Patent Application
20070149987
1. Field of the Invention
The invention generally relates to a vessel wound closure device. More particularly, the invention relates to a vessel wound closure device for sealing puncture wounds in a blood vessel such as those that result from certain interventional procedures.
2. Related Art
A large number of therapeutic and diagnostic procedures involve the percutaneous introduction of instrumentation into a blood vessel, for example, percutaneous transluminal coronary angioplasty (PTCA). Such procedures most often involve accessing an intended site through the femoral artery. Ideally, closing and healing of the resultant vascular puncture wound successfully completes the procedure.
Traditionally, the application of external pressure to the skin at the entry site of the instrumentation into the patient has been employed to stem bleeding from the wound. A nurse or physician, for example, applies pressure to the wound site until clotting and tissue rebuilding has occurred sufficiently to seal the perforation. In some situations, the external pressure is maintained for an hour or more, during which time the patient is uncomfortably immobilized. Thus patient comfort and physician efficiency are impaired where such external pressure techniques are employed. Moreover, the patient may require immobilization even after the wound is sealed to minimize the risk of wound re-opening.
Additionally, the risk of hematoma exists while bleeding from the vessel occurs. Such hematoma risk continues until sufficient clotting of the wound site occurs. Moreover, external pressure devices, such as femoral compression systems, are often unsuitable for some patients. For example, patients with substantial amounts of subcutaneous adipose tissue, as the skin surface in such patients may be a considerable distance away from the vasculature puncture site. Inaccurate skin compression, and thus less effective wound healing, tends to occur as a result.
U.S. Pat. No. 5,383,896 to Gershony, et al. discloses a device that applies pressure to a puncture site internally for a limited period of time, after which the device is removed. The device in Gershony includes a shaft with an expandable balloon and a guidewire tip at its distal end. The distal end of the device is introduced into a blood vessel through an introducer sheath that is typically used in percutaneous interventional procedures. The balloon is then inflated and withdrawn until the balloon hemostatically engages the inner surface of the blood vessel, after which the introducer sheath is removed. A fixation collar on the shaft applies tension to the balloon for a medically sufficient time and thereafter the balloon is deflated and the entire device is removed from the body.
U.S. Pat. No. 5,645,566 to Brenneman, et al. discloses a device that applies pressure to the outside wall of a punctured blood vessel from a distance using a balloon, a sheet and a foam pad. The pressure applying device is located using a balloon in the vessel (similar to that of Gershony) and a radiopaque marker.
PCT Application WO 98/11830, published Mar. 26, 1998, S. Barak, Inventor, discloses various embodiments of an apparatus for hemostasis. Among them is a device that positions an “anchor” against an inner surface of an artery wall and a balloon outside the wall. The balloon is inflated to pinch the artery wall, after which the anchor is withdrawn. The balloon is maintained against the puncture until hemostasis is achieved.
Other arterial closure devices include bioabsorbable materials intended to remain in the body until they are absorbed as in U.S. Pat. Nos. 5,282, 827 and 5,662,681.
U.S. Pat. No. 5,391,183 to Janzen, et al. describes a device that inserts hemostatic material through a tissue channel and against the outside wall of the vessel around the puncture site.
U.S. Pat. No. 5,690,674 to Diaz discloses a biodegradable plug that has two substantially parallel disks joined at their centers by a waist. The plug is positioned so that the distal disk is on the interior wall of the blood vessel, the proximal disk is on the exterior wall, and the waist is in the wound of the vessel wall.
Another known closure devices include U.S. Pat. No. 5,741,223 to Janzen, et al. This '223 patent discloses the placement of a plug to seal a puncture site.
U.S. Pat. No. 5,354,271 to Voda which discloses suture threads with barbed ends, wherein the suture threads are deployed into a vessel and then the barbed ends penetrate through the vessel wall and expand to prevent retraction thereof back into the vessel. The suture threads are then tied or otherwise secured across the puncture site.
