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`US 20040044365Al
`
`(19) United States
`(12) Patent Application Publication
`Bachman
`
`(10) Pub. No.: US 2004/0044365 Al
`Mar. 4, 2004
`(43) Pub. Date:
`
`(54) SrNGLE CATHET ER M lTRAL VALVE
`REPAIR DEVICE AND METHOD FOR USE
`
`(52) U.S. C l.
`
`. ......................... _ ................................. 606/213
`
`(76)
`
`inventor: AJan B. Bachman, Milford, CT (US)
`
`(57)
`
`ABSTRACT
`
`Correspondence Address:
`Edwards Lifcsciences LLC
`Law l)ept.
`One Edwards Way
`lrvine, CA 92614 (US)
`
`(21) Appl. No.:
`
`10/233,879
`
`(22) Filed:
`
`Sep. 3, 2002
`
`Publication Classification
`
`(51)
`
`lnt. C J.7
`
`................................ .. ..... .... ............ A610 l /00
`
`A sing le catheter mitral valve repair device for stabilizing a
`tis.sue portion and selectively applying a tissue fastener
`thereto. The single catheter mitral valve repair device of the
`present invention includes an extendable engagement tip
`having at least one vacuum port formed thereon, at least one
`deployable fastener in communication with the engagement
`lip, and at least one actuator member in communication with
`the port. The deployable fastener is cap able of controllably
`engaging and fastening a tissue segment located proximal to
`the engagement tip.
`
`,.---to
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`16
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`NeoChord v. Univ of Maryland
`Exhibit 1008
`Page 1 of 20
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`NeoChord v. Univ of Maryland
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`NeoChord v. Univ of Maryland
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`NeoChord v. Univ of Maryland
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`NeoChord v. Univ of Maryland
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`NeoChord v. Univ of Maryland
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`NeoChord v. Univ of Maryland
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`NeoChord v. Univ of Maryland
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`NeoChord v. Univ of Maryland
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`Page 11 of 20
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`NeoChord v. Univ of Maryland
`Exhibit 1008
`Page 12 of 20
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`Patent Application Publication Mar. 4, 2004 Sheet 12 of 12 US 2004/0044365 Al
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`NeoChord v. Univ of Maryland
`Exhibit 1008
`Page 13 of 20
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`US 2004/0044365 Al
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`Mar. 4, 2004
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`1
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`SINGLE CATHETER MITRAL VALVE REPAIR
`DEVICE AND METHOD FOR USE
`
`CROSS REFERENCE TO RELATED
`APPLICXflONS
`
`[0001] This application discloses subject mauer related to
`our co-pending U.S. patent appl ication Ser. No. 09/562,406,
`fi led May 1, 2000, entitled Minimally Invasive Mitral Valve
`Repair Method and Apparatus. The disclosure of the afo re(cid:173)
`mentioned United States patent application is incorporated
`by reference herein in its entirety.
`
`BACKGROUND OF THE INVENTION
`
`[0002]
`In vertebrate animals, the bean is a hollow mus(cid:173)
`cular organ having four pumping chambers: the left atrium,
`the left ventricle, the right atrium and the right ventricle. The
`atria are isolated from their respective ventricles by one-way
`valves located at the respective atrial-ventricular junctions.
`These valves are identified as the mitral (or bicuspid) valve
`on the left side of tbe heart, and tricuspid va lve on the righ t
`side of the heart. The exit valves from the left and right
`ventricles are identified as tbe aortic and pulmonary valves,
`respectively.
`[0003] The valves of the bean are positioned in valvular
`annu luses that comprise dense fibrous rings attached either
`directly or indirectly to the atrial and ventricular muscle
`fibers. Valve leaflets comprising flexible collagenous struc(cid:173)
`tures are attached to, and extend inwardly from, the annu(cid:173)
`luses to meet at coapting edges. The aortic, tricuspid and
`pu lmonary valves each have th ree leaflets, while the mitral
`valve only bas two. To normal operation, the leaflets of the
`mitral valve open as left ventricle dilates thereby permitting
`blood to flow from the left atrium into the left ventricle. Tbe
`leaflets then coapt (i.e. close) during the contraction cycle of
`the left ventricle, thereby preventing the blood from return(cid:173)
`ing to the left atrium and forcing the blood to exit lhe left
`ventricle through the aortic valve. Simi larly, tbe tricuspid
`valve regulates llow from the righ t atrium into the righ t
`ventricle, and tbe pulmonary valve regulates blood exiting
`the right ventricle.
