United States Patent [19J
`Lazarus
`
`111111111111111111111111111111111111111111111111111111111111111111111111111
`US005104399A
`5,104,399
`[11] Patent Number:
`[45] Date of Patent: Apr. 14, 1992
`
`[54] ARTIFICIAL GRAFf AND IMPLANTATION
`METHOD
`
`[75]
`
`Inventor: Harrison M. Lazarus, Salt Lake City,
`Utah
`[73] Assignee: Endovascular Technologies, Inc.,
`Menlo Park, Calif.
`
`[21] Appl. No.: 166,093
`
`[22] Filed:
`
`Mar. 9, 1988
`
`Related U.S. Application Data
`[63] Continuation-in-part of Ser. No. 940,907, Dec. 10,
`1986, Pat. No. 4,787,899, which is a continuation of
`Ser. No. 559,935, Dec. 9, 1983, abandoned.
`
`[56]
`
`[51]
`Int. Cl.s ................................................ A61F 2/06
`[52] u.s. Cl ......................................... 623/1; 606/153;
`604/96
`[58] Field of Search ......................... 623/1, 2, 66, 901;
`128/334 R, 334 C; 604/96; 606/153
`References Cited
`U.S. PATENT DOCUMENTS
`3,938,528 2/1976 Bucalo .
`4,562,596 1/1986 Kornberg ... .' ............................ 623/1
`4,617,932 10/1986 Kornberg ........................ 128/334 R
`4,665,918 5/1987 Garza et al. ............................ 623/1
`4,776,337 10/1988 Palmaz ................................ 128/344
`
`Primary Examiner-David J. Isabella
`Attorney, Agent, or Firm-Flehr, Hohbach, Test,
`Albritton & Herbert
`ABSTRACT
`(57]
`An intraluminal grafting system includes a hollow graft
`which has a proximal staple positioned proximate its
`proximal end and a distal staple adapted proximate its
`distal end. The system includes a capsule for transport(cid:173)
`ing the graft through the lumen and for positioning the
`proximal end of the graft upstream in a lumen which
`may be a blood vessel or artery. A tube is connected to
`the capsule and extends to exterior the vessel for manip(cid:173)
`ulation by the user. A catheter is positioned within the
`tube to extend from the cavity and through the graft to
`exterior the body. The catheter has an inflatable mem(cid:173)
`brane or balloon proximate the distal end thereof which
`is in communication via a channel with inflation and
`deflation means located exterior the vessel. With the
`inflatable membrane deflated, the capsule is positioned
`in the lumen and manipulated to a desired location. The
`inflatable membrane is manipulated by the rod away
`from the graft. The force exerted by the inflatable mem(cid:173)
`brane and the structure of the staples urges the staples in
`the vessel wall, retaining the graft in position. The re(cid:173)
`mainder of the intraluminal grafting system is then re(cid:173)
`moved from the corporeal vessel.
`
`10 Claims, 5 Drawing Sheets
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`Medtronic and Medtronic Vascular
`Exhibit 1005 - Page 1
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`

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`U.S. Patent
`
`Apr. 14, 1992
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`Sheet 1 of 5
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`5,104,399
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`Medtronic and Medtronic Vascular
`Exhibit 1005 - Page 2
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`U.S. Patent
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`Apr. 14, 1992
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`Sheet 2 of 5
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`5,104,399
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`~67
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`f-.-n
`73 I
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`L7'
`l ~s GOA
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`Fig. 4
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`Fig. 3
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`18
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`22
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`Fig. 5
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`Fig. 6
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`Medtronic and Medtronic Vascular
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`U.S. Patent
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`Apr. 14, 1992
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`Sheet 3 of 5
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`5,104,399
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`Fig. 6a
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`Medtronic and Medtronic Vascular
`Exhibit 1005 - Page 4
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`U.S. Patent
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`Apr. 14, 1992
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`Sheet 4 of 5
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`5,104,399
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`Fig. 7
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`18-z....
