US20160235567A1 - Delivery device and system for open surgical repair - Google Patents

Abstract

A device for delivering a prosthesis to a damaged body vessel includes first and second generally elongated members joined to each other along a length thereof. A distal end of each of the elongated members is insertable through an outer layer of skin to access the vessel. The distal ends are cooperatively maneuverable between a closed position for retaining the prosthesis during delivery to the vessel and an open position for releasing the prosthesis upon delivery. Each of the elongated members has a prosthesis retaining member disposed at a distal tip. The retaining members are configured for retaining the prosthesis in a constricted condition when the distal ends are in the closed condition for delivery of the prosthesis to the damaged vessel.

Description

BACKGROUND
• 1. Technical Field
• The preferred embodiments described herein relate generally to devices for delivering a medical interventional device for repair of body structures that define body lumens. More particularly, they relate to delivery devices for delivering expandable prostheses and like devices for repairing damaged body structures and gaining hemostasis or fluid stability during emergency open surgical medical procedures.
• 2. Background Information
• Trauma physicians frequently encounter patients having traumatic injury to a body vessel, such as lacerated vessels or even transected vessels, resulting from gunshots, knife wounds, motor vehicle accidents, explosions, etc. Significant damage to a body vessel may expose a patient to deleterious conditions such as the loss of a limb, loss of function of a limb, increased risk of stroke, impairment of neurological functions, and compartment syndrome, among others. Particularly severe cases of vascular injury and blood loss may even result in death. In such severe situations, the immediate goal is to obtain hemostasis while maintaining perfusion of adequate blood flow to critical organs, such as the brain, liver, kidneys, and heart.
• Examples of treatment that are commonly performed by trauma physicians to treat body vessel injuries include the clamping of the vessel with a hemostat, the use of a balloon tamponade, the ligation of the damaged vessel at or near the site of injury, and/or the insertion of one or more temporary shunts. However, conventional surgical repair is generally difficult with actively bleeding, moribund patients. In many instances, there is not enough time to repair the body vessel adequately by re-approximating and suturing the body vessel. Thus, the trauma physician may simply insert a temporary shunt into the vessel. However, use of temporary shunts has been linked to the formation of clots. This may require returning the patient to the operating room for treatment and removal of the clots, often within about 36 to 48 hours of the original repair. Since such shunts are generally placed as a temporary measure to restore blood flow and stop excessive blood loss, the shunt is typically removed by a specialized vascular surgeon once the patient has stabilized (generally a few days later). After removal, the vascular surgeon will typically replace the shunt with a vascular graft, such as a fabric graft that is sewn into place. With respect to ligation, ligation of the damaged blood vessel may result in muscle necrosis, loss of muscle function, or a potential limb loss or death.
• Due to the nature of the body vessel injury that may be encountered, the insertion of shunts or ligation of a blood vessel, for example, often requires that such treatments be performed within a very short period of time. Such treatments may occupy an undue amount of time and attention of the trauma physician at a time when other pressing issues regarding the patient's treatment require immediate attention. In addition, the level of particularized skill required to address a vascular trauma and stabilize the patient may exceed that possessed by the typical trauma physician.
• Some open surgical techniques utilize sutures to affix damaged tissue portions to fittings that have been deployed with the vessel. Such techniques require the trauma physician to take sufficient time to tie the sutures properly. Even though in modern medicine sutures can be tied in relatively rapid fashion, any step in a repair process that occupies physician time in an emergency situation is potentially problematic. In addition, the use of sutures to affix the vessel to the fitting compresses the tissue of the vessel against the fitting. Compression of tissue may increase the risk of necrosis of the portion of the vessel tissue on the side of the suture remote from the blood supply. When present, necrosis of this portion of the vessel tissue may result in tissue separation at the point of the sutures. In this event, the connection between the vessel and the fitting may eventually become weakened and subject to failure. If the connection fails, the device may disengage from the vessel. Therefore, efforts continue to be made to develop suitable techniques that reduce the physician time required for such repair, so that this time can be spent on other potentially life-saving measures, and so that the blood flow may be more quickly restored and any resulting damage caused by lack of blood flow is minimized.
