WO2015126985A1

WO2015126985A1 - Device and method for implanting temporary seal

Info

Publication number: WO2015126985A1
Application number: PCT/US2015/016441
Authority: WO
Inventors: Michael DOCHERTY; Hassan Osman; Imad HASSAN; Peter W. J. HINCHLIFFE; Pierluca Lombardi
Original assignee: Maquet Cardiovascular Llc
Priority date: 2014-02-18
Filing date: 2015-02-18
Publication date: 2015-08-27

Abstract

A seal deployment tool according to an example embodiment of the present invention comprises a housing, a seal reshaper and a plunger. The housing has a channel therethrough, wherein the channel terminates at or near a distal end in an opening and is configured to initially house a seal element therein. The seal reshaper is positioned along the channel proximal to the opening and has a geometry configured to deform the seal element from the expanded shape having a first profile to a confined shape having a second profile due to relative movement between the seal element and the seal reshaper, the first profile being larger than the second profile. A plunger is movable with respect to the housing and configured to displace the seal assembly through the channel and deploy the seal element out of the opening. A method for deploying a seal element is also included.

Description

DEVICE AND METHOD FOR IMPLANTING TEMPORARY SEAL

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims priority to U.S. Provisional Patent Application serial No. 61/941,424, filed February 18, 2014, the entire contents of which are expressly incorporated by reference herein.

BACKGROUND

[0002] Anastomoses are performed as part of a variety of surgical procedures, including, for example, coronary artery bypass graft (CABG) surgery. In CABG, for example, it may be necessary to create an incision in a wall of a first vessel, e.g., the aorta, and connect a graft between a second vessel, e.g., a coronary artery, and the incision in the first vessel, thereby bypassing restricted sections of the coronary system. In such surgeries, a temporary seal may be desired to temporarily close off the incision made in the aorta or other vessel until the graft is completed.

SUMMARY

[0003] A seal deployment tool according to an example embodiment of the present invention includes a housing, a seal reshaper and a plunger. The housing has a channel therethrough, wherein the channel terminates at or near a distal end in an opening and is configured to initially house a seal element therein. The seal reshaper is positioned along the channel proximal to the opening and has a geometry configured to deform the seal element from the expanded shape having a first profile to a confined shape having a second profile due to relative movement between the seal element and the seal reshaper, the first profile being larger than the second profile. A plunger is movable with respect to the housing and configured to displace the seal assembly through the channel and deploy the seal element out of the opening.

[0004] According to an example embodiment, the seal reshaper of any described example embodiment includes one or more arms that are configured to pivot toward the seal element and compress the seal element. Each of the one or more arms include a curved end configured to engage the seal element and deform the seal element into the confined shape.

[0005] According to an example embodiment, the seal reshaper of any described example embodiment is included in a cartridge assembly that is insertable into a cavity in the housing.

[0006] According to an example embodiment, the one or more arms of any described example embodiment are configured to move toward the seal element to compress the seal element automatically in response to the cartridge assembly being inserted into the cavity of the housing.

[0007] According to an example embodiment, the plunger of any described example embodiment extends proximally from the housing and is directly actuatable by a user pressing the plunger.

[0008] According to an example embodiment, the housing of any described example embodiment includes a pistol grip and a trigger coupled to the plunger. The housing is configured to actuate the plunger in response to the trigger being pulled.

[0009] A system according to an example embodiment of the present invention includes a seal deployment tool and an extension assembly attachable to the tool. The seal deployment tool includes a housing, a seal reshaper and a first plunger. The housing has a channel therethrough, wherein the channel terminates at or near a distal end in an opening and is configured to initially house a seal element therein. The seal reshaper is positioned along the channel proximal to the opening and has a geometry configured to deform the seal element from the expanded shape having a first profile to a confined shape having a second profile due to relative movement between the seal element and the seal reshaper, wherein the first profile is larger than the second profile. The first plunger is movable with respect to the housing and configured to displace the seal assembly through the channel and deploy the seal element out of the opening. One or more arms of the seal reshaper are configured to pivot toward the seal element and compress the seal element. Each of the one or more arms include a curved end configured to engage the seal element and deform the seal element into the confined shape. The one or more arms are configured to move toward the seal element to compress the seal element automatically in response to the cartridge assembly being inserted into the cavity of the housing. The seal reshaper is included in a cartridge assembly that is insertable into a cavity in the housing. A second plunger of the extension assembly is located proximal to the first plunger and configured to actuate the first plunger when the second plunger is actuated.

[0010] According to an example embodiment, the seal reshaper of any described example embodiment includes a taper longitudinally along the channel configured to deform the seal element as the seal element is moved distally along the channel toward the opening.

[0011] According to an example embodiment, the taper of any described example embodiment includes a first lateral side having a first dimension or radius different than a second dimension or radius of a second lateral side of the taper.

[0012] According to an example embodiment, the taper of any described example embodiment includes a first lateral side having a first slope that is substantially constant along a length of the channel and a second lateral side having a second slope that is variable along the length of the channel.

[0013] According to an example embodiment, the taper of any described example embodiment includes a first lateral side having a first slope and a second lateral side having a second slope that is greater than the first slope.

[0014] According to an example embodiment, the taper of any described example embodiment includes a first lateral side that is substantially semi-circular along a length of the channel and a second lateral side that is initially substantially semi-circular and becomes increasing angled or pointed along the length of the channel.

[0015] According to an example embodiment, the housing of any described example embodiment includes a first housing component and a second housing component, wherein the first and second housing components are movable with respect to each other and wherein relative movement of the first and second housing components towards each other causes movement of the seal element through the taper of the channel.

[0016] According to an example embodiment, the seal deployment tool of any described example embodiment further includes a lock preventing relative movement between the first and second housing components until the lock is released.

[0017] According to an example embodiment, the lock of any described example embodiment includes a projection creating interference between the first and second housing components and a button in operable communication configured to displace the projection when the button is pressed in order to remove the interference.

[0018] According to an example embodiment, the seal deployment tool of any described example embodiment further includes an interlock to prevent relative movement between the first and second housing components after the first and second housing components have been moved relatively together.

[0019] According to an example embodiment, the seal deployment tool of any described example embodiment further includes a lock preventing actuation of the plunger until the lock is released.

[0020] According to an example embodiment, the plunger of any described example embodiment includes a slot engagable with the lock, wherein the lock is movable transversely with respect to the plunger to release the lock from the slot.

[0021] A method of deploying a seal element of a seal assembly according to an example embodiment of the present invention includes the steps of: causing relative movement between a first housing component of a seal deployment tool and a second housing component of the seal deployment tool, wherein the first housing component initially contains the seal element in an expanded shape; causing relative movement between a seal reshaper and a seal element of the seal assembly automatically due to the relative movement between the first and second housing components; deforming the seal element into a confined shape smaller than the expanded shape automatically due to the relative movement between the seal reshaper and the seal element; actuating a plunger in operable communication through the first and second housing components; and deploying the seal element out of an opening in a distal end of the seal deployment tool with the plunger.

