|Publication number||US20060122634 A1|
|Application number||US 11/004,445|
|Publication date||Jun 8, 2006|
|Filing date||Dec 3, 2004|
|Priority date||Dec 3, 2004|
|Also published as||CA2587660A1, EP1833381A1, US8500755, US20080119875, WO2006060594A1|
|Publication number||004445, 11004445, US 2006/0122634 A1, US 2006/122634 A1, US 20060122634 A1, US 20060122634A1, US 2006122634 A1, US 2006122634A1, US-A1-20060122634, US-A1-2006122634, US2006/0122634A1, US2006/122634A1, US20060122634 A1, US20060122634A1, US2006122634 A1, US2006122634A1|
|Inventors||Takashi Ino, Michael Drews, Donnell Gurskis|
|Original Assignee||Ino Takashi H, Drews Michael J, Gurskis Donnell W|
|Export Citation||BiBTeX, EndNote, RefMan|
|Patent Citations (22), Referenced by (45), Classifications (7), Legal Events (1)|
|External Links: USPTO, USPTO Assignment, Espacenet|
The invention relates generally to apparatus and methods for fastening devices to tissue or other devices, and, more particularly, to apparatus and methods for delivering fasteners during heart valve replacement, placement of other prostheses, or repair of body organs in general and vascular surgery, such as wound closure, anastomosis, hernia repair, and grafting procedures for aneurysm repair.
Prosthetic heart valves have been used to replace defective human valves in patients. A prosthetic valve generally includes a sewing ring or suture cuff that may be attached to and/or extend around a valve member. The sewing ring may be made from a biocompatible fabric and/or other material through which a needle and suture may pass. The sewing ring may be part of a single piece prosthetic valve, or may be part of a multiple piece prosthetic valve assembly.
In a typical aortic valve replacement procedure, the aorta may be incised and the defective valve leaflets removed, leaving a desired placement site that may include a fibrous tissue layer or tissue annulus. Needles carrying sutures may be directed through the fibrous tissue or desired placement site within the tissue annulus to form an array of sutures. Free ends of the sutures may be extended out of the thoracic cavity and laid, spaced apart, on the patient's body.
The needles and sutures may then be threaded individually through a sewing ring, typically delivering between ten and twenty (12-20) sutures through the sewing ring. Once the sutures have been directed through the sewing ring, the sutures may be pulled up taught and the sewing ring may be slid over the sutures or “parachuted” down into place adjacent the placement site tissue. The sewing ring may then be secured in place by knot tying knots in the sutures. This procedure is time consuming as doctors often use three to ten knots per suture.
If the sewing ring is separate from a valve member of a multiple component prosthesis, the valve member may be introduced into the placement site, and secured to the sewing ring. The sutures may be tied, not only to secure the sewing ring to the biological mass and, but to secure the valve member to the sewing ring (and consequently, to the tissue annulus).
During heart valve replacement procedures, the patient may be on cardiopulmonary bypass (CPB), which may reduce the patient's oxygen level and/or create non-physiological blood flow dynamics. The longer a patient is on CPB, the greater the risk for long-term or even permanent health damage. Existing suturing techniques extend the duration of CPB and, consequently, increase the health risks due to the patient. Furthermore, the fixturing force created by suturing varies significantly from suture to suture, even for the same medical professional.
Sewing rings can also be tedious and time consuming to secure to a valve orifice. To assemble multiple component heart valves, for example, one component has to be sewn into another in vivo, resulting in a complex and time consuming process. The complexity of the procedure also provides a greater opportunity for mistakes and requires a patient to be on cardiopulmonary bypass for a lengthy period.
The invention is directed to apparatus and methods for fastening devices to tissue or other devices, and, more particularly, to apparatus and methods for delivering fasteners during heart valve replacement. The invention may be deployed to secure a prosthesis to surrounding tissue, or to secure one prosthesis to another, or a portion of a prosthesis to a coordinating prosthesis.
In accordance with one embodiment, a fastener delivery tool is provided that includes a loading chamber for receiving a fastener having a plurality of tines in a relaxed state. The tool also includes a releasable retaining member for limiting movement of the fastener within the loading chamber. An ejection track is coupled to the loading chamber. A handle is provided that includes a lever, and a tongue and pusher member coupled to the lever. Movement of the lever advances the tongue to engage the tines so as to transform the fastener from the relaxed state to a constrained state. Movement of the lever also advances the fastener from the loading chamber down the ejection track. A trigger is depressed to eject the fastener from the tool.
In another embodiment, a method for delivering a fastener is provided that includes providing a fastener delivery tool having a fastener therein, the fastener including a pair of tines in a relaxed state. The fastener is secured in the fastener delivery tool using a releasable retaining member. A tongue is advanced in the fastener delivery tool so as to transform the fastener from a relaxed state to a constrained state while the fastener is secured with the releasable retaining member. The retaining member is released and the fastener is advanced in the constrained state distally within the fastener delivery tool using a pusher member. The fastener is ejected from the fastener delivery tool by depressing an actuator.