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`22
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`19
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`Fig. B
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`22
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`Fig. Ba
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`Medtronic and Medtronic Vascular
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`U.S. Patent
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`Apr. 14, 1992
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`Sheet 5 of 5
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`5,104,399
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`,5104
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`138
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`116
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`liB
`116
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`v-134
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`I
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`5
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`126
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`140
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`Fig. 9
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`Fig. 10
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`Fig. II
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`Medtronic and Medtronic Vascular
`Exhibit 1005 - Page 6
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`1
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`5,104,399
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`ARTIFICIAL GRAFf AND IMPLANTATION
`METHOD
`
`RELATED APPLICATIONS
`This application is a continuation-in-part of U.S. pa(cid:173)
`tent application Ser. No. 940,907 filed Dec. 10, 1986,
`entitled "Intraluminal Graft Device, System and
`Method", now U.S. Pat. No. 4,787,899, which is a con(cid:173)
`tinuation of U.S. patent application Ser. No. 559, 935,
`filed Dec. 9, 1983, also entitled "Intraluminal Graft
`Device, System and Method", now abandoned. The
`contents of both applications are hereby incorporated
`by reference.
`
`BACKGROUND OF THE INVENTION
`1. Field
`This invention relates to a medical prosthesis and,
`more particularly, to a graft prosthesis for placement 20
`within a corporeal lumen, such as the lumen of a blood
`vessel or artery.
`2. State of the Art
`Various fluid conducting body lumens, such as veins
`and arteries, may deteriorate or suffer trauma so that 25
`repair is necessary. For example, various types of aneu(cid:173)
`rysms or other d.eteriorative diseases may affect the
`ability of the lumen to conduct fluids and in turn may be
`life-threatening. In some cases, the damaged lumen is
`repairable only with the use of prosthesis such as an 30
`artificial vessel or graft.
`·
`For repair of vital vessels such as the aorta, surgical
`repair is significantly life-threatening. Surgical tech(cid:173)
`niques employed involve major surgery in which an
`artificial section of vessel is spliced into the diseased or 35
`obstructed lumen. That is, the damaged or diseased
`portion of the lumen may be surgically removed or
`bypassed and an artificial or donor graft inserted and
`stitched to the ends of the vessel which were created by
`the removal of the diseased portion. Kaj Johansen, An- 40
`eurysms, Scientific American, 247:110-125, July 1982. A
`variation of the typical suturing technique is described
`by Albe.rt W. Krause, et al., Early Experience with Intra(cid:173)
`luminal Graft Prosthesis, American Journal of Surgery,
`145:619-622, May 1983. The device illustrated in U.S. 45
`Pat. No. 3,908,662 to Razgulov, et al. is an example of a
`device to be used in such a surgical procedure.
`Other devices for the repair of lumens or vessels such
`as veins and arteries include a nitinol coil with a graft.
`The nitinol coil is reduced in dimension when cool. 50
`When placed in the body its temperature increases, and
`it returns to a preselected dimension to hold a graft
`within the lumen of the vessel. Such devices are dis(cid:173)
`cussed in detail in Charles T. Dottner, et al., Translumi(cid:173)
`nal Expandable Nitinol Coil Stent Grafting: Preliminary 55
`Report, Radiology 147:259-260, April 1983, and An(cid:173)
`drew Cragg, et al., Nonsurgical Placement of Arterial
`Endoprostheses: A New Technique Using Nitinol Wire,
`Radiology 147:261-263, April 1983. The use of devices
`such as the previously discussed nitinol wire may not be 60
`desirable due to the danger of penetrating and damaging
`the vessel's wall during the emplacement process.
`U.S. Pat. No. 4,140,126 to Choudhury discloses a
`device for intraluminal repair of an aneurysm. This
`device is positioned in a vessel in a collapsed form and 65
`then hooked into the vessel with hooks that are mechan(cid:173)
`ically extended by the user. This device is mechanically
`complex and in turn is susceptible to mechanical failure.
`
`2
`Other intraluminal devices are known, for uses other
`than the repair of a diseased lumen or vessel. U.S. Pat.