`[0004] For a number of clinical reasons various problems
`with heart valves can develop. One common form of bean
`disease involves tbe deterioration or degradation of the heart
`valves, which leads to stenosis and/or insufficiency. Heart
`valve stenosis is a condition in which the valve does not
`open properly. Insufficiency is a condition in which the valve
`does not close properly. Insufficiency of the mitral valve,
`most common because of the relatively bigb fluid pressures
`in the left ventricle, results in mitral valve regurgitation
`(" MR"), a condition in which blood reverses its intended
`course and flows ''backward" from the left ventricle to the
`left atrium during bean contractions.
`[0005] A number of surgical techniques have been devel(cid:173)
`oped to repair degraded or otherwise incompetent heart
`valves. A common procedure involves replacement of a
`native aortic or mitral valve with a prosthetic heart valve.
`Such procedures require the surgeon to access the heart
`through the patient's chest (or possibly percutaneously),
`surgically remove the incompetent native heart valve and
`associated tissue, remodel the surrounding valve annulus,
`and secure a replacement valve in the remodeled annulus.
`W hile these procedures can be very effective, there are
`
`as.sociatcd shortcomings. For example, the highly invasive
`nature of the implantation procedure typically resu lts in
`substantial patient discomfort and requires patients to
`remain hospitalized for, extended recovery periods. In addi(cid:173)
`tion, the two basic types of commerciaHy available replace(cid:173)
`ment valves, mechanical valves, and tissue valves, have
`shortcomings of their own. Mechanical replacement valves
`typically offer extended operational lifetimes, but the patient
`is usually requi red to maintain a regimen of anticoagulant
`drugs for the remainder of bis or her life. Tissue valves
`typically offer a higher degree of acceptance by tbe body
`thereby reducing or eliminating the need for anti-coagulants,
`but the operational lifetimes of tissue valves is typically
`shorter than mechanical valves and thus may require a
`subsequent replacemeot(s).
`[0006] As an alternative to prosthetic heart valve replace(cid:173)
`ment, it is often preferable to remodcltbe native heart valve
`and/or surrounding tissue. Remodeling procedures often
`preserve left ventricular function be tier than mitral valve
`replacement because the subvalvular papillary muscles and
`chordae teodioeae are preserved (most prosthetic valves do
`not utilize these muscles). Typically, valvular remodeling is
`accomplished by implanting a prosthetic ring ('·annu loplasty
`ring") into tbe valve annulus to reduce and/or stabilize the
`structure of the annu lus. Annuloplasty rings are typically
`constructed of a resilient core covered witb a fabric sewing
`material. Annuloplasty procedures can be performed alooe,
`or tbey can be performed in conjunction with other proce(cid:173)
`dures sucb as leaflet repair. Although aonuloplasty proce(cid:173)
`dures have become popular and well accepted, reshaping tbe
`surrounding annulus and traditional leaflet repairs do no t
`always lead to optimum leaflet coaptation. As a result, some
`patients may still experience residual mitral valve regurgi(cid:173)
`tation following aonuloplasty procedures.
`
`[0007] A rece ntly developed technique known as a "bow(cid:173)
`tie" repair bas also been advocated for repairing insufficient
`heart valves, in particular the mitral valve. The mitral valve
`bow-tie technique involves, in its simplest form, suturing tbe
`anterior and posterior leaflets toget her ncar the middle of
`tbeir coapting edges, thereby causing blood to ftow through
`two newly formed side openings. Wbile this does reduce the
`volume of blood that flows from the atrium to the ventricle,
`this loss is more than compensated by improved leailet
`coaptation, which reduces mitral regurgitation. As originally
`developed by Dr. Ouavio Alfieri, this process involved
`arresting the heart, and placing the patient on extra corporeal
`bypass and required invasive surgery to access and suture
`the leaflets together. More rccenlly, however, some have
`advocated a "beating heart" procedure in which the leaflets
`arc accessed remotely and the heart remains active through(cid:173)
`out the procedure.
`
`[0008] A particular method for performing a beating heart
`bow-tie procedure (i.e. without extra corporeal bypass) has
`been proposed by Dr. Mcbmet Oz, of Columbia University.
