSL *

8A-8C show another exemplary modality of an aparatQ_JjlQ. ...... includes a positioning member 214 and cartridge 216 generally similar to other embodiments in this document. As shown, the positioning member 214 can include a tubular body 240 that includes an adapter 248 at its proximal end 242 and a balloon 246 at its distal end.

244. Cartridge 216 may include a tubular member 220 that includes a sealant 2 and support member 230 therein, and a housing 223, which may include a deployment mechanism 260 therein, similar to any of the other embodiments herein. document. In some embodiments, the relative lengths of tubular body 240 and tubular member 220 can be such that a distal end 244 of tubular member 220, and consequently sealant 2, can be located adjacent balloon 246, thereby eliminating the need for Advance the entire cartridge 216 during use.

Positioning member 214 may include a lock to selectively prevent positioning member 214 from moving relative to housing 223 and / or a bypass mechanism to automatically retract positioning member 214. For example, the lock may include a lock. hydraulic, eg a balloon or

J ί \ · 1 ν _1_, expandable membrane 261, surrounding an adapter 248 that is located inside housing 223. An interior of membrane 261 can communicate with inflation line 248c that communicates with the interior of balloon 246 or alternatively, a separate inflation line (not shown) can be contacted, if desired. In certain aspects, a bellows structure (not shown) may be provided in adapter 248 that expands and / or retracts when activated by fluid. In certain aspects, a mechanical lock (not shown) may be provided that can be manually activated to lock and / or release adapter 248 from housing 223 or membrane 261 may be configured to direct expandable retainers or other features in engagement between the adapter 248 and housing 223, if desired.

Initially, as shown in Figure 8A, membrane 261 can collapse similar to balloon 246. When balloon 246 expands, fluid can also expand membrane 261, as shown in Figure 8B, thereby coupling the housing 223 and preventing subsequent axial movement of positioning member 214 relative to housing 223. When balloon 246 is subsequently deflated, as shown in Figure 8C, the fluid can also be evacuated from inside the membrane 261,

<img file="MX354129B_D0040.tif" />

decoupling the position member A '^ ffi? ^ * hto ^^{; k}2d: 'ⁱf · 'of housing 223, and allowing · - · ei ·'

<img file="MX354129B_D0041.tif" />

• Positioning 214 subsequently retracts relative to housing 223, eg, to retract collapsed balloon 246 through sealant 2 and / or into tubular member 220, similar to other embodiments herein. In certain aspects, a bellows lock can be expanded and / or retracted and coupled to retainers or other features between adapter 248 and housing 223. In certain respects, a mechanical lock can be attached separately, eg, before or after balloon 246 is expanded .

Housing 223 and adapter 248 may include cooperating features that automatically retract positioning member 214 when balloon 246 deflates or when the lock is otherwise decoupled. For example, as shown in Figures 8A-8C, a deflection mechanism may be provided that includes a spring 262 coupled between a first rack 264 (coupled to tubular member 220) of deployment mechanism 260 and adapter 248 of the deployment member. positioning 214. For example, a compression spring 262 can be positioned around proximal end 242 of tubular body 240 of positioning member 214 within housing 223 of cartridge 216. As shown, a first end of the spring

262 can be attached or supported on a

<img file="MX354129B_D0042.tif" />

of the first zipper 2 64, and a second end. .J _______ spring 262 can be attached to or supported on a distal end of adapter 248. In the initial configuration shown in Figure 8A, spring 262 can be in a relaxed state, or in a slightly compressed state, eg. , if it is desired to deflect the first rack 264 distally within the housing 223.

In use, an actuator (not shown) of deployment mechanism 260 can be activated to direct first rack 264 proximally, consequently retracting distal end 224 of tubular member 220 to expose sealant 2, which may also advance second rack 266 and distal end 234 of support member 230, similar to other embodiments herein, as shown in Figure 8B. As the first rack 264 translates proximally into housing 223, the first end of spring 262 can be proximally directed toward the second end. However, with hydraulic lock 261 activated, adapter 248 of positioning member 214 can be restricted from moving proximally, thereby compressing spring 262 to a higher potential energy state, also as shown in Figure 8B.

I Μ. ΡI * 5! ^

Subsequently, when balloon 246 is desired, fluid can be evacuated through inflation line 248c, thereby causing both balloon 246 and membrane 261 to collapse. Due to the potential energy stored in spring 262, adapter 248 of positioning member 214 can automatically be directed proximally, thereby retracting proximally collapsed balloon 246, eg, through sealant 2 and into the end distal 224 of tubular member 220, as shown in Figure 8C. Support member 230 can remain substantially stationary during this action, thereby preventing sealant 2 from moving proximally as balloon 236 retracts. Optionally, as shown in Figures 9Ά and 9B, the support tube 230 may include a stop or other feature 237 that can be attached to a second rack 266 to prevent retraction of the support member 230 when the positioning member 214 retracts . Additionally or alternatively, the second rack 266 and / or other deployment mechanism components (not shown) may include a brake or other features that prevent proximal movement of the second rack 266, eg, to prevent inadvertent retraction of the support member

230.

Optionally can be provided

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<img file="MX354129B_D0043.tif" />

diversion mechanism to delay CUlapsu ¹ of 1 · »—— membrane 261 for a predetermined time relative to balloon 236, eg, to allow the balloon to begin to collapse or to completely collapse before membrane 2 61 collapses. Therefore, the delay can ensure that balloon 246 collapses substantially before positioning member 214 is released and spring 262 automatically retracts balloon 246 through sealant 2. For example, in some embodiments, a restriction (not shown) may be provided in the hydraulic circuit that communicates from inflation line 248c into membrane 261. Therefore, when fluid is initially evacuated through the inflation line 248c, fluid can be evacuated more quickly from balloon 246 than membrane 261.

In some embodiments, the inflation fluid delivered into balloon 246 and membrane 261 can be selected to facilitate the desired time or delay in collapse. For example, differently dimensioned orifices or other flow receptors may be provided at the branches of the fluid path from inflation line 248c to the insides of balloon 246 and membrane 261, and fluid with a desired viscosity may be provided

IMPIA to cause a delay in the flow of f

INDUfTIUAL

INDUrnUAL war ramifications. The internal diameters of the flow writers can be selected to allow the balloon 236 to deflate completely before the membrane 261 collapses and the positioning member 214 retracts through the sealant 2 and into the support tube 230.

In an exemplary embodiment, the fluid viscosity can be relatively higher than that of water, eg, by including a radiopaque contrast mixture, which can also facilitate monitoring of balloon 246 under fluoroscopy or other generation of external images. In certain embodiments, a mechanical lock can simply be disengaged at any time, eg, after ensuring that balloon 236 has substantially collapsed, to retract positioning member 214 and direct collapsed balloon 246 through sealant 2 to the member. support 230, as shown in Figures 8C and 9B.

With further reference to Figures 10A-10C, apparatus 10 of Figures 1A-2B (or any of the other embodiments herein) can be used to position and deliver sealant 2 within a puncture, eg, extravascularly just above or otherwise adjacent to an arteriotomy in a blood vessel or other body lumen that communicates with a puncture, as further described in the modality shown in

Figures 1A-2A, the cartridge (together with the sealant 2 within the tubular member 20) can initially be provided at the proximal end 42 of the positioning member 14. For example, the adapter 48 in the positioning member 14 and the housing 23 in cartridge 16 they can initially be connected to each other,

eg, using one or more releasable catches (not shown). In some embodiments, as shown in the embodiment of Figures 8A-8C (or apparatus 710 of Figures 16A-16D), cartridge 216 may initially be provided such that distal end 224 of tubular member 220 is positioned adjacent to balloon 246, eg, as disclosed in U.S. Patent No. 7,335,220 and U.S. Publication No. 2008/0082122, which are incorporated by reference elsewhere in this document.

As shown in Figures 10B and 10C, cartridge 16 can be distally slidable along positioning member 14, eg, by disconnecting housing 23 from adapter 48, and then advancing cartridge 16, eg ., until the distal end 24 of the tubular member 20 is positioned adjacent to the positioning element 46. For example, the retainers in the housing 23 and the adapter 48 can simply be detached as one housing 23 advances away sufficient force. In some iMPIt's. „E ±

rNrA'STídAí- - of the adapter 48 with modalities, one of the housing and the adapter 48 may include an actuator or lock which can be activated (not shown) to separate the retainers and / or otherwise allow the cartridge 16 to advance relative to the positioning member 14.

Optionally, cartridge 16 and / or positioning member 14 may include cooperative features that limit distal movement of cartridge 16 relative to positioning member 14. For example, housing 23 of cartridge 16 may include a gap and the member Positioning 14 may include a retainer or other feature (both not shown) that can reside within the gap when cartridge 16 is advanced to a distal position.

Additionally or alternatively, one or more markers may be provided on apparatus 10, eg, to identify when components are located at one or more desired positions or otherwise to facilitate use of the apparatus.

10. For example, positioning member 14 may include one or more markers 43 at predetermined locations on elongate member 40. Such markers can provide visual confirmation when cartridge 16 has advanced to a desired distal positioni ^ vp ^ j ^ j · ', 'Fgah.ctó:

*** - · .—— marker (s) 43 emerge (s) from housing 23 conforming.

cartridge 16 advances over positioning member 14.

Turning to Figures 10A-10G, an exemplary method of sealing a puncture 90 is shown,

eg, using apparatus 10 of Figures 1A-2B (or again any of the other modalities herein) to deliver a sealant 2, eg, to achieve hemostasis within puncture 90. Generally, the Puncture 90 extends from the skin of a patient 92 through the intermediate tissue, eg, to a body lumen 94. In an exemplary embodiment, puncture 90 may be a percutaneous puncture that communicates with a blood vessel 94, such as a femoral artery, carotid artery, and the like.

In an exemplary method, puncture 90 can be created using known procedures, eg, using a needle, guidewire, one or more dilators, and the like (not shown). An introducer sheath 80 can be advanced through puncture 90 into vessel 94, eg, on a guide wire (not shown) placed through puncture 90 into vessel 94. Introducer sheath 80 may provide access to vessel interior 94 for one or more instruments (not shown), eg, to allow one or more diagnostic and / or diagnostic procedures to be performed.

7

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intervention by vessel 94. By con® * eteawxicAN &lt;er (losg Dt PtóPitDM »\ (KDUTSIAL ------- procedure (s) by vessel 94, any such instrument (s) can be removed of puncture 90, leaving introducer sheath 80 extending through puncture 90 into vessel 94.

Referring to Figures 10A, the positioning member 14 can be inserted into and / or through the lumen of the introducer sheath 80, eg, with the expandable positioning element 46 in a folded condition. Cartridge 16, along with sealant 2, may initially be provided at proximal end 42 of positioning member 40 with actuator 62 in the first or distal position, eg, as shown in Figure 2A. Therefore, the distal end 24 of tubular member 20 can initially be located outside of puncture 90 when positioning member 14 advances into puncture 90.

Still referring to Figure 10A, distal end 44 of positioning member 14 can be inserted through puncture 90 (via introducer sheath 80) and into vessel 94. If the cartridge is configured such that sealant 2 is placed immediately adjacent to the positioning element, similar to the cartridge 216 of Figures 8A-8C, the distal end 224 of the tubular member through the introducer sheath in another form, as shown in

<img file="MX354129B_D0044.tif" />

0 and entering vessel 94 ........ From Figures 10A and 10B, distal end 24 of tubular member 20 may remain outside of puncture 90.

Once the positioning element 46 is placed within the vessel 94, that is beyond a distal end 84 of the introducer sheath 80, the positioning element 46 can be expanded to an enlarged condition, as shown. After expanding the positioning element 46, the positioning member 40 can be removed at least partially until the positioning element contacts the wall 96 of the vessel 94, eg, to substantially seal the puncture vessel 94 90. In an exemplary method, shown in Figures 10A and 10B, this may involve a two-step process (although it can be completed in substantially one continuous action). First, with the myth 46 positioning element expanded within the vessel, the positioning member 14 can be removed until the positioning element 46 makes contact with the distal end 84 of the introducer sheath 80, which can provide a first tactile feedback. to the user (that is, that the positioning element 46 has contacted the introducer sheath 80, eg, with

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ΙΝΓΠΤΙ'Ί Γ MEXICAN ·. ·. ' · Basis on weight and / &amp;^THE£ ^ LatéTtói (Increased to proximal movement).

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Positioning 14 can be further removed until the positioning element 46 makes contact with the vessel wall 96 and resists further removal, thereby providing a second tactile feedback.

The introducer sheath can be pulled proximally by the positioning element 46 as the positioning member 14 is removed,

eg, until the end of introducer sheath 80 is withdrawn from vessel 94 into puncture 90, as shown in Figure 10B.

Proximal tension may be applied and / or maintained on positioning member 14 to hold positioning element 46 against vessel wall 96, eg, to seal puncture 90 from vessel 94 and / or prevent further removal of the positioning member 14. Proximal tension can be maintained manually or using a tension device (not shown) to provide temporary hemostasis, eg, during subsequent steps.