In still another embodiment, a fastener delivery tool is provided that includes a loading chamber for receiving at least one fastener having a plurality of tines in a relaxed state, the loading chamber including a release pin on which said at least one fastener is loaded. The tool further includes an ejection track communicating with the loading chamber and a lever coupled to a tongue and a pusher member. The tongue is engageable with the plurality of tines of the fastener so as to transform the fastener from the relaxed state to a constrained state. The pusher member is also engagable with a proximal end (e.g., a loop portion) of the fastener so as to translate the fastener to a distal tip of the tool. The fastener is then ejected by depressing a trigger or other actuator.
In still another embodiment, a fastener delivery tool is provided that includes a staging area or section in which a plurality of fasteners are loaded. The fasteners may be loaded individually or within a cartridge. Multiple fasteners may be loaded into the tool, thereby permitting the user to eject or “fire” multiple fasteners successively without having to reload between ejections.
Other aspects and features of the present invention will become apparent from consideration of the following description taken in conjunction with the accompanying drawings.
FIGS. 16(a) and 16(b) are top and side views of the distal end of a fastener delivery tool, illustrating exemplary configurations for an elongated distal tip for the tool.
Turning to the drawings,
A cartridge retainer 16 is provided on the shaft 9 that may be movable along the axial direction of the shaft 9. As described more fully below, the cartridge retainer 16 may be used to retain or otherwise secure the cartridge 7 for the subsequent deployment steps of the fastener 6. In addition, the cartridge retainer 16 may transform the fastener 6 into a partially constrained state.
FIGS. 2(a) and 2(b) illustrate the distal end of the fastener delivery tool 2. As best seen in
The fastener 6 may be secured or otherwise retained in a groove 7(a) or slot in the cartridge 7. The cartridge 7 containing the fastener 6 may be inserted (in the direction of arrow A in
Still referring to FIGS. 2(a) and 2(b), the distal tip 4 of the tool 2 includes an ejection track 23. The ejection track 23 is connected to or otherwise communicates with the loading chamber 18. During deployment of the fastener 6, the tines 6(a), 6(b) may be forced into the U-shaped configuration and the fastener 6 may be advanced from the loading chamber 18 and into the ejection track 23 (described in more detail below).
FIGS. 3(a) and 3(b) illustrate the next step involved in deploying the fastener 6. As seen in FIGS. 3(a) and 3(b), the cartridge retainer 16 may be advanced distally (shown by arrow B in
FIGS. 5(a) and 5(b) illustrate the tongue 26 advancing in the direction of arrow C shown in
FIGS. 7(a) and 7(b) illustrate the fastener 6 being advanced through the ejection track 23. After the fastener 6 has assumed the U-shaped configuration, the retaining member 20 may be moved from the engaged state to the disengaged state.
Still referring to FIGS. 7(a) and 7(b), the pusher member 30 contacts a proximal end of the fastener 6 and pushes or advances the fastener 6 down the ejection track 23. In one embodiment, the pusher member 30 continues to advance the fastener 6 until the fastener 6 reaches a position within the ejection track 23 shown in FIGS. 7(a) and 7(b). In this position, the faster 6 is positioned such that the tines 6(a), 6(b) project slightly from the distal-most end of the tool 2.
This configuration may permit a physician or other user to probe areas of tissue for the optimal insertion location. For example, the physician may probe an area of tissue that may be calcified or plaque-laden and not suitable for placement of a fastener 6. In this regard, the physician may move instead to another more potentially desirable location adjacent the calcified location. Once the desired location is reached, the fastener 6 may be completely ejected from the tool 2, e.g., by depressing the trigger 14 (shown, for example, in
FIGS. 8(a) and 8(b) illustrate partial top and side views, respectively, of the fastener delivery tool 2 with the handle 10 and lever 12 removed for clarity. In FIGS. 8(a) and 8(b), the loading chamber 18 of the device is empty and the cartridge retainer 16 is withdrawn in the proximal direction, permitting loading of another cartridge 7 carrying a fastener 6 into the tool 2. FIGS. 9(a) and 9(b) illustrate a fastener delivery tool 2 loaded with a single fastener 6 (the cartridge 7 is hidden simply for the sake of clarity). As seen in
With reference to FIGS. 11 (a) and 11(b), additional depression of the lever 12 on the handle 10 advances the tongue 26 such that the teeth 26(a) drop into the loop portion 6(c) of the fastener (shown best in
Referring now to FIGS. 12(a) and 12(b), the fastener 6 is then transformed into the fully constrained state (i.e., U-shaped configuration) by advancing the tongue 26 distally, e.g., by partially depressing the handle 10 of the tool 2. The teeth 26(a) of the tongue 26 may advance between the tines 6(a), 6(b) of the fastener 6 to direct the fastener 6 into the U-shaped configuration. At this stage, the fastener 6 may still be retained by retaining member 20.