• What is needed is a device for delivering a prosthesis for repair of a damaged body vessel, such as an artery or a vein, (and in particular a transected vessel) during emergency open surgery. It would be desirable if the delivery device was easy for a trauma physician to use, and was useful for the rapid introduction of a prosthesis into a body vessel, thereby providing a conduit for blood or fluid within the damaged body vessel.
BRIEF SUMMARY
• The problems of the prior art are addressed by the features of the present invention. In one aspect, a device for delivering a prosthesis to a damaged body vessel is disclosed, wherein the prosthesis is of a type having a constricted condition for delivery to the damaged body vessel, and an expanded condition upon deployment at the damaged vessel. First and second generally elongated members are joined to each other along a respective length thereof. Each of the elongated members has a proximal end accessible to an operator during use of the device, a distal end for insertion through a body opening from an outer layer of skin to access the damaged body vessel, and a pivot point intermediate the proximal and distal ends along the length for joinder to the other elongated member. The elongated members are arranged along the pivot point such that the respective distal ends are cooperatively maneuverable between a closed position for retaining the prosthesis during a delivery to the damaged body vessel and an open position for releasing the prosthesis upon the delivery. The first elongated member has a first prosthesis retaining member disposed at the distal tip thereof, and the second elongated member has a second prosthesis retaining member disposed at the distal tip thereof. The first and second prosthesis retaining members are configured for retaining the prosthesis therebetween in the constricted condition when the distal ends are in the closed condition for delivery of the prosthesis at the damaged vessel.
• In another aspect, a system for open surgical repair of a damaged wall portion of a body vessel is disclosed. A prosthesis has a first end and a second end. The prosthesis is expandable from a constricted condition wherein at least the first and second ends have a diameter less than a diameter of the body vessel at the damaged wall portion, to an expanded condition wherein the prosthesis ends engage an interior surface of the body vessel. A first splittable sheath maintains the prosthesis first end in the constricted condition, and a second splittable sheath maintains the prosthesis second end in the constricted condition. Each of the sheaths has a tab extending therefrom, and is configured for splitting upon a withdrawal of the tab such that the respective prosthesis end is expandable from the constricted condition to the expanded condition. A delivery device is provided for delivery of the prosthesis to the damaged wall portion. The delivery device comprises first and second generally elongated members, wherein each elongated member has a proximal end accessible to an operator, and a distal end for insertion through the damaged wall portion. The elongated members are joined at a pivot point such that the distal ends are maneuverable between a closed position for retaining the prosthesis during delivery to the damaged wall portion, and an open position for releasing the prosthesis upon deployment at the damaged wall portion. The first elongated member has a first retaining member disposed at the first elongated member distal end, and the second elongated member has a second retaining member disposed at the second elongated member distal end. The first and second retaining members are configured for retaining the prosthesis therebetween in the constricted condition for insertion through the damaged wall portion when the distal ends are arranged in the closed position.
• In yet another aspect, a method for open surgical repair of a damaged portion of a body vessel is disclosed. A device having a prosthesis assembly loaded therein is positioned for delivery to the damaged vessel portion through an open air pathway. The device comprises first and second generally elongated members, wherein each generally elongated member has a proximal end accessible to an operator, a distal end for insertion to the damaged vessel portion, and is joined to the other elongated member along a length thereof Each of the distal ends extends to a distal tip. The first elongated member has a first prosthesis retaining member disposed at the first elongated member distal tip, and the second elongated member has a second prosthesis retaining member disposed at the second elongated member distal tip. The elongated members are arranged such that the distal ends are cooperatively maneuverable between a closed position having the prosthesis assembly loaded therein, and an open position. The prosthesis assembly comprises a prosthesis having first and second ends, and respective first and second