<td>Devices</td><td>tensile</td><td>ex empiares</td><td>are disclosed in</td><td>the</td>

<td>Document from</td><td>Publication</td><td>of the</td><td>United States</td><td>No.</td>

<td> 2004/0267308,</td><td>which is</td><td colspan="2">incorporated by reference in</td><td>other</td>

part of this document.

Turning to Figure 10C, the cartridge

<img file="MX354129B_D0045.tif" />

sealant 2) can then advance distally over the sealant. ,."the_....

positioning member 14 inside puncture 90.

As shown, the distal end 24 of tubular member 20 can enter introducer sheath 80 and advance toward positioning element 46. Cartridge 16 can advance until a component of cartridge 16 meets a stop on the positioning member 14, thereby preventing further advancement of the cartridge 16 and / or spacing the sealant 2 a predetermined distance from the positioning element 46. Alternatively, the cartridge 16 may advance the interior of the introducer sheath 80 until the distal end 24 contacts the expanded positioning element 46, tactile feedback of sufficient, or the sealant within the puncture 90.

Optionally, which can be provided by cartridge 16 has advanced 2 is otherwise positioned to provide a sleeve or locking device (not shown) in cartridge 16 that can couple introducer sheath 80 to tubular member 20 as cartridge 16 advances , similar to other modalities in this document or modalities that are disclosed in the document of publication of the United States No. 2009/0088793, the full disclosure of which is expressly incorporated by reference in this document.

Cartridge housing 23 16 may include one or more features that can be coupled to mating features (also not shown) on the sheath adapter

eg, to couple the movement of the tubular member 20 and / or other components of the cartridge 16 to the introducer sheath similar to other embodiments herein.

In certain scenarios, if a cartridge is provided, such as the cartridge 216 of Figures 8A-8C, which includes the distal end 244 of the tubular member 220 and the sealant 2 immediately adjacent to the positioning element 246, the cartridge 216 does not advance and it is simply inserted into the sheath 80 together with the positioning member 214. Therefore, the distal end 224 of tubular member 220 can be briefly exposed within vessel 94 before positioning element 246 expands and entire apparatus 210 is removed to direct positioning element 246 against vessel wall 96. In certain aspects, sealant 2 may be slightly embedded within distal end 224, eg, if it is desired to minimize exposure of sealant 2 to fluid, it may be flush, or may extend slightly from distal end 24, eg, as shown in Figure 11 and further described elsewhere in this document.

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<img file="MX354129B_D0046.tif" />

Optionally, for the Fignrac 'modality, positioning member 214 and cartridge 216 may advance into introducer sheath 80 until a marker (not shown) at proximal end 222 of tubular member 220 is aligned with adapter 83 of introducer sheath 80, which can provide a visual indication that positioning element 246 is positioned distally beyond distal end 84 of sheath 80, that is, within vessel 90. After the positioning element 246 has expanded and the positioning member 214 and the cartridge 216 retracted to position the positioning element 246 against the vessel wall 94, the sheath 80 can be retracted a desired distance to expose the distal end 224 of tubular member 220 within puncture 90 adjacent positioning element 246, if desired. Optionally, tubular member 20 may include another marker (not shown), which can be aligned with adapter 83 of introducer sheath 80 when sheath 80 has been sufficiently retracted.

If desired, cartridge 216 may include a trigger lock (not shown), eg, at the distal end of housing 223, and sheath 80 can be retracted until adapter 83 engages with the trigger lock . Without activator attached to activated lock K_iT! T -.! 6Í.txibl &lt;© qúS'P activating actuator 262 can prevent deployment mechanism 260, thereby preventing unintentional deployment of sealant 2.

In some embodiments, sheath 80 may be coupled to cartridge 216 when the apparatus

210 sufficiently that the tubular limb movement has advanced introducer 80

<td>inside</td><td>of the</td><td>sheath</td><td colspan="2">80, eg in such</td><td>shape</td>

<td>Or the</td><td>sheath</td><td>80 se</td><td>couple to</td><td>movement</td><td>or of</td>

<td> 220 .</td><td>Can</td><td>to be</td><td>desirable</td><td>that</td><td>sheath</td>

<td>i have</td><td>a</td><td colspan="3">default length</td><td>with</td>

such that the ends are related to the tubular member 220 and

the tubular member 220 are aligned with each other,

eg, substantially coextensive with one another. Therefore, when tubular member 220 (and consequently sheath 80) is retracted, sealant 2 can be exposed beyond distal end 84 of sheath 80.

Then, turning to Figure 10D with continued reference to apparatus 10 of Figures 1Ά-2Β, actuator 62 can be

<td>Activate,</td><td>P</td><td>eg.</td><td>direct the</td><td colspan="2">actuator</td><td> 62</td><td>to</td><td>the</td><td>second</td>

<td>position</td><td>or</td><td>proximal</td><td>, provoking</td><td>this</td><td colspan="2">way</td><td>than</td><td>the</td><td>member</td>

<td>tubular</td><td> 20</td><td>(and the</td><td colspan="2">introducer sheath</td><td> 80,</td><td>yes</td><td>I know</td><td colspan="2">couple to</td>

tubular member 20 or not yet removed) begin to retract relative to positioning member 14, sealant 2, and support member

<img file="MX354129B_D0047.tif" />

delay provided in the deployment mechanism shown, see, eg, Figure 2B) can allow tubular member 20 to retract, with support member 30 preventing substantial proximal movement of sealant 2, until sealant 2 it is substantially exposed within puncture 90 beyond distal end 84 of the introducer sheath, as shown in Figures 10D and 10E.

As actuator 62 continues to move toward the second position, support member 30 can begin to advance, as shown in Figures 10E and 10F, thereby compressing sealant 2 against expanded positioning element 46 and / or arteriotomy and vessel walls 96.

When sealant 2 is exposed within puncture 90, sealant 2 can be exposed to blood and / or other bodily fluids within puncture 90. This exposure can cause sealant 2 to absorb fluid and activate to provide hemostasis, as further described elsewhere in this document. If sealant 2 includes the distal section that is formed from uncrosslinked precursors, the precursors can articulate and bond sealant 2 relative to surrounding tissue, eg, by bonding the outer surface of vessel wall 96 and /or

<img file="MX354129B_D0048.tif" />

INÍTraüV MLZ.IK.AWZ, ·. . .

other tissue adjacent to the arteriotomy, or otherwise penetrate into the arteriotomy ......

optionally extending into vessel 94, which may improve the resulting seal and / or cause migration of proximal section 4 of sealant 2, eg, away from arteriotomy and vessel wall 96.

After sufficient time, the positioning element 46 can be folded down, and the apparatus 10 can be removed from the puncture 90, leaving the sealant 2 inside the puncture 90 and / or against the vessel wall 96, as shown in the Figure 10G. Initially, the positioning member 14 can be retracted through the sealant 2, eg, into the support member 30, eg, as shown in Figures 9A and 9B. Optionally, the 14-position member can be automatically retracted, eg, using a self-retracting assembly (not shown), such as those described elsewhere in this document.

In some embodiments, an actuator, eg, a single button, or a pair of opposing buttons (not shown), may be provided on the positioning member 14. The button (s) can be located on the adapter 48, which can be secured to the table on which the patient or other fixed surface is placed during the procedure. The pressure design can retract deflated balloon 46 through compressed sealant 2 as it is removed from container 94

Continuing the reference

Ti λ: r V i í * h y- * .i · .- x · the member d¡®^T'^ gs; r & SSnájni ^ Rtj>' and the puncture 90 Figures 9A and 9B, stationary when the positioning member 214 retracts, as described elsewhere in this document, thereby preventing the sealant 2 from being directed proximally away from the vessel wall 96 when the positioning element 46 is pulled through the sealant

2. If desired, the support member 30 can be further advanced, eg, to compress the sealant 2 within the puncture 90. The support member 30 and any other component of the apparatus 10 still extending into the puncture 90 it can then be removed, leaving the sealant 2 within the puncture and / or against the vessel wall 94.

Turning to Figure 11, another exemplary embodiment of an apparatus 310 for sealing a puncture through tissue is shown. Generally, similar to the previous modalities, the apparatus 310 can include a positioning member

314 and a cartridge 316 which is carried in the positioning member 314 to deliver a sealant 2 therein into a puncture (not shown). Positioning member 314 may include a tubular body 340 that includes an adapter at its proximal end (not shown) and a balloon 346 at its distal end 344. Including a tubular member 320 that includes a second member of support

330 in the same. Similar to the embodiment of Figures 8A-8C, the relative lengths of tubular body 340 and tubular member 320 can be such that a distal end

324 of the tubular member 320, and consequently the sealant 2, can be located immediately adjacent to the balloon 346.

Therefore, there is no need to advance the entire 316 cartridge during use.

Tubular member 320 may include a composite distal end 324 that includes a distal tip segment 325 that is formed differently than the distal end portion!

adjacent. For example, distal segment 325 may include a plurality of slits or others that extend axially, helically, or otherwise along at least a portion of the distal segment

325.

Additionally or alternatively, the distal segment 325 may have a relatively thinner wall thickness than the adjacent distal end 324 and / or may be formed from weaker material which can divide, bend, collapse, expand, or deform from another easy way to expose the sealant 2 in it.

As shown, sealant 2 can include a proximal or main section 2a and a distal or tip section 2b that is formed from precursors

<img file="MX354129B_D0049.tif" />

distal section 2b can extend at least parciajjjggfiie ·· »- '' from distal segment 325 of the tubular member

320, eg, as shown in Figure

11.

An example, apparatus 310 may be provided to the user with distal section 2b exposed, or the user may advance the support member

330 a predetermined distance,

eg, using an actuator or handle (both not shown) from the 316 cartridge.

If distal section 2b extends at least partially from distal segment 325, distal section 2b may optionally have a rounded or other shape, eg, to provide a substantially atraumatic and / or conical shape (not shown) to facilitate introduction to an introducer sheath and / or puncture.

The apparatus 310 can be inserted into a puncture, eg, through a pre-positioned introducer sheath (not shown) with the positioning element 346 folded down such that the positioning element

346 and distal segment 325 can be exposed beyond the introducer sheath within puncture and / or vessel 94. Positioning element 346 can be expanded and directed against vessel wall 96, as shown in Figure 11, and The introducer sheath can be removed, if necessary to expose the distal segment seals 25, similar to other modalities herein.

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THE ΓΚΟΡΤΣΑ ”

INOUSCáIAU

<img file="MX354129B_D0050.tif" />

With distal section 2b of sealant 2 partially exposed, crosslinking can be initiated, thereby attaching sealant 2 to arteriotomy, vessel wall 94, and / or surrounding tissue, similar to other modalities herein. The support member 330 can then be advanced to press the sealant 2 against the vessel wall and / or the positioning element 346, thereby applying an outward expanding force on the distal segment 325 of the tubular member 320 according to the sealant 2 is compressed. This can cause distal segment 325 to split, fold, fold, or otherwise deform to expose sealant 2 within the puncture. Positioning element 346 can be folded (eg, using any of the apparatus and methods herein), and apparatus 310 can be removed from the puncture, similar to other embodiments herein. Attaching distal section 2b to vessel wall 96 can prevent binding of sealant 2 and / or decoupling of sealant 2 when apparatus 310 is removed.

Therefore, distal segment 325 can provide a skirt or cover over sealant 2 to minimize premature exposure of sealant 2 to fluid, yet can still be opened to expose sealant 2 without having to retract

<img file="MX354129B_D0051.tif" />

330, positioning element 346, and / or vessel wall 96.

Turning to Figure 12, another exemplary embodiment of an apparatus 410 for sealing a puncture through tissue is shown. Generally similar to the previous embodiments, the apparatus 410 may include a positioning member 414 and a cartridge 416 that is carried in the positioning member 414 to deliver a sealant 2 therein within a puncture (not shown). Cartridge 416 may not include a tubular member carrying a sealant and a support member therein. Instead, cartridge 416 may include a sealant sleeve 450 carrying sealant 2 therein, and surrounding a distal end 434 of a support member 430 adjacent sealant 2, and a handle or adapter 423 at the end. proximal 432 of support member 430. As shown, cartridge 416 may initially be provided adjacent an adapter 448 of positioning member 414, although alternatively cartridge 416 may initially be provided such that sealant sleeve 450 and sealant 2 are located immediately adjacent to a positioning element 446 of the positioning member 414, eg, similar to apparatus 710 shown in Figures 16A-16D and further described elsewhere in this document.