U.S. Pat. No. 5,324,306 discloses a mass of hemostatic material pushed against the outside wall of a vessel at a puncture site. Manual pressure is applied to ensure blood flow has stopped.
U.S. Pat. No. 5,868,778 discloses a balloon used in combination with a procoagulant injected at the puncture site in order to seal a puncture site of a vessel.
U.S. Pat. No. 5,792,152 discloses a flexible needle with suture attached thereto that is deployed across a puncture site of a vessel. The flexible needle and suture are introduced into the vessel via an entry lumen, proceed through a U-shaped return lumen, and exit the vessel through an exit lumen. Thereafter the suture is drawn further outward from the vessel and tied or otherwise secured across the puncture site.
U.S. Pat. No. 5,441,517 discloses an anchor inserted into a vessel and urged against an inner wall of the vessel as a collagen plug is deployed externally of the puncture site to expand and fill the tissue tract leading to the puncture site. A filament attaches the plug to the anchor. After emplacement, a tamping member may be used to urge the plug against the external puncture site to help seal the same.
U.S. Patent Publication No. 2004/0006352 discloses an arterial closure device comprising an assembly in which clasp arms, to which a suture is initially secured, are deployed within a vessel. Penetrating members including suture catches are then separately deployed to snag or capture the sutures associated with a respective clasp arm. The sutures are then pulled taught by pulling the penetrating member with suture catches out from the vessel, and then tied or otherwise secured to close the puncture site. Thereafter the assembly is withdrawn from the body.
None of the known art disclose or suggest a vessel wound closure device that separately deploys a suture and snare within a vessel, whereby the suture is captured within the snare, withdrawn, and then tied to produce a suture stitch across the puncture site of the vessel, thereby minimizing the amount of material introduced or left within the lumen of the vessel, maximizing wound healing, and rendering the vessel more amenable to subsequent interventional or therapeutic procedures at or near the same site.
Various embodiments of the invention described herein comprise a vessel wound closure device that separately deploys a suture and a snare within a vessel to produce a suture across a puncture site of a vessel. Once deployed within the vessel, the suture is captured within the snare, withdrawn, and then secured to provide a stitch across the puncture site of the vessel. The various embodiments of the vessel wound closure device described herein thus minimize the amount of material introduced or left within the vessel or between edges of the puncture site, maximize healing of the puncture site, and render the vessel amenable to subsequent interventional or therapeutic procedures at or near the same site.
In some embodiments, the vessel wound closure device comprises a sheath, a pair of movable vessel penetrating members associated with the sheath, whereby the vessel penetrating members are moved to penetrate the vessel wall adjacent a puncture site, each penetrating member creating a small hole in the vessel wall adjacent the puncture site. A suture is deployed into the vessel through one of the penetrating members, and a single filament snare loop is deployed into the vessel through the other of the penetrating members. The single filament snare loop includes a pair of strands that extend beyond a proximal end of the sheath, whereby movement of one or both of the strands determines the size of the snare loop within the vessel. The suture is captured by the snare loop within the vessel, and then withdrawn by retracting the respective penetrating members. Thereafter, the suture is tightened by further withdrawing the suture and snare via withdrawal of the respective penetrating members. Once tightened as desired, the suture is tied, or otherwise secured, externally of the puncture site so as to create a stitch across the puncture site. Excess suture material is then cut and the wound closure device and its components removed from the patient. In some instances, the sheath of the vessel wound closure device is inserted through an introducer already in place from a preceding procedure. In other instances, the sheath of the vessel closure device is inserted over a guidewire remaining from a preceding procedure, the introducer from the preceding procedure having been removed. Where the introducer from the preceding procedure has been removed and the sheath of the vessel wound closure device is inserted over a guidewire in the vessel, then the location of the vessel penetrating members of the vessel wound closure device is determined by blood flashback through one or both of the respective vessel penetrating members of the device.