[0022] According to an example embodiment, the seal reshaper includes a taper in the channel, and the method of any described example embodiment further involves causing relative movement between the seal reshaper and the seal element includes moving the seal element through the taper to roll the seal element upon itself.

[0023] According to an example embodiment, the seal reshaper of any described example embodiment includes at least one arm with a curved end, wherein causing relative movement between the seal reshaper and the seal element includes moving the at least one arm and deforming the seal element includes contacting the seal element with the curved end and compressing the seal element with the at least one arm.

[0024] According to an example embodiment, the method of any described example embodiment further includes inserting the distal end of the seal deployment tool through an aperture in an anatomical structure, wherein the deploying includes deploying the seal element into the anatomical structure.

[0025] According to an example embodiment, the method of any described example embodiment further includes reverting the seal element back to its expanded shape inside of the anatomical structure and sealing the aperture with the seal element in its expanded shape.

[0026] According to an example embodiment, the anatomical structure is a blood vessel, and the method of any described example embodiment further includes forming an incision in the blood vessel to create the aperture prior to the inserting.

[0027] A seal assembly deployment tool according to an example embodiment of the present invention includes a first housing component, a second housing component and a plunger. The second housing component is slidably coupled to the first housing component, wherein the second housing component has: a distal end in which an opening is defined; a channel in communication with the opening; and a proximal end attached to the housing. Movement of the second housing component relative to the first housing component induces folding of a seal element positionable within the channel. The plunger is movably positioned at least partially within the housing and configured to deploy the seal element through the opening.

[0028] A seal deployment tool according to an example embodiment of the present invention includes a reshaping plunger longitudinally moveable with respect to a housing. The housing includes a distal tip for interfacing with an aperture, wherein distal movement of the reshaping plunger towards the housing's distal tip causes a seal to reshape itself from a first profile that would not fit within the aperture to a second profile that will fit into and/or through the aperture.

[0029] According to an example embodiment, the seal deployment tool of any described example embodiment further includes a displacement plunger different than the reshaping plunger, wherein longitudinal movement of the displacement plunger expels the seal to at least partially be expelled from the distal tip of the housing.

[0030] According to an example embodiment, in any described example embodiment, a length of travel the displacement plunger moves with respect to the distal tip to dispel the seal from the tip is less than a length of travel the reshaping plunger moves with respect to the distal tip to transition the seal from the first profile to the second profile.

[0031] According to an example embodiment, in any described example embodiment, the displacement plunger and the displacement plunger are configured to reshape the seal and displace the seal respectively through movement in a single longitudinal direction.

[0032] According to an example embodiment, in any described seal deployment tools, the tool is sterilized to a sterility assurance level equal to or greater than 10^"3 SAL. [0033] A method for introducing a seal into an aperture through use of a tool according to an example embodiment of the present invention includes causing, through longitudinal movement imparted to the tool: (i) reshaping of the seal from a first profile to a second profile different than the first profile, wherein the first profile of the seal is not able to fit within a first diametrical space, and (ii) displacing of the seal from the tool.

[0034] According to an example embodiment, in any described example embodiment, the longitudinal movement includes a first longitudinal movement for reshaping that occurs separately from a second longitudinal movement for displacing the seal.

[0035] According to an example embodiment, in any described example embodiment, the first longitudinal movement for reshaping and the second longitudinal movement for displacing the seal occur in the same direction.

[0036] According to an example embodiment, in any described example embodiment, the longitudinal movement for reshaping and the longitudinal movement for displacement occur through the use of at least one plunger.

[0037] According to an example embodiment, in any described example embodiment, the first longitudinal movement for reshaping and the second longitudinal movement for displacement occur through the use of two plungers. Each of the two plungers is (i) moveable with respect to each other and (ii) the distal tip.

[0038] According to an example embodiment, in any described example embodiment, displacing begins prior to the completion of reshaping.

[0039] According to an example embodiment, in any described example embodiment, reshaping and displacing occur at least partially simultaneously.

BRIEF DESCRIPTION OF THE DRAWINGS

[0040] The following descriptions should not be considered limiting in any way. With reference to the accompanying drawings: [0041] Figure 1 is a perspective view of a seal deployment tool according to one embodiment disclosed herein in an initial configuration;

[0042] Figure 2 is a perspective view of a seal assembly according to one embodiment disclosed herein that is deployable from any of the tools disclosed herein, including the tool of Figure 1 ;

[0043] Figure 3A is a cross-sectional view of the tool of Figure 1 taken generally along section line 3 A-3 A in Figure 1 ;

[0044] Figure 3B is a cross-sectional view of the tool of Figure 1 taken generally along section line 3B-3B in Figure 1 ;

[0045] Figure 4 A is perspective view of a portion of the tool of Figure 1 taken of a side generally opposite to that shown in Figure 1 ;

[0046] Figure 4B is an enlarged elevation view of an interlock shown in Figure 4A;

[0047] Figure 4C is an elevation view of an proximal housing component illustrating features of the interlock shown in Figure 4A;

[0048] Figure 4D is a front view of the housing component of Figure 4C;

[0049] Figure 5 is an exploded view of the tool of Figure 1 ;

[0050] Figure 6 is a perspective view of the tool of Figure 1 transitioned to an intermediate configuration ready for deployment of a seal or seal assembly therefrom;

[0051] Figure 7 is a perspective view of the tool of Figure 6 with a portion of a housing removed to show internal components of the tool;

[0052] Figure 8 is a perspective view of the tool of Figure 6 in a fully deployed configuration after actuation of a plunger to deploy a seal element of the seal assembly from the tool; [0053] Figure 9 schematically illustrates the tool in the configuration of Figure 6 being inserted through an incision or wall aperture in a blood vessel;

[0054] Figure 10 illustrates the tool and blood vessel of Figure 9 after the tool has been transitioned to the fully deployed configuration of Figure 8, the seal element shown deployed from the tool;

[0055] Figure 11 illustrates the blood vessel and seal assembly of Figures 9 and 10 after the tool has been removed from the incision site/wall aperture;

[0056] Figure 12 illustrates the seal assembly and blood vessel of Figures 9-11 as it is being unraveled/dissasembled for removal from the blood vessel after a graft is installed;

[0057] Figure 13 is an enlarged view of the seal assembly in the channel of the tool of Figure 3 prior to deployment;

[0058] Figures 13A-13F are cross-sectional views of the channel of the tool and where applicable the seal element of Figure 13, at various locations along the longitudinal length of the channel, designated by the sectional lines A-A, B-B, C-C, D-D, E-E, and F-F of Figure 13, respectively;

[0059] Figure 14 is a perspective view of a seal deployment tool containing a removable cartridge, according to an embodiment disclosed herein;

[0060] Figure 15 is a perspective view of the tool of Figure 14 with the cartridge removed from and aligned with the housing thereof;

[0061] Figure 16 is an enlarged view of the cartridge of Figure 15 having a cover (shown in Figure 15) removed to show an interior of the cartridge;

[0062] Figure 17 is a perspective view of the tool of Figure 14 with a portion of the housing removed to show an interior of the tool and received cartridge;

[0063] Figure 18 a perspective view of a system according to an embodiment herein including the tool and cartridge of Figure 14 and an extension assembly; [0064] Figure 19 an exploded view of the system of Figure 18;

[0065] Figure 20 is a perspective view of a tool according to an embodiment disclosed herein having a housing with a pistol grip and the cartridge of Figure 14; and

[0066] Figure 21 is a perspective view of the tool of Figure 20 having a portion of the housing removed to show an interior of the tool.