As seen it may include a relatively large, better in the proximal portion Figure

eg dimensioned

<img file="MX354129B_D0052.tif" />

452 in diameter to abut or otherwise contact an adapter or proximal end 83 of an introducer sheath 80 (not shown, see, eg, Figures 13A-13C), and a relatively small diameter distal portion 454, eg, sized to fit adapter 83 and / or lumen of introducer sheath 80. For example, introducer sheath adapter 83 may include one or more valves, eg, a hemostatic valve therein, and distal portion 454 of the sleeve may be sized to enter adapter 83 and open at least partially the valve as cartridge 416 is advanced, eg, to facilitate sealant 2 and / or support member 430 to enter the lumen of the introducer sheath, as described below.

Sleeve 450 can be relatively short in length compared to support member 430, eg, such that sleeve 250 can slide proximally on support member 430 a desired distance. For example, sleeve 450 may have a total length of between about five and forty millimeters (5-40 mm), between about ten and twenty-four millimeters (10-24 mm), and the like, and distal portion 454 may have a length , eg, between about \ Γ ·· three and twenty millimeters (3-20 mm), understand¹ twenty-four millimeters (12-24 mm), between about ^ - ~~ eighteen millimeters (15-18 mm), and the like, eg, sufficient to substantially cover sealant 2.

Optionally, sleeve 450 may include an interior lumen 456 configured to provide preferential and / or different frictional interference with an outer surface of support member 430. For example, interior lumen 456 may allow sleeve 450 to slide freely proximally to support member 430, while providing improved friction that resists distal movement of sleeve 450 on support member 430. Also, alternatively, sleeve 450 may be releasably attached to distal end 434 of support member 430, eg, using a low-bond adhesive, and the like, which may be released or otherwise overcome when the Cartridge 416 advances into an introducer sheath, as described below.

In an exemplary embodiment, sleeve 450 may be formed from an outer annular body and a section of tubing that is received at least partially within the annular body (not shown). In certain aspects, sleeve 450 can be integrally formed as a single piece, eg, by molding, machining, casting, and the like. The components of

ΓΓ ν \ β '' '. 1 iVt χ * ¿' · '.- &lt;&lt;' + sleeve 4 50 can be made from the^L'ñέism ^ ¿^ tέ ¢ i · al · .3. ·^;'' or a different one, eg, plastic, metal, or materials. — ... composites. Exemplary materials and methods for making sleeve 450 are disclosed in US Patent No. 7,993,367, the full disclosure of which is expressly incorporated by reference herein.

Turning to Figures 13A-13C, apparatus 410 can be used to position and deliver sealant 2 within puncture 90, eg, extravascularly just above or otherwise adjacent to an arteriotomy in a blood vessel or other body lumen 94 that communicates with a puncture 90 as further described elsewhere in this document. As shown in Fiqura 13A, cartridge 416, with sleeve 450 positioned over sealant 2 and distal end 434 of support member 430, may initially be provided at proximal end 442 of positioning member 414. For example, adapter 448 in locating member 414 and housing 423 in cartridge 416 can initially be connected to each other, eg, using one or more liberal retainers (not shown). As shown in Figure 13B, cartridge 416 can be distally slidable along positioning member 414, eg, by disconnecting housing 423

4 • r · τι &lt;· ΤΗ »TT Tvt ?? ax 1 ϊ 1 A- A of adapter 44 8, and then advance the car e-1IsluíTMAl. ---....- positioning element 446.

Continuing reference to Figures 13A-13C, the apparatus 40 can generally be used in cooperation with an introducer sheath 80 to deliver the sealant 2 within a puncture 90. The introducer sheath 80 may be part of a system or equipment that includes the apparatus 410 or it can be a standalone device. Generally, introducer sheath 80 includes a proximal end 82, a distal end 84 dimensioned for insertion into a puncture 90 through tissue, and a lumen 8 6 extending between proximal and distal ends 82, 84. The introducer sheath 80 can be formed from a substantially rigid, semi-rigid, and / or flexible tubular body that includes an adapter 83 at the proximal end 82. Introducer sheath 80 may be of sufficient length to extend from a patient's skin through any intervening tissue within a blood vessel or other body lumen, eg, having a length of between about ten centimeters and twenty centimeters (10-20 cm), and can have an outer diameter of between about 1.6 millimeters and five millimeters (1.6-5 mm). Distal end 84 can be tapered and / or can include a substantially atraumatic distal tip to facilitate advancement through a puncture.

Introducer sheath 80 can be

<img file="MX354129B_D0053.tif" />

plastic with known materials and / or methods, eg

tubular body and adapter 83 substantially permanently connected together, eg, using an interference fit, one or more mating connectors (not shown), adhesive bonding, ultrasonic welding, and the like. Adapter 83 may generally include one or more seals, eg, one or more hemostatic seals (not shown) therein, which can prevent the flow of blood or other fluids out of adapter 83 from lumen 86, and still accommodate insertion of one or more instruments into lumen 8 6, such as positioning member 414 and / or cartridge 416. Optionally, as shown, adapter 83 may include a side port 89 that communicates with lumen 86, eg, to couple a source of saline or other fluid (not shown) to adapter 83.

Initially, as shown in Figure 13A, positioning member 414 can be inserted into and / or through lumen 86 of introducer sheath 80, eg, with expandable positioning element 446 in a folded condition. Cartridge 416, along with sealant 2 and support member 430, may initially be provided at proximal end 442 of positioning member 440, eg, as shown in Figure 12. Therefore, the distal end 454 initially outside of sleeve 4 50 Locate · j

INCU'.T'itU '' • -z-— - the puncture 90 and separated from the adapter when the positioning member 414 advances into the puncture 90.

Still referring to Figure 13A, distal end 444 of positioning member 414 can be inserted through puncture 90 (via introducer sheath 80) and into vessel 94. Once the positioning element 446 is placed into the vessel 94, that is, beyond the distal end 84 of the introducer sheath 80, the positioning element 446 can be expanded to an enlarged condition, and the myth positioning member 414 it can be removed at least partially until the positioning element 446 makes contact with the vessel wall 96, eg, similar to other embodiments herein.

Turning to Figures 13B and 13C, cartridge 416 (which carries sealant 2) can be advanced distally on positioning member 414 toward introducer sheath 80. As cartridge 416 advances, sleeve 450 can contact the introducer sheath 80, which can prevent further advancement of sleeve 450. For example, distal portion 454 of sleeve 450 may at least partially enter adapter 83 of introducer sheath 80 and portion

1.Μ Λ- '1; ·' proximal 4 52 of sleeve 4 50 can be supported 3¾ as best seen in Figure 13C, thus preventing __________ further advancement of sleeve 450. If sleeve 450 according to releasably to support member 430, advancement of cartridge 416 to this point can release sleeve 450 from distal end 434 of support member 430.

Cartridge 416 can advance more distally toward positioning element 446, whereby sleeve 450 can remain substantially stationary relative to introducer sheath 80 and, consequently, slide proximally on support member 430. Therefore, distal end 434 of support member 430 can exit distal portion 454 of sleeve 450 and enter lumen 86 of introducer sheath, thereby expelling sealant 2 from sleeve 450 and into lumen. 86 of the sheath, as shown in Figure 13C. The distal portion 454 of the sleeve 450 may have sufficient length and / or other characteristics to at least partially open the valve (s) (not shown) within the introducer sheath adapter 83, e.g. , to facilitate the sealant 2 and the distal end 434 of the support member 430 advancing into the lumen 86 of the introducer sheath. Therefore, sleeve 450 can protect sealant 2 until sealant 2 passes through adapter 83 and any valve .1. 11A JL A \ ¡NSTiTinOMFXfCA'-A · ζ ₍ .

in it, inside the lumen 8 6 ^old ^ »oíS®aL Saliía⁵¹· * 'Introducer 80.

Cartridge 416 can then be advanced to direct sealant 2 through lumen 86 of the sheath until sealant 2 is positioned adjacent to positioning element 446 and / or vessel wall 94. Optionally, cartridge 416 may advance until a component of cartridge 416 finds a stop in positioning member 414, thereby preventing further advancement of cartridge 416 and / or sealant 2 a predetermined distance from positioning element 446. For example, approximately zero to five millimeters (0-5 mm) from the positioning element 4. In some embodiments, cartridge 416 may advance until sealant 2 contacts positioning element 446 and / or vessel wall 94 and resistance is detected.

The introducer sheath 80 can then be at least partially retracted to expose the sealant 2 within puncture 90 beyond the distal end 84 of the introducer sheath. Optionally, sleeve 450 may include one or more locking elements (not shown) that can couple introducer sheath 80 to sleeve 450. Therefore, if the user proximally pulls sleeve 450 instead of introducer sheath 80, the introducer sheath 80 and sleeve 450 are introducer sheath 80.

As introducer sheath 80 is retracted, support member 430 can prevent substantial proximal movement of sealant 2, thereby exposing sealant 2 within puncture 90. When sealant 2 is exposed within puncture 90, the sealant 2 may be exposed to blood and / or other bodily fluids within puncture 90. This exposure can cause sealant 2 to absorb fluid and / or otherwise expand within puncture 90, eg, to provide hemostasis.

If desired, once the sealant 2 is exposed within the puncture 90, the support member 430 can advance to compress or tamp the sealant 2, eg, against the positioning element 446. Optionally, the Support 430 can include one or more markers (not shown), eg, at or adjacent to proximal end 432, and support member 430 can advance within puncture 90 a desired distance, which can be confirmed by the marker monitoring. Additionally or alternatively, the positioning member 414 may include a detent or other feature through which the support member 430 can pass when it advances a predetermined distance. The retainer can provide audible confirmation that the

-Τ --ΤίΧΧ '' Α support member 430 ha λ '··' ivl z λ '.' advanced the^{fN 3} t anther '' default (in addition to or instead of provided by

Once sealant 2 has been exposed long enough and / or rammed by the support member

430, the positioning element 446 can be folded down, and the positioning member 414 is removed from the vessel 94 and the puncture

90, eg, by pulling down the positioning element 446 through the sealant and the support member 430.

Support member 430 can be kept substantially stationary during removal of the positioning member

414, eg. , to prevent migration and / or removal of the sealant within puncture 90.

Optionally, the cartridge

416 may include an auto-refraction assembly, similar to other embodiments in this document, that can automatically retract positioning member 414.

Once the positioning member 414 is completely removed, the support member 430 can be removed from the puncture 90, leaving the sealant 2 within the puncture 90.

of

Turning to Figures 16A-16D, another embodiment of an apparatus is shown.

710 generally including a positioning member 714 for delivering a sealant therein within a puncture (not shown). Similar to apparatus 410 of Figure 12, cartridge 716 may include a sleeve of

<img file="MX354129B_D0054.tif" />

distal end 7 34 of a support member 7 30 adjacent sealant 2, and a handle or adapter 723 at the proximal end 732 of support member 730. The sealant sleeve 750 may include a relatively large diameter proximal portion 752 surrounding a portion of the distal end 734 of the support member 730, eg, dimensioned to abut or otherwise contact an adapter or proximal end 783 of an introducer sheath 780, as shown in Figure 16D, and a relatively small diameter distal portion 754 surrounding the sealant 2, eg, sized to enter adapter 783 and / or lumen 786 of introducer sheath 780. Adapter 783 may include a cavity adapted to releasably receive

<td>the portion of</td><td>small diameter</td><td>of</td><td>the sleeve</td><td>of sealant. TO</td>

<td colspan="2">difference from apparatus 410,</td><td>the</td><td>cartridge</td><td>716 can</td>

<td>provide</td><td>initially from</td><td>such</td><td>way that</td><td>the sleeve of</td>

<td>sealant 750</td><td>and the sealant</td><td> 2</td><td>are located</td><td>immediately</td>

adjacent to a positioning element 746 of the positioning member 714.

Handle 723 may include an outer housing or bead 772 surrounding an inner housing or frame 774 and one or more actuators 760, 764 to allow and / or cause movement of one or more components of apparatus 710 relative to each other, such as

As shown, the outer housing 772 includes and _e., ..-. UQa ^ "first opening or slot 773 within which the first and second actuators 760 and 762 are provided, a second slot 775 within which provides the third actuator 764.

The opening 773 may include one or more features for interacting with the first and / or second actuators 760, 762 as described below.

Inner housing 774 may be axially slidable relative to outer housing 772, eg, between a starting, proximal, and distal position. For example, the outer housing 772 may include clam shell halves or other components that can be attached around the inner housing 774 such that the cooperating rails and grooves (not shown) allow the inner housing 774 to slide axially without substantial lateral movement. In an exemplary embodiment, one or more elongated ribs or rails (not shown) may be molded or otherwise provided on the inner surfaces of the outer housing 772 which can be slidably received between the rails or grooves (also not shown) on the Inner housing 774.

The 72 3 handle may include ... a 77 6 distal pocket that

-......

/ X is integrally formed ('with you ..be otherwise extended from outer housing 772. It can

776 for attaching adapter 723 to an introducer sheath, such as sheath 780 shown in Figure

16D. For example, the pod

780 may include an adapter includes a pair of axially extending along opposite sides of the adapter

783. Tines 778 include tabs or retainers that can be slidably received within recesses 783a, eg, when apparatus 710 is inserted into it during use, as described below.

