Patent Application
20130053861
The present disclosure relates generally to medical devices for emergency open surgical repair of body structures that define a lumen. More particularly, it relates to deployment systems used for repairing damaged body structure and gaining 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 or fluid stability while maintaining perfusion of adequate blood flow or fluid 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 deployment 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 surgery. It would be desirable if such deployment device was easy for a trauma physician to use, and can rapidly introduce a prosthesis into two vessel portions of a transected vessel, thereby providing a conduit for blood within the injured body vessel.
Accordingly, a deployment device is provided herein to address at least some of the shortcomings of the prior art. The device can include a retaining member and a sheath portion. The retaining member is movable between a closed position and an open position. In the closed position, the retaining member can be positioned over at least an intermediate segment of a prosthesis to retain the segment in a compressed configuration, whereas in the open position, the retaining member can be positioned away from the prosthesis to allow the segment to move to an expanded configuration. The sheath can be configured to retain at least an outer segment of the prosthesis in a compressed configuration. The outer segment can be associated with at least one of a first outer end and a second outer end of the prosthesis. The sheath is removable from the outer segment to allow for expansion thereof when the retaining member is in the closed position. An actuation member may be coupled to the retaining member, and is movable between a first position and a second position to move the retaining member between the closed and open positions. A support frame may be provided to house the actuation member. The retaining member may have a first clamp and a second clamp pivotably coupled to the support frame. In one aspect, the first and second clamps can be slidably engaged with a distal portion of the actuation member such that linear movement of the actuation member between the first and second positions causes the clamps to pivot between the open and closed configurations.
In another embodiment, a deployment system can include a prosthesis, a retaining member, and an actuation member. The prosthesis is radially movable between a compressed configuration and an expanded configuration, the prosthesis oriented about a longitudinal axis. The retaining member is movable between a closed position and an open position. In the closed position, the retaining member can be positioned over an intermediate segment of the prosthesis to retain the intermediate segment in the compressed configuration. In the open position, the retaining member can be positioned away from the prosthesis to allow the intermediate segment to move to the expanded configuration. The actuation member can be coupled to the retaining member and operable to move the retaining member between the closed and open positions. The actuation member is movable along a translational axis between a first position and a second position to correspond to the closed and open positions of the retaining member.
In yet another embodiment, a method of treating a body vessel can include one or more of the following steps. A first outer end of a prosthesis can be inserted in a first vessel portion of a body vessel. The prosthesis may have an intermediate segment retained in a compressed configuration with a retaining member. A second outer end of the prosthesis can be inserted in a second vessel portion of the body vessel. The retaining member can be removed from the intermediate segment of the prosthesis, whereby the intermediate segment and the first and second outer ends of the prosthesis are allowed to move to the expanded configuration. In one aspect, the first and second outer ends of the prosthesis can be retained in the compressed configuration with a retaining sheath. The retaining sheath can be removed from the first and second outer ends after being inserted to allow for expansion and engagement between the first and second outer ends of the prosthesis and the corresponding first and second vessel portions prior to removing the retaining member. In another aspect, the intermediate segment of the prosthesis can be retained in the compressed configuration by a first clamp and a second clamp. An actuation member can be coupled to the first and second clamps and is operable to cause movement of the clamps away from intermediate segment to allow for expansion of the intermediate segment of the prosthesis.