`No. 3,874,388 to King, et al. discloses a system for clos(cid:173)
`ing off a septal defect or shunt in the intravascular sys-
`5 tern in the myocardial area. U.S. Pat. No. 3,334,629 to
`Cohn discloses a device for restricting the flow of
`blood. U.S. Pat. No. 4,056,854 to Boretus, et a!. teaches
`construction and placement of an artificial aortic heart
`valve. U.S. Pat. No. 3,834,394 to Hunter et al. teaches
`10 construction of an intraluminal device to occlude a
`blood vessel. U.S. Pat. No. 3,540,431 to Mobin-Uddin
`teaches construction of an umbrella-like filter for intra(cid:173)
`luminal use. MEDI-TECH, Inc. of Watertown, Mass.
`sells a device known as the GREENFIELD Vena Cava
`15 filter for intraluminal placement. U.S. Pat No. 3,938,528
`discloses a device that is implanted into the vas-deferens
`or similar lumen for the splicing of the lumen parts.
`None of the devices noted above discloses a reliable
`and quick means or method to repair a vessel intralumi(cid:173)
`nally.
`
`SUMMARY OF THE INVENTION
`An artificial intraluminal prosthesis for placement in a
`fluid conducting corporeal lumen had a hollow graft of
`preselected cross-section and length. The proximal end
`of the graft is placed upstream within the lumen. The
`graft is deformable to conform substantially to the inte(cid:173)
`rior surface of the lumen. Staples are attached to the
`proximal end and preferably to the distal end of the
`graft for stapling the graft to the wall of the lumen.
`. Each staple has wall engaging members. The wall
`engaging members of the proximal staple are generally
`angulated in a downstream direction and have tips for
`engaging the vessel wall. The wall engaging members
`of the distal staple are angulated in a direction generally
`perpendicular to the longitudinal or central axis of the
`graft, and also have tips for engaging the wall.
`Generally, the staples are formed into a V-shaped
`lattice or framework. In an alternative embodiment, the
`staples'framework is U-shaped or sinusoidal. The frame
`of the staples allows for radial deformation resulting in
`a spring-like effect when a compressed staple is allowed
`to expand within a vessel and to sustain itself in that
`expanded condition.
`Preferably, the graft is made of a material suitable for
`permanent placement in the body such as nylon or da(cid:173)
`cron. Prior to emplacement, the graft is formed to be
`substantially cylindrical in shape and formed to have a
`plurality of substantially evenly placed circumferential
`bifolds along the length thereof. An optional radio(cid:173)
`opaque seam on the exterior of the graft may run along
`the longitudinal axis of the graft in order for the user to
`observe graft placement through fluoroscopy or by
`x-ray.
`The system for intraluminally engrafting the hollow
`graft has placement means for emplacing the graft into
`the lumen and positioning it at a preselected position.
`The placement means includes a capsule shaped and
`sized for positioning within the lumen. A hollow tube
`extends from the capsule to exterior the vessel for ma(cid:173)
`nipulation by the user. The graft is retained within the
`capsule for positioning the graft in the lumen. The
`placement means includes operation means for remov(cid:173)
`ing the graft from the capsule and for subsequently
`urging the staples into the wall of the lumen.
`Preferably, the operation means includes a catheter
`slidably positioned within the hollow tube to extend
`from the capsule to exterior the lumen. The catheter
`
`Medtronic and Medtronic Vascular
`Exhibit 1005 - Page 7
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`5,104,399
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`3
`desirably has an inflatable membrane operable by means
`for inflating and deflating the membrane. Pusher means
`is attached to the catheter and sized for passing through
`the capsule and for urging the hollow graft with at(cid:173)
`tached staples out of the capsule through an upstream 5
`or front end aperture.
`After the proximal portion of the graft is removed
`from the capsule, the inflatable membrane is desirably
`moved to within the circumference of the proximal
`staple and inflated to urge wall engaging members of 10
`the proximal staple into the wall.
`The balloon is then deflated, and the replacement
`means manipulated to remove the remainder of the graft
`from the capsule, thus exposing the distal staple. Prefer(cid:173)
`ably, the distal staple is placed and affixed in a manner 15
`similar to the proximal staple.
`The placement means is then removed from the lu-
`men.