DETAILED DESCRIPTION

[0067] A detailed description of one or more embodiments of the disclosed apparatus and method are presented herein by way of exemplification and not limitation with reference to the Figures.

[0068] For purposes of the description hereinafter, the words "upper," "lower," "right," "left," "vertical," "horizontal," "top," "bottom," "lateral," "longitudinal," "axial," and like terms, if used, shall relate to the invention, as it is oriented in the drawing figures. When appropriate, the terms "proximal" and "distal" are in reference the user that uses the tool to deploy a seal element, typically towards a portion of a patient's anatomy. The term "distal" shall for instance mean situated away from the user, while the term "proximal" shall mean situated more towards the user. It is to be understood that the invention may assume many alternative variations and embodiments except where expressly specified to the contrary. It is also to be understood that the specific devices and embodiments illustrated in the accompanying drawings and described herein are simply example embodiments of the invention.

[0069] Referring now to the Figures, a seal deployment system is illustrated including a deployment tool 10 for deploying a seal or seal assembly. One example of a seal assembly, designated with the reference numeral 100, is illustrated throughout the Figures and shown in more detail in Figure 2. For ease of discussion, reference herein will be made to the seal assembly 100, although it is to be understood that use of the seal assembly 100 is optional, may include only some or even a single one of the components illustrated and described, and that other seals or seal assemblies may alternatively or additionally be deployed by the tool 10. It is also noted that the term "seal", when used herein as a noun, generally refers to a structure to cause at least a partial blockage, impedance, or hindrance to fluid flow, and while when used as a verb similarly refers to at least partially blocking, impeding, or hindering the flow of fluid.

[0070] Turning to Figure 2, the illustrated seal assembly 100 includes a seal element 102 that provides the aforementioned fluid seal when deployed by the tool 10 into an opening in an anatomical structure of a patient, whether human or non-human, including for instance a non-human practice mannequin having a simulated anatomical structure similar in shape and size to a human patient. A tensioner 104 may be optionally included, having a pair of legs 103 extending from a vertex 99 is shown in Figure 2, the tensioner 104 is initially coupled to or secured with the seal element 102 via a tether 106, which spans between ends 105 of the legs 103 of the tensioner 104. The tensioner 104 is, or includes, a spring or biasing member that holds in tension the tether 106 in order to assist in maintaining the seal element 102 in a deployed state, e.g., by pulling the seal element 102 firmly against an interior wall of the structure in which the seal element 102 is installed. For example, in order to create a tensioning force with the legs 103 that is communicable by the tensioner 104 to the seal element 102 via the tether 106, the legs 103 may be arranged such they are resiliently displaced toward each other by the tether 106 from a default or unstressed position at which they are spread apart by a distance greater than the length of the tether 106, and therefore stressed when held together by the tether.

[0071] The seal element 102 may be formed of one or more components, and is preferably formed by a strand, strip, or continuous element 108 arranged in a pattern to form the initial, default, or expanded configuration of the seal element 102. In the illustrated embodiment, the continuous element 108 is wound in a spiraling pattern that gives the seal element 102 a bowl, cup, or umbrella shape. It is noted that the seal element may form other shapes, e.g., a flat plate or disc, may be concave, convex, flat, or combinations thereof, and/or that the pattern of the continuous element 108 used to form the expanded shape of the seal element 102 may differ from that shown, e.g., serpentine, zig-zag, random loops or swirls, etc. A seam or connection 110 or series of seams or weakened connections 110 such as perforations are shown to be formed between adjacent portions of the continuous element 108. As discussed in more detail below, the connection(s) 110 is intended to be broken or separated in order to enable the seal element 102 to be unraveled or dissembled into just the continuous element 108. The connection(s) 110 can be made fluid tight to help ensure that a good seal is formed by the seal element 102.

[0072] A stem 112 is optionally included and may extend from the seal element 102. The stem 112 may optionally include a handle 114 arranged to facilitate a user's ability to easily grab or manipulate the stem 112. The stem 112 is either integrally formed with or otherwise secured to the seal element 102 such that pulling or exerting a tensile force on the stem 112 will exert a pulling force on the seal element 102, such as directly on the continuous element 108. In the illustrated embodiment, the stem 112 is a portion of the continuous element 108 that extends from the seal element 102. When a suitable force is exerted on the seal element 102 via the stem 112, the connection 110 between adjacent portions of the continuous element 108 will begin to part, rip, tear, break, and/or separate, such that continued application of the force will unravel or disassemble the seal element 102 in a predictable predetermined manner along the connection 110. This disassembly may occur until the seal element 102 achieves a smaller profile that facilitates removal from the aperture that the seal element 102 was sealing prior to disassembly. Preferably such profile is smaller than the profile of the aperture. The unraveling thus enables the seal element 102 to be removed from an aperture having a smaller size than the original, expanded, or first profile of the seal element 102 (i.e., prior to unraveling) and the continuous element 108 may thus be easily pulled out of the aperture in the anatomical structure, including those apertures of an anatomical structure which may already be partially sutured closed.

[0073] Suitable examples for the seal assembly 100 are also disclosed in U.S. Patent No. 6,814,743 to Chin et al., U.S. Patent Publication No. 2006/0079915 to Chin et al., and U.S. Patent Publication No. 2009/0043243 to DeLipski et al., which patent references are incorporated herein by reference in their respective entireties. Suitable examples for the seal assembly 100 further include the temporary vascular and cardiovascular seals made commercially available by MAQUET Cardiovascular, LLC of Wayne, NJ, USA, under the trade name HEARTSTRING.

[0074] Figures 1, 3 A and 3B illustrate an embodiment of the tool 10 in a first or initial configuration, while the tool 10 is shown exploded in Figure 5. The tool 10 preferably includes a distal end or tip 12 having an opening 14, which is arranged for deployment of a seal assembly therefrom, e.g., during a surgical operation or procedure using the tool 10. The tip 12 of the tool 10 is configured to be inserted into an aperture, such as an incision or puncture, in or through an anatomical structure, such as a vein or artery, of a patient. As will be discussed in more detail below, a seal assembly can be fully or partially deployed by the tool 10 through the opening 14 in order to seal the opening in the anatomical structure, preferably at the interior wall of the anatomical structure. The tip 12 is preferably cylindrical, and at its proximal end is internally flared outward.