For the purposes of promoting an understanding of the principles of the present disclosure, reference will now be made to the embodiments illustrated in the drawings, and specific language will be used to describe the same. 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 deployment device described herein can be useful for repair of vessels, 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. This device can be particularly useful for introducing a prosthesis for repair of a lacerated artery or vein during emergency surgery, and particularly, to obtain fluid stability or hemostasis while maintaining blood perfusion. For instance, during an open surgical procedure a trauma pathway is created in the body by the physician to access the desired body vessel. The trauma pathway is typically perpendicular or obliquely angled relative to the desired body vessel. To this end, the deployment device provides a mechanism to deploy the prosthesis within the body vessel portions, while maintaining the device within the trauma pathway and relatively perpendicular to the desired body vessel. In one example, the deployment device can include a retaining member and a removable sheath. The retaining member can move between closed and open positions. In the closed position, the retaining member is placed over an intermediate segment of the prosthesis to retain the intermediate segment in a compressed configuration. In the open position, the retaining member is positioned away from the prosthesis to allow for expansion of the intermediate segment. The removable sheath can retain one or both outer segments of the prosthesis in a compressed configuration. The outer segment can be associated with a first and/or second outer end of the prosthesis. The removable sheath can be removed from the outer segment to allow for expansion of the outer segment of the prosthesis when the retaining member is in the closed position. Preferably, expansion of the outer segment is after the outer segment of the prosthesis is inserted into the respective vessel portions. An actuation member is operable to move the retaining member between the closed and open positions. Clamps can define the retaining member and can be pivotable in response to linear movement of the actuation member. Other applications for the deployment device will become readily apparent to one skilled in the art from the detailed description.
Some portions of the prosthesis 15 may also be retained by a removable tubular sheath 17, although the deployment devices described herein are operable without the use of the removable sheath. The removable sheath 17 may be fitted at least partially over the first and second outer ends 18A, 18B of the prosthesis 15 to selectively retain the outer ends in the compressed configuration for insertion into an end opening of the a vessel. In one example, the removable sheath may retain the entire prosthesis from the first end to the second end of the prosthesis. In another example, the removable sheath may include two sheath portions, with a first sheath portion retaining one of the outer segments of the prosthesis 15 associated with the first outer end 18A, and a second sheath portion retaining the other outer segment of the prosthesis 15 associated with the second outer end 18B. In other words, the removable sheath may not be disposed over the intermediate portion, which is retained instead by the retaining member 14. One or more retraction members, such as retraction members 19A, 19B, 19C, 19D, can be coupled to the removable sheath 17. The retraction member is operable for peeling and/or splitting the removable sheath from the respective outer ends 18A, 18B toward the middle of the prosthesis 15 to allow for expansion thereof during or after the retaining member 14 is moved from the closed position. To this end, the retraction member may have a slackness to allow for a segment of the retraction member to be radially oriented for insertion into the body vessel along with the outer end of the prosthesis. In one example, the retraction member and the removable sheath are formed from single piece of sheath material. Here, the outer end of the removable sheath is everted along the prosthesis to form the retraction member. Alternatively, the retraction member may include a tension member, such as a wire or a filament, metal or plastic, having a first end attached to the outer end of the removable sheath and a second end accessible outside the body.
The removable sheath 17 may be configured for peeling and/or splitting by use of any well-known means or material that permits the tubular sheath to be separated, preferably longitudinally, along a relatively predictable path. The removable sheath 17 may be pre-split at the base of the retraction members. The removable sheath is usually, but not necessarily separated into two or more portions, thereby opening a fissure along the length that permits its removal from around the prosthesis situated therein. 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 sheath material. Preferably, the mechanism for splitting the removable sheath can withstand being subjected to a curve to the degree required by the particular application without kinking or premature separation. In one example, the removable sheath can comprise a splittable polymer such as molecularly oriented, non-isotropic PTFE that is used to make the PEEL-AWAY® Introducer Sheath. Such sheath is commercially available from Cook Medical Inc. (Bloomington, Ind.), which is also described in, e.g., 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. In another example, the split line can be enhanced by adding at least one preweakened feature, such as a score line, perforations, or reduced wall thickness regions, extending longitudinally along the length of the removable sheath. The longitudinal preweakened feature may be included anywhere from one or more orthogonal predetermined split lines to a helical type arrangement that may comprise only a single predetermined split line. The preweakened feature may have sheath portions that engage each other with a zipper-like or tongue-and-groove-like interface, or any other splittable connection interface along the contacting lateral edges of the sheath portion. Other examples of removable sheath configurations can be found in U.S. Pat. No. 6,447,540 to Fontaine et al. and U.S. Pat. No. 6,827,731, each of which is incorporated herein by reference in its entirety. The removable sheath can have more than one split lines.