`
`4
`The placement means includes a capsule 18 which has a
`front end portion 20 and a back end portion 22. A tube
`26 is affixed to the back end portion 22 of the capsule 18
`and is sized in length 25 to extend exterior the body for
`manipulation by the user. That is, the tube 26 can be
`manipulated to move the capsule 18. The placement
`means also includes operation means, as more fully
`discussed hereinafter and a wire guide 24.
`The capsule 18 is sized for positioning in the lumen.
`As can be seen in FIGS. 1, 6 and 8, the capsule is hollow
`and is also sized in length 21 and as indicated by the
`broken line in cross section by the dimensioning arrows
`23 to contain the graft 12 for transport through the
`lumen.
`The operation means preferably includes a hollow
`catheter 27 slidably positionable over the wire guide 24.
`The catheter 27 has an inflatable membrane ("balloon")
`30 positioned proximate the front end 29 of the catheter
`27. Means to operate th~ membrane 30 between inflated
`20 and deflated conditions include a channel 34 formed in
`the wall of catheter 27 to be in fluid communication
`between the interior of the inflatable membrane 30 and
`a syringe 38. The channel 34 extends along the length 28
`of the catheter 27 to the syringe 38 or other means to
`insert and remove fluid to inflate and deflate the mem(cid:173)
`brane 30.
`A pusher means here shown as a cylindrically shaped
`button 31 is affixed to and surrounds the catheter 27. It
`is placed on the catheter 27 behind or downstream of
`30 the membrane 30 as best seen in FIGS. 1 and 6. The
`button 31 is sized to engage the graft 12 with staples
`within the capsule 18 for urging the graft 12 with staples
`out of the capsule 18 as more fully discussed hereinafter.
`As seen in FIG. 1, syringe mechanism 38 is connected
`through a connector 40 via an extension tube 42 to the
`channel 34. Those skilled in the art will recognize that
`the catheter 27 with the channel 34 and inflatable mem(cid:173)
`brane 30 are very similar in both structure and function
`to a balloon dilation catheter. It should also be recog-
`nized that the syringe is preferably a conventional sy(cid:173)
`ringe having a sleeve 44 within which a hand actuated
`piston 46 is sealably and slidably movable in an in(cid:173)
`wardly and outwardly direction 48 to insert a fluid via
`the tube 42 and channel 34 to the membrane 30 to re(cid:173)
`spectively inflate and deflate the membrane 30. The
`fluid inserted to inflate may be an air or saline solution
`or such other fluid as desired by the user. Of course the
`fluid may be extracted to deflate the membrane 30 by
`operating the piston 46 in an outward direction 48.
`The artificial graft 12, shown in FIG. 2, is preferably
`made of a deformable material having a high tissue
`ingrowth rate. Various dacron, nylon and teflon materi(cid:173)
`als as well as various polymer materials are regarded as
`suitable. At present the desired material has been found
`to be Plasma TFE made by Atrium Medical Corp. of
`Clinton Drive, Hollis, N.H. (03049).
`The graft 12 is preferably formed to have a plurality
`of substantially evenly spaced circumferential bifolds 50
`(similar to the bifolds of a bifold door) along its length
`52. The bifolds 50 facilitate both axial 54 and radial 56
`deformation of the graft 12. Therefore, when emplaced,
`the graft 12 may readily conform to the interior shape of
`the lumen. The length 52 of the graft 12 is selected by
`the user. Typically, the length 52 of the graft 12 will be
`65 selected to be longer than the portion of the lumen to be
`repaired. The radial 56 or cross-sectional size of the
`graft 12 is also selected by the user typically to conform
`substantially to, or be slightly larger than, the interior
`
`40
`
`BRIEF DESCRIPTION OF THE DRAWINGS
`In the drawings, which illustrate the best mode pres(cid:173)
`ently contemplated for carrying out the invention,
`FIG. lis a partially cut-away perspective view of an
`intraluminal graft system of the instant invention;
`FIG. 2 is a perspective view of a slightly bent graft 25
`device of the instant invention;
`FIG. 3 is an enlarged view of a proximal staple of the
`instant invention;
`FIG. 4 is an enlarged view of a distal staple of the
`instant invention;
`FIG. 5 is an enlarged side view of a capsule of the
`ir:stant invention;
`FIGS. 6, 6A and 7 are cross-sectional views of the
`intraluminal graft device and placement means of the
`instant invention showing an intraluminal graft being 35
`emplaced into a lumen;
`FIG. 8 is a perspective exploded view of an alternate
`embodiment of the capsule;
`FIG. 8A is a partial perspective view of an alternate
`capsule;
`FIG. 9 is an enlarged view of an alternate embodi(cid:173)
`ment of a proximal staple of the instant invention;
`FIG. 10 is an enlarged view of an alternate embodi(cid:173)
`ment of a distal staple of the instant invention; and
`FIG. 11 is an enlarged partial view of an alternate 45
`embodiment of a staple of the invention.