sheaths configured for maintaining the first and second prosthesis ends in a constricted condition. Each of the first and second sheaths includes a tab member for selectively splitting the sheath. The distal ends of the device are passed through the open air pathway to the damaged vessel portion with the distal ends in the closed position. The distal ends are maneuvered such that the first sheath and the first constricted prosthesis end are inserted into a first side of the damaged vessel portion, and such that the second sheath and the second constricted prosthesis end are inserted into a second side of the damaged vessel portion. The first sheath tab member is pulled for splitting the first sheath, wherein the first prosthesis end expands to engage an inner surface of the first side of the damaged vessel portion. The second sheath tab member is pulled for splitting the second sheath, wherein the second prosthesis end expands to engage an inner surface of the second side of the damaged vessel portion.
BRIEF DESCRIPTIONS OF THE DRAWINGS
• FIG. 1 illustrates one example of a delivery device for delivering a prosthesis for implantation within a body vessel;
• FIG. 2 is an enlarged view of the distal end of the delivery device, illustrating the retaining members of the delivery device in an open position;
• FIG. 3 is another enlarged view of the distal end of the delivery device, with the retaining members in an opposite rotational orientation when compared to the orientation ofFIG. 2;
• FIG. 4 is a side view of one example of a radially expanded prosthesis suitable for deployment at a target site by the delivery device ofFIG. 1;
• FIG. 5 is a side view of the prosthesis in condition for deployment, wherein each end of the prosthesis is constricted in a splittable sheath;
• FIG. 6 is a side view of the prosthesis ofFIG. 5 loaded into a delivery device for deployment;
• FIG. 7 illustrates a leg of a patient that has been opened to expose a damaged body vessel;
• FIG. 8 illustrates the body vessel ofFIG. 7, wherein the vessel has been cut into two end portions;
• FIG. 9 is an enlarged view of the delivery device and the respective ends of the prosthesis as inserted into the vessel end portions ofFIG. 8, prior to expansion of the prosthesis;
• FIG. 10 illustrates the delivery device and respective prosthesis ends following splitting of the sheath and expansion of the prosthesis; and
• FIG. 11 illustrates the prosthesis deployed in the vessel in an expanded condition following removal of the sheaths.
DETAILED DESCRIPTION OF THE DRAWINGS AND THE PRESENTLY PREFERRED EMBODIMENTS
• For the purposes of promoting an understanding of the principles of the invention, reference will now be made to the embodiments illustrated in the drawings, and specific language will be used to describe the same. It should nevertheless be understood that no limitation of the scope of the invention is thereby intended, such alterations and further modifications in the illustrated device, and such further applications of the principles of the invention as illustrated therein being contemplated as would normally occur to one skilled in the art to which the invention relates. It is understood that like-referenced numerals are used throughout the Figures to designate similar components.
• Throughout the specification, when referring to a medical device, or a portion of a medical device, the terms “distal” and “distally” shall denote a position, direction, or orientation that is generally towards, or in the direction of, the patient when the device is in use. The terms “proximal” and “proximally” shall denote a position, direction, or orientation that is generally away from the patient, or closer to the operator, during use of the device.
• The delivery device described herein can deploy a prosthesis that is useful for repair of body structures that define lumens, ducts, or passageways of the body, with the term “body vessel” used in the specification to describe these structures in general, during open surgical repair. In one example, the prosthesis can be particularly useful for repair of a lacerated or transected body vessel during emergency open surgery, and particularly, to obtain hemostasis or fluid stability while maintaining blood perfusion or fluid flow. While some prosthetic devices are only implanted temporarily for treatment, a prosthesis as further described herein can be implanted permanently by utilizing the delivery device described herein, thereby obviating the need for further surgical intervention and repair. The prosthesis can be secured in a rapid manner during emergency surgery without the use of a ligature or suture placed around the vessel. In another example, the prosthesis can be deployed for implantation during bypass surgery.