A collar, knot or other locking means may also be used to help tighten the suture prior to tying or otherwise securing the suture to form the stitch across the puncture wound of the vessel. Collagen or other thrombogenic material can be incorporated into the locking means to aid hemostasis at the puncture site. The collar, knot or other locking means is preferably bioabsorbable to accommodate resorption thereof in vivo. The collagen or other thrombogenic material may include therapeutic agents such as procoagulants, antimicrobial agents, anesthetics, or the like.
In other embodiments, the vessel wound closure device comprises a body, a first movable vessel penetrating member associated with the body and a second vessel penetrating member associated with the body, a suture slidably housed within one of the vessel penetrating members and a snare slidably housed within the other of the vessel penetrating members, whereby the first and second vessel penetrating members are movable relative to one another and the body so as to penetrate the vessel wall adjacent a puncture site, each vessel penetrating member creating a small hole in the vessel wall adjacent the puncture site. The body has a proximal end and a distal end and further comprises a first exit port at a distal end thereof through which a first vessel penetrating member is deployed, a second exit port at the distal end thereof through which a second vessel penetrating member is deployed, a movable stabilizer foot at the distal end thereof which foot is deployable upon entry of the distal end of the body sufficiently into the vessel, and a flashback port through which flashback blood escapes to indicate when the distal end of the body is located sufficiently within the vessel to deploy the stabilizer foot and the first and second vessel penetrating members. Separately designated slides control the movement and deployment of the stabilizer foot, the first and second vessel penetrating members, the suture, and the snare. The suture is deployed into the vessel through one of the vessel penetrating members, and the snare loop is deployed into the vessel through the other of the vessel penetrating members. In practice, the suture is captured by the snare loop within the vessel, and then withdrawn by retracting the respective vessel penetrating members. Thereafter, the suture is tightened by further withdrawing the suture and the snare via withdrawal of the respective vessel penetrating members. Once tightened as desired, the suture is tied, or otherwise secured, externally of the puncture site so as to create a stitch across the puncture site. Excess suture material is then cut and the vessel wound closure device and its various components are removed from the patient.
In some embodiments, the vessel wound closure device with the stablizer foot is inserted through an introducer already in place from a preceding procedure. In other cases, the introducer from the preceding procedure has been removed and the vessel wound closure device with the stabilizer foot is inserted into the vessel over a guidewire already in place.
The above and other features of the invention, including various novel details of construction and combinations of parts, will now be more particularly described with reference to the accompanying drawings and claims. It will be understood that the various exemplary embodiments of the invention described herein are shown by way of illustration only and not as a limitation thereof. The principles and- features of this invention may be employed in various alternative embodiments without departing from the scope of the invention.
These and other features, aspects, and advantages of the apparatus and methods of the present invention will become better understood with regard to the following description, appended claims, and accompanying drawings where:
a-7c illustrate various other suture arrangements to create the suture stitch according to the invention.
a and 8b illustrates various options of deploying the snare relative to the suture according to the embodiment of
The first guide 11 is preferably opposite the second guide 12, although other arrangements of the first guide 11 relative to the second guide 12 are readily accommodated, in the artisan's discretion. Although
The vessel wound closure device 1 of
Although the first vessel penetrating member 20 and the second vessel penetrating member 30 are shown as generally circular in cross-section, the artisan should readily appreciate that other cross-sectional configurations are contemplated by the various embodiments described herein. For example, an oval cross-section of either or both of the first and second vessel penetrating members may help assure a more reliable orientation of the snare 32 or suture 22 relative to one another when deployed within the vessel.
Further, either or both of the suture 22 and snare 32 could be pre-bent to help orient the suture and snare relative to one another when deployed within the vessel. The materials comprising the suture and snare may be, for example, a polypropylene, a shape memory alloy, or a stainless/coated steel, in the various embodiments described herein. Ideally, where a shape memory alloy is used to comprise a pre-bent suture or snare. The suture 22 may further comprise knots 22A, or other projections, to assist the capturing of the suture 22 by the single filament snare 32. Moreover, the size of the loop of the single filament snare 32 within the vessel is readily increased or decreased by the medical practitioner by movement of a snare strand 32A extending beyond a proximal end of the wound closure device 1 while maintaining another snare strand 32B in place, the other snare strand 32B also extending beyond the proximal end of the wound closure device.