`
`DESCRIPTION OF THE ILLUSTRATED
`EMBODIMENT
`FIG. 1 illustrates a system 11 for intraluminally plac- 50
`ing a prosthesis in a fluid conducting corporeal lumen.
`The system 11 includes a hollow graft 12 of preselected
`cross-section and length. The graft 12, as more fully
`shown in FIG. 2, has a proximal end 14 for placement
`upstream within a lumen such as a blood vessel. A prox- 55
`imal staple or anchoring element 16 is positioned proxi(cid:173)
`mate the proximal end 14 of the graft 12 and is here
`shown with portions extending through the graft 12 for
`stapling the graft 12 through the interior wall 13 of the
`graft 12 into the wall of the lumen. A distal staple or 60
`anchoring element 17 is positioned proximate the distal
`end 88 of the graft 12 and is here shown with portions
`extending through the graft 12 for stapling the graft 12
`to the interior wall 13 of the graft 12 into the wall of the
`lumen.
`The system 11 (FIG. 1) includes placement means for
`inserting the graft 12 into the lumen and for positioning
`the graft 12 at a preselected position within the lumen.
`
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`5,104,399
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`penetration is facilitated by the use of three or more. Of
`cross-section of the involved lumen. Since the graft 12 is
`course it is most preferred that a wall engaging member
`made of a deformable material with bifolds, it can
`readily be collapsed or squeezed into the capsule 18.
`be adapted to each support member to facilitate engage-
`As shown in FIG. 2, two staples or "securing rings"
`ment with the wall and also to assist in holding the
`16 and 17 are positioned about the circumference of the 5 upstream or proximal end of the graft 12 more securely
`against the wall of the lumen to minimize fluid (e.g.,
`substantially cylindrically shaped graft 12. Preferred
`staples are shown in FIGS. 3, 4, 9 and 10.
`blood) leakage during the post-therapy healing process.
`The staples 16 and 17 are collapsible from an initial
`The proximal staple 16 may be unitarily formed, or
`diameter to a second smaller diameter. The initial diam-
`may be condtructed by interconnecting separate, V-
`eter of the staples will be generally the same as the 10 shaped support members having vessel wall engaging
`diameter 56 of the graft 12 and the same as or slightly
`members 70. That is, a stainless steel spring wire may be
`larger than that of the lumen into which the graft 12
`bent to form the apexes 62 and abutment points 63 and
`with staples 16 and 17 is to be placed. The second diam-
`soldered or welded at a selected point to be unending as
`eter will be the same or slightly smaller than inside
`shown. Alternately, separate legs of support members
`diameter of the capsule 18. Also, the staples 16 and 17 15 70 may be welded, glued or soldered together as appro-
`will generally be made of a metal suitable for use in the
`priate to obtain desired strength.
`body or biocompatible plastic. A stainless steel wire
`A preferred proximal staple 104 (FIG. 9) is also com-
`material is presently preferred because of its excellent
`prised of a plurality of V -shaped support members 106.
`spring characteristics. As best seen in FIG. 2, the staples
`Each support member 106 has an apex 108 and two free
`16 and 17 are positioned within the graft 12 and may 20 ends or legs 110. A leg 110A abuts to and is adjoined to
`even be stitched thereto. The staples 16 and 17 are sized
`the leg 110B of another V-shaped support member
`to urge the graft 12 outwardly against the inside surface
`106A at an abutment point 112. The V -shaped support
`of the lumen into which the graft 12 is placed.