The relative length of them is configured such that the ones extend outside the distal ends thereof.

Ramp or tapered distal edges facilitate insertion, discounted proximal edges that can engage the distal ends thereby engaging movement of sheath 780 and outer housing 772 of adapter 723, also as described below.

As can be seen in Figure 16C, apparatus 710 may include a rack and pinion arrangement which can be τ λ and ό Τ &amp; '

Λ - * -Λ -γ \. ; &lt;1 similar to any of the other modá'í ^ icfe'iáés ^ éír ^ &amp; s ^ e 'document. For example, as shown, a cream 11 was "7", can be attached to a proximal end 732 of support member 730 and can be slidably received within outer and / or inner housings 772, 774. A pinion 768 can be rotatably mounted to the inner housing 774 which engages the rack 766 by means of a plurality of interlocking teeth 766a, 768a, eg, similar to other embodiments herein. The second or supporting actuator 762, eg, a button pivotably coupled to the inner housing 774, engages the pinion 768, eg, via interlocking teeth 762b, 768b, to selectively rotate pinion 768. For example, as described below, the second actuator 762 can be depressed to cause the pinion 768 to rotate, thereby causing rack 766 to advance distally, thereby advancing support member 730.

Optionally, as shown, a first actuator or lock 7 60 may be provided on adapter 723 to prevent relative movement of the outer and inner housings 772, 774 until the movement of the support member 730 is activated and / or limited For example, as best seen in Figure 16C, the lock actuator 760 may be pivotally mounted

<img file="MX354129B_D0055.tif" />

<img file="MX354129B_D0056.tif" />

iNsrrrtTo '/ · _ · <·,' - * 7; .____ 'in the Wfe> -gámLeH- ^ Tⁱ‘^{: v}Inner 774 and include a distal end 76 otherwise engage a distal edge 773b of the opening

773 in the outer housing 772. As a result, the inner housing 774 can be substantially secured in the proximal position and cannot be directed into the distal position until the lock actuator 760 is activated to disengage the distal end 760a of the actuator 760 from the edge. distal 773b of opening 773.

Additionally or alternatively, the first actuator 760 may include a detent or other locking feature 760b to selectively lock the support member 730 relative to the inner housing 774. For example, as shown in Figure 16C, a detent 760b extends toward inside from the first 760 actuator that is not coupled with any other features. When the first actuator 760 is activated, that is, it is directed inward to disengage the distal end 760a of the actuator 760 from the distal edge 773 of the outer housing 772, the retainer 760b may drop down into the inner housing 774. As discussed herein, once the inner and outer housing portions 774, 772 are movable relative to each other, the handle 723 can be moved proximally causing the outer sheath 780 to retract and expose the sealant.

V · '· \ / τ Ό T &lt;

XX v -iL. .uu to

MÍáKXKV INSTITUTE

Subsequently, when the actuator subsequently activates, the rack

766 can advance, causing support member 730 to tamp the sealant into the arteriotomy, as described herein, until a distal end

766b of rack 7 66 passes under detent 7 60b and the gap (not shown) therein.

in the hollow, the zipper proximally, preventing next! of the support member catch 760b is captured in a

<td>With</td><td>the catch</td><td>760b</td><td>captured</td>

<td> 766</td><td>I dont know</td><td colspan="2">can direct</td>

<td>this</td><td>he way</td><td>the</td><td>movement</td>

<td> 730</td><td>coupled to</td><td>the</td><td>zipper</td>

66'.

The apparatus 710 may also include a third or balloon retraction actuator 764, eg, to selectively retract the positioning element 746 through the sealant 2 after deployment, similar to other embodiments herein. For example, as shown in Figure 16C, the third actuator 764 can be slidably mounted in the inner housing 774 and can be selectively coupled to the adapter 748 of the positioning member 714. The adapter 748 can be constructed and / or operated in a similar way to any of the other embodiments in this document or in the documents that are incorporated by reference in this document.

<img file="MX354129B_D0057.tif" />

<img file="MX354129B_D0058.tif" />

64

<img file="MX354129B_D0059.tif" />

once he

Initially, the third actuator coupled to the inner housing 774 decoupled from the inner housing 774 sealant 2 has been deployed and / or rammed. For example, as best seen in Figure 16C, the third actuator 764 may include a third arm 764c that can be disengaged from the inner housing 774 such that the proximal movement of the third actuator 764 relative to the outer housings and / or Inner 772, 774 causes proximal movement similar to that of adapter 748, thereby directing positioning element 746 proximally, similar to other embodiments herein.

In addition, the third actuator

764 may include a second arm 764b that can be slidably positioned adjacent a proximal end

766c zipper

766. With the second arm 764b positioned in this way, the third arm 764c can remain coupled with the adapter 748. When the rack 766 is directed distally, eg, when the second actuator 762 is activated, the second arm 764b can slide out of the proximal end 766c of rack 766, thereby decoupled third arm 764c from inner housing 774. For example, as shown, a spring or other diverter mechanism 764a may be provided on the third actuator 764.

8 ν Λ; Τ Τ '1 £ ν 1 ra ££ W £; A gffi! TT; TC MJVVV ·· .. ·' / '' Tí (or optionally, the outer housing 772i) ^ p'g ^ a ^^ it is <ia¿ri> '·· the second arm 7 64b outward when the zipper a. — 7.6 ^ .— is directed distally to clear the second arm 764b from the proximal end 766c of the rack 766. In addition, the spring or deflection mechanism 764a may require the actuator to be depressed in order to disengage the third arm 764c from the inner housing, thereby preventing inadvertent movement of the positioning element 746. The third actuator 764 can then be steered proximally to retract adapter 748 and positioning element 746.

Apparatus 710 can be used to deliver sealant 2 within a puncture, eg, that communicates with a body lumen within a patient's body, similar to other embodiments herein. Initially, introducer sheath 780 shown in Figure 16D can be positioned through the puncture within the body lumen, eg, as described elsewhere in this document.

Optionally, introducer sheath 780 can be provided as part of an introducer kit, eg, including a dilator 7 90 and a guide wire 7 99, and / or a system that also includes apparatus 710. Dilator 790 can include a proximal end 792 and a distal end 794 dimensioned to be slidably received through the lumen ending in

TO.- · ..

786 of the introducer sheath> ·

IKebiUi * ».

a conical, atraumatic and / or other distal tip to facilitate insertion of dilator 790 and introducer sheath 780 into a puncture (not shown) through guidewire 799. As shown, the

eg, to dilator

790 it may include a proximal housing 796 that includes the tines 798 and seals 798a configured similar to the distal girdle 776 of the apparatus 710. The dilator 790 can be directed into the adapter 783 and lumen 786 of the introducer sheath 780 until the tines 798 enter and the retainers 798a exit from steps 783a on adapter 783.

Therefore, dilator 790 and introducer sheath 780 can be coupled together such that guide wire 799 (already placed through a puncture into a body lumen, not shown, as described elsewhere in this document) can be reloaded at the distal end

94 and the lumen

796 of dilator 790 to insert dilator 790 and introducer sheath 780 into the puncture. Once the introducer sheath 780 is positioned as desired, the tines 798 can be pressed inward to disengage the retainers 798a from the recesses 783a and allow dilator 790 to remove the lumen 798 from the introducer sheath 780. The sheath introducer 780 can then be used to access the body lumen and carry out one or more procedures,

<img file="MX354129B_D0060.tif" />

<img file="MX354129B_D0061.tif" />

of this document. ................... When it is desired to seal the puncture, any instrument inserted through the introducer sheath 780 can be removed and the apparatus 710 can be prepared, eg ., as shown in Figures 16A and 16B. With the positioning element 746 folded down, the distal end 734 of the positioning member 714 can be directed into the adapter 783 of the introducer sheath 780, through the lumen 786, and into the body lumen. Because sealant sleeve 750 and sealant 2 are located immediately adjacent to positioning element 746, as distal end 744 enters the introducer sheath

780, sleeve 750 may be in contact with introducer sheath 780, which may prevent further advancement of sleeve 750. An example, distal portion 754 of sleeve 750 may at least partially enter adapter 783 of introducer sheath 780. and proximal portion 752 of sleeve 750 may be supported on adapter 783, thereby preventing further advancement of sleeve 750. If sleeve 450 is releasably attached to support member 730, advancement of positioning member 714 can release sleeve 750 from distal end 734 of support member 730.

<img file="MX354129B_D0062.tif" />

Positioning member 714 can

<img file="MX354129B_D0063.tif" />

inside introducer sleeve 780, for 1 oa^:

750 it can remain substantially stationary relative to the introducer sheath 780 and consequently slide proximally on the support member 730. Thus, the distal end 734 of the support member 730 can protrude from the distal portion 754 of the sleeve 750 and It will enter lumen 786 of the introducer sheath, thereby expelling sealant 2 from sleeve 750 and into lumen 786 of the sheath, similar to other embodiments herein. Optionally, distal portion 754 of sleeve 750 may have sufficient length and / or other characteristics to at least partially open valve (s) (not shown) within introducer sheath adapter 783, e.g. For example, to facilitate the sealant 2 and the distal end 734 of the support member 730 advance into the lumen 786 of the introducer sheath. Therefore, sleeve 750 can protect sealant 2 until sealant 2 passes through adapter 783, and any valves therein, into lumen 786 of introducer sheath 780.

The positioning member 714 can then advance until the positioning element 746 is positioned beyond the distal end 784 of the introducer sheath 780, that is, within the body lumen.

iNsrmiTQ muio

As you are ©^£'-g ^^

<img file="MX354129B_D0064.tif" />

Tines 778 in housing gullet 776 can be attached to and inserted into recesses 783a in sheath adapter 783, eg, until the retainers 778a engage the distal ends of the gaps 783a, as described above. With the retainers 778a coupled with the recesses 783a, the introducer sleeve 780 and the outer housing 772 can be coupled together in such a way that they move together, similar to other embodiments in this document.

The relative length of the positioning member 714 and the introducer sheath 780 can be configured such that the sealant 2 remains within the lumen 786 of the sheath, eg, proximal to the distal end 784 of the introducer sheath 780, while the positioning element 746 is exposed beyond distal end 784. Positioning element 746 can then be expanded, eg, by inflating positioning element 746 using fluid from syringe 148 and / or in a similar manner to other embodiments herein. The entire apparatus 710 and introducer sheath 780 can then be retracted (regardless of whether the apparatus adapter 723 or sheath adapter 783 is manipulated) until the expanded positioning element 746 contacts the wall of the body lumen adjacent to puncture.

<img file="MX354129B_D0065.tif" />

760

Once properly positioned

<img file="MX354129B_D0066.tif" />

it can be activated to disengage the movement of the outer and inner members 772, 774. For example, while holding the outer housing 772, the first actuator 760 can be pressed inward to decouple the distal end 760a of the first actuator 760 from the distal end from the distal end 773b of outer housing 772, and then outer housing 772 can be retracted proximally, that is, away from the patient and puncture. With the inner housing 774 coupled to the positioning member 714 and the support member 730, this action causes the inner housing 774 to slide into the outer housing 772, that is, from the proximal position (shown in Figures 16A- 16C) to the distal position, thereby retracting introducer sheath 780 relative to support member 730 and exposing sealant 2 within the puncture adjacent to the positioning element

746.

With the inner housing 774 in the distal position, the second actuator 762 can be activated to advance the support member 730, eg, to tamp or compress the sealant 2 against the expanded positioning element 746 and / or outer wall of the body lumen, eg, through an arteriotomy, similar to other modalities herein. For example, with particle

Figures 16C, the second actuator 762 can be - inward, thereby rotating the pinion 768, advancing the rack

766, and consequently advancing the support member

730 to direct the distal end

734 towards the positioning element 746 and compress the sealant 2 between them.

a

Optionally, the second actuator 762 may include or more features, eg, tabs or retainers 762a that can engage with the outer housing 772 when the second actuator 762 is fully depressed.

For example, as shown in Figures 16Ά and 16B, opening 773 in outer housing 772 may include one or more gaps

773a that can be aligned with the tabs

762a on the second actuator 762 when the inner housing 774 has been fully directed to the distal position. With tabs 762a received inside the gaps

773a, the inner housing

774 it cannot move proximally relative to the outer housing 772, thereby securing the outer and inner housings 772, 774 relative to one another.

Once the sealant 2 has been exposed long enough and / or has been tamped by the support member 730, the positioning element 746 can be folded down, and the

IMPIfo '· ÍNSyiTUTO MEXICANO J Positioning member 714 can be removed from the body, eg, by pulling the positional element down through the sealant 2 and the support member 730.

For example, the positioning element 746 can be deflated using syringe 148, and then the third actuator 764 can be activated to withdraw the positioning element 746 folded through the sealant 2 and into the distal end 734 of the support member 730 , similar to other modalities in this document.