`The method and devices for performing the method are
`described in PCT publication WO 99/00059, published Jan.
`7,1999. In one embodiment of the disclosed procedure, the
`associated device consists o[ a forceps -like grasper used to
`grasp and hold the mitral valve leaflets in a coapted position
`for suturing. Since the mjtral valve lea.Jlets meet and curve
`toward and slightl y into the left vent ricular cavity at their
`mating edges, the grasper device .is passed through a sealed
`aperture in !be apex of the left ventricle. The edges of the
`
`NeoChord v. Univ of Maryland
`Exhibit 1008
`Page 14 of 20
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`Mar. 4, 2004
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`2
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`mating mitral valve leaflets arc then grasped and held
`together, and a fasten ing device such as a clip or suture is
`utilized to fasten them. The fastening device should be
`applied to the leaflcttis.suc with sufficient tissue purchase to
`prevent tear out or other failure, but close enough to the
`edges to ensure that the newly created side boles are as large
`as possible. The Mehmet Oz disclosure thus illustrates that
`teeth of the grasper device can be linearly s lidable with
`respect to one another so as to permit alignment of the mitral
`valve leaflets prior to fastening. Since the procedure is done
`on a beating heart, it will. be readily understood that the
`pressures and motions within the left ventricle and mitral
`valve leaflets arc severe. Thus the procedure taught by Dr.
`Mehmet Oz is very skill-intensive.
`
`[0009] The bow-tie technique has proved to be a viable
`aliernative for treating otherwise incompetent heart valves.
`Noncthclcs.s, several shortcomings associated with currcot
`bow-tie procedures have been identified. Current systems
`include devices having mechanical graspers, barbed mem(cid:173)
`bers, and vacuum devices that simultaneously capture and
`retain the valve leaflets prior to applying a fastening device
`thereto. Often, use of these devices results in the less than
`optimal leaflet stabilization and fastener placement. Many of
`these problems arise from the (act that the surgeon is
`required to capture, retain and fasten the leaflets in one
`relatively inflexible procedure. These difficulties arc com(cid:173)
`pounded when the leaflets are small or calcined making
`them difficult to puU together, and in beating heart proce(cid:173)
`dures in which the leaflets are actively functioning through(cid:173)
`out the surgery. In light of the foregoing, there is presently
`a need for improved systems for stabilizing mu l(jple tis.sue
`heart valve leaflets and placing a fastening device there
`between. More specifically, there is a present need for an
`improved bow-tie procedure [or repairing a patient's mitral
`valve.
`
`BRIEF SUMMARY OF THE INVENTION
`
`[0010) The single catheter mitral valve repair device of the
`present invention may be used to repair tissue throughout a
`patient's body. However, it is particu larly usefu l in repairing
`dysfunctional mitral valve tissue by stabilizing discreet
`valvular tissue pieces and deploying a fastening device
`therethrough, thereby coapti ng the tissue pieces. The present
`invention may also be used to repair arterial septal defects
`{ASD), ventricular septal defects (YSD), and defects asso(cid:173)
`c iated with patent foramen ova le {PFO).
`
`In one aspect, the repair device of the present
`[0011]
`invention comprises an extendable engagement tip having at
`least one port formed thereon, at least one deployable
`fastener in communication with the engagement tip, and one
`or more actuator members in communication with the
`port(s). The deployable fastener is capable of controllably
`the
`engaging and fastening tissue located proJdmal to
`engagement Lip.
`
`In another aspect of the present invention, the
`[0012)
`repair device comprises a handle, an elongated body, aod an
`extendable engagement tip. "Ibe handle comprises a station(cid:173)
`ary handle body, an engagement tip actuator in communi(cid:173)
`cation with the stationary handle body, a fastener deploy(cid:173)
`ment housing in commuoication with the stationary handle
`body, and a vacuum connector capable of placing a vacuum
`source in communication with the stationary handle body.
`
`The elongated body comprises a flexible body member, at
`least one vacuum lumen, one or more actuation lumens and
`one or more fastener lumens. Optionally, the elongated body
`can also comprise one or more auxiliary lumens. The one or
`more actuation lumens are capable of receiving one or more
`actuation members therein. Similarly, the one or more
`fastener lumens are capable of receiving at least one deploy(cid:173)
`able fastener therein. The extendable engagement tip com(cid:173)
`prises a fastener deployment housing capable of attaching to
`the elongated body, an actuation ftaoge attached to the
`fasteuer deployment housing, an extendable tip attached to
`the actuation flange and in communication with the engage(cid:173)
`ment tip actuator, a vacuum port in communication with the
`vacuum connector, and at least one deployable fastener in
`communication with the fastener deployment housing.
