CROSS-REFERENCE TO RELATED APPLICATIONS
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This application claims the benefit of U.S. Provisional Application No. 61/370,304, filed Aug. 3, 2010, which is incorporated herein by reference in its entirety.
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The preferred embodiments described herein relate generally to medical device delivery systems for open surgical repair of body structures that define body lumens. More particularly, they relate to medical device delivery systems for repairing damaged body structures and gaining hemostasis or fluid stability during emergency open surgical medical procedures.
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, or the insertion of one or more temporary shunts. However, conventional surgical repair is generally difficult with such actively bleeding, moribund patients. In many instances, there is simply not enough time to repair the body vessel adequately by re-approximating and suturing the body vessel. In many situations, the trauma physician will simply insert a temporary shunt (such as a Pruitt-Inahara 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 shunts are generally placed as a temporary measure to restore blood flow and stop excessive blood loss, the shunt is typically removed when the patient has stabilized (generally a few days later) by a specialized vascular surgeon. After removal, the vascular surgeon will 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 rapidly performed at great speed, and with a high degree of physician skill. 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 may exceed that possessed by the typical trauma physician. In particular, traumatic episodes to the vessel may require the skills of a physician specially trained to address the particular vascular trauma, and to stabilize the patient in the best manner possible under the circumstances of the case.
Some open surgical techniques utilize sutures to affix damaged tissue portions surrounding fittings that have been deployed with the vessel, which requires the trauma physician to take time to tie the sutures properly. Although 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 the tissue separating 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 develop techniques that reduce the physician time required for such techniques, so that this time can be spent on other potentially life-saving measures, and the blood flow is more quickly restored and damage caused by lack of blood flow is minimized
Trauma physicians generally find it difficult to manipulate a prosthesis for insertion into a body vessel that has been traumatically injured. For example, one difficulty arises from the trauma physician trying to limit the size of the opening created for gaining access to the injured vessel so that such opening requiring healing is as small as possible. Another difficulty is that the injured vessel can be anywhere in the body, having different surrounding environments of bone structure, muscle tissue, blood vessels, and the like, which makes such obstructions difficult to predict in every situation and leaves the trauma physician working with an even further limited access opening. Another potential consideration is the amount of body vessel removed during a transection. The goal would be to remove a portion of the body vessel as small as possible. Yet, a small portion removed from the vessel leaves such a small space between the two vessel portions, thereby making it difficult to introduce the prosthesis between the two vessel portions.
Thus, what is needed is a delivery device for delivering a prosthesis for use in repair of an injured body vessel, such as an artery or a vein, (and in particular a transected vessel) during emergency open surgery. It would be desirable if such delivery device was easy for a trauma physician to use, and can rapidly introduce a prosthesis into a body vessel, thereby providing a conduit for blood or fluid within the injured body vessel.
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The problems of the prior art are addressed by the features of the following examples. In one aspect, a delivery system can include a sleeve and first and second retraction members. The sleeve can be configured to retain segments of a prosthesis in a compressed configuration. The sleeve can have a first outer segment and a second outer segment associated with a first outer end and a second outer end of the prosthesis, respectively. The first retraction member can be coupled to the first outer segment of the sleeve, and the second retraction member can be coupled to the second outer segment of the sleeve. In response to retraction of the first and second retraction members, the first and second outer segments of the sleeve are removed from the corresponding outer ends of the prosthesis. Such removal allows for the expansion of the outer ends of the prosthesis in an outside-in direction.
In another aspect, the delivery system can include a handle and an actuation member movably attached to the handle. An assembly can be disposed at a distal end of the handle. The assembly can include a sleeve configured to retain segments of a prosthesis in a compressed configuration. The sleeve can have a first outer segment and a second outer segment that are associated with a first outer end and a second outer end of the prosthesis, respectively. A first retraction member can be coupled between the first outer segment of the sleeve and the actuation member, and a second retraction member can be coupled between the second outer segment of the sleeve and the actuation member. In response to movement of the actuation member relative to the prosthesis from a first position to a second position, the first and second outer segments of the sleeve are removed from the corresponding outer ends of the prosthesis. This removal allows for the expansion of the outer ends of the prosthesis in an outside-in direction. The handle may include a guiding member to redirect the retraction members from a direction generally along the longitudinal axis to a direction different from the longitudinal axis, such as along the translational axis of the actuation member, which is generally perpendicular to the longitudinal axis. The actuation member may include a retaining member configured to removably attach with each of the retraction members.