• FIG. 1 illustrates one example of a delivery device10 that may be utilized to deliver a prosthesis for implantation within a body vessel. Delivery device10 includes a pair ofelongated members14,30 movably joined to each other in known manner, such as at apivot point12.Elongated members14,30 include respective proximal ends16,32 and distal ends18,34. Proximal ends16,32 can includerespective finger loops17,33 to facilitate grasping and control of the device by the operator. If desired, the proximal end ofelongated members14,30 can also include optional cooperatingmembers15,31. Conventional cooperatingmembers15,31 can be provided, e.g., as spacers to maintain a distance betweenelongated members14,30, or as locking members to enableelongated members14,30 to be locked together, e.g., for maintaining the respective distal ends18,34 in a closed or otherwise fixed position. If desired, distal ends18,34 may have a downward curve or angle along their length distal ofpivot point12. Providing a curved distal region may enhance the ability of the operator to reach the desired portions of the vessel during implantation.
• Those skilled in the art will appreciate that the general structure, composition, and configuration of delivery device10 may be similar in some respects to that of a vascular clamp or a conventional forceps device. Theelongated members14,30 may be formed, e.g., from a metal or metal alloy, such as stainless steel or nitinol, as well as from various plastic compositions, such as ABS and nylon. The delivery device should be provided with as small a profile as possible, in order to avoid any significant obstruction to the surgeon's view into the body opening, while at the same time allowing sufficient travel at the distal end of the device to enable the retaining members to unclamp the medical interventional device and be removed without unduly interfering with the interventional device, as further described herein.
• Distal end18 ofelongated member14 terminates atdistal tip19.Distal end34 ofelongated member30 terminates atdistal tip35. A retaining member suitable for receiving and retaining a medical interventional device, such as a prosthesis, for implantation is provided at each distal tip. As shown inFIG. 1, retainingmember20 is provided atdistal tip19, and retainingmember36 is provided atdistal tip35. Retainingmembers20,36 are cooperatively sized and shaped to retain the prosthesis therebetween as the prosthesis is delivered to the target site. In the orientation shown inFIG. 1, the retainingmembers20,36 are spaced in an open position.
• Retainingmembers20,36 may be more clearly observed inFIGS. 2 and 3.FIG. 2 is an enlarged view of the distal end of delivery device10, illustrating the retainingmembers20,36 in the position as shown inFIG. 1.FIG. 3 is another enlarged view of the distal end of delivery device10, wherein retainingmembers20,36 are rotated180 degrees from the orientation ofFIGS. 1 and 2.
• In each of the rotational orientations shown inFIGS. 2 and 3, each retaining member is spaced from the other retaining member a distance that approximates the open position of device10 illustrated inFIG. 1. In this example, retainingmember36 comprises a generallyrigid wall member37 having a pair ofwings38 projecting in a transverse direction therefrom. Eachwing38 preferably includes at least oneaperture39 or corresponding element for receiving a tab of a splittable sheath, as further described herein. The presence of the apertures also allows the user to view the vessel as the end of the prosthesis is inserted therein.Wall member37 also includes a generallycylindrical portion40 having a bore therein for receivingdistal tip35 of elongated memberdistal end34. Retainingmember36 may also include one or more appendages, such asarms42,ledge44, andribs45. Arespective arm42 may be positioned along an underside of eachwing38, andledge44 may be provided along the bottom portion of retainingmember36. Together,arms42 andledge44 assist in the alignment of the prosthesis in the delivery device, as further shown inFIGS. 6, 9, and 10. When present,ribs45 provide strength and support to retainingmember36.
• In the referenced example, retainingmember20 comprises generallyrigid cradle member21. Retainingmember20 includes a generallycylindrical portion24 having a bore therein for receivingdistal tip19 of elongated memberdistal end18.Cradle member21 may include one or more appendages for aligning the prosthesis when positioned in the delivery device. In the example shown, the appendages may includearms26,ledge28, and one ormore ribs29,29′. As shown in the figures, therespective arms26,42 andledges28,44 of retainingmembers20,36 are cooperatively sized and spaced to retain the prosthesis when the delivery device is in a closed position prior to deployment at the target site. When present,ribs29 in contact withcylindrical portion24 add reinforcement to the cylindrical portion.Rib29′ provides strength and support to retainingmember20. In addition to providing structural support,ribs45 and29′ may be arranged to interact with each other when clamped over the prosthesis to grip the prosthesis and inhibit it from sliding transversely when the tabs of the sheath are pulled, as described herein.