Optionally, as described above, the third actuator 764 can remain engaged with the inner housing 774 until the rack

766 it advances enough to release the third arm 764c from the third actuator. Then, the proximal movement of the third actuator 764 relative to the outer and inner housings 772,

774 causes that and all the positioning member

714 also move proximally, thus removing the positioning element

746 through the sealant 2 and into the distal end 734 of the support member 730. The length of the slot 775 in the outer housing 772 can be configured to withdraw the positioning element 746 a desired distance within the distal end 734.

Once r 11 v that the positioning element *

<img file="MX354129B_D0067.tif" />

Through the sealant 2, the entire apparatus 710 for removing the support member 730 from the puncture, leaving the sealant 2 within the puncture.

Turning to Figure 14, an exemplary embodiment of a sheath pickup assembly is shown.

550 which can be provided in an and / or introducer sheath may include a member a cartridge a puncture apparatus 510 for sealing

516, simi

<td> 580.</td><td>Usually,</td><td>the</td><td>apparatus 510</td>

<td>of</td><td>positioning</td><td>(not</td><td>shown) and</td>

<td>lar</td><td>To anybody</td><td>of</td><td>the others</td>

As shown, the cartridge modalities in this document.

516 it includes a housing 523, which can be coupled to a tubular member carrying a sealant and / or a support member (not shown for simplicity). The introducer sheath

580 includes a tubular body including proximal and distal 582 ends,

584, and an adapter

583 at the proximal end

582, also generally similar to other modalities in this document.

As shown, sheath adapter 583 includes a pickup adapter 583a that includes a recess 583b therein. Cartridge housing 523

516 includes the sheath pickup assembly 550 of the stud 23a shown therein, eg, in Figure 2B, which includes a slide pickup 552 slidable into the

Τ 'τχ ./7 Ό fi 1 JV1 £ -.

housing 523, eg, between the first and sides. For example, housing 523 may include distal passage 523a into which pickup adapter 583a can be received when cartridge 516 advances into introducer sheath 580, similar to any of the modalities described elsewhere in this document.

With sheath pickup 552 in a first position, pickup adapter 583a can pass through distal passage 523a and into an opening 553 in sheath pickup 552, eg, until gap 583b in the Pickup Adapter 583a aligns with Pod Pickup 552. Thereafter, if sheath pickup 552 is laterally directed to the second position, sheath pickup 552 may enter recess 583b, thereby preventing subsequent axial movement of introducer sheath 580 relative to housing 523.

In the embodiment shown in Figure 14, sheath pickup 552 can be diverted to one of the first and second positions, eg, by means of a spring 556 or other diverting mechanism. For example, sheath pick-up 552 can be biased to the first position such that the default position for sheath pick-up 552 allows cartridge 516 to separate from introducer sheath 580. To overcome the deviation of spring 556, a hydraulic actuator can be provided

<img file="MX354129B_D0068.tif" />

7. A slideable piston 534 is included within a chamber 558. As shown, piston 534 can be moved laterally within the chamber to cause piston 534 to engage sheath pickup 552, eg, to overcome spring 556 and move the sheath uptake the deviation of the

552 from first position to second position.

In addition, as shown, chamber 558 can communicate with a fluid line 559 through which fluid can be delivered and / or evacuated, thereby directing piston 534 between its engaged and disengaged positions. In some modalities, the fluid line

559 may be coupled to the same inflation line positioning as the positioning member element (not shown). For example, with further reference to Figure 1A, if syringe 148 is pressed to deliver fluid through inflation line 48c to inflate balloon 46, fluid can be delivered substantially simultaneously within fluid line 559, thereby directing piston 534 to engage sheath pickup 552 into the second position, thereby engaging introducer sheath 580 with housing 523. Thereafter, if syringe 148 is used to evacuate fluid to collapse balloon 46, the fluid can also be evacuated from fluid line 559, thereby decoupling sheath uptake 552 and allowing cartridge 5 L. 6_s, e ^_to^..

detach introducer sleeve 580.

Therefore, sheath pickup assembly 550 may also provide a safety feature that allows immediate separation of cartridge 516 from introducer sheath 580 if fluid pressure is lost in fluid line 559, eg, if balloon 46 breaks or otherwise leaks fluid. Without the fluid pressure in fluid line 559, spring 556 can automatically direct sheath pickup 552 to the first position, and decouple sheath pickup 552 from sheath adapter 583a. Also, during deflation, fluid flow from fluid line 559 to piston 534 may be slower than from balloon 4 6 such that balloon 46 deflates before the sheath pickup assembly is released. 550, which can ensure that the balloon inflated by 46 is not pulled by spring 556. Also, if balloon 46 breaks, sheath pickup assembly 550 can be released in such a way that access to the body lumen is maintained even if the positioning member 14 is removed from the body lumen since the introducer sheath 580 can remain inside. of the puncture.

100

In some modalities

<img file="MX354129B_D0069.tif" />

they can

<img file="MX354129B_D0070.tif" />

<img file="MX354129B_D0071.tif" />

characteristics in the cartridge, eg in e_1 ^αΊ ^ jami.antO) -do —- any of the modalities in this document to secure an introducer sheath relative to the cartridge. For example, within the sleeve 23a shown in Figure 2B, a simplified sheath pickup can be provided that automatically engages with the features in the adapter of an introducer sheath (not shown). For example, a retainer may be provided within the sleeve 23a, eg, in a tubular sleeve or other support (not shown) that can be configured to freely enter the introducer sheath adapter, still preventing subsequent removal, eg, similar to the modalities disclosed in United States Patent Document No. 7,993,367. If the sheath lock is provided on the tubular member of the cartridge, with the sheath engaged by means of the sheath lock, a deployment mechanism that retracts the tubular member can automatically retract the introducer sheath as well.

For example, after an apparatus, such as apparatus 210 of Figures 8A-8C, is inserted into an introducer sheath (not shown), the sheath lock can engage the sheath adapter to housing 223 (eg, inside a 23a gualdera, similar to what is shown in Figure

101 impiof

2B). With the positioning element 24 6 ^^) ^^^ 0 ^ fejitró.;.

........... *> '' biLUyíkLAL of a vessel, the entire apparatus 210 and the introducer sheath can then be removed together until the positioning element 246 is positioned against the vessel wall,

eg, similar to the method shown in Figures 10A and 10B (except that cartridge 216 is positioned within the sheath). Therefore, in some embodiments, the expanded positioning element 246 is not used to pull the introducer sheath back into the puncture, which can reduce stress on the positioning element 246.

Optionally, apparatus 210 may include a release feature that allows cartridge 216 and introducer sheath to retract further after positioning element 246 is positioned against the vessel wall. For example, when the positioning element 236 is positioned against the vessel wall, a release feature actuator, eg, in the housing

223, can be activated, allowing cartridge 216 and sheath to retract relative to the positioning member

214 a predetermined distance, eg approximately

1.5 cm.

Therefore, the distal end 224 of the tubular member

220 and the sheath can be retracted away from the positioning element 246, which can exceed the

102 ·> · Friction in the puncture around before unfolding the sealant

2.

In this way, the tissue surrounding a relatively small puncture can impose introductory friction by resisting retraction, causing the apparatus to advance relative to the deployment mechanism 260 being activated, thereby

<td colspan="2"></td>

<td>of</td><td>profile</td>

<td>in the</td><td>sheath</td>

<td>which</td><td>can</td>

<td>sheath</td><td>when</td>

<td>i which</td><td>can</td>

sealant 2 direct the positioning element 246 and further into the puncture (and potentially into the vessel), rather than just retracting the tubular member

220 and the sheath to spread the sealant out of the glass.

Optionally, a stabilizer can be provided that can be attached between the housing

223 and the introducer sheath, eg, to prevent cartridge 216 from moving substantially relative to the sheath.

Turning to Figures 15A and 15B, another exemplary embodiment of an apparatus 610 is shown that includes a bleed assembly 650 in a housing 623 of cartridge 616. Generally, apparatus 610 can include a cartridge 616 that includes a tubular member carrying a sealant and a support member (not shown) coupled to housing 623. Apparatus 610 may also include a positioning member, similar to other embodiments herein, or the positioning member may be omitted.

103

The Bleeding Assembly 650

<img file="MX354129B_D0072.tif" />

. tMSTmnu m *. «cane, se ext léEtduaf '¹¹¹ housing 623 and may include a pickup which can be received within an adapter 83 or otherwise coupled to an introducer sheath 80, similar to other embodiments herein. Bleed assembly 650 also includes a lumen 653 that communicates with a bleed port 654 and aligned to communicate with lumen 86 of introducer sheath 80. For example, as best seen in Figure 15B, during use, the cartridge 616, eg, the tubular member (not shown), can be advanced into the lumen 86 of the sheath until sheath uptake 652 enters sheath adapter 83. As shown, sheath pickup 652 may include a tip 652a that extends into and / or opens valve (s) 83a of sheath adapter 83. Furthermore, sheath pickup 652 may be elastically or otherwise coupled to a wall 83b of adapter 8.3, thereby preventing subsequent separation of introducer sheath 80 from housing 623.

In use, apparatus 610 (with the distal end of the tubular member positioned adjacent to the positioning element, not shown) can be inserted into introducer sheath 80, similar to other embodiments herein. The relative lengths of the introducer sheath 80 and the positioning member can be predetermined from

4 A / ίΌ η '' - '••' Λ

MEXiCAM INSTITUTE. » rt such that the distal end 8 4 of the vairia'b ^ p ^ gdci ^ tor ^ - '' 80 is offset from the positioning element _en ..- .. mia.—. predetermined distance when sheath pickup 652 mates with sheath adapter 83. For example, distal end 84 may be spaced 0.1 to two millimeters (0.1—2.0 mm) from the positioning element when sheath pickup 652 is docked.

Due to this distance and the space around the cartridge within lumen 86 of the sheath, blood can flow through lumen 8 6 of the sheath when distal end 84 is exposed within the vessel. Pressure within the vessel may cause blood flow through sheath lumen 86 into lumen 653 of sheath pickup assembly 650 and out of bleed port 654. When apparatus 610 is removed to direct the expanded positioning element against the vessel wall, the positioning element can isolate puncture, and consequently sheath lumen 84, from vessel pressure, and thus blood flow to It will be suspended through lumen 84 of the sheath and outside of bleed port 654, providing visual confirmation that the positioning element is in position against the vessel wall.

In some embodiments, the relative lengths of the introducer sheath 80 and cartridge 616 can be set

105

<img file="MX354129B_D0073.tif" />

IKSTJTUTV Μ £. ·; Κ> ΝΟ SEE THE FSO?: RX'A «>

<img file="MX354129B_D0074.tif" />

in such a way that the distal end 8 4 of the sheath contacts or is in slight interference with¹ the positioning eTemenFcT * when sheath pickup 652 is coupled with sheath adapter 83. In this configuration, blood may not flow into lumen 86 of the sheath while apparatus 610 is introduced into the vessel, eg ., when the positioning element expands and retracts into the vessel. If the introducer sheath 80 is subsequently retracted (eg, together with the tubular member), this configuration may allow the introducer sheath 80 to be reintroduced into the puncture, with the bleeding signal being used to indicate when the introducer sheath 80 it is again in contact with the positioning element.

In some modalities, bleeding can be used to position the introducer sheath at a desired location relative to the arteriotomy and / or vessel wall. For example, as shown in Figures 15A and 15B, an introducer sheath 80 may be provided that includes one or more side ports 85 (one shown) at the distal end 84 communicating with the sheath lumen 86. Side port 85 may be offset by a predetermined distance from distal end 84 of sheath 80, eg, 1.5 cm.

106 _. , INSTITUTCLMEXICaNO, t

Dilator C can be providedⁿ&lt;? · 'Shown) which includes a tare sized distal end to be inserted into sheath lumen 86 and a relatively small bleeding lumen extending from one or more lateral ports at the distal end to a proximal end of the dilator . When the dilator is fully inserted into the lumen 86 of the sheath, the side ports can be aligned with each other in such a way that a fluid path is provided from outside the distal end 84 of the sheath 80 into the dilator to a port of bleeding at the proximal end of the dilator.

Therefore, when the lateral ports are placed within a blood vessel and exposed to the pressure of blood, blood will enter the lateral port (s) 85 of the sheath 80, within the ) lateral port (s) of the dilator, and will travel to the lumen of the dilator. Blood exiting the bleeding port provides visual confirmation that distal end 84 is positioned within the vessel. Once the lateral port 85 in the sheath 80 is no longer exposed to arterial blood pressure, eg, when the distal end 84 is withdrawn through the vessel wall into the puncture, the signal to bleeding stops. Therefore, visual confirmation is provided that the sheath extends into the vessel at approximately the distance that the port (s)

107 side (s)

<img file="MX354129B_D0075.tif" />

distal 84. Alternatively, you can prop ^ JimüiuHU'P · “ΤΓΓΓ * WTy 'bleed port in the dilator such that when the dilator is fully inserted into lumen 86 of the sheath, the port is exposed beyond the distal end 84 of the sheath. The port can be spaced from the distal end 84 of the sheath by a predetermined distance, eg, approximately two centimeters, such that, when bleeding stops, sheath 80 can advance the predetermined distance to position the distal end 84 adjacent to the vessel wall.