In particular,
In
As shown in
The resistance identifying the capture of the suture 22 within the snare 32 is often best felt as the second penetrating member 30 is being retracted. When such retraction of the second vessel penetrating member 30 does not result in resistance to indicate that the suture 22 has been successfully captured within the snare 32, then the snare 32 is re-deployed, as before, within the vessel V until successful capture of the suture 22 in the snare 32 is achieved. After retraction of the second vessel penetrating member 30 with the captured suture 22 and snare 32 is achieved, the first vessel penetrating member 20 is also retracted, leaving only the loose ends of the suture 22 and snare 32 along the extravascular surface of the vessel wall w of the vessel V adjacent the puncture site. The guidewire 40 may then be withdrawn in conventional manner.
The suture 22 and snare 32 are then cut and tied, or otherwise secured, as shown, for example, in
Alternatively, as shown in
A still further alternative, as shown in
A still further alternative, as shown in
Collagen or other thrombogenic material can be incorporated into the locking means to aid hemostasis at the puncture site where such a locking means is used. The collar 55, knot, or locking means is preferably bioabsorbable to accommodate resorption thereof in vivo. The collagen or other thrombogenic material may include therapeutic agents such as procoagulants, antimicrobial agents, anesthetics, or the like.
a and 8b illustrate various options for positioning the snare 32 relative to the suture 22 and vessel V, wherein that option illustrated in
Preferably the needles 21, 31 of the respective first and second vessel penetrating members 20, 30 are as small as possible in order to limit damage to the vessel wall. Such needles generally 18 gauge to 22 gauge needles, and preferably 21 gauge needles. The outer diameter of 21 gauge needles is approximately 0.032 inches. Of course, the artisan will readily appreciate that needles of other sizes are readily usable with the vessel wound closure device described herein. Similarly, the materials that comprise the sutures or snare are preferably biocompatible materials exhibiting high tensile and knot strength, although other materials may also be used with the vessel wound closure device described herein.
The portion of the wound closure device 101 proximal of the sheath 110 comprises a pair of generally parallel rails 102, 103 upon which ride slides 123, 124, 133 and 134 that regulate movement of various components discussed in further detail below. A grip 104, having an exterior surface and an interior channel, provides a rest for an operator's hand or digits along the exterior surface thereof, and provides a transition piece in which the various components passing therethrough the interior of said grip 104 are appropriately connected to extend proximal to distal and are regulated by the slides 123, 124, 133 and 134
Referring to
A first vessel penetrating member slide 123 is connected to a proximal portion of the first vessel penetrating member 120 and regulates movement thereof. A suture slide 124 is connected to a proximal end of the suture 122 and regulates movement thereof. A distal end of the introducer 110 also includes a first exit port 125, through which the first vessel penetrating member 120 and suture 122 are manipulated. A suture storage unit 126 may be provided at a proximal end of the vessel wound closure device 101, if desired, in order to spool suture material therefrom as needed in practice.
A second vessel penetrating member slide 133 is connected to a proximal portion of the second vessel penetrating member 130 and regulates movement thereof. A snare slide 134 is connected to a proximal end of the snare 132 and regulates movement thereof. A distal end of the sheath 110 also includes a second exit port 135, through which the second vessel penetrating member 130 and snare 132 are manipulated.
For those instances when the vessel wound closure device 101 is inserted over a guidewire, and not within a preexisting introducer from a preceding procedure, then positioning of the device 101 appropriately within the vessel may be achieved by the identification of blood flashback. Accordingly, a flashback port 160 is provided on the grip 104, for example. Of course, the flashback port 160 could instead be located elsewhere along the introducer in the artisan's discretion.