A safety lock 20 can be removably attached to the actuation member 16 to maintain the actuation member 16 in the first position and prevent movement of the retaining member 14 to the open position, thereby preventing inadvertent expansion of the prosthesis. Removal of the safety lock 20 from engagement with the actuation member 16 can permit the actuation member to move the second position.
According to
The proximal portion 22 of the actuation member 24 can extend proximally beyond the proximal end 32 of the tubular body 30. A button 39 can be coupled to the proximal portion 22 to increase the surface area of contact for the end user during operation of the actuation member 16. The button 39 can be an enlarged member having a cross-section that is larger than the cross-section of the proximal end of the passageway 38. The proximal surface of the button 39 can be planar and may be further frictionally enhanced with surface irregularities, such as grooves, dimples, protrusions, or the like, formed in the proximal surface to improve grippability for the end user. The distal portion 26 of the actuation member can extend distally beyond the distal end of the passageway 38 of the support frame. The distal portion 26 can be coupled to the retainer member 14 in a manner to move the retainer member between the closed and open positions.
The intermediate body 24 is configured to transfer forces from the proximal portion 22 of the actuation member to the distal portion 26 of the actuation member. To this end, the intermediate body 24 can be a rigid elongated body that generally can extend substantially parallel to the translation axis TA. In one example, the intermediate body is substantially linear, i.e., does not have bent portions at the axial ends. In another example, the axial ends of the intermediate body can be enlarged or bent to increase surface area contact. For instance, the proximal portion 22 of the intermediate body 24 can be a rigid elongated body, which may extend obliquely, or at least perpendicular, to the translation axis TA. The proximal portion 22 can be fixed in a secured relationship to the intermediate body 24 by any attachment mechanism, such as by adhesives, soldering, welding, or other common attachment mechanisms. The distal portion 26 of the actuation member can be a rigid elongated body that can generally extend obliquely, or at least perpendicular, to the translation axis TA. In one example, the proximal portion 22 and the distal portion 26 extend in opposite directions away from the translational axis TA, or may extend in the same direction.
In one example, the actuation member 16 can include multi-components, although the actuation member can be formed from a single piece. The intermediate body 24 can include two shafts 24A, 24B. The proximal portion 22 and distal portion 26 can be formed by bent regions 22A, 22B, 26A, 26B along the respective ends of each shaft. The button 39 can be formed from two halves 39A, 39B, which when coupled form a disc shape with a smaller diameter portion and an outer flange, as shown in
One or more biasing members 43 can be coupled between the support frame 18 and the actuation member 16 to bias the actuation member in either the first or the second position, preferably in the first position, and thus the retainer member 14 in either the open or the closed positions, preferably in the closed position. In one example, the biasing member 43 is a compression spring having a first end engaged with the distal end of the button, such as an aperture receiving the first end of the compression spring. The compression spring can be extended within the passageway 39 so that the second end of the compression spring is engaged with an inner radial flange (not shown) formed in the passageway. The compression spring may surround the intermediate body 24, such as the shafts 24A, 24B. The biasing member 43 can provide an axial spring force to the proximal portion 22, which in turns provides the retaining member 14 a radially inward retaining force Fs that is substantially perpendicular to the translational axis TA. The combined opposed radially inward retaining forces are greater than the radial expansion forces of the prosthesis such that the clamps can retain the prosthesis in the compressed configuration.