[0075] The seal assembly 100 is initially housed within a channel 16 in a distal housing component 18, as seen best in Figures 3-4. The distal housing component 18 may optionally include grip sections 17 comprising a plurality of tactile ribs to enhance or improve the ability of a user to grip the tool 10 therewith. The distal housing component 18 is movably coupled to a proximal housing component 20. The distal housing component 18 may be referred to as a "sleeve" or "barrel" since it is generally positioned radially outwardly or external to the proximal housing component 20, although it is noted that the distal housing component 18 may alternatively be positioned radially within the proximal housing component 20, or optionally partially internal to and partially external to the proximal housing component 20. Additionally, the proximal housing component 20 may be referred to as a "plunger" or "reshaping plunger" since it facilitates the reshaping of the seal element 102. More specifically, relative movement between the housing components 18 and 20 toward each other causes the seal assembly 100, namely the seal element 102, to progress distally through the channel 16 toward the opening 14. It is additionally noted that while housing components 18 and 20 are each shown as an assembly of halves 18A/18B and 20A/20B respectively (see Figures 4C, 4D and 5), e.g., for ease of manufacture and/or assembly, each may also be formed as a single component.

[0076] In the illustrated embodiment, the proximal housing component 20 includes a hollow extension or tube 22, which may extend distally therefrom. The tube 22 may be integrally formed with the proximal housing component 20 or formed as a separate component. In the illustrated embodiment, the tensioner 104 of the seal assembly 100 is initially at least partially housed within the tube 22 and, may maintain its location due to friction, as the tensioner would be under stress and apply a radial outward contact force to the inner wall of the tube 22. Additionally, a distal end 24 of the tube 22 may be positioned adjacent to the seal element 102 of the seal assembly 100. In this way, moving the distal housing component 18 with respect to the proximal housing component 20 will push or displace in a distal direction the seal assembly 100 along the channel 16, e.g., via the distal end 24 directly pushing against the seal element 102 and/or indirectly via the tube 22 carrying the tensioner 104.

[0077] The tool 10 may include a seal reshaper. For example, the channel 16 in the illustrated embodiment is constructed as a seal reshaper in the form of a taper 26. The taper 26 is geometrically arranged with respect to the seal element 102 to cause the seal element 102 to be reshaped from a first shape having a first profile to a second shape having a second profile, with the second profile being smaller than the first profile. The reshaping of the seal element 102 may be accomplished through folding, wrapping, or rolling the seal element 102 upon itself as the seal element 102 is moved distally through the channel 16. In other words, the taper 26 is arranged to cause the seal element 102 to transition into a deformed or confined shape. This may also be referred to as its rolled or folded shape. It is noted that the initial shape of the seal element 102 may be at least partially rolled or folded in some embodiments, and fully expanded or unrolled in other embodiments. Advantageously, moving the housing components 18 and 20 relative to each other automatically causes movement of the seal element 102 through the channel 16, which in turn automatically causes deformation of the seal element 102 to its confined or deformed shape by the taper 26. The taper 26 may be comprised of one or more continuous or discontinuous surfaces, rails, and/or guides positioned along at least a portion of the length of the channel 16. [0078] The tool 10 is illustrated in Figures 6-7 with the housing components 18 and 20 having already been moved or actuated toward each other, and with the seal element 102, in its confined shape, protruding partially from the opening 14 in the tip 12 of the tool 10. In this configuration, it is noted that the seal element 102 may be at most only partially extending out from the opening 14, as illustrated. In this way, the seal element 102 is held by the tool 10 in its folded shape and is immediately ready for deployment. In one embodiment, the seal element 102 may be completely held within the tool 10 and not protrude from the opening 14.

[0079] The tool 10 may include a deployment piston or plunger 28 in order to perform the deployment of at least the seal element 102 from the tool 10. More specifically, the deployment plunger 28 includes a head 30 at its proximal end that is able to be pressed by a user in order to actuate the plunger 28 distally through the housing components 18 and 20. The proximal region of the proximal housing component 20 may include one or more flanges 32 to facilitate actuation of the plunger 28. For example, a user may actuate the plunger 28 by positioning one or more fingers on the distal facing surfaces 33 of the flanges 32 and the user's thumb proximally behind the head 30 to provide leverage for squeezing the fingers and thumb together to cause distal movement of the plunger 28 through the tool 10.

[0080] In the illustrated embodiment, as seen clearly, for example, in Figures 3-4 and 6, a distal region 29 of the plunger 28 extends at least partially through the proximal housing component 20 and is aligned with the tube 22. After the housing components 18 and 20 have been moved toward each other, the distal region 29 of the plunger 28 may be positioned immediately proximate to the seal assembly 100 and/or extending through the tube 22 (as shown in Figure 7), specifically, for example, adjacent to the tensioner 104 of the seal assembly 100. Actuating the plunger 28 will therefore push the seal assembly 100, via engagement against the tensioner 104, in the distal direction. This will in turn exert a force on the seal element 102 and dislodge the seal element 102 from the tip 12, thereby deploying the seal element 102 from the tool 10, as shown in Figure 8. The tool 10 can then be withdrawn from the surgical site, with friction or interference between the seal element 102 and the aperture it seals having sufficient resistance to cause the tensioner 104 to also exit out of the opening 14. Conveniently, starting from the condition the tool 10 is received for use, the seal element 102 can be shaped to a configuration to pass through the aperture and displaced from the tool 10 while the tip 12 is aligned with and at least partially inserted into the aperture. The user is not required to disassemble various components

[0081] The process of using the tool 10 described above is also shown schematically in Figures 9-12. In Figure 9, the tip 12 of the tool 10 is illustrated as inserted into an aperture, perforation or incision 120 in a blood vessel 125. For example, it may be necessary to make an incision or puncture into a patient's aorta or other blood vessel while performing CABG surgery, with the seal assembly 100 held against an interior wall surface 127 of the vessel 125 and used for temporarily stopping or slowing the flow of blood through the incision 120 (i.e., the site of anastomosis) out of the aorta or other blood vessel until a surgeon or other medical personnel completes a bypass with a graft (i.e., suturing the graft about the incision 120 and connecting the graft to another blood vessel). It is to be appreciated that the aorta is merely one example of a blood vessel, and CABG surgery merely one example of a medical procedure, and that those of ordinary skill in the art will recognize a number of other vascular, cardiovascular, and surgical procedures that may benefit from the tool 10. That is, in general, the tool 10 may be used to deploy a seal element, such as the seal element 102,

[0082] The seal element 102 is illustrated as being already in its folded shape in Figure 9, as the transition of the tool 10 from the configuration of Figure 1 to the configuration of Figure 6 may occur before insertion of the tip 12, or alternatively may occur once the tip 12 is placed inside the incision 120. Once the tip 12 is positioned through the incision 120, the plunger 28 is actuated as described above, deploying or ejecting the seal element 102 from the opening 14 in the tip 12. Once cleared from the tip 12, the seal element 102 is able to resiliently spring back and revert to its initial expanded shape, as shown in Figure 10, having a larger profile than the seal element 102 when in its confined shape. The incision 120 can be sized so that it is larger than the profile of the seal element 102 in its confined shape, thereby enabling the seal element 102 to be inserted through the incision 120, but smaller than the profile of the seal element 102 when it reverts or expands back to its initial expanded shape, thereby enabling the seal element 102 to seal the incision 120. Withdrawing the tool 10 leaves just the seal assembly 100 in place, with the tensioner 104 pulling the seal element 102 against the interior wall 127 of the vessel 125 in order to promote a good seal with the seal element 102.