• Retainingmembers20,36 may be formed in any conventional manner, such as by injection molding. Some examples of suitable compositions of the retaining members include ABS, nylon, polyurethane, polypropylene, and polycarbonate. The retaining members then may be engaged with respectivedistal tips19,35 in any conventional manner, such as via adhesion as thedistal tips19,35 are received in respective retaining member bores24,40. Alternatively, the retaining members may be insert molded directly overtips19,35 ofelongated members14,30, respectively. In another example, the retaining members may be formed from metal or metal alloys (casting and sintering), and welded, riveted, screwed, or crimped onto the delivery device in known fashion.
• FIG. 4 illustrates one example of aprosthesis100 that may be deployed at the target site via delivery device10.Prosthesis100 may be a conventional stent/graft device of the type known for implantation in a body vessel. In the example shown,prosthesis100 includesstent106overlying graft body110. One or more anchoring members, such asbarbs120, are generally provided along the prosthesis, typically along the proximal anddistal ends102,104 of the prosthesis, for anchoring the prosthesis in the body vessel. The anchoring members may be configured to radially extend from the stent a suitable distance and at a suitable angle for anchoring the prosthesis in the tissue of the vessel.
• Those skilled in the art will appreciate that many examples of prostheses suitable for use herein are known in the art. Some examples of suitable prostheses are described in U.S. Patent Application Publications 2012/0035708 and 2012/0035706, incorporated herein by reference in their entireties. As stated above and as shown in the incorporated-by-reference documents, the prosthesis can include a generally tubular graft body and/or one or more anchoring members and/or supporting members (e.g., stents) together defining a fluid passageway. The prosthesis is expandable between a radially compressed, delivery configuration, and a radially expanded, deployed configuration (FIG. 4). Preferably, the prosthesis is self-expandable, that is, it is capable of expansion upon removal of an outer constraining member without the necessity of additional mechanical means to effect such expansion, such as an inflatable balloon. Such self-expandable prostheses are well known in the medical arts, and examples of such are provided in the incorporated-by-reference documents. If desired, a mechanically expandable prosthesis may be utilized in some applications.
• The anchoring members and/or supporting members can be attached to the graft body by sutures sewn therein, wire, staples, clips, bonding agents, or other methods that are known for achieving a secure attachment to the graft body. The prosthesis has a size and shape suitable for at least partial placement within a body vessel, such as an artery or vein, and most particularly, for placement at the site of a vascular trauma. The prosthesis may be easily manipulated during delivery to a body vessel such as a transected artery or vein during emergency surgery, and particularly, to obtain hemostasis while maintaining blood perfusion.
• The supporting member can be any stent pattern known to one skilled in the art. Examples of stent patterns include the Z-STENT® and ZILVER® stent, each available from Cook Medical Incorporated, of Bloomington, Ind. The anchoring member and/or supporting member can be formed of a biocompatible metal known in the art for such use, such as stainless steel (e.g., 316L SS), titanium, tantalum, nitinol or other shape memory materials, or a high-strength polymer. Preferably, the anchoring member can provide vessel fixation, while avoiding adverse conditions such as pressure induced necrosis of the medium muscular arteries of the type that may result from tying ligatures circumferentially around a connector or a vascular conduit. As stated above, the supporting member can comprise one ormore stents106. The anchoring members can includebarbs120, as well as various alternative structures, such as fibers, bristles, or outer protruding and penetrable media. Stents and other supporting structures having anchoring members suitable for engagement with a vessel wall are well known in the medical arts.
• Thegraft body110 can be formed from conventional materials well known in the medical arts. The graft body may comprise an expanded polytetrafluoroethylene (ePTFE), polytetrafluoroethylene, silicone, polyurethane, polyamide (nylon), as well as other flexible biocompatible materials. The graft body can also be formed from known fabric graft materials such as woven polyester (e.g. DACRON®), polyetherurethanes such as THORALON® from Thoratec Corporation (Pleasanton, Calif.), polyethylene such as an ultra-high molecular weight polyethylene (UHMwPE), commercially available as DYNEEMA®. The graft body may also comprise a bioremodelable material as further described in the incorporated-by-reference documents.
• Although the examples shown herein illustrate one or more stents positioned on an outer surface of a graft body, this arrangement may be reversed. That is, the stent structure may be positioned interiorly of the graft body. In some embodiments, a stent structure may be positioned both interiorly and exteriorly of the graft body. In still further embodiments, one or more stents may be encapsulated within the graft body.