One or more channels, such as channels 42, 44, can be formed into the tubular body 30 along side of the passageway 38 to permit the retraction members to pass therethrough to the proximal end of the device 10. The cross-sectional shape of the channels can be any shape known in the art, such as, e.g., circular, rectangular, elliptical, or oblong (as shown). The channels 42, 44 can be positioned on opposite sides of the passageway to correspond to the outer ends of the prosthesis. A pair of openings 45A, 45B can be formed in the safety lock 20 to allow for the retraction members to pass through from the channels 42, 44.
In
The proximal portion 66 of the clamps can protrude from the distal portion 68 in order to be received by the notch 46, where the proximal portion 66 can be coupled to the legs 48A, 48B and to the distal portion 26 of the actuation member 16. In one example, one or more pivot rods, such as pivot rods 69A, 69B, may be extended laterally across the notch 46, and be fixed in a secured position with the legs 48A, 48B. The proximal portion 66 of the clamps can have a bore 73 extending laterally through the body of proximal portion 66 for receiving the corresponding pivot rod 69A, 69B. To this end, the clamps 60, 62 can pivot about an axis PA defined by the corresponding pivot rod 69A, 69B between the closed position (
Further in
According to
In
Turning to the operation of the deployment device 10 without the removable sheath and the retraction member,
With reference to
Under the force F, the distal portion 26 of the intermediate body 24 is moved along the translational axis TA within the slot 79 of the clamps to slide against the edge 81 closer to the second end 82 of the slot 79. The confronting surfaces 71 of the clamps 60, 62 begin to separate from one another as the clamps 60, 62 begin to be pivotably displaced outward about the respective pivot axes PA. To this end, the surfaces that define the recesses 70 begin to move outward away from one another to permit the respective segment of the prosthesis 15 to expand to the expanded configuration. The slot 79 can be reoriented during movement of the clamp to a position where the slot is substantially parallel to the translational axis TA. Preferably, when the outer flange of the button contacts the proximal surface of the support frame and/or when the distal portion of the intermediate body contacts the second end of the slot, the clamps are in a position to allow for the full expansion of the prosthesis.
The components of the device can be machined or molded from a biocompatible polymer or metal as can be appreciated by those skilled in the art. Actuation member 16 can further comprise an electromechanical actuator coupled to the device, such as an electric motor coupled to a power source and/or controls for electronically controlling the speed, direction, and force of the actuation member. In one example, the actuation member can be operable with a push of a button as can be appreciated by those of ordinary skill in the art.
A concise description of prosthesis 15 will now be provided. The prosthesis can include a generally tubular graft body and/or one or more anchoring members 99 and/or supporting members together defining a fluid passageway. The prosthesis is movable between the radially compressed, delivery configuration and the radially expanded, deployed configuration. The prosthesis can be balloon expandable; however, it is preferred that the prosthesis is self-expandable. 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 may be used to achieve 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 transected artery or vein during emergency surgery, and particularly, to obtain hemostasis while maintaining blood perfusion. The anchoring member and/or supporting member can be any stent pattern known to one skilled in the art. Examples of stent patterns is the Z-STENT® and ZILVER® stent, each available from Cook Medical Inc. (Bloomington, Ind.). The anchoring member and/or supporting member can be formed of a biocompatible metal, such as stainless steel (e.g., 316L SS), titanium, tantalum, nitinol or other shape memory materials, or a high-strength polymer. Preferably, anchoring devices can be included on at least the anchoring members to provide vessel fixation, while avoiding adverse conditions associated with disturbing the vasa vasorum and/or 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. The anchoring devices can include various shaped member structures, including barbs, fibers, bristles, or outer protruding and penetrable media.
The graft body 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 include a bioremodelable material, such as reconstituted or naturally-derived collagenous materials, extracellular matrix material (ECM), submucosa, renal capsule membrane, dermal collagen, dura mater, pericardium, fascia lata, serosa, peritoneum or basement membrane layers, intestinal submucosa, including small intestinal submucosa (SIS), stomach submucosa, urinary bladder submucosa, and uterine submucosa. One non-limiting example of a suitable remodelable material is the SURGISIS® BIODESIGN™, commercially available from Cook Medical Inc. (Bloomington, Ind.). Another suitable remodelable material is the graft prosthesis material described in U.S. Pat. No. 6,206,931 to Cook et al., which is incorporated herein by reference in its entirety.