[0083] During a CABG procedure or other anastomosis, after the tool 10 is removed, a graft 130 can be installed about the incision 120, e.g., sutured to the vessel 125, as shown in Figure 12. Thereafter, the stem 112 can be pulled to unravel or disassemble the seal element 102, as shown in Figure 12 and described above. It may be desirable to cut the tether 106 to remove tension on the seal element 102 before unraveling the seal element 102 with the stem 112 in order to facilitate removal thereof.

[0084] It is noted further that the tool 10 can be arranged to prevent accidental or inadvertent actuation or relative movement of the components of the tool 10 at undesirable times. For example, referring back to the initial configuration of the tool 10 in Figures 1 and 3-4, it can be seen that the tool 10 optionally includes a lock 34 comprising a projection 36 coupled to the proximal housing component 20 and a button 38 coupled to the distal housing component 18. As can be best seen in Figures 3 A and 3B, relative movement between the housing components 18 and 20 is initially prevented by interference between the projection 36 and a proximal end 40 of the distal housing component 18. The projection 36 is located on a cantilever 42, formed between two longitudinally extending slits 44 on opposite sides thereof.

[0085] One or more fingers 46 are located at the radially inward side of a button 38, which itself is located on the proximal end of a cantilever 39 extending proximally from a top side of the distal housing component 18. In this way, pressing the button 38 radially inwardly causes the finger 46 to press against a free end 48 of the cantilever 42, displacing the projection 36 radially inwardly. When the projection 36 is moved sufficiently radially inward by use of the button 38, interference between the proximal end 40 and the projection 36 is removed, thereby enabling relative collapsing movement between the housing components 18 and 20. In this way, actuation of the housing components 18 and 20 relative to each other in order to roll the seal element 102 can be prevented until desired by a user, and made accomplishable by the user pressing the button 38 to release the lock 34.

[0086] If desired, an interlock 59 can optionally be provided between the housing components 18 and 20 to prevent them from moving away from each other after they have been moved together (e.g., moved longitudinally together). This is best illustrated in Figures 3A, and 4A, 4C and 4D. For example, in one embodiment, the tool 10 includes a series of teeth 53 arranged sequentially to form a ratchet 55 that incrementally engages with a pawl or ramp 56 on a cantilever 54 (generally on the opposite side of the proximal housing from cantilever 42) and thereby significantly limits relative movement of the housing components 18 and 20 away from each other at any relative position therebetween. In this way, moving the housing components 18 and 20 together will cause the pawl 56 to "climb" the teeth 53, pushing the cantilever 54 radially outwardly, until the pawl 56 is moved to the end of the ratchets 55. After climbing each of the teeth 53, the cantilever 54 can resiliently snap or return to its initial position, creating interference between the pawl 56 and the teeth 53. It is noted that the distal housing component 18 may alternatively include a latch or other protrusion and the proximal housing component 20 include a notch. It is also noted that other one-directional interlocks can be provided, such as a resilient split ring or c- ring, etc.

[0087] Similarly, in an exemplary embodiment, premature actuation of the plunger 28 can be prevented by optional inclusion of a lock 58 that selectively restricts movement of the plunger 28 with respect to the housing 20. The lock 58 includes an opening, aperture, or hole 60 that is sized to selectively permit the plunger 28 to pass therethrough. However, the lock 58 is laterally movable with respect to the plunger 28 (i.e., in a direction transverse or perpendicular to the longitudinal direction of the plunger 28) in order to offset or misalign the plunger 28 with respect to the hole 60. As shown in Figures 3 and 5, the plunger 28 accordingly includes a key way, notch, or slot 62 into which a portion of the lock 58 is initially located, which enables the misalignment between the hole 60 and the plunger 28. By moving the lock 58 toward the proximal housing component 20, the hole 60 is moved into alignment with the plunger 28. In this way, actuation of the plunger 28 can be prevented until specifically desired by a user, and made accomplishable by the user pressing the lock

58 toward the proximal housing component 20.

[0088] Figures 4A and 4B show an interlock 59 that may be optionally included in order to prevent movement of the lock 58 relative to the plunger 28 until after the housing components 18 and 20 have been moved relative to each other. The interlock 59 includes one or more deflectable beams 61 with the proximal housing component 20 and a ram or spreader 63 with the distal housing portion 18. Moving the housing components 18 and 20 toward each other causes the ram 63 to be inserted between the beams 61 in order to spread the beams 61 apart, i.e., away from each other. As shown in Figure 4B, the lock 58 has one or more portions, designated with the reference numerals 65a, 65b, and 65c (collectively, "the portions 65"), which create overlaps 67a, 67b, and 67c, respectively, (collectively, "the overlaps 67") with respect to the beams 61. The overlaps 67 result in interference between the lock 58 and the beams 61, preventing the lock 58 to be actuated, and therefore also preventing the hole 60 to be aligned with the plunger 28. By spreading the beams 61 apart with the ram 63 due to relative movement of the housing components 18 and 20 toward each other, the interference between the portions 65 and the beams 61 at the overlaps 67 is removed and the lock is permitted to be moved. Advantageously, the interlock

59 thus prevents the lock 58 from prematurely releasing the plunger 28, i.e., the plunger 28 cannot be actuated until after the seal element 102 has already been reshaped by the taper 26 due to the relative movement between the housing components 18 and 20 as discussed above.

[0089] Figure 13 illustrates a distal end of the tool 10, with Figures 13A-13F showing various cross-sections of the taper 26 along the length of the channel 16. For simplicity and clarity, only the seal element 102 and those portions of taper 26 relating to the surface(s) or sides that would contact the seal element 102 are shown. Not shown are the portions of the housing component 18 that creates the surfaces of contact that otherwise would exist as one of skill in the art would understand per Figure 13. As can be appreciated from these Figures, the channel 16 includes a first lateral side 64 having a radius or dimension that is larger than a corresponding radius or dimension of a second lateral side 66. The difference in dimensions between the first and second lateral sides 64 and 66 results in a shoulder 68 and assists in ensuring that the seal element 102 is consistently folded or rolled in the same direction, e.g., either clockwise or counter-clockwise, by setting which side of the seal element 102 overlaps on top of the other. More specifically, for example, the larger dimension of the lateral side 64 permits a side of the seal element 102 engaged against the lateral side 64 (and designed generally with the numeral 102a) to be positioned radially outwardly of a side of the seal element engaged against the lateral side 66 (and designated with a numeral 102b), thus causing the side 102a to overlap on top of the side 102b. Also, the first side 64, while continuing to taper, retains a substantially rounded or semi-circular shape, while the roundedness of the opposite side 66 is lost, and the side 66 becomes more harshly or severely angled, flattened, ellipsoidal, or pointed. This promotes an increased degree of rolling or folding of the seal element 102 against the side 66, while the shoulder 68 frustrates rolling against the side 64. Distally along the length of the channel 16, the shoulder 68, as can be seen by comparing Figure 13F to Figure 13 A, becomes significantly rounded, which further assists in the side 102a of the seal element 102 folding over the side 102b as the seal element 102 traverses through the channel 102. In addition, from Figure 13 it can be seen that the first lateral side 64 of the taper 26 has a slope that is generally consistent along the length of the channel 16 (i.e., in the longitudinal or proximal-distal direction), while the slope of the second side 66 of the taper 26 is variable. A first portion 66a has a slope greater than that of the first lateral side 64, while a second portion 66b has a slope that is about equal to that of the first lateral side 64. These features together reliably cause the seal element 102 to fold in a consistent manner, such that deployment occurs substantially consistently each time the tool 10 is used, or consistently between deployments of different ones of the tool 10, although it is to be appreciated that each of the above-described features is optional and that other combinations of these and other features may be included in non-illustrated embodiments.