Further, in another aspect, a method of open surgical repair of a body vessel is provided. The method can include one or more of the following steps, including inserting a first outer end of a prosthesis in a first vessel portion of a body vessel. The first outer end of the prosthesis can be retained in a compressed configuration by a sleeve portion. A second outer end of the prosthesis can be inserted in a second vessel portion. The second outer end of the prosthesis can be retained in a compressed configuration by a sleeve portion. The sleeve portions can be composed of a single sleeve or multiple sleeves. Sleeve portions can be removed from the respective first and second outer ends of the prosthesis. The first and second outer ends of the prosthesis can be allowed to move to an expanded configuration for engagement with the corresponding vessel portion of the body vessel. In one example, the sleeve portions can be removed with application of an activation agent configured to rapidly weaken or to dissolve the sleeve portions.
BRIEF DESCRIPTIONS OF THE DRAWINGS
FIG. 1A is an elevation view of an example delivery system having a prosthesis retained in a compressed configuration by a removable sleeve.
FIG. 1B is an end view of the system of FIG. 1A.
FIGS. 2A-2B are elevation views of the system FIG. 1A, depicting operation of the system for removal of the sleeve from the prosthesis.
FIG. 3A is a perspective view of an example delivery system, and in particular, a system for use with the delivery system of FIG. 1A.
FIG. 3B is a cross-sectional view of the system of FIG. 3A taken along line 3B-3B.
FIG. 3C is a perspective view of a distal end of the system of FIG. 3A, depicting a guiding element.
FIG. 3D is a cross-sectional view of the system of FIG. 3C taken along line 3D-3D.
FIG. 4A is a perspective view of a partial distal end of the system of FIG. 3A, depicting a handle body with a sharp edge.
FIG. 4B is an end view of the distal end of the system of FIG. 4A, depicting a sharp edge of the handle body with a distal tip in dashed lines.
FIGS. 5A-5E illustrate a method of open surgical repair of a body vessel with a delivery system deploying a prosthesis.
FIG. 6A is an elevation view of another delivery system for deploying a prosthesis, depicting a removable sleeve that can dissolve.
FIGS. 6B-6E are partial elevation cross-sectional views of a damaged body vessel, depicting alternative method steps of deploying a prosthesis using the system of FIG. 6A.
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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. 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. It is understood that like-referenced numerals are used throughout the Figures to designate similar components.
The delivery system 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 theses structures in general, during emergency 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, the prosthesis can be implanted permanently thereby obviating the need for further surgical intervention and repair. In one application with respect to a blood vessel, blood vessels are of two types, namely arteries and veins. Generally speaking, arteries are elastic vessels that carry oxygenated blood away from the heart, and veins are elastic vessels that transport blood to the heart and that then transport blood to the lungs for oxygenation. The walls of both arteries and veins generally consist of three layers or tunics. The inner layer is referred to as the tunica intima, which is composed of endothelium and delicate collagenous tissue. The middle layer is referred to as the tunica media, which is composed of typically a muscular layer, and consists of smooth muscle and elastic fibers. The outer layer is referred to as the tunica adventitia, which is the outer covering of the vessel, and is composed of connective tissue, collagen, and elastic fibers. The tunic adventitia includes small vessels, referred to as vasa vasorum, which supply nutrients to the tissue. Preferably, the prosthesis controllably interacts with the tunica intima, basement membrane, and tunica media, and avoids interaction with the tunica adventitia to not disrupt the vasa vasorum residing in the tunica adventitia. The prosthesis can be secured in a rapid manner without the use of a ligature or suture placed around the vessel.