Subsequently, introducer sheath 80 can be held in this position, eg, when apparatus 610 is inserted to deliver the sealant. As the positioning element advances through lumen 86 of the sheath, the location of the positioning element relative to the vessel wall and the arteriotomy based on the known position of the introducer sheath 80 are known. For example, with a lateral port 85 offset 2 cm from distal end 84 of sheath 80, a user may know that the expanded positioning element need only retract 2 cm to reach the vessel wall. This modality for positioning the sheath 80 can minimize the drag of the expanded positioning element through. · »

108 of the glass, which can reduce xav; '

MEXiCAN INSTITUTE · »! 'risk of «ROH®®mpíer ·, .ei! NúU; Tkj.u. -element of positioning in calcium or other material inside the vessel and / or false positive tactile positioning on the vessel wall due to a restriction or bifurcation of the vessel.

Figures 17A-17F schematically illustrate a method of delivering a sealant from apparatus 810 to an arteriotomy site. Apparatus 810 may include any of the features described in connection with apparatus 710. For example, apparatus 810 may include a sealant 2 positioned at a distal portion of a positioning assembly 814. Positioning assembly 814 extends through the puncture and into the vessel, such that the positioning element of the vessel lumen and sealant is outside the wall of the sealing 2 arteriotomy one member

After the of

17A). Expanding the apparatus 810 element of the relative arteriotomy site positioning to the site of a sheath 880 exposes the and advancing sealant than the positioning element

836 deflates (Figure 17E), positioning element 846 can be moved proximally through sealant 2 (Figure 17F), leaving sealant 2 out of the vessel. The support member

109

<td colspan="2">830 can</td><td>keep</td><td>the</td>

<td>withdraw</td><td>the</td><td>element</td><td>of</td>

<td>withdraw</td><td>the</td><td>element</td><td>of</td>

To xv aiir. . · Seal position ^ '^ ME ^^ httas ttmuswAt. * · «*« - positioning 846. After Sje, positioning 846, the entire 810 appliance, including the 880 sheath and the 814 positioning assembly, can be removed from the patient. The 810 appliance and methods of using the 810 appliance They are described in detail below.

As shown in Figures 17A through 17F, apparatus 810 can include a handle 823. Handle 823 can include an outer housing 872 and an inner housing 874. The outer housing 872 can be moved relative to the inner housing 874, for example , when sheath 880 is moved proximally relative to positioning assembly 814.

Handle 823 must include one or more actuators to control apparatus 810. Each actuator can control one

<td colspan="2">or more functions</td><td>of the</td><td>apparatus 810</td><td>. Said one or</td><td>plus</td>

<td>actuators</td><td>they should</td><td>to be</td><td>positioned</td><td>anywhere</td><td>to what</td>

<td>throughout the</td><td>mango</td><td> 823.</td><td colspan="2">In Figures 17A through 17F,</td><td>the</td>

<td>actuators</td><td> 860,</td><td> 862,</td><td>864, and 848 are</td><td>they position what</td><td>long</td>

of handle 823 based on the procedure step that controls each actuator. The configuration of the actuators shown in Figures 17A to 17F reduces the confusion associated with the operation of apparatus 810 by

110

<img file="MX354129B_D0076.tif" />

only require the user to move his or her^FftaoprO; x ^ jialinente. ^ for each subsequent step of the procedure. Although.-The-S Figures 17A through 17F illustrate four actuators 860, 862, 864, and 848, fewer or more actuators can be used to perform the same functions.

Apparatus 810 may include inflation line 48c. Inflation line 48c is in fluid communication with positioning element 846. Inflation line 48c connects to syringe 148 or other device to deliver fluid to positioning element 846.

Apparatus 810 may include a first actuator 860 to control fluid flow through inflation line 48c. The first actuator 860 moves between an open position and a closed position. As shown in Figure 17A, when the first actuator 860 is in the open position, the syringe 148 can deliver a fluid through the inflation line 48c to expand the positioning element 846. In Figure 17B, the first actuator 860 moves to the closed position and restricts the flow of fluid through the inflation line 48c to maintain the expanded state of the positioning element 846. After the positioning element 846 expands, apparatus 810 moves proximally such that positioning element 846 is adjacent to

111

Τ Τ. ΧΓ * Γ »ΤΓ

<img file="MX354129B_D0077.tif" />

MEXICAN INSTITUTE

OE LA PR 'V'fF DAD V ®

INDUSTRIAL arteriotomy

Apparatus 810 may include a second actuator 862 to control movement of sheath 880 relative to positioning assembly 814. Second actuator 862 moves between a first position and a second position. In the first position (Figures 17A and 17B), sheath 880 cannot be moved relative to positioning assembly 814. Thus preventing inadvertent exposure of sealant 2. Moving the second actuator 862 from the first position to the second position, as shown in Figure 17C, allows the sleeve 880 to move relative to the positioning assembly 814. Retracting the sleeve 880 exposes the sealant 2 to the arteriotomy site, while positioning assembly 814 remains stationary. Retracting sheath 880 can also cause a portion of outer housing 872 to at least partially cover second actuator 862.

Apparatus 810 may include a locking mechanism to prevent inner housing 874 from moving relative to outer housing 872. As sheath 880 retracts, outer housing 872 moves between a first position and a second position. When the outer housing 872 is in the first position (Figures 17A and 17B), the inner housing 874 can be moved with

112 in relation to exterior accommodation 872.

<img file="MX354129B_D0078.tif" />

exterior 872 is on the

<img file="MX354129B_D0079.tif" />

Inner housing 874 is unable to move proximally relative to outer housing 872.

As shown in Figures 17C and 17D, apparatus 817 may include a third actuator 864. The third actuator

864 it moves between a first position and a second position. Moving the third actuator 864 from the first position to the second position advances the support member

830 for tamping down sealant 2. Tamping down sealant 2 can prevent substantial movement of sealant 2 and facilitate hemostasis.

Moving the third actuator 864 from the first position to the second position can release the retraction lock 816. The retraction lock 816 prevents the positioning assembly 814 from inadvertently retracting before tamping the sealant 2. Releasing the retraction lock 816 allows at least a portion of the positioning assembly 814 to move proximally relative to the support member 830.

The apparatus may include a fourth actuator 848 capable of moving between a first position and a second position. Unlocking the retract lock 816 allows movement of the fourth actuator 848. Move the room

113 actuator 848 from first position to

IMPIAINSTITUTO MtMCANO V; _;

OSLA the followWdcF ^ osicTon retracts at least a portion of the assembly «te pWjTCToñami'ento

814 relative to support member 830.

In Figure 17E, the first actuator 860 is moved to the open position to allow fluid flow through inflation line 48c. When the first actuator 860 is in the open position, the syringe 148 can deflate the positioning element 846. In Figure 17F, the positioning member 814 retracts through the sealant 2, such that the entire apparatus 810 can be remove from patient.

As described above, apparatus 810 may include a drive mechanism to control fluid flow to positioning element 846. The drive mechanism may include any of the features described below in connection with Figures 18A-20B, gaskets or in combination with each other.

Figures 18A and

18B represent the first actuator

860a moving between the open position and the closed position. The figures

18A-1

18B-1 illustrate a cross sectional view of the inflation line.

Exterior housing

The handle 872a includes an opening through which a portion of the first actuator 860a extends. In Figures 18A and 18B, the first

114 actuator 860a is a valve but the

<img file="MX354129B_D0080.tif" />

tFJTIT'.HV MEXICANL * \ ;. ·· · '

PE LA EK'H'ÍESAl ». · ......

prii óTran'o r

60a and valve can also be AU ^ TT'ra'Sos * components?

The valve may include a clamping mechanism to restrict fluid flow through inflation line 48a.

The first actuator 860a can move between the open position (Figure 18A) and the closed position (Figure 18B). In the open position, fluid can flow through inflation line 48a. In the closed configuration, the fluid cannot flow through the inflation line 48a. Although Figures 18Ά and 18B depict the first actuator 860a as a rocker, the first actuator 860a can take other forms.

Figures 19A and 19B depict an apparatus having the first actuator 860b and a deflation actuator 866b. Figures 19A-1 and 19B-1 illustrate cross-section tracks of inflation line 48b. A link portion 867b connects the first actuator 860b to the deflation actuator 866b. Although the link portion 867b shown in Figures 19A and 19B includes multiple link members, the link portion 867b may include only one link member (see Figures 19E-19F). The outer housing 872b includes two openings through which a portion of the first actuator 860b extends

115 and the deflation actuator 866b.

ΒΛΤΓτυτο mex »ca ·». ·

PE LA

<img file="MX354129B_D0081.tif" />

<img file="MX354129B_D0082.tif" />

Similar to

860b can move

Figures 18A and 18B, the first actuator from a first position to a second position to restrict the flow of fluid through inflation line 48b. Moving the first actuator 860 from the first position to the second position causes the deflation actuator 866b to move from a first position to a second position. Moving the deflation actuator 866b from the second position to the first position causes the first actuator 860b to move from the second position to the open position to allow fluid flow through inflation line 48b.

Similar to Figures 19A and 19B, Figures 19C and 19D may include a first actuator 860c and a deflation actuator 866c connected via link portion 867c. Link portion 867c may include one or more link members. Unlike Figures 19A and 19B, the first actuator 860c and deflation actuator 866c are different from valve 884c. For example, valve 884c can be positioned distal to first actuator 860c and deflation actuator 866c.

The first actuator 860c can be moved from a first position to a second position to close valve 884c and restrict fluid flow through the supply line.

116 inflation.

deflated position

TM ΟΪ í-íMove the first actuator 8 60c p_sfeimeí) ax the second position causes the actuator of

866c move from a first position to a second position. Moving the deflation actuator from the second position to the first position causes the first actuator 860c to move from the second position to the first position and open valve 884c.

Similar to Figures 19A-19D, Figures 19E and 19F may include a first actuator 860d and a deflation actuator 866d connected via the link portion

867d. Unlike Figures 19A and 19B, link portion 867d only includes a member of. link. Furthermore, similar to Figures 19C and 19D, the first actuator 860d and deflation actuator 866d are different from valve 884d. For example valve 884d may be positioned distal to first actuator 860d and deflation actuator 866d.

The first actuator 860d can be moved from a first position to a second position to close valve 884d and restrict fluid flow through the inflation line. Moving the first actuator 860d from the first position to the second position causes the deflation actuator 866d to move from a first position to a second position. Move the actuator

117

IMPIM7

IHFrtTUTO MíUCAN ”> · - ·, / la pri ^ fi ^ íBeJsT ^ esTte ^ éfe ·· deflated from the second position to

<td>provokes</td><td>that he</td><td>first</td><td>actuator 860d</td><td colspan="2"></td><td></td>

<td>second</td><td>position</td><td>to</td><td>first position</td><td>and open the</td><td colspan="2">valve</td>

<td>884d. The</td><td>apparatus</td><td>than</td><td>have the first</td><td>actuator</td><td>and</td><td>the</td>

Deflation actuator can be helpful in minimizing the confusion associated with operating the apparatus. For example, if the apparatus includes additional actuators to control the steps carried out between inflation and deflation of the positioning element, the additional actuators can be positioned along the handle between the first actuator and the deflation actuator. The actuators can be positioned based on the procedure step that each actuator controls, such that the user can move their hand proximally for each subsequent procedure step. The deflation actuator can be positioned proximally to the additional actuators because deflation of the positioning element is the final step before removing the apparatus.

As described above, the first actuator and the valve can be separate components. As shown in Figures 20A-20B, the first actuator 960 moves between a first position and a second position to control the position of valve 961. Moving the first

118 actuator 960 from first position

<img file="MX354129B_D0083.tif" />

second position (Figure 20B) moves valve 961 from an open position to a closed position. In the closed position, valve 961 restricts fluid flow through inflation line 948. Figures 20A-1 and 20B-1 illustrate cross-sectional views of inflation line 948 moving from an open configuration to a closed configuration. Moving the first actuator 960 from the second position to the first position moves valve 961 from the closed position to the open position, thereby allowing fluid to flow through inflation line 948.

The first actuator 960 may be a lever. A bolt connects the first actuator 960 to valve 961. Valve 961 may be a slide valve having a clamping mechanism to restrict fluid flow through inflation line 948. Move the first actuator 960 between the first. position and the second position slides valve 961 linearly between the open position and the closed position. Although Figures 20A-20B depict the first actuator 960 as a lever, the apparatus may include any other mechanism capable of moving valve 961, such as a rack and pinion arrangement, a cam mechanism, or any other actuator.