`
`[0013) The present invention also discloses a method of
`repairing tissue using the repair device of tbc present inven(cid:173)
`tion aod comprises graspiog a fi rst tissue portion with a
`vacuum force, stabilizing the first tissue portion with a
`mechanical force, deploying a tis.suc ffastencr into the s ta(cid:173)
`bilized first tissue portion, disengaging the first tissue por(cid:173)
`tion, grasping at least a second tissue portion with a vacuum
`force, stabilizing at least a second tissue portion with a
`mechanical force, deployiog at least a second tissue fastener
`into at least the second stabil ized ti.ssue portion, d isengaging
`atleast tbe second tissue portion, and coapting the first tissue
`portion and at least the second tissue portion with the first
`tissue fastener and at least the second tissue fastener.
`
`[0014) Other objects, features, and advantages of the
`present invention will become apparent from a consideration
`of the fo llowing detailed description.
`BlUEF DESCRIP"TION OF THE DRAWiNGS
`[0015) The apparatus of the preseot invention will be
`explained in more detail by way of the accompanying
`dra\vings, wherein:
`
`[0016) F lG. 1 shows a perspective view o( the mitral
`valve repair device of tbc present invention;
`
`[0017) FIG . 2 shows a perspective view of the handle
`portion of the mitral valve repair device of the present
`invention;
`
`[0018) FIG. 3 shows a cross-sectional view of the handle
`portion of lbe mitral valve repair device of the present
`invention;
`
`[0019) FlGS. 4A a nd 4U s how alternate cross-sectional
`views of tbe elongated body of the mitral valve repair device
`of the present invention;
`
`[0020) FIGS. SA and 58 show alternate perspective
`views of the engagement tip of tbe mitral valve repair device
`of the present invention;
`
`[0021] FTG . 6 shows a cross-scctiona I view of the engage(cid:173)
`ment tip o[ the mitral valve repair device of lbc present
`invention;
`
`[0022) FIGS. 7A and 78 sbow alternate perspective
`views of the engagement tip of I be mitral valve repair device
`of the present invention in an extended position;
`
`[0023) FIG. 8 shows a cross-sectional view of the engage(cid:173)
`ment tip of the mitral valve repair device of the present
`invention in a retracted position wherein the deployable
`needle is deployed;
`
`NeoChord v. Univ of Maryland
`Exhibit 1008
`Page 15 of 20
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`Mar. 4, 2004
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`[0024) FIG. 9 shows a cross-sectional view of the engage(cid:173)
`ment tip of the mitral valve repair device of the present
`invemion in a retracted position wherein the deployable
`needle is retracted and is engaging a needle catch;
`
`[0025) FIG. 10 shows a perspective view of the mitral
`valve repair device of the present invention having attached
`fastener material to a fi rst tissue portion;
`[0026] FIG. 11 shows a perspective view of the mitral
`valve repair device of the present invention having auached
`fastener material to a second tis.sue portion;
`[0027] FIG. U shows a perspective view of discreet tis.'>ue
`portions having fastener material positioned therethrough;
`and
`
`[0028] FIG.13 shows a perspective view of discreet tissue
`portions being coapted with fastener materiaL
`
`DESCRIPTION OF THE PREFERRED
`EMBODIMENTS
`[0029) Disclosed herein is a detailed description of various
`embodiments of the present invention. This description is
`not to be taken in a limiting sense, but is made merely for
`the purpose of illustrating the general principles of the
`invention. The overall organization of the description is fo r
`the purpose of clarity only and is not intended to limit the
`present invention.
`
`[0030) The single catheter mitral valve repair device of the
`present invention is designed for use in a surgical treatment
`of bodily tis.sue. As those skilled in the art will appreciate,
`the exemplary single catheter mitral repair device disclosed
`herein is designed to minimize trauma to the patient before,
`during, and after a minimally invasive surgical procedure
`while providing improved tissue stabili7..ation and enhanced
`placement of a fastening device thereon. While the single
`catheter mitral valve repair device of the present invention
`may be used to repair tissue throughout a patient's body, it
`is particu larly useful in repairing dysf11nctional mitral valve
`tissue by stabilizing discreet va lvular tissue pieces and
`deploying a fastening device therethrough, thereby coapting
`the tissue pieces. The present invention may also be used to
`repair arterial septal defects (ASD), ventricular septal
`defects (VSD), and defects associated with patent fo ra men
`ovale (PFO).