`members 106 are connected one to another in a gener-
`In one embodiment, the proximal staple 16 (FIG. 3)
`ally circular arrangement around the longitudinal axis
`has a plurality of V-shaped support members 60. Each 25 114 to form an unending fence-like arrangement similar
`to the arrangement of proximal staple 16 (FIG, 3).
`V-shaped support member 60 has an apex 62 with two
`"free ends " or legs, for example 60A, 60B, 60C and
`In FIG. 9, wall engaging members 116 are adapted to
`60D. A free end 61A abuts and is adjoined to the free
`the support members 106 at or near at least three abut-
`end 61B of another V -shaped support member 60 at an
`ment points 112 of the proximal staple 104. However, in
`abutment point 63. The plurality of at least three V- 30 the preferred proximal staple 104, an extension member
`shaped support members 60 are each connected one to
`118 is also mounted to the staple 104 at abutment point
`another in a generally circular arrangement around the
`112. Each of these extension member 118 may have an
`longitudinal axis 67 as shown. With the use of an elasti-
`optional and additional wall engaging member 120 at-
`cally deformable or spring material, it can be seen that
`tached thereto. The wall engaging members 116, 120
`the staple of FIG. 3 can be compressed to make the 35 are all mounted to proximal staple 104 at an angle 122
`angle 64 smaller to in turn reduce the staple diameter to
`comparable to angle 75 for staple 16 of FIG. 3. the
`fit within the capsule 18.
`preferred mounting angle of the vessel wall engaging
`A wall engaging member 70 is attached to each sup-
`members 116, 120 is from about 30• to about 60 degrees.
`port member 60 generally along the length 66 of one of
`For ease in insertion into wall of the lumen, wall engag-
`the legs 60A, 60B and preferably at or proximate each 40 ing members 116, 120 are all preferably mounted gener-
`of at least three abutment points 63 of the proximal
`ally at the same angle 122. That is, the members 116 and
`staple 16. The preferred wall engaging members 70 are
`120 are in reality quite small and difficult to mount with
`barbs or elongated tine-like members with sharp points
`precision. Thus the angles may vary as much as 10
`71. The wall engaging members 70 are attached to the
`degrees. Further, the extension 118 is used to provide
`support members at an angle 75 which may vary from 45 additional axial length to the staple 104 without affect-
`ing the size of the support members 106 and in turn the
`about ·15• to about 135 degrees from the longitudinal or
`central axis 67 of the proximal staple 16. Preferably the
`second or smaller diameter when collapsed inside cap-
`wall engaging members 70 angulate away from the axis
`sule 18.
`67 in a downstream direction 100 (FIG. 6); and thus the
`A distral staple 17 (FIG. 4) also preferably comprises
`angle 75 is preferably less than 90• and desirably in the 50 a plurality of V -shaped support members 65. Each V-
`range from about 30• to about 60•.
`shaped support member is formed to have an apex 69,
`It should be noted that the number or quantity of
`and two free ends or legs 71A and 71B. A free end 71A
`support members 60 is determined by the axial length 66
`abuts and is adjoined to the free end 71B of another
`of the staple as well as by the cross sectional size of the
`V -shaped support member 65 at an abutment point 73.
`lumen and in turn the capsule 18. FIG. 3 depicts a plu- 55 the V-shaped support members 65 of the distal staple 17
`rality of six support members 60 which has been found
`are connected one to another in a generally circular
`to be suitable for use in the lumen of selected animals
`arrangement similar to the staple shown in FIG. 3. At a
`where the lumen is comparable in size to an adult aorta.
`plurality of the abutment points 73 wall engaging mem-
`That is, the lumen has an average or effective diameter
`bers 72 are attached generally at an angle 76 preferably
`of about 12 to 18 millimeters.