[0090] A tool 200 according to one embodiment is shown in Figures 14-17. Similar to the tool 10, the tool 200 is arranged to house, deform, and deploy the seal assembly 100 or another seal or seal assembly. The tool 200 includes a housing component 202 having a cavity 204 that is receptive of a cartridge assembly 205. The cartridge assembly 205 includes a tip 206 having an opening 207, which are substantially analogous to the tip 12 and the opening 14 discussed above. That is, the tool 200 is arranged to roll the seal element 102 of the seal assembly 100 and then deploy the rolled seal assembly out of the opening 207 and through an incision or other aperture into an anatomical structure in which the tip 206 is inserted.

[0091] In one embodiment, the cartridge assembly 205 may optionally include a mechanism that forms either a permanent or removable connection with the housing 202. For example, in the illustrated embodiment, a body 208 of the cartridge assembly 205 optionally includes a ramp 209 protruding or extending therefrom that is selectively engagable with a window 210 of the housing 202. For example, in this embodiment, the ramp 209 forms a shoulder 212 at one end that protrudes from the cartridge 206 beyond the extents of the recess 204, thus creating interference between the edge of the window 210 and the shoulder 212 when the ramp 209 is aligned with the window 210, as shown in Figures 14 and 17. The interference between the shoulder 212 and the window 210 prevents the cartridge assembly 205 from being withdrawn from the recess 204 of the housing 202, thereby locking the cartridge assembly 206 in position within the housing 202.

[0092] In order to enable the shoulder 212 to be aligned with the window 210, the ramp 209 can be coupled to the body 208 in a cantilevered, resilient, or biased manner that enables the ramp 209 to be retracted into and extended from the body 208. By enabling the ramp 209 to be retracted into the body 208, the interference between the shoulder 212 and the edge of the window 210 can be selectively removed and the body 208 inserted into the recess 204. When the body 208 is fully inserted into the recess 204, the shoulder 212 and the window 210 become aligned, and the ramp 209 is able to return to its extended configuration, thereby creating the aforementioned interference between the shoulder 212 and the window 210.

[0093] In one embodiment, an end 214 of the ramp 209 opposite from the shoulder 212 is connected to the body 208 of the cartridge assembly 205 in a resiliently cantilevered or hinged manner. In another embodiment, the ramp 209 may be formed as a latch, button, or other member that is biased to the extended position by a spring or other biasing element. In one embodiment, a user can manually press the ramp 209 in order to retract the ramp 209 into the body 208, which removes the interference between the shoulder 212 and the window 210, thereby enabling the cartridge assembly 205 to be disengaged from the housing 202 (e.g., enabling reuse of the housing 202 with a new cartridge assembly). In some embodiments, the tool 200 is fully disposable, and the cartridge assembly 205 becomes permanently locked with respect to the housing 202 in order to prevent reuse thereof.

[0094] The cartridge assembly 205 includes a seal reshaper 216, which is arranged to deform, e.g., fold or roll, the seal element 102 of the seal assembly 100. The reshaper 216 of the tool 200 includes one or more arms, designated separately as arms 218a and 218b in the Figures (but which may be collectively referred to as "the arms 218"), which are movable relative to the seal element 102. More specifically, the arms 218 are movable toward each other, thereby compressing the seal element 102 therebetween. The arms 218 may optionally terminate in curved or arcuate ends 220, which assist in causing the seal element 102 to be rolled into a cylindrical, tube, or taco shape (e.g., as shown in Figures 6 and 7), when compressed between the arms 218. It is to be appreciated that a single one of the arms 218 may be included in one embodiment, with the seal element 102 compressed by the single one of the arms 218 against a stationary inner wall of the body 208, e.g., which inner wall may be curved or shaped similarly to the curved ends 220.

[0095] The arm or arms 218 protrude from the body 208 in a biased or resilient manner, e.g., generally similar to the ramp 209 discussed above. For example, the arms 218 in the illustrated embodiment are connected by a resilient member, hinge, or spring 221, which urges the arms 218 generally away from each other and outwardly from the body 208. Again similar to the ramp 209, the extending of the arms 218 away from the body 208 causes the arms 218 to be forcibly pushed or retracted into the body 208 by interference with the housing 202 as the body 208 is increasingly inserted into the recess 204 of the housing 202. In this way, it is noted that the body 208 forms a distal housing component and the housing 202 forms a proximal housing component, similar to the housing components 18 and 20 discussed above, and that inserting the body 208 of the cartridge assembly 205 into the housing 202 automatically causes actuation of the arms 218 toward each other, just as actuation of the housing components 18 and 20 toward each other resulted automatically in the seal element 102 being displaced along the channel 16 and reshaped by the taper 26. Advantageously, the mere act of inserting the cartridge assembly 205 into the housing 202 deforms the seal element 102 into the rolled or folded shape, which is ready for deployment as described above.

[0096] Once the cartridge assembly 205 is engaged with the housing 202, the seal element 102 is automatically deformed and ready for deployment, e.g., through an incision or aperture in a wall of a blood vessel such as an aorta. A plunger 222 is slidably coupled with respect to the housing 202, and insertable into the body 208 of the cartridge assembly 208 via a channel 224 formed therethrough. The seal assembly 100 is positioned along the channel 224 such that pressing the plunger 222 toward the housing 202 causes the plunger 222 to travel through the channel 224 push the deformed seal element 102 along the channel 224 and out of the body 208 via the opening 207 in the tip 206. The tool 200 can then be pulled away, e.g., similar to the tool 10 discussed above, leaving the seal element 102 within the anatomical structure. It is understood that the general procedure of Figures 9-12 is applicable to the tool 200.

[0097] Although the seal reshaper 216 and the seal reshaper taper 26 of the channel 16 are different solutions for folding, rolling, deforming, or reshaping the seal element 102, it is noted that both have a geometry that enables the seal element 102 to be deformed due to relative movement between the geometry and the seal element 102. For example, in the tool 10 the seal element 102 moves with respect to the taper 26 of the channel 16, and in the tool 200 the arms 218 move with respect to the seal element 102, but in both embodiments it is relative movement of the seal element 102 with respect to geometry of the reshaper 216 or the taper 26 that results in the deforming of the seal element 102. Additionally it is noted that the deploying of the seal element can occur immediately and directly from the same structure that deforms the seal element. For example, this is made accomplishable by positioning the seal deforming structure, be it the reshaper 216 or the taper 26, along the channel that leads to the opening through which the seal element is deployed. Advantageously, this avoids the need for some known seal deployment devices to deform a seal element in a first device, insert the deformed seal element into a second device after deforming, and then deploy the seal element into an anatomical structure with the second device.