`
`[0031] FIG.l shows the single catheter mitral valve repair
`device of the present invention. As shown, tbe repair device
`10 comprises a handle portion 12 attacbed to an elongated
`body 14. An engagement tip 16 is positioned on the distal
`portion of the elongated body 14. A vacuum connector 18 is
`allached to the handle 12. As those skilled in the art will
`appreciate, the present invention may be manufactured from
`a variety of materials including, without limitation, various
`metals, plastics,
`tbermoplast ics, silicones, elastomers,
`ceramics, composite materials, or various combinations of
`tbe aforementioned materials. For example, the handle 12
`may be manufactured [rom polyethylene, while the elon(cid:173)
`gated body 14 is manufactured by an elastomer. In an
`alternate embodiment the elongated body 14, the engage(cid:173)
`ment tip 16, or both may incorporate radio-opaque or
`ecbogenic materials, thereby enabling the surgeon to pre(cid:173)
`cisely position the repair device 10 within the patient's body.
`
`[0032] FTG. 2 shows a perspective view of the handle 12
`of tbe present invention. As sbown in FIG. 2, the handle 12
`
`comprises a stationary handle body 20 having a tip actuator
`22 and a fastener deployment actuator 24 in communication
`tberewith. The tip actuator 22 and fastener deployment
`actuator 24 are movable relative to the stationary handle
`body 20. Exemplary tip actuator members or fastener
`deployment housings may include, for example, buttons,
`levers, slidable fixtures, or toggles. The distal portion of tbe
`stationary handle body 20 includes a coupling orifice 26
`capable of receiving the elongated body 14 therein. In
`add ition, the stationary bandle body 20 may include a handle
`flange 28 located thereon. The stationary handle body 20,
`fastener deployment actuator 24, or tip actuator 22, may
`include at least one grip member 30 positioned thereon. As
`shown in FIG. 2, a vacuum connector 18 is in communi(cid:173)
`cation with the handle 12.
`[0033] FlG. 3 shows a cros.s sectional v iew of ihe handle
`12 of the present invention. As s hown in FIG. 3, the
`stationary handle body 20 defines an act11ation channel 32,
`which is in communication with the coupling orifice 26
`formed on the distal portion of the stationary handle body
`20. The actuation channel 32 formed inside the stationary
`handle body 20 is capable of receiving the tip actuator 22
`and the fastener deployment actuator 24 independemly and
`in telescoping relation therein. Those skilled in the art will
`appreciate that the present invention permits a user to
`actuate the tip act113tor 22 or the fastener deployment
`actuator 24 independently .. As sbown, a bias member 34 may
`be positioned within the actuation channel 32 and may
`communicate in biasing relation with the fastener deploy(cid:173)
`ment actuator 24. The tip actuator 22 is in communication
`with at least one actuator extension member (see FIG. 7)
`positioned within one or more actuation lumens (see FIG. 4)
`formed in the elongated body 14. Similarly, the fastener
`deployment actuator 24 is in communication with at least
`one fastener extension member (see F lG. 6) positioned
`within one or more fastener lumens (see FIG. 4) formed in
`the elongated body 14. The vacuum connector 18 is to be
`connected to an external vacuum source and is in flllid
`communication with the vacuum lumeo 36 formed in the
`elongated body 14.