`60 perpendicular to the longitudinal axis 77 of the distal
`It should also be noted that wall engaging members
`staple. The angle 76 between the wall engaging member
`70 are used to penetrate and hook into the interior sur-
`72 and the longitudinal axis 77 may vary between about
`face of the lumen to hold the graft 12 in place; Although
`45 degrees and about 115 degrees. Preferably, the wall
`in some cases two wall engaging members 70 may be
`engaging members 72 of the distal staple are sufficiently
`sufficient, it is preferred that at least three be provided. 65 short so as not to perforate the vessel wall.
`If the lumen is an artery or vein, some deformation is
`A preferred distal staple 124 is depicted in FIG. 10. It
`typically experienced so that actual penetration or
`has a plurality of V-shaped support members 126
`hooking may be difficult with only two and hooking or
`formed with an apex 128 and two free legs 130A and
`
`Medtronic and Medtronic Vascular
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`7
`130B. A leg 130A abuts and is adjoined to the leg 130B
`of an adjacent V -shaped support member 126 at an
`abutment point 132. The V-shaped support members
`126 of distal staple 124 connect one to another in a
`generally circular arrangement about axis 134 to form a 5
`fence-like arangernent similar to the staples shown in
`FIGS. 3 and 4.
`Wall engaging members 136 are mounted at or near at
`least three abutment points 132 of distal staple 124.
`Distal staple 124 has extension members 138 mounted at 10
`a plurality of abutment points 132 with a separate wall
`engaging member l.W mounted thereto, all similar to
`that shown for staple 104 (FIGS. 9) As in distal staple
`17, the wall engaging members 136, 14{) are mounted to
`the staple 124 at an angle which may vary from about 15
`45• to about us·. Preferably the angle varies from
`about 75• degrees to about 105 degrees, and is most
`desirably generally perpendicular to axis 134. As in
`proximal staple 104, both the corresponding wall engag(cid:173)
`ing members 136, 14{) are mounted at the same angles to 20
`the staple 124.
`The support members may also be U-shaped, as
`shown in FIG. 11 for all of the aforementioned staples
`16, 17, 104 and 126. The arrangement would thus ap(cid:173)
`pear generally sinusoidal. In another alternative ern- 25
`bodirnent, the vessel wall engaging members 70, 72, 116,
`120, 136 and 14{) of FIGS. 3, 4, 9 and 10 may be barbed
`like fish hooks similar to barbed member 139 shown in
`FIG. 11.
`Referring now to FIG. 6, portions of the system 11 30
`(FIG. 1) for intraluminal engrafting are shown cross(cid:173)
`sectionally within a lumen 90. The system 11 including
`the graft 12 and capsule 18 may be constructed in a
`variety of different sizes in order to accommodate and
`be compatible with a variety of differently sized (in 35
`cross-section) corporeal lumens. In FIGS. 6 and 7, the
`capsule 18 is shown to be smaller than the lumen 90 so.
`that the various surfaces may be better illustrated. Typi(cid:173)
`cally, the cross-sectional size (i.e., area normal to axis
`54) of the pertinent system components such as the 40
`capsule 18 and graft 12 are selected to be substantially
`the same as or slightly smaller then the lumen 90. It
`should be further recognized that the corporeal lumen
`90 illustrated is substantially circular in cross-section.
`However, lumens such as blood vessels may vary 45
`widely in cross-section along with their length but will
`elastically deform to receive the capsule 18 and other
`components of the system 11. The lumens are also not
`straight in that they have many curves as they course
`throughout the body.
`As shown in FIG. 5, the capsule 18 preferably has a
`rounded or tapered edge surface 92 between the side
`surface 94 and the front 20. The tapered surface 92
`facilitates entry into and positioning within the lumen
`90 by providing a contact surface to stretch the lumen 55
`especially in those places where the lumen 90 may be
`constricted or smaller in cross-section than the capsule
`18 and the graft 12. A corporeal Iuman such as a blood
`vessel or artery can stretch and deform. The tapered
`surface 92 can urge or force the deformation desired in 60
`order to facilitate placement as the capsule 18 is urged
`into and through the Juinen 90 by exerting an em placing
`force on the exterior end 96 of the tube 26.