Portions of the prosthesis can also include a coating of one or more therapeutic agents along a portion of the stent structure and/or the graft body. Therapeutic agents for use as biocompatible coatings are well known in the art. Non-limiting examples of suitable bio-active agents that may be applied to the vascular conduit include thrombo-resistant agents, antibiotic agents, anti-tumor agents, antiviral agents, anti-angiogenic agents, angiogenic agents, anti-mitotic agents, anti-inflammatory agents, angiostatin agents, endostatin agents, cell cycle regulating agents, genetic agents, including hormones such as estrogen, their homologs, derivatives, fragments, pharmaceutical salts and combinations thereof. Those skilled in the art will appreciate that other bioactive agents may be applied for a particular use. The bioactive agent can be incorporated into, or otherwise applied to, portions of the vascular conduit by any suitable method that permits adequate retention of the agent material and the effectiveness thereof for its intended purpose. 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. Non-limiting examples of such conditions include aneurysms, such as abdominal aorta aneurysms, and surgery for tumor removal.
In one example, the axial length of the prosthesis 15 relative to the length of the prosthesis retaining chamber 64 is such that the outer ends 18A, 18B of the prosthesis 15 can extend outwardly beyond the chamber ends. In this instance, the outer ends 18A, 18B of the prosthesis may be expanded slightly to a greater diameter than the radially compressed diameter of the prosthesis retained within the chamber. Preferably, such greater diameter of the outer ends of the prosthesis is less than the overall diameter of the vessel portion end opening. In one example, the prosthesis may be specially configured so that radial compression of a substantial intermediate portion of the prosthesis (e.g., at least about 80% L; L is length of prosthesis) to the first diameter, results in the outer ends of the prosthesis (e.g., each up to about 10% L) having the greater diameter that is about 30% greater than the compressed configuration. To this end, the prosthesis is structured to expand up to about 3% in diameter or less for every 1% of exposed length.
Another step of the operation may be to remove the removable sheath 17 away from the prosthesis 15 when present on the prosthesis. In
To reduce the delivery profile of the outer end of the prosthesis with the removable sheath and the retraction members, the first and second bores 90, 91 can be moved radially toward the prosthesis as close as possible, while maintaining the structural strength of the device. Another approach is shown in
Methods of use and medical treatment with the deployment device will now be discussed. Although the discussion will focus primarily on the operation of deployment device 10, it can be appreciated that the other embodiments of the deployments devices described herein can be similarly operated and used. Although the example described below illustrates use of the deployment device to deliver a prosthesis for interconnecting a blood vessel, the deployment device can deliver a prosthesis to other lumens, ducts, and passageways of the body, and the term “body vessel” will be used to describe in general its use. It is contemplated that the device can be used to deploy a prosthesis within an opening, such as a laceration, formed in the wall of the body vessel without transecting the body vessel.
According to
In
In
It can be appreciated by those skilled in the art that specific features of each embodiment of the deployment device are interchangeable among the device embodiments, even where no references to the specific features are made.
Drawings in the figures illustrating various embodiments are not necessarily to scale. Some drawings may have certain details magnified for emphasis, and any different numbers or proportions of parts should not be read as limiting, unless so designated in the present disclosure. Those of skill in the art will appreciate that embodiments not expressly illustrated herein may be practiced within the scope of the present invention, including those features described herein for different embodiments may be combined with each other and/or with currently-known or future-developed technologies while remaining within the scope of the claims presented here. It is therefore intended that the foregoing detailed description be regarded as illustrative rather than limiting. In addition, it should be understood that the following claims, including all equivalents, are intended to define the spirit and scope of this invention.