• FIG. 5 illustrates theprosthesis100 in a condition for deployment. Eachend102,104 of the prosthesis is constricted and maintained in a respectivesplittable sheath130,140. Anintermediate length105 ofprosthesis100 between proximal anddistal ends102,104 is not constrained. Those skilled in the art will appreciate thatprosthesis100 has a length suitable for bridging a damaged area of tissue in the body vessel, as further described herein. For example, a prosthesis may have a length between about 40 and 100 mm, and more typically, between about 50 and 70 mm. With a prosthesis of about 50 to 70 mm, approximately 10-12 mm at each axial end of the prosthesis is sheathed and inserted into a respective vessel end.
• Many suitable examples of splittable sheaths for maintaining a prosthesis, such asprosthesis100, in a constricted, or compressed, condition prior to deployment at the target site are known in the art. As stated above and as shown inFIG. 5, a separate splittable sheath constrains each end of the prosthesis.Sheaths130,140 can be made of any material that is biocompatible and suitable for retaining the prosthesis ends102,104 in the radially constricted condition, and yet still capable of being split and/or peeled from the prosthesis in known fashion. It is desirable that the sheath is made from materials that are as thin as possible to reduce the overall delivery profile of the system.
• The sheath can be configured to be separated, preferably longitudinally, along a relatively predictable path. The material of the sheath is configured to be split or cut into two or more portions by movement of thesheath tab132,142 relative to the prosthesis. This action opens a fissure along the length of the sheath that permits removal of a split portion of the sheath from the prosthesis. A predetermined split line may be formed in the sheath through which the tear or split progresses due to properties of, and/or features incorporated into the material. In one example, the sheath can comprise a splittable polymer such as a molecularly oriented PTFE of a type commonly utilized in splittable sheaths, such as the PEEL-AWAY® Introducer Sheaths commercially available from Cook Medical Incorporated. Splittable sheaths are described, e.g., in U.S. Pat. No. 4,306,562 to Osborne and U.S. Pat. No. 4,581,025 to Timmermans, each of which is incorporated herein by reference in its entirety. The sheath can include one or more pre-weakened features, such as a score line, perforations, or reduced wall thickness regions, extending longitudinally along the length of the sheath to provide for controlled splitting of the sheath along a relatively predictable pathway.
• In the example shown, each of thesplittable sheaths130,140 includes aseparate tab132,142 at an end thereof. Typically,tab132,142 is positioned at the end of therespective sheath130,140 farthest from theintermediate length105 of the prosthesis, as shown inFIG. 5.Sheath130,140 may also include asecond tab136,146 along the radially opposite side of sheath fromtab132,142. Typically,tab136,146 is positioned at the end of the respective sheath closest to theintermediate length105 of the prosthesis.Tabs136,146 are provided to facilitate removal of the lower portions of the sheath following a splitting and removal of the upper portions, as further described herein.
• FIG. 6 illustratesprosthesis100 loaded into delivery device10.Respective sheaths130,140 are positioned to constrict the proximal anddistal ends102,104 of the prosthesis. As explained above, retainingmembers20,36 are in the open, or spaced, position as shown inFIGS. 1-3 when the prosthesis and sheaths are loaded into the delivery device. Once the prosthesis and sheaths have been loaded into delivery device10, retainingmembers20,36 are maneuvered into the closed position shown inFIG. 6. The retaining members may be easily maneuvered between the open and closed positions by manipulating therespective finger loops17,33, or analogous structure, provided along the proximal ends16,32 of the delivery device in well-known fashion. Preferably, anend132A,142A of each oftabs132,142, is threaded through anaperture39 of arespective wing38 of retainingmember36, as shown inFIGS. 6 and 9.
• Use of delivery device10 for deploying a prosthesis at a target site is described with reference toFIGS. 7-10.FIG. 7 depicts one example of a body vessel for deployment of a prosthesis, in this case abody vessel220 in the leg of a patient. Thebody vessel220 has previously been subjected to a traumatic episode, resulting in aportion222 ofbody vessel220 being torn away or otherwise severely damaged. Pre-surgery preparation has been applied to the leg and a trauma pathway has been formed therein in order to gain direct, open air, access to the body vessel and the damaged portion thereof. After clamping thebody vessel220 on both ends of theportion222 to restrict blood flow temporarily, thebody vessel220 can be cut or transected by the clinician into twoend portions220A,220B, as shown inFIG. 8. The transection may be at the damagedportion222 of theblood vessel220, and extend as far away as necessary from the damaged portion to remove unhealthy and/or unrepairable portions of the body vessel.