119

<img file="MX354129B_D0084.tif" />

Apparatus 810 may include a

IΜ PT

Institute ^Μϊ3! 5ί \ 1ι · ΐ \ · ¢. i · 'second &lt;8 ^^ ϊϊι3) £ 1οΥ * - · ^ -6 £ to control sheath movement 88 0 with, - · positioning assembly 814. Outer housing 872 may include an opening through which at least a portion of the second actuator 862 extends. As shown in Figures 21A and 21B, the second actuator 862 may be a spring-loaded button.

The second actuator 862a moves between a first position (Figure 21A) and a second

When the second actuator is in the first position, the second actuator prevents proximal movement of the sheath relative to the positioning assembly. When the second actuator 862a is in the second position, the sheath can be moved proximally relative to the positioning assembly. As the sheath moves proximally, the outer housing 872a prevents the second actuator 862a from moving to the first position. Although the second actuator 862a illustrated in Figures 21A, any other locking mechanism described herein can be used to control movement of the sheath relative to the positioning assembly.

As shown in Figures 22A and 22B, the second actuator 862b may include a retainer 869b. When the

120 second actuator

<img file="MX354129B_D0085.tif" />

22A), the sheath cannot be moved remotely to 1 bone • position. When the second actuator 862b is in the

<td>second position</td><td>(Figure</td><td>22B)</td><td>, the</td><td>catch</td><td>869b</td><td>locks the</td>

<td colspan="2">second actuator 862b</td><td>in</td><td>a</td><td colspan="2">position</td><td>pressed,</td>

<td>allowing of</td><td colspan="2">this way</td><td>than</td><td>the</td><td>sheath</td><td>move</td>

<td>proximally with</td><td>relationship</td><td>to the</td><td colspan="2">assembly of</td><td colspan="2">positioning.</td>

As the sheath moves proximally, the outer housing 872b moves over the second actuator 862b and keeps the second actuator 862b depressed.

Apparatus 810 may also include a mechanism to restrict the distance that sheath 880 can be moved relative to positioning assembly 814. For example, as shown in Figures 21B and 22B, the sheath can be moved only until the end The distal inner housing 874 rests on the distal end of the outer housing 872 or a different feature on the handle 823.

As described above, handle 823 may include a locking mechanism to lock inner housing 874 relative to outer housing 872. As shown in Figures 17A-17F, the locking mechanism may include one or more protrusions 863 positioned at along an inner wall of outer housing 872 and one or more elastic members 875 positioned in inner housing 874.

one and Τ \ ίξ Τ Γ '.....' ¿'ϊ :.

) i '/ A Κ V- · -' &lt;·. · '

As sheath 880 moves proximally, 'da¿c4wé more elastic members 875 flex hiKÍa,' edenLTtr '^toj?^>,'"' * 7 move past one or more projections 863. After said one or more elastic members 875 move past said one or more projections 863, the inner housing 874 is unable to move proximally relative to the outer housing 872.

In Figures 23A and 23B, the locking mechanism includes at least two protrusions 863 along the inner wall of outer housing 872 and at least two resilient members 875 positioned at a proximal end of inner housing 874. The resilient members 875 are capable of flexing inward to move distally past said one or more protrusions 863. As sheath 880 is removed, elastic members 875 flex inward and move past projections 863. After elastic members 875 move past projections, inner housing 874 cannot move proximally relative to outer housing 872.

Alternatively, the locking mechanism may include one or more protrusions 863 positioned in the inner housing 874 and one or more elastic members positioned along the inner wall of the outer housing 872. Other locking mechanisms may also be used.

122

IM P10 'ι; · »Ί« Α &lt;· - described in this document to block *! the inner housing 874 relative to the outer housing 872.

The apparatus 810 may include a mechanism for releasing the positioning assembly 814 from the inner housing 874. Releasing the positioning assembly 814 allows the positioning assembly 814 to move proximally while maintaining the position of the support member 830. Alternatively, the apparatus 810 it may include a mechanism for releasing the inner housing from the outer housing.

Figures 24A through 24C illustrate a mechanism for preventing support member 830 from advancing before retracting outer sheath 880. As shown in Figure 24A, the locking mechanism may be a tab 873 that prevents movement of the third actuator. 864. However, after sheath 880 is moved proximally (Figure 24B), tab 873 is moved proximally to enable movement of third actuator 864 from a first position (Figure 24B) to a second position (Figure 24C). Other locking mechanisms described in this document may also be used to prevent support member 830 from advancing.

Figures 25A and 25B illustrate a mechanism for advancing support member 830. Moving third actuator 864

123 from the first position rtfTíTVTO Y-, ·· ..

¿Σ la \ ¿.ya to the second position • '' - p ^ Woca '^ TJUé a link element 8 65 extends already véwwe ··¹ ^ 'ΠΓίΤΤίΊΚϊ ^' of support 830. Support member 830 may extend until a portion of support member 830 rests on a feature of the handle, such as the distal end of inner housing 874 or outer housing 872. The distance that the support member 830 can advance can also be limited by the distance that the link element 865 can extend.

Figures 26A and 26B illustrate apparatus 810 with a spring member 870. Moving the third actuator 864 from the first position to the second position causes the spring member 870 to expand and advance the support member 830 distally. Bracket 830 can extend until a portion of bracket member 830 rests on a feature of the handle, such as the distal end of inner housing 874 or outer housing 872. The distance that support member 830 can advance can also be limited by the distance that spring member 870 can expand. Other mechanisms can be advanced to advance support member 830, such as the rack and pinion arrangement described in connection to the apparatus 710 or any other actuator.

124

How I know

Itr er τπ ·, go ti ·> · ..- ** '* <* X, · described above, the apparatus 810 may include a positioning assembly lock 814 relative to the inner housing

874. Moving the third actuator 864 from the first position to the second position can release the retraction lock

816 by moving a lever 817 from a first position to a second position. When lever 817 is in the second position, the positioning assembly can move relative to the

Retract positioning 814 to outer housing fourth positioning 814

<td>actuator</td><td> 848</td><td>of the</td><td>assemble</td><td>of</td>

<td>provokes</td><td>than</td><td>the</td><td>assemble</td><td>of</td>

<td>retract</td><td>going</td><td>the</td><td>sealant 2.</td><td>The</td>

support member 830 can retain the position of sealant 2 while positioning assembly 814 retracts. After the positioning element 814 is retracted, the entire apparatus 810 can be removed from the patient. Other locking mechanisms described herein can also be used to lock the position of the positioning assembly 814 relative to the inner housing 874.

Figures 28A-28F schematically illustrate a method of delivering a sealant similar to the method shown in Figures 17A-17F. However, as described above, handle 823 does not have to include four actuators 860, 862,

864, and 848. For example, as shown in Figures 28A125

J. · i ΜΙ 3 e. 4- # 4- X- - V Ββπτυρ * £ '(. 28F, the handle does not include the first driveab ^: cté &amp; ®ú instead, the inflation line 4 8c includes one,' Eá 'valve 882 moves between a first position and a second position.When valve 882 is in the first position, as shown in Figure 28A, fluid can flow from the syringe to positioning member 846. When valve 882 is moved from the first position to the second position, as shown in Figure 28B, fluid can no longer flow from the syringe to positioning member 846.

Figures 29A-29B illustrate an apparatus 1010 for delivering a sealant to an arteriotomy site. The apparatus 1010 may include any of the features of the sealant delivery apparatus that are discussed herein. For example, apparatus 1010 may include a positioning assembly 1014 having a handle 1023 and a positioning element 1046. At least a portion of the positioning assembly 1014 may extend through a sheath 1080. An inflation line 48c can extend from the positioning element 1046 to a syringe 148 or any other mechanism to inflate and deflate the positioning element 1046. The inflation line 48c may include a first actuator 1082 to control fluid flow to the positioning element 1046. The handle

6

1023 may include a that the 1080 pod will

K Ά. &lt;P ¿and liad .1.

MÍSIW INSTITUTE ', ^the_t w ___ second actuator 1 $ '6'2 pa'i * a ~ allow

S6LA i retract 1 positioner 1014, a third actuator 1064 to advance a support member (not shown), and / or a fourth actuator 1048 to retract at least a portion of the positioning assembly 1014 relative to pod 1080.

Pod 1080 may include a mechanism to indicate when a distal portion of the pod enters a vessel. For example, the 1080 sheath may include one or more inlet openings 1089 in a distal portion of the 1080 sheath. As the 1080 sheath enters the vessel, blood can flow into the 1080 openings and out of an outflow opening. of the user.

As shown in Figure 29A, sheath 1080 may also include an adapter 1083 to engage handle 1023. For example, adapter 1083 may include one or more openings to engage one or more tabs on the handle, or vice versa. Pressing the sheath adapter 1083 can release the sheath 1080 from the positioning assembly 1014. The sheath adapter may also include a catch to engage the sealant sleeve (not shown). As positioning assembly 1014 enters sleeve 1080, sleeve pickup can be attached to the sealant sleeve to transfer the sealant from the sealant sleeve to the

127

<img file="MX354129B_D0086.tif" />

pod 1080.

The apparatus

You? ' \ »A &lt;'' ñ

X lA'jL .aL V'A tttíTnVTO '' - *

QELA FROf ^ *** &lt;| ·TO··

1010 may also include an inflation indicator 1002.

The inflation indicator

1002 indicates when the positioning element

1046 it inflates to a predetermined pressure and signals the user to seal the inflation line 48c. As shown in Figure 29B, the inflation line connects to the plunger system 1004.

As the positioning element 1046 is inflated, the arrow member 1005 moves from a first position to a second position. As arrow member 1005 moves to a second position, pointer 1002 moves from a first position to a second position. When the indicator

1002 is in the second position, the positioning element

1046 fully inflates.

As the positioning element 1046 deflates, the arrow member 1005 moves from the second position to the first position and the indicator 1002 moves from the second position to the first position. When the indicator 1002 is in the first position, the positioning element 1046 is not fully inflated.

Indicator 1002 can include a first indicator 1003a and a second indicator 1003b. When the positioning element 1046 is not fully inflated, the first indicator 1003a can be seen through the opening 1006 of the

8 X 1 '. 1. F- £ - '' 'ü ^ nv.-u ·' »! £.« * «·> '' Ά <ΧΛ, <νχν. · -> Λ- ·· _ 'handle 1023. When the positioning element 1046 this

X

J .J'A fully inflated, the second indicator 1003b can be seen through opening 1006 of handle 1023.

Any of the sealant delivery apparatus discussed in this document may be a component of a system that includes, but is not limited to, a guidewire or dilator. The guide wire may include any of the features described in connection with the guide wire 799 described above. The dilator may also include one or more of the features described in relation to the dilator 790 described above and / or the dilator 1190 (Figures 30A-30B) or the dilator 1290 (Figures 31A-31C) described below.

As described and shown in Figures 30A-31C, the dilator may contain a lumen of fluid that allows blood to flow from an inlet opening near the distal tip of the dilator to an outlet opening near the proximal end of the dilator. . Blood flow leaves the proximal port when the tip of the sheath enters the vessel. The sheath can then be advanced to ensure that the distal tip of the sheath is in the lumen of the vessel.

As shown in Figures 30A-30D, dilator 1190 includes an elongated structure 1191 having a lumen extending therethrough. The 1190 dilator can

129

<img file="MX354129B_D0087.tif" />

also include a proximal portion 1193 qtje'iNP ^ t ^ e '' 'ΟΓΓ' 'dilator adapter 1196 to engage a distal portion 1192 having a tapered end. As shown in Figure 30A, the dilator adapter 1196 may be U-shaped. The U-shaped dilator adapter 1196 defines an opening to receive a proximal end of the sheath. Dilator adapter 1196 may also include adapter members 1197a, 1197b configured to engage an outer surface of the sheath. Dilator adapter 1196 may as well include one or more tabs to engage a corresponding feature of the sheath. For example, as shown in Figure 30A, adapter members 1197a, 1197b may include tabs 1198a, 1198b, and / or adapter 1196 may include tabs 1199a, 1199b near an upper surface of the dilator adapter.

Dilator 1190 may also include a bleeding feature to help determine when distal portion 1192 of dilator 1190 enters the vessel. For example, dilator 1190 can include one or more inlet openings 1194 in a distal portion 1192 of dilator 1190. As shown in Figure 30A, dilator 1190 can include two inlet openings 1194. Inlet openings 1194 can be position proximal to the portion

130 conical structure

IMPI. · Elongated 1191 and / or along

<img file="MX354129B_D0088.tif" />

same plane transverse to the longitudinal axis of the di 1 at ador

1190.

The dilator

1190 may also include one or more outlet openings

1195 positioned proximal to the 1196 dilator adapter.

As the picture shows

30A, the dilator 1190 may include an outlet opening 1195. The outlet opening 1195 may be positioned along the same plane as one of the inlet openings 1194. The dilator adapter may include a steering feature 1197 to indicate the direction in which the blood flow will flow out. As shown in Figure 30C, the steering feature 1197 may be an arrow along an upper surface of the dilator adapter

1196.