`[0034] The elongated body 14 of the present invention
`may be manufactured in a variety of leogtbs or diameters as
`desired by the user. FIGS. 4A and 48 show cross-sectional
`views of two embodiments of the elongated body 14 of the
`present invention. As shown in FrG. 4, the elongated body
`14 of the present invention may comprise at least one
`vacuum lumen 36. In the illustrated embodiment, the
`vacuum lumen 36 is disposed in the center of the device;
`altbough those skilled in the art wilE appreciate that the
`present invention may be easily manufactured with the
`vacuum lumen 36 positioned at various locations within or
`alongside tbe elongated body 14. The body member 38 may
`further include one or more tip actuation lumens 40a, 40b,
`one or more auxi liary lumens 42, and one or more fastener
`lumens 44 formed therein. For example, FIG. 48 shows an
`alternate embodiment of the present inven tion wherein the
`body member 38 forms a vacuum lumen 36, lip actuation
`lumens 40a, 40b, auxiliary lumens 42, and two fastener
`lumens 44a, 44b therein. Those skilled in the art will
`appreciate that the one or more auxjliary lumens 42 of the
`present invention are capable of receiving a guidewire,
`thereby enabling the present invention to be directed to an
`area of interest in vivo with a g11idewire. The elongated body
`14oft be present invention may be attached to the baodle 12
`
`NeoChord v. Univ of Maryland
`Exhibit 1008
`Page 16 of 20
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`Mar. 4, 2004
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`in a variety of manners, including, for example, adhesively
`auachcd or in snap-fit relation.
`
`(0035) FIG. SA shows a perspective view of the engage(cid:173)
`ment tip 16 auacbed to the elongated body 14 of the present
`invention. The engagement tip 16 comprises a fastener
`deployment housing 46, an extendable tip 48, and an actua(cid:173)
`tion !lange 50 in communication with the fastener deploy(cid:173)
`ment housing 46 and the extendable tip 48. The fastener
`deployment housing 46 further includes at least one vacuum
`port 52 having a tissue support 54 located therein, and a
`fastener deployment port 56 located thereon. The tissue
`support 54 may comprise a series of vanes or other supports
`positioned across or proximate to the vacu um port 52. The
`vacuum port 52, positioned on the fastener deployment
`hous ing 46, is in lluid communication with the vacuum
`connector 18 positioned on the handle l2 through the
`vacuum lumen 36 formed in tbc elongated body 14. Simi(cid:173)
`larly, the fastener deployment port 56 is in communication
`with the fastener deployment actuator 24 located on the
`handle 12 through fastener lumen 44 formed in tbe elon(cid:173)
`gated body 14. In an alternate embodiment illustrated in
`FIG. 58, a plurality of fastener deployment ports 56 may be
`formed on the fastener deployment housing 46 and may be
`in communication with a plurality of fastener lumens 44
`formed in the elongated body 14 (see FIG. 48). The
`extendable tip 48 of the present invention is in communi(cid:173)
`cation with the tip actuator 22 located on the handle 12
`through the actuation lumens 40a, 40b formed in the elon(cid:173)
`gated body 14. The extendable tip 48 may include a fastener
`receiver pori 58 capable of receiving the deployable needle
`64 therein (see FIG. 6). The fastener receiver pori 58 is
`coaligned with or positioned proximate to the fastener
`deployment port 56 formed on the fastener deployment
`housing 46. The fastener receiving port 58 is capable of
`receiving the deployable needle 64 therein and includes a
`needle catch 68 a11acbed to fastener materia1 62 (sec FIG. 6).
`The needle catch 68 may comprise a variety of devices
`capable of engaging and retaining the deployable needle 64
`therein, including, for example, a ferruled or sized ring. In
`addition, the extendable tip 48 may include a fastener
`channel 60 capable of receiving fastener material62 therein.
`Preferably the fasteLler channel 60 is open on the distal end
`of extendable ti p 48, as illustrated. Exemplary fastener
`materials include, for example, thread, wire, monofilament,
`braided lilament, suture material, needles, sutures, staples,
`buuons, tissue-graspers, tissue clasps, barbs, and other tis(cid:173)
`sue-coaption devices.
`
`(0036) FIG. 6 shows a eros.'> sectional view of tbe engage(cid:173)
`ment tip 16. "!be vacuum port 52 is in fluid communication
`with the vacuum lumen 36. A deployable needle 64 is in
`communication with the deployment housing 66 positioned
`within the fastener lumen 44. The receiver port 58 is in
`communication with the auxiliary lumen 42 located in the
`elongated body 14. A needle catch 68, which is capable of
`engaging and retaining the deployable needle 64, is auached
`to fastener material 62 which is positioned within tbc
`receiver port 58 and which extends through the auxiliary
`lumen 42 around the distal cod of the engagement tip 16 and
`back towards tbe handle U .