• Aprosthesis100 is selected to have a length sufficient to bridge the laceration in the vessel or the gap between thebody vessel portions220A,220B, and a radial expanded cross-section sufficient to engage the inner walls of the body vessel portions.Prosthesis100 havingsheath portions130,140 in place at the respective distal ends of the prosthesis (FIG. 5) is loaded into delivery device10. If desired, delivery device10 may be supplied with a prosthesis of a desired length/diameter pre-loaded into the delivery device. As shown inFIG. 6 and as described above,prosthesis100 is captured between retainingmembers20,36 which have been maneuvered into the closed position as shown.
• The distal end of delivery device10 having the prosthesis loaded therein is maneuvered into the damaged leg portion shown inFIG. 8 through an open air opening of the type shown inFIGS. 7, 8. The respective ends of the prosthesis covered bysheaths130,140 are inserted into respective vessel ends220A and220B. Typically, the ends are inserted to the maximum distance allowed by the retaining members (FIG. 9). In this event, the anchoring members of the prosthesis are in position to engage the tissue upon expansion of the prosthesis. Thevessel portion220A may be manually pulled over thefirst sheath130. The delivery device10 and theprosthesis100 can then be manipulated in order to introducesecond sheath140 into thevessel portion220B by a sufficient distance for the purposes of engagement and/or anchoring.
• Respective ends132A,142A oftabs132,142 are pulled to split theunderlying sheath130,140. For vessels at a lesser depth in the leg, the ends132A,142A may be accessible to the physician. In this instance, the tabs may be pulled by hand. For deeper vessels, a needle holder or like device may be used to pull the respective tabs in known fashion. Alternatively, a respective prosthesis end can be inserted into eithervessel portion220A or220B, and the tab associated with that prosthesis end can be pulled. Then the opposite end of the prosthesis can be inserted into the other vessel end and its tab can be pulled. In this example, the anchoring members on the first end will keep the prosthesis engaged with the vessel end during manipulation to insert/deploy the second end. Since the vessels are elastic, they are often stretched slightly in order to properly engage the prosthesis. In some cases, it may be difficult to keep both vessel ends in position over the sheaths prior to pulling the tabs, and thus, the sequential insertion as described may be advantageous.
• Astabs132,142 are pulled from the vessel, a split portion ofsheath130,140 engaged withtab132,142 is likewise removed. Once relieved from the constraints imposed bysheaths130,140, prosthesis distal ends102,104 self-expand to the interior diameter of the vessel, as shown inFIG. 10. In one variation, the prosthesis ends may be sized to expand to a diameter slightly greater (e.g., about 1-2 mm greater) than the interior diameter of the vessel, thereby causing the vessel to stretch slightly. This increases the likelihood of creating a secure engagement between the anchoring members with the interior vessel wall, and also minimizes the likelihood of blood leakage upon restoration of blood flow through the vessel. The needle holder may be maneuvered to grasptabs136,146 and thereby remove a remaining portion of sheaths130A,140A.
• Once the respective prosthesis ends have been inserted into the vessel ends as described, the retaining members can be opened to free the prosthesis, and the delivery device can be removed from the surgical site.
• Upon self-expansion of the prosthesis,barbs120 engage the interior vessel wall, as shown inFIG. 11.Barbs120 may be provided in a circumferential ring-like pattern around the prosthesis as shown, or may be provided in a more random pattern. In another alternative, two or more rows of barbs may be provided along each end of the prosthesis.Stent106 is not shown in this figure, to better illustrate the barbs. In addition, in someembodiments graft body110 may overlie the stent, such that the stent would not be visible. As shown, theprosthesis100 is fully deployed and expanded to interconnect the first andsecond vessel portions220A,220B of thebody vessel220 to form a conduit, e.g., for blood flow. As stated,prosthesis100 can be adapted for permanent placement within the patient, thereby obviating a need for subsequent surgical intervention. Once the prosthesis is in place and all portions of the sheath have been removed, blood flow is restored by unclamping or untying each end of the vessel.
• Although the device has been described in connection with its primary intended use for repair of vascular trauma, those skilled in the art will appreciate that the device may also be used to repair other traumatic conditions, such as trauma in other body vessels and cavities, as well as during bypass surgery.
• It is therefore intended that the foregoing detailed description be regarded as illustrative rather than limiting, and that it be understood that it is the following claims, including all equivalents, that are intended to define the spirit and scope of this invention.