The lumen that extends through the elongated structure

1191 it can have a variable diameter. For example, the lumen may have a first diameter 1189 in the distal portion 1192 and the proximal portion 1193 of the elongated structure 1192 and a second diameter 1188 between the distal portion 1192 and the proximal portion 1193. The first diameter

1189 may be less than the second diameter diameter

1189 it may include a diameter that is greater than the outer diameter of the guidewire and less than the second diameter 1188. In some embodiments, the first diameter

131

1189 is less than about 1188 diameter and / or less or the mitaidiTindsil &lt;CANsetfuhdei ,. one

ΟΣ L *. -ΑΓ »C · '/ · J. :

LSU4 / 5TR1AL * same as approximately three-fourths of the second diameter

1188. In some embodiments, the first 1189 diameter is approximately two-thirds of the second

The lumen diameter can vary while the outer diameter of the elongated structure

1191 It remains the same. For example, the proximal portion

1193 it may have an outer diameter that is the same as a portion between proximal portion 1193 and distal portion 1192. The variable diameter allows proximal portion 1193 and distal portion 1192 of dilator 1190 to form a seal around the guidewire. As such, blood only flows through inlet openings 1194 to outlet opening 1195.

Figures 31A-31C illustrates a dilator 1290 that includes an elongated structure 1291 having a lumen extending therethrough. Dilator 1290 may also include a proximal portion 1293 that has a dilator adapter 1296 to engage the sheath and / or a distal portion 1292 that has a tapered end. As shown in Figure 31A, the dilator adapter 1296 may include adapter members 1297a, 1297b configured to engage the sheath. For example, the pod may include the corresponding characteristics to receive the

132 1297a adapter members

1297b.

The

<img file="MX354129B_D0089.tif" />

miem® ^^

UNOUSTIUAL

<img file="MX354129B_D0090.tif" />

1297a, 1297b may also include one or more tabs to engage a corresponding feature of the sheath.

For example, as shown in Figure 31A, adapter members 1297a, 1297b may include tabs facing outward 1298a, 1298b and / or inward facing tabs 1299a, 1299b. The tabs can be positioned near (eg, tab 1299a, 1299b) and / or on a distal portion (eg, tab 1298a, 1298b) of adapter members 1297a, 1297b.

Dilator 1290 may also include a bleed feature to help determine when distal portion 1292 of dilator 1290 enters a vessel. For example, dilator 1290 may include one or more inlet openings 1294 in a distal portion 1292 of dilator 1290. As shown in Figure 31A, dilator 1290 may include two inlet openings 1294. The openings in

<td colspan="2">entry 1294</td><td>can be</td><td>position</td><td>proximal</td><td>to</td><td>Serving</td>

<td>conical</td><td>of the</td><td>structure</td><td>elongated</td><td>1291 and / or</td><td>the</td><td>throughout the</td>

<td>same</td><td>flat</td><td>cross</td><td colspan="2">to the longitudinal axis</td><td>of the</td><td>dilator</td>

1290. Dilator 1290 can also include one or more outlet openings 1295. As shown in Figure 31A, dilator 1290 can include an outlet opening 1295. In some embodiments, outlet opening 1295 can be

MEXICAN INSTITUTE> »* · dfe plan --- 1-.¾¾.

fashion 1 units .. the opening along a plane

133 position along the same 1294 inlet openings. In other 1295 outlet openings it can be positioned differently from any of the 1294 inlet openings.

For example, outlet opening 1295 can be positioned along a plane that is perpendicular to the plane passing through inlet openings 1294.

The lumen that extends through the elongated structure 1291 may have a variable diameter. For example, the lumen may have a first diameter 1289 at the distal portion 1292 and the proximal portion 1293 of the elongated structure 1292 and a second diameter 1288 between the distal portion 1292 and the proximal portion 1293. The first diameter 1289 may be less than the second diameter 1288. The first diameter 1289 may include a diameter that is greater than the outside diameter of the guidewire and less than the second diameter 1288. In some embodiments, the first diameter 1289 is at least about half of the second diameter 1288 and / or less or same as approximately three-fourths of the second diameter 1288. In some embodiments, the first diameter 1289 is approximately two-thirds of the second diameter 1288.

The lumen diameter may vary while the outer diameter of the elongated structure 1291 remains

134 the same. For example, the proximal hold portion.

U't? &lt;JTKIAL · an outer diameter that proximal portion 1293 and variable allows it to be the same as a portion between the distal portion 1292. The diameter proximal portion 1293 and the distal portion 1292 of dilator 1290 form a seal around the guide wire. As such, blood only flows through inlet openings 1294 to outlet opening 1295.

In any of the aforementioned dilators, the diameter of any of the outlet openings may be less than the diameter of any of the inlet openings. For example, the diameter of any of the outlet openings may be less than or equal to half the diameter of any of the inlet openings.

Figures 32A-32D-1 illustrate how any of the aforementioned positioning assemblies engage any sheath. Figure 32A illustrates an apparatus 1310 before the apparatus 1310 is delivered through the sheath 1380. The apparatus 1310 can include any of the features of the sealant delivery apparatus described above. Positioning assembly 1314 must be coupled to sleeve 1380, such that movement of handle 1323 may also move sleeve 1380. For example, sleeve 1323 may include a gullet portion 1376 configured to engage an adapter 1383.

135 from pod 1380.

<img file="MX354129B_D0091.tif" />

As shown in luriiíTkLAL gualdera 1376 can include two prongs 1378, and each prong 13.7.H.

may include a beard 1379 positioned in a distal portion of barb 1378. Adapter 1383 may include openings 1385 to receive barbs 1378. Other barb-less clamping mechanisms may be used to engage apparatus 1310 with sheath 1380, such as a pressure fit, interference fit, or screw mechanism.

As described above, sealant 1302 is initially positioned at a distal portion of positioning assembly 1314 (Figure 32A). Before positioning assembly 1314 enters sheath 1380, a sleeve of sealant 1350 covers sealant 1302 to prevent exposure of sealant 1302 to the environment. Sealant sleeve 1350 can include any of the characteristics of sealant sleeve 450 described above. As positioning assembly 1314 enters sleeve 1380, sealant 1302 is transferred from sealant sleeve 1350 to sleeve 1380 (Figure 32B). Sleeve Adapter 1383 and / or Gauge 1376 retains sealant sleeve 1350. Sleeve Adapter 1383 and / or Wand 1375 retains sealant sleeve 1350 even when 1280 sleeve retracts (Figure 32C) or sealant 1302 is rammed using the support member

1330 (Figure 32D).

136

In some modalities as shown

<img file="MX354129B_D0092.tif" />

FROM L * PROFIEPAU

INDUSTRIAL spikes engage an outer portion of sheath adapter 1483. For example, adapter 1483 may include grooves 1486 configured to engage beards 1478. Sheath adapter 1483 may also include an inner diameter that is less than a diameter. exterior of 1450 sealant sleeve to facilitate transfer of sealant from 1450 sealant sleeve to 1480 sleeve.

Figures 34A-34I describe a method of using the system that includes any of the sealant and dilator delivery apparatus described herein. The method may include one or more of the steps described below. A procedure sheath (not shown) can be inserted through puncture 1504 into a vessel wall 1506 to gain access to a vessel lumen. After guide wire 1502 extends through the procedure sleeve and into the vessel, the procedure sleeve can be removed from the tissue tract, leaving guide wire 1502 in place with the distal tip of guide wire 1502 positioned within the lumen of the vessel. Dilator 1508 can then advance through the sheath of the

<td>closing</td><td> 1510,</td><td>and</td><td>the assembly</td><td>dilator-sheath</td><td>It can</td>

<td>move along</td><td>on</td><td>the</td><td>guide wire</td><td>1502 (Figure 34A).</td><td>It can</td>

use any of the mechanisms described in this

137 document to use to determine when 'NOUíTMIal.

Dilator-sheath enters the lumen of the vessel (eg, a bleeding port in the dilator and / or sheath).

After a distal end of sheath 1510 extends into the vessel lumen, dilator 1508 and guide wire 1502 can be proximally retracted and removed leaving the distal end of sheath 1510 within the vessel lumen (Figure 34B) . A positioning assembly 1512 can also be inserted into the proximal end of sheath 1510 and advanced distally through sheath 1510 (Figures 34C-34E). As described herein, the positioning assembly 1512 may include a sealant 1516 positioned at a distal portion of the positioning assembly 1512 before entering sheath 1510. After a positioning element 1514 extends outside the distal end of the sheath 1510 and into the vessel lumen, the positioning element 1514 can expand into the vessel lumen (Figure 34F).

Positioning assembly 1512 can then be removed to seat positioning element 1514 against puncture of vessel 1504, and sealant 1516 and sheath 1510 outside of vessel wall 1506 (Figure 34G). Sheath 1510 can then be partially retracted to expose sealant 1516 (Figure 34H). The support member

138

IMPIfe · '⁷ 1

1518 you can then advance to ramming & lT08ieil - '^ dp'r ^ 1516_t.^OF (NDU.'TSJAL '** -> --- against vessel wall 1506 (Figure 341). Positioning element 1514 can then be reduced in cross section (eg, deflated) and proximally retracted through of sealant 1516. Support member 1518 can be left in position against the sealant during proximal retraction of positioning element 1514, to maintain the location of the sealant. After removal of positioning element 1514, support member 1518 and sheath 1510 can be removed from the patient if it is still present within the tissue tract, leaving sealant 1516 positioned adjacent to vessel wall 1506.

In one implementation of the invention, the positioning element 1514 is an inflatable balloon carried in a distal region of an elongated balloon catheter arrow. The balloon catheter shaft comprises an elongated tubular body having a central lumen extending therethrough to position the inflatable balloon in fluid communication with an inflation medium source that can be coupled to the proximal end of the shaft . A central core wire extends through at least a portion of the central lumen, and through the balloon, to support the distal end of the balloon. The core wire can extend distally beyond the balloon for a length of

139 iMPie-n at least about 2 mm to 10 cm, and pref eriblems®'to ^ y unq $ · 3 °^£ 'AmCÚSTWA'cm to 5 cm to provide a flexible feed segment

The inner diameter of the central lumen is greater than the outer diameter of the core wire, to provide an inflation lumen and enable balloon inflation.

The sealant

1516 it is preferably provided with a central lumen such that it can be pre-mounted at a distal end of the balloon catheter shaft, proximal to the infallible balloon.

Sealant 1516 can be formed as a cylindrical plug, having a central lumen extending therethrough. Alternatively, sealant 1516 can be provided in a sheet or membrane form, which can be rolled back in one or two or three or four or more layers around the catheter shaft.

Referring, for example, to Figures 34F and 34G, the sealant is positioned on the distal catheter shaft and spaced a short distance from the proximal surface of the inflated balloon. The space can be dimensioned to cooperate with the anticipated wall thickness of the vessel, as illustrated in Figure 34G, such that the inflated balloon can be positioned against the interior wall of the vessel and the sealant is positioned directly outside of the puncture adjacent to the outer wall of the vessel. The space measured in an axial direction between the distal end of the sealant and the

140

<td>surface</td><td>TMPI proximal of the globe usually ^ p ^ ft'r.á.NmasJdrr / cit.</td>

<td>about 4 mm,</td><td>and, in some modalities, not greater than about 3 mm</td>

or 2 mm.

Using this construction, the sealant can be pre-positioned on the balloon catheter shaft at the point of manufacture, or, in any event, at the clinical site

<td>before</td><td>the</td><td colspan="2">introduction</td><td colspan="2">catheter</td><td>balloon inside</td><td>of the</td>

<td>patient.</td><td>The</td><td>catheter</td><td>of</td><td>balloon and</td><td>the</td><td colspan="2">sealant are guided</td>

<td>then</td><td>how</td><td>just one</td><td colspan="2">drive by</td><td>the</td><td>sheath 1510, from</td><td>the</td>

<td>Exterior</td><td>of the</td><td>patient,</td><td>to the</td><td>inside</td><td>of the</td><td>proximal end of</td><td>the</td>

sheath 1510, and guided by sheath 1510 to the vessel wall. The balloon can then be inflated into the vessel, and the system can be removed proximally as a unit without any internal relative movement between the balloon catheter and the sealant from the distal position illustrated in Figure 34F to the proximal, seated position in Figure 34G. The proximal retraction of the outer sleeve then exposes the sealant.

While the invention is susceptible to different modifications, and alternative forms, specific examples thereof have been shown in the drawings and described in detail in this document. It should be understood, however, that the invention is not limited to the particular forms or methods disclosed, but rather, the invention.

141 must cover all

<img file="MX354129B_D0093.tif" />

IM «• si'TITUTÜ MEXICANO modifications,

<img file="MX354129B_D0094.tif" />

Alternatives that fall within the attached claims alean.

142