`The inside of the capsule 18 has a smooth bore cavity
`98 (FIG. 6) formed therein sized to receive the graft 12. 65
`As can be seen, the catheter 27 may be centrally posi(cid:173)
`tioned within the cavity 98. Lead or guide wire 24 may
`be positioned within the lumen 90 in a manner known in
`
`50
`
`5,104,399
`
`8
`the art and then threaded through the interior of the
`catheter 27. The tube 26 is affixed to the capsule 18 at its
`back 22 to extend rearwardly or downstream 100
`through an opening 102 made in the lumen for inserting
`the pertinent components of the system 10. The catheter
`27 can slidably mate within the hollow tube 26.
`The capsule 18 as shown in FIG. 5 has an aperture 19
`formed in its front end 20 which is sized for passage of
`the graft 12 with staples 16 and 17. That is, the graft 12
`with staples 16 and 17 are urged through aperture 19 for
`placement in the lumen 90 as hereinafter discussed. The
`capsule 18 is formed of any medically acceptable mate(cid:173)
`rial. A variety of nylon and teflon materials are known
`to be acceptable along with selected metals. It is here
`preferred to use stainless steel as the staples are easier to
`urge outwardly through the aperture 19. The connec(cid:173)
`tion means is structured to provided a smooth exterior
`surface as seen in FIG. 5.
`As shown in FIG. 6, the graft 12 is positioned within
`the cavity 98 of the capsule 18. The graft 12 and staples
`16 and 17 are preferably sized as hereinbefore discussed
`when in an undeformed condition to be slightly larger
`in cross-section than the cross-section of the lumen 90
`and yet deformable to fit into the cavity 98. An external
`or radial force is thereby exerted outwardly against the
`interior surface 150 of the cavity 98 to retain the graft 12
`within the capsule 18. Further, the lumen engaging
`portion of the disclosed staples may frictionally engage
`the interior surface 104 of the capsule 18 to further
`restrain and retain the graft 12 within the cavity during
`placement in the lumen.
`As shown in FIG. 8, the capsule 18 preferably con(cid:173)
`sists of two connecting tubular portions 152, 89 which
`mate together by connections means which are here
`shown to be a coacting male threaded member lOlB
`and female threaded member lOlA. Such a construction
`is used to aid in placing the graft 12 within the capsule
`18 so as to house it within the capsule 18. The proximal
`portion 89 of the capsule 18 can be disconnected from
`the distal portion 152. The distal end 15 of graft 12 is
`then positioned within the distal portion 152 of the
`capsule 18. The proximal end 14 of the graft 12 is simi(cid:173)
`larly positioned into the proximal portion 89 of the
`capsule which is then connected to the distal portion
`152. The catheter 27 is then extended into the capsule
`and the graft 12. The connection means is preferably
`selected to minimize the amount of relative rotation
`between the proximal and distal portions 152, 89 to
`minimize twisting of the graft 12.
`Whatever the form of the capsule 18, it can be seen in
`FIG. 6 that an opening 102 is formed in the lumen 90
`such as an artery, vessel or other similar corporeal lu(cid:173)
`men. A guide wire 24 may be then sequentially inserted
`therethrough and manipulated to a desired location. An
`appropriately sized capsule 18 with graft 12 are inserted
`through the opening 102 and into the lumen 90 over the
`guide wire 24. With the graft 12 in position as shown in
`FIG. 6, the capsule 18 is urged in an upstream direction
`by exerting a positioning force on the exterior 108 of
`tube 26 (FIG. 1). Then the catheter 27 may be inserted.
`Of course, the guide wires 24, catheter 27, and tube 26
`are each sized to be of sufficient length 25 and 28 so that
`the capsule 18 and graft 12 may be positioned through
`the lumen 90 to a desired position which may be some
`distance from the entry point 102. It will also be recog(cid:173)
`nized by those skilled in the art that appropriate radio(cid:173)
`logical techniques such as fluoroscopy can be used to
`assist the user in positioning the capsule 18 and in turn
`
`Medtronic and Medtronic Vascular
`Exhibit 1005 - Page 10
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`

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`5,104,399
`
`9
`the graft 12 at a precise desired position within the
`lumen 90. This position, in all likelihood,