Claims (11)

1. A device for delivering a prosthesis to a damaged body vessel, the prosthesis of a type having a constricted condition for delivery to said damaged body vessel and an expanded condition upon deployment at the damaged vessel, the device comprising:

first and second generally elongated members joined to each other along a respective length thereof, each of the elongated members having a proximal end accessible to an operator during use of said device, a distal end for insertion through a body opening from an outer layer of skin to access said damaged body vessel, and a pivot point intermediate said proximal and distal end along said length for joinder to the other elongated member, each of said distal ends extending to a distal tip, said elongated members arranged along said pivot point such that said distal ends are cooperatively maneuverable between a closed position for retaining the prosthesis during a delivery to said damaged body vessel and an open position for releasing the prosthesis upon said delivery;

the first elongated member having a first prosthesis retaining member disposed at said first elongated member distal tip, and the second elongated member having a second prosthesis retaining member disposed at said second elongated member distal tip; said first and second prosthesis retaining members configured for retaining said prosthesis therebetween in said constricted condition when said distal ends are in said closed condition for delivery of said prosthesis at said damaged vessel.

2. The device ofclaim 1, said prosthesis including first and second ends, and a respective sheath at each end for maintaining said end in said constricted condition, wherein a first one of said retaining members includes a wall having a pair of members projecting therefrom in a generally transverse direction, each projecting member including an opening therein for receiving a tab member extending from a respective one of said sheaths.

3. The device ofclaim 2, wherein said first retaining member further includes a ledge member for use in alignment of said prosthesis in said constricted condition.

4. The device ofclaim 3, wherein said second retaining member comprises one or more members maneuverable in conjunction with said first retaining member for aligning said prosthesis in said device in said constricted condition.

5. The device ofclaim 2, wherein each of said retaining members includes at least one rib, the ribs of the first and second retaining members configured to cooperatively grip said prosthesis therebetween for inhibiting lateral movement of said prosthesis when said elongated member distal ends are arranged in the closed position.

6-15. (canceled)

16. A method for open surgical repair of a damaged portion of a body vessel, comprising:

positioning a device having a prosthesis assembly loaded therein for delivery to said damaged vessel portion through an open air pathway, the device comprising first and second generally elongated members, each generally elongated member having a proximal end accessible to an operator, a distal end for insertion to said damaged vessel portion, and being joined to the other elongated member along a length thereof, each of the distal ends extending to a distal tip; said first elongated member having a first prosthesis retaining member disposed at said first elongated member distal tip, and said second elongated member having a second prosthesis retaining member disposed at said second elongated member distal tip, said elongated members arranged such that said distal ends are cooperatively maneuverable between a closed position having said prosthesis assembly loaded therein, and an open position; the prosthesis assembly comprising a prosthesis having first and second ends, and respective first and second sheaths configured for maintaining said first and second prosthesis ends in a constricted condition, each of said first and second sheaths including a tab member for selectively splitting said sheath;

passing said distal ends of said device through said open air pathway to said damaged vessel portion with said distal ends in said closed position;

maneuvering said distal ends such that said first sheath and said first constricted prosthesis end are inserted into a first side of said damaged vessel portion;

maneuvering said distal ends such that said second sheath and said second constricted prosthesis end are inserted into a second side of said damaged vessel portion;

pulling said first sheath tab member for splitting said first sheath, wherein said first prosthesis end expands to engage an inner surface of said first side of said damaged vessel portion; and

pulling said second sheath tab member for splitting said second sheath, wherein said second prosthesis end expands to engage an inner surface of said second side of said damaged vessel portion.

17. The method ofclaim 16, further comprising:

removing said tab members and said first and second sheaths from the body vessel; and

removing said distal ends of the device from said pathway.

18. The method ofclaim 16, wherein each of said prosthesis ends includes one or more anchoring members, said anchoring members being positioned along said prosthesis ends such that said anchoring members engage said respective inner surfaces of said first and second sides of said damaged vessel portion upon said expansion of said prosthesis ends.

19. The method ofclaim 16, each of said first and second sheaths including a second tab member, further comprising:

removing a first portion of each of said first and second split sheaths by withdrawing said tab member from the body vessel; and

removing a second portion of each of said first and second split sheaths by withdrawing said second tab member from the body vessel.

20. The method ofclaim 16, said first prosthesis retaining member comprising a pair of members projecting therefrom, one of said projecting members including an opening therein receiving an end of the tab member of the first sheath, and the other projecting member including an opening therein receiving an end of the tab member of the second sheath, and wherein said first sheath tab member end is pulled for splitting said first sheath, and said second sheath tab member end is pulled for splitting said second sheath.

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