[0098] It is of course to be appreciated that multiple seal assemblies can be deployed by the tool 200, for example, to perform multiple graft anastomosis procedures performed on the same patient, by removing the cartridge assembly after its seal assembly has been deployed (e.g., by pressing the ramp 209 as discussed above) and installing a new cartridge assembly within the housing 202. A spring or other biasing member 226 can accordingly be included to bias or urge the plunger 222 away from the tip 206, thereby automatically resetting the tool 200 for reuse after the new cartridge has been installed into the housing 202. Empty cartridge assemblies (those having had their seals assemblies deployed) can be disposable and thus discarded after use. Additionally, the housing 202 with the plunger 222 can be discarded after all graft anastomosis procedures have been performed on a patient. A kit comprising a quantity of seal deployment cartridges assemblies greater than two may be employed. The kit may include a deployment tool. Optionally, the tool may be provided separately. Such a kit may be sterilized and packaged together, preferably with a hermetic seal. An example kit would comprise one tool, and at least two or more deployment cartridge assemblies, wherein each deployment cartridge assembly comprises a seal or seal assembly.

[0099] A system 300 is illustrated in Figures 18 and 19. The system 300 includes an extension assembly 302 connected to the tool 200. The extension assembly may take on the form of a number of structures and shapes. As illustrated, the extension assembly 302 comprises a primary plunger 306, a proximal flange 311 (similar to a syringe flange), a cannula 313, a coupler 315 comprising a twist lock 304. The extension assembly 302 is releasably coupled to a proximal flange 305 of the tool 200 via the twist lock 304. The twist lock may comprise one or more arms 307 that assist in reversibly engaging the tool 200 through the proximal flange 305. The primary plunger 306 operates similarly to the plungers 28 and 222 in that it is actuated by a user pressing a proximal end of the plunger 306 distally toward a body 308 of the assembly 302. The plunger 306 is configured to move longitudinally with respect to the cannula 313, coupler 315, and proximal flange 311 in order to actuate the plunger 222 in order to use the tool 200 as described above. One or more springs 226 may be utilized on plunger 222 to maintain primary plunger 306 in a distal position prior to deployment. The system 300 advantageously enables seal deployment tools, such as the tool 200, to be actuated from a relatively remote location. For example, the extension assembly 302 may be connected to the tool 200 and the tool 200 fed into a trocar or other minimally invasive port, in order to perform a CABG procedure without open chest surgery. More specifically, the extension assembly 302 may have a sufficient length to allow it to deploy a seal 102 of a seal assembly 100 from a location remote and external to a body cavity, while the tool 200 is located at least partially internal to the patient's body cavity during a minimally invasive procedure.

[00100] A tool 400 is shown in Figures 20 and 21. The tool 400, similar to the tool 200, uses the cartridge assembly 205 and resembles the tool 400 in many respects. For example, similar to the tool 200, the tool 400 includes a housing 402 with a cavity 404 that receives the cartridge assembly 205 therein. The housing 402, similar to the housing 202 of the tool 200, includes a window 406 resembling the window 210 of the tool 200. That is, the window 406 is arranged to interact with the ramp 209 in a similar manner to the interaction between the ramp 209 and the window 210.

[00101] Unlike the tool 200, the housing 402 of the tool 400 includes a pistol grip or handle 408, which can be held in a user's hand and gripped accordingly, and a trigger 410 that can be pulled by one or more of the user's fingers while holding the tool 400 by the handle 408. After the cartridge assembly 205 is inserted into the cavity 404 (e.g., in essentially the same manner as discussed above with respect to the tool 200, such that the housing 402 automatically actuates the arms 218 of the cartridge assembly 205 to fold or roll the seal element 102 stored therein), a user can pull the trigger 410 in order to deploy the seal element 102 from the tip 206 of the cartridge assembly 205. More specifically, actuation of the trigger 410 causes rotation of a linkage 414 about a pin or pivot 415. Rotation causes the linkage 414 to press against a driver 416, which is fixedly connected to a plunger 418. In this way, rotation of the linkage 414 can be transferred into axial movement of the plunger 418 via the driver 416. The plunger 418 operates similar to the plunger 222 of the tool 200, in that it is inserted into the body of the cartridge assembly 205 and actuation of the plunger 418 pushes or forces the seal assembly 100 out of the tip 206 of the cartridge assembly 205. Alternatively to pulling the trigger 410, a user may directly press on a proximal end 420 of the plunger 418 that extends out from the housing 402 in order to deploy the seal assembly 100. Like the spring or biasing element 226, one or more spring or biasing elements 422 can be included by the tool 400 to automatically reset the driver 416, as well as the trigger 410, back to their initial positions. In this way, a user may pull the trigger 410 any number of times in order to incrementally advance the piston 418 through the housing 402, and incrementally push the seal element 102 out through the tip 207. For example, in one embodiment the tip 206 may have a length that extends an increased distance distally from the tool 400 and requires the trigger 410 to be pulled multiple times in order to deploy the seal element 102 out through the opening 207.

[00102] While the invention has been described with reference to an exemplary embodiment or embodiments, it will be understood by those skilled in the art that various changes may be made and equivalents may be substituted for elements thereof without departing from the scope of the invention. In addition, many modifications may be made to adapt a particular situation or material to the teachings of the invention without departing from the essential scope thereof. Therefore, it is intended that the invention not be limited to the particular embodiment disclosed as the best mode contemplated for carrying out this invention, but that the invention will include all embodiments falling within the scope of the claims. Also, in the drawings and the description, there have been disclosed exemplary embodiments of the invention and, although specific terms may have been employed, they are unless otherwise stated used in a generic and descriptive sense only and not for purposes of limitation, the scope of the invention therefore not being so limited. Moreover, the use of the terms first, second, etc. do not denote any order or importance, but rather the terms first, second, etc. are used to distinguish one element from another. Furthermore, the use of the terms a, an, etc. do not denote a limitation of quantity, but rather denote the presence of at least one of the referenced item.

Claims

What is claimed is:

1. A seal element deployment tool, comprising: a housing having a channel therethrough, the channel terminating at a distal end in an opening and configured to initially house a seal element therein; a seal reshaper positioned along the channel proximal to the opening and having a geometry configured to deform the seal element from an expanded shape having a first profile to a confined shape having a second profile due to relative movement between the seal element and the seal reshaper, the first profile being larger than the second profile; and a plunger movable with respect to the housing and configured to displace the seal assembly through the channel and deploy the seal element out of the opening.

2. The tool of claim 1 , wherein the seal reshaper comprises one or more arms that are configured to pivot toward the seal element and compress the seal element, each of the one or more arms including a curved end configured to engage the seal element and deform the seal element into the confined shape.