In practice, the vessel wound closure device 101 is inserted into a vessel through a preexisting introducer from a preceding procedure, or over a guidewire extending into a vessel after removal of the preexisting introducer. In the former case, positioning of the vessel wound closure device 101 within the vessel is determined in conventional manner relying on the dimensions, position or markings of the preexisting introducer, whereas in the latter case, flashback of blood from the vessel through the flashback port 160 determines when the vessel wound closure device 101 is appropriately positioned within the vessel.
Once the distal end of the sheath 110 of the vessel wound closure device 101 is appropriately positioned within the vessel, then remaining procedures are generally as follows regardless of whether the device 101 is inserted through a preexisting introducer or over a guidewire, unless otherwise indicated herein. First, the stabilizer foot activation lever 160 is activated to deploy the stabilizer foot 150 within the vessel. Then, the entire vessel wound closure device 101 is retracted until the stabilizer foot 150 abuts the interior wall of the vessel.
The second vessel penetrating member slide 133 is then pushed distally to deploy the second vessel penetrating member 130. The snare slide 134 moves in unison with the second vessel penetrating member slide 133 at this point. Once the second vessel penetrating member 130 is deployed, the second vessel penetrating member slide 133 is locked and the snare slide 134 is slid independently further distally until the snare 132 is deployed beyond the needle 131 and within the vessel.
Next, the first vessel penetrating member slide 123 is pushed distally to deploy the first vessel penetrating member 120. The suture slide 124 moves in unison with the first vessel penetrating member slide 123 at this point. Once the first vessel penetrating member 120 is deployed within the vessel, then the first vessel penetrating member 123 is locked and the suture slide 124 is slid independently further distally until the suture 122 is deployed beyond the needle 121 and within the vessel.
As in earlier embodiments, the snare 132 is deployed downstream of the suture 122 to enhance the capture of the suture by the snare. The suture 122 may further comprise knots or other projections, as in earlier described embodiments, also to enhance capture thereof by the snare. Capture of the suture 122 by the snare 132 is identified by resistance felt by an operator as the snare slide 134 is slid proximally to retract the snare 132, ideally with the suture 122 captured thereby. Should resistance not be experienced by the operator, then the snare slide 133 is moved distally again to redeploy the snare 132 as before. This process repeats itself until the suture 122 is successfully captured by the snare 132.
Once the suture 122 is captured by the snare 132, then the snare 132 is retracted by proximally sliding of the snare slide 134, and the second vessel penetrating member 130 is retracted by proximally sliding of the slide 133. The first vessel penetrating member 120 is also retracted by proximally sliding of the slide 123. The stabilizer foot 150 is de-activated and returned to its non-deployed state flush with the exterior surface of the sheath 110 by the stabilizer foot lever 151. The entire vessel wound closure device 101 is then removed from the vessel through the incision tract, and loose ends of the of suture are knotted as in earlier described embodiments to form a stitch across the puncture site.
Of course, although the various embodiments described herein are directed to creating a single stitch across a vessel wound by deployment of a suture and snare from a first vessel penetrating and a second vessel penetrating member, various other embodiments could comprise creating more than a single stitch across the vessel wound. Such embodiments may comprise additional vessel penetrating members, sutures and snares, for example, that are otherwise deployable as described herein.
The various exemplary embodiments of the invention as described hereinabove do not limit different embodiments of the systems and methods of the invention. The material described herein is not limited to the materials, designs or shapes referenced herein for illustrative purposes only, and may comprise various other materials, designs or shapes suitable for the systems and methods described herein, as should be appreciated by the artisan.
While there has been shown and described what is considered to be preferred embodiments of the invention, it will, of course, be understood that various modifications and changes in form or detail could readily be made without departing from the spirit or scope of the invention. It is therefore intended that the invention be not limited to the exact forms described and illustrated herein, but should be construed to cover all modifications that may fall within the scope of the appended claims.