`[0037) FIGS. 7/\. a nd 78 sbow the eogagemeot tip 16 of
`the present invention in an extended configuration, thereby
`enabling the present invention to grasp and stabilize tis.sue
`located proximate thereto with a vacuum fo rce. As shown in
`
`FIG. 7A, actuation members 70a, 10b arc slidably received
`in the fastener deployment housing 46 and the extendable tip
`48, thereby pcrmiuing the extendable Lip 48 to be moved, in
`telescoping relation, relative to the fastener deployment
`~ousing 46. Exemplary actuation members 70a, 10b may
`mcludc, for example, rods, shafts, or conduits. 1be actuation
`members 70a, 10b communicate with the tip actuator 22
`positioned on the handle 12 through Lhe actuation lumens
`40a, 40b positioned in the elongated body 14. To actuate the
`extendable tip 48, the user advances the tip actuator 22
`towards the stationary handle body 20, thereby advancing
`the actuation members 70a, 10b and resultlno in the extend(cid:173)
`ible tip 48 extending from tbe fastener depl;yment housing
`46. 'fb retract the extendible tip 48, the user retracts the lip
`actuator 22 away from the stationary handle body 20,
`thereby ret racting the actuation members 70a, 70b and
`resulting in the extendible tip 48 re tracting towards the
`fastener deployment housing 46. Those skilled in the art will
`appreciated that actuation of the tip actuator 22 results in the
`longitudinal movement of tbe actuation member 70a, 10b
`positioned in the tip actuator lumens 40a, 40b of the
`elongated body 14, thereby resulliog in the longitudinal
`extension and retraction of the extendable lip 48. FIG. 7B
`shows and alternate embodiment in which there are a
`plurality (two in the illustrated case) of deployment ports 56,
`fastener receiver ports 58 and corresponding fastener chao(cid:173)
`nels 60. FIG. 78 illustrates another alternate embodiment in
`which the faster material is stored within the vacuum lumen
`36 (as opposed to the auxiliary lumen 42, see FIG. 6).
`(0038) FIGS. 8 and 9 show cross sectional views of the
`engagement tip 16 of the present invention during use
`wherein a mechanical stabilization force may be applied to
`captured tis.o;uc. FIG. 8 shows a cross sectional view of the
`engagement tip 16 wherein the deployable needle 64 bas
`been deployed from the fastener deployment port 56 located
`on the fastener deployment housing 46 through the fastener
`receiver port 58 and into the extendable tip 48. The deploy(cid:173)
`able needle 64 is attached to the deploymem housing 66
`positioned within the one or more fastener lumens 44 of tbe
`elongated body 14. The deployment hous ing 66 is coupled
`to the fastener deployment actuator 24 positioned on the
`handle 12. To deploy the deployable needle 64, the user
`advances the fastener deployment actuator 24 on the handle
`12 towards the sHilionary handle body 20, which results in
`the longitudinal movement of tbe deployment housing 66
`within the fastener lumen 44 of Lhe elongated body 14.
`Longitudina I movement of tbe deployment bousing 66
`results in the deployable needle 64 advancing through the
`fastener deployment port 56 into tbe fastener receivino port
`58 and engaging the needle catch 68 located there~. As
`shown in FIG. 8, the deployable needle 64 has engaged the
`needle catch 68. 'fbe needle catch 68 is auacbed to the
`fastener material 62 located within the auxiliary lumen 42.
`(0039) FIG. 9 shows a cross sectional view of Lhe engage(cid:173)
`ment tip 16 of the present invention wherein the deployable
`needle 64, having engaged and been retained by tbe needle
`catch 68 auachcd to the fastener material 62, is positioned
`within the fastener lumen 44 of the elongated body 14. To
`retract the deployable needle, the user moves the fastener
`deployment actuator 24 rearwardly away from the stationary
`handle body 20. 1\s a result, tbe deployment housing 66
`moves in a reward longitudinal motion which results in the
`deployable needle 64, which is attached to the deployment
`housing 66, moving rearwardly. The deployable needle 64,
`
`NeoChord v. Univ of Maryland
`Exhibit 1008
`Page 17 of 20
`
`

`
`US 2004/0044365 Al
`
`Mar. 4, 2004
`
`5
`
`having the needle catch 68 and the fastener material 62
`attached thereto, retracts through the fastener receivi ng port
`58 and enters the fastener deployment port 56. As shown in
`FIG. 9, the fastener material 62 is in communication with
`the auxiliary lumen 42 and the fastener lumen 44,