3. The tool of claim 2, wherein the seal reshaper is included in a cartridge assembly that is insertable into a cavity in the housing.

4. The tool of claim 3, wherein the one or more arms are configured to move toward the seal element to compress the seal element automatically in response to the cartridge assembly being inserted into the cavity of the housing.

5. The tool of claim 4, wherein the plunger extends proximally from the housing and is directly actuatable by a user pressing the plunger.

6. The tool of claim 4, wherein the housing includes a pistol grip and a trigger coupled to the plunger and configured to actuate the plunger in response to the trigger being pulled.

7. A system including the tool of claim 4 and an extension assembly attachable to the tool and having a second plunger proximal to the plunger and configured to actuate the plunger when the second plunger is actuated.

8. The tool of claim 1, wherein the seal reshaper comprises a taper longitudinally disposed along the channel configured to deform the seal element as the seal element is moved distally along the channel toward the opening.

9. The tool of claim 8, wherein the taper includes a first lateral side having a first dimension or radius different than a second dimension or radius of a second lateral side of the taper.

10. The tool of claim 8, wherein the taper includes a first lateral side and a second lateral side generally opposite the first lateral side, wherein each of the first and second lateral sides have a change in dimension or radius per unit length that is different than the other of the first and second lateral sides.

11. The tool of claim 8, wherein the taper includes a first lateral side having a first slope that is substantially constant along a length of the channel and a second lateral side having a second slope that is variable along the length of the channel.

12. The tool of claim 8, wherein the taper includes a first lateral side having a first slope and a second lateral side having a second slope that is greater than the first slope.

13. The tool of claim 8, wherein the taper includes a first lateral side that is substantially semi-circular along a length of the channel and a second lateral side that is initially substantially semi-circular and becomes increasing angled or pointed along the length of the channel.

14. The tool of claim 8, wherein the housing comprises a first housing component and a second housing component, the first and second housing components movable with respect to each other, wherein relative movement of the first and second housing components towards each other causes movement of the seal element through the taper of the channel.

15. The tool of claim 14, wherein the first housing component and second housing component are movable with respect to each other longitudinally.

16. The tool of any of claims 14 and 15, further comprising a lock preventing relative movement between the first and second housing components until the lock is released.

17. The tool of claim 16, wherein the lock comprises a projection creating interference between the first and second housing components and a button in operable communication with the projection and configured to displace the projection when the button is pressed in order to remove the interference.

18. The tool of claim 14 or 15, further comprising an interlock to prevent relative movement between the first and second housing components after the first and second housing components have been moved relatively together.

19. The tool of claim 14, further comprising a lock preventing actuation of the plunger until the lock is released.

20. The tool of claim 19, wherein the plunger includes a slot engagable with the lock, and the lock is movable transversely with respect to the plunger to release the lock from the slot.

21. The tool of claim 20, wherein the slot is reversibly engagable with the lock, wherein in a first interference position movement of the plunger is retrained by the lock and in a non-interference position, movement of the plunger is not restrained by the lock.

22. A method of deploying a seal element, comprising: causing relative movement between a first housing component of a seal deployment tool and a second housing component of the seal deployment tool, the first housing component initially containing the seal element in an expanded shape, the expanded shape having a first profile; causing relative movement between a seal reshaper and a seal element of the seal assembly automatically due to the relative movement between the first and second housing components; deforming the seal element into a confined shape having a second profile smaller than the first profile of the expanded shape automatically due to the relative movement between the seal reshaper and the seal element; actuating a plunger in operable communication through the first and second housing components; and deploying the seal element out of an opening in a distal end of the seal deployment tool with the plunger.

23. The method of claim 22, wherein the seal reshaper includes a taper in the channel, and causing relative movement between the seal reshaper and the seal element includes moving the seal element through the taper to roll the seal element upon itself.

24. The method of claim 22, wherein the seal reshaper includes at least one arm with a curved end, wherein causing relative movement between the seal reshaper and the seal element includes moving the at least one arm and deforming the seal element includes contacting the seal element with the curved end and compressing the seal element with the at least one arm.

25. The method of claim 22 further comprising inserting the distal end of the seal deployment tool through an aperture in an anatomical structure, wherein the deploying includes deploying the seal element into the anatomical structure.

26. The method of claim 25 further comprising reverting the seal element back to its expanded shape inside of the anatomical structure and sealing the aperture with the seal element in its expanded shape.

27. The method of claim 23, wherein the anatomical structure is a blood vessel, and the method further comprises forming an incision in the blood vessel to create the aperture prior to the inserting.

28. A seal assembly deployment tool comprising: a housing component; a sleeve slidably coupled to the housing component, the sleeve having a distal end in which an opening is defined, a channel in communication with the aperture, and a proximal end attached to the housing, wherein movement of the sleeve relative to the housing induces folding of a seal element of a seal assembly; and a plunger movably positioned at least partially within the housing and configured to deploy the seal element through the opening.

29. A seal deployment tool comprising: a reshaping plunger longitudinally moveable with respect to a housing, the housing comprising a distal tip for interfacing with an aperture; wherein distal movement of the reshaping plunger towards the housing's distal tip causes a seal to reshape itself from a first profile that would not fit within the aperture to a second profile that will fit into and/or through the aperture.

30. The seal deployment tool of claim 29, further comprising a displacement plunger different than the reshaping plunger, wherein longitudinal movement of the displacement plunger expels the seal to at least partially be expelled from the distal tip of the housing.

31. The seal deployment tool of claim 30, wherein a length of travel the displacement plunger moves with respect to the distal tip to dispel the seal from the tip is less than a length of travel the reshaping plunger moves with respect to the distal tip to transition the seal from the first profile to the second profile.

32. The seal deployment tool of any of claims 30 and 31, wherein the displacement plunger and the displacement plunger are configured to reshape the seal and displace the seal respectively through movement in a single longitudinal direction.

33. The seal deployment tool of any of the proceeding claims, wherein the tool is sterilized to a sterility assurance level equal to or greater than 10^~3 SAL.

34. A method for introducing a seal into an aperture through use of a tool, the method comprising: causing, through longitudinal movement imparted to the tool:

(i) reshaping of the seal from a first profile to a second profile different than the first profile, wherein the first profile of the seal is not able to fit within a first diametrical space and the second profile is able to fit within the first diametrical space, and

(ii) displacing the seal from the tool.

35. The method of claim 34, wherein the longitudinal movement includes a first longitudinal movement for reshaping that occurs separately from a second longitudinal movement for displacing the seal.

36. The method of claim 35, wherein the first longitudinal movement for reshaping and the second longitudinal movement for displacing the seal occur in the same direction.

37. The method of claim 35, wherein the longitudinal movement for reshaping and the longitudinal movement for displacement occur through the use of at least one plunger.

38. The method of claim 35, wherein the first longitudinal movement for reshaping and the second longitudinal movement for displacement occur through the use of two plungers, each of the two plungers (i) moveable with respect to each other and (ii) the distal tip.

39. The method of claim 35, wherein displacing begins prior to the completion of reshaping.

40. The method of claim 35, wherein reshaping and displacing occur at least partially simultaneously.