FIGS. 13(a) and 13(b) illustrate the trigger assembly 32 abutting and pushing against a clamp 38 that is fixedly coupled to the pusher member 30. Movement of the clamp 38 distally causes corresponding distal movement of the pusher member 30 within the tool 2. The pusher member 30 then advances distally such that the cam 20(a) on the retaining member 20 exits the groove 30(a) in the pusher member, thereby moving the retaining member 20 to the disengaged position. Additional advancement of the handle 12 pushes the fastener 6 down the ejection track 23 of the tool. During this phase of deployment, both the tongue 26 and pusher member 30 move distally in unison. Advancement of the fastener 6 may stop when the tines 6(a), 6(b) project just beyond the distal-most end of the tool 2 (as shown in FIGS. 13(a) and 13(b).
FIGS. 14(a) and 14(b) illustrate ejection of the fastener 6 from the tool 2. After the spring 36 has been fully compressed and the actuating lever 12 is in the position shown in
As seen in
FIGS. 15(a) through 15(e) illustrate the various stages of an exemplary method that may be used to deliver a fastener 6 using the fastener delivery tool 2.
FIGS. 16(a) and 16(b) illustrate alternative configurations, A, B, and C, for an elongated distal tip or snout 4 of the tool 2. The tool 2 may include distal tips 4 of varying lengths in order to facilitate the delivery process. For example, the tips 4 may have lengths between about ten and four hundred millimeters (10-400 mm), or between about five and fifty millimeters (5-50 mm).
The tips 4 may be integrally formed with the tool 2. Alternatively, the tips 4 may be removable and/or interchangeable. In this alternative, the tips 4 and/or tool 2 may include one or more detents or other connectors (not shown) for removably attaching an individual tip 4 to the tool 2. In addition, as best seen in
Tip A shown in
Turning to FIGS. 17(a)-17(c), tool 2 may be used to deliver one or more fasteners 6, e.g., during a heart valve replacement procedure. For example, the tool 2 may be used to deliver a plurality of fasteners 6 through a sewing cuff or ring 51 of a prosthetic heart valve 50 into surrounding tissue. Alternatively, it will be appreciated that the tool 2 may be used to deliver one or more fasteners 6, e.g., to secure other devices to tissue or to another device, or to secure tissue structures together.
As shown, the prosthetic valve 50 is a multiple component prosthesis, e.g., including a gasket member 52 (around which the sewing cuff 51 may extend), and a valve member or “crown” (not shown, e.g., including a frame and a plurality of leaflets, not shown). Exemplary embodiments of single or multiple component prosthetic heart valve assemblies that may be implanted using the tool 2 are disclosed in U.S. Pat. No. 6,371,983 and in co-pending applications Ser. Nos. 10/327,821, filed Dec. 20, 2002, and 10/765,725, filed Jan. 26, 2004. The entire disclosures of these references are expressly incorporated by reference herein.
Initially, the gasket member 52 may be advanced into the annulus 90, e.g., by a separate tool (not shown), and maintained at a desired location, e.g., at a site from which native valve leaflets have been removed. The distal tip 4 of the tool 2 (loaded with a fastener 6) may be placed against the sewing cuff 51 with the tip 4 substantially perpendicular to the sewing cuff 51. The tool 2 may be actuated, e.g., by activating the lever 12 and/or trigger 14, to deliver the fastener 6 through the sewing cuff 51 into the underlying tissue. Once the fastener 6 is ejected from the distal tip 4, the tines of the fastener 6 may at least partially recross within the tissue, thereby capturing a portion of the sewing cuff 51 and the underlying tissue within the loop of the fastener. A plurality of fasteners 6 may be successively delivered about a circumference of the sewing cuff 51 to affix the prosthetic valve 50 to the surrounding tissue 90.
Optionally, the fasteners 6 may be removable from tissue 90 and prosthetic valve 50, e.g., if it is desired to remove the valve 50 or relocate a particular fastener. For example, a pliers-like tool (not shown) may be used to remove a fastener after ejection of the fastener 6 from the tool 2, e.g., if the fastener 6 is oriented incorrectly or the fastener 6 does not penetrate deeply enough into the tissue 90. The physician grasp the loop portion 6(c) of the fastener 6, which may remain at least partially exposed, using the pliers-like tool. The fastener 6 may then be pulled or otherwise retracted proximally to remove the tines of the fastener 6 from the delivery site. A replacement fastener 6 may be loaded into the tool 2 and/or delivered to the delivery site, similar to the methods described above.
In an alternative embodiment, a tool may be provided that may accommodate loading multiple fasteners 6 into the tool 2 simultaneously or successively before delivery. Such a tool 2 may be desirable because the tool 2 does not have to be removed from the body cavity to load successive fasteners 6, which may accelerate delivery of the fasteners 6.
While embodiments of the present invention have been shown and described, various modifications may be made without departing from the scope of the present invention. The invention, therefore, should not be limited, except to the following claims, and their equivalents.
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|Cooperative Classification||A61B17/068, A61B17/0644, A61B2017/00862|
|European Classification||A61B17/068, A61B17/064D|
|Feb 24, 2005||AS||Assignment|
Owner name: ARBOR SURGICAL TECHNOLOGIES, INC., CALIFORNIA
Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNORS:INO, TAKASHI HARRY;DREWS, MICHAEL J.;GURSKIS, DONNELL W.;REEL/FRAME:015786/0790
Effective date: 20050215