Patent Application
20110208169
Aspects of the present invention are directed to devices for applying surgical fasteners and, in particular, devices for rapidly and reproducibly applying surgical fasteners.
Operations involving the piercing of tissue benefit from control of the velocity of penetration. Tissue is visco-elastic and hence a rapid approach with a cutting instrument is beneficial to prevent tissue from moving away from the penetrator. For example, it is well known to employ scalpels having ultrasound superimposed, in order to cut with very low operator loads and to improve accuracy for initial incision. It would be beneficial therefore to control the velocity of approach of the distal point of a fastener intended for application in soft tissue. This would be particularly true when the configuration of the tissue relative to the screw applicator demands driving the screw away from normal to the tissue plane.
Biologically derived scaffold materials, generally known as extra cellular matrix (ECM), or other types of meshes present a particular challenge for fasteners, because they do not contain through holes for the fastener to pass through making them difficult to penetrate. If the fastener is applied too slowly to the mesh it would likely lead to the mesh material winding up into the threads of the fastener, thereby preventing effective penetration of the fastener. Preferably, the fastener pierces the mesh under rapid rotation and is rotated and advanced through the mesh material before it is distorted or reacts in response to the penetration forces.
Surgical repair of hernias with surgical mesh requires that the mesh be secured with sutures and/or fasteners to assure adequate fixation to the abdominal wall for repair and healing. In repairs such as ventral hernias, the mesh can require numerous fasteners applied using an applicator device with multiple fasteners to achieve the desired apposition of the mesh to the abdominal wall. One such device is an applicator disclosed in U.S. Pat. No. 5,582,616. Applicators of this type rotate the fastener into the mesh and underlying tissue as the surgeon squeezes the handle. The full stroke of the lever must be completed to fully seat the fastener. To achieve full seating of the fastener, the surgeon must oppose the end of the applicator on the exterior abdominal wall of the patient with his free hand, usually for several seconds, while depressing the lever. If the surgeon stops advancing the lever before full stroke, the fastener stops rotating and is not fully seated in the tissue. The surgeon must resume squeezing the lever to finish the fastener application so that it is fully seated. U.S. patent application Ser. No. 12/172,287 described an applicator having an actuator that is capable of storing energy for delivery of a fastener. The actuator is controllable in order to control or interrupt the release of the stored energy. The reference teaches a “dampening means” to control the rate of energy release to a smooth, deliberate action. It does not address the issues related to the delivery of fasteners at slow rates. Thus, during the time it takes to complete the sequence of events to insert a fastener, it is a likely that there would be movement of the applicator tip relative to the fixation site causing the misapplication of the fastener. Other applicators as described in U.S. Pat. No. 5,645,209 employ compressed gas to drive the applicator or as described in U.S. patent application Ser. No. 11/801,507, an electric motor. Although these applicators improve the control and speed of fastener application they require more component parts which add to weight, cost, reliability and shelf life of the devices.
Therefore, there is a need for an device that provides for instantaneous delivery of a surgical fastener with rapid rotational velocity in a reproducible manner without the drawbacks of traditional devices such as compressed air and electric motor devices.
Aspects of the present invention are directed to a device for the delivery of surgical fasteners. The device comprises a lever in mechanical cooperation with a resilient element for storing energy, a drive mechanism which cooperates with the resilient element and at least one surgical fastener, and a release mechanism for rapidly releasing stored energy from the resilient element to the drive mechanism. In certain embodiments, at least partial depression of the lever stores energy in the resilient element; while release of the lever from the at least partial depressed position does not release the stored energy from the resilient element. In other embodiments, at least partial depression of the lever does not store energy in the resilient element if the lever is released prior to the release of energy to the drive mechanism. The drive mechanism converts stored energy from the resilient element upon activation of the release mechanism to deliver at least one surgical fastener.
In certain embodiments, the device is designed to deliver screw-like fasteners. In these embodiments, delivery is via the imparting of rotational and axial energy to the fastener. The device may be designed such that one complete depression of the lever stores sufficient energy to deploy one surgical fastener into tissue, whereas in other embodiments, one complete depression stores sufficient energy to deploy multiple fasteners.
The devices may further comprise a trigger for releasing the stored energy. Release of the stored energy may be selectably triggered upon complete depression of said lever. Additionally, the device may be equipped such that upon complete depression of the lever, the release mechanism must be triggered before further energy is stored. The device may also include a handle and an elongate tubular member, for containing a plurality of surgical fasteners, extending distally from the handle. The surgical fasteners may be iteratively deployable, such as for example, aligned along their axes.
In some embodiments, the device comprises an electric motor in mechanical cooperation with a resilient element for storing energy, rather than a lever. The electric motor upon being powered may direct energy into the resilient element.
Additional aspects of the present invention are directed to methods of securing a surgical mesh to a tissue using the devices of the present invention. Such methods may comprise providing a surgical mesh; providing a surgical fastener delivery system, and applying at least one fastener to secure the mesh to a tissue. The surgical fastener delivery system may be as described herein and may comprise an elongate tubular member containing a plurality of surgical fasteners, extending distally from the handle, and having a distal tip. The distal tip of the elongate tubular member may be positioned against the surgical mesh and the at least one fastener may secure the mesh to a tissue by depressing the moveable lever in relation to a stationary handle on the applicator.
A kit is also disclosed comprising a device for the delivery of surgical fasteners and multiple fastener cartridges. The kit may comprise various amounts of fastener cartridges, various sizes of fasteners, various types of fasteners, or a combination thereof. The cartridges may be disposable elongated tubular members containing multiple fasteners.
This summary is provided to introduce a selection of concepts in a simplified form that are further described below in the Detailed Description. This summary is not intended to identify key features or essential features of the claimed subject matter, nor is it intended to be used as an aid in determining the scope of the claimed subject matter.
Other features of the subject matter are described below.
The foregoing and other aspects of the present invention will become apparent from the following detailed description of the invention when considered in conjunction with the accompanying drawings. For the purpose of illustrating the invention, there are shown in the drawings embodiments that are presently preferred, it being understood, however, that the invention is not limited to the specific instrumentalities disclosed. The drawings are not necessarily drawn to scale. In the drawings:
Aspects of the present invention are directed to devices for the delivery of surgical fasteners. The devices provide for the delivery of fasteners in a fast, reproducible, uninterrupted motion. Such delivery may be facilitated through the storage of energy in a resilient element in mechanical cooperation with a lever. Once the resilient elmenent has stored an amount of energy required to fully deploy at least one fastener, the energy may be released and the fastener deployed. Preferably the amount of energy required to fully deploy a fastener is consistent with one complete depression of the lever. In this embodiment, if, for example, a surgeon releases the lever in mid-stroke the spring remains partially wound, but the drive to the fastener is not released. A full stroke of the lever is required to release the spring and obtain propulsion of one fastener. This full stroke can be made in one smooth sweep of the lever or by building the stroke in several smaller increments. At the release of the spring and the consequent driving of one fastener, the mechanism automatically returns to its original position so that the next deployment is identical to the prior deployment. The energy storage capabilities of the resilient element avoids the difficulties of having to maintain the applicator in a fixed position over an extended period of time. Additionally, the devices of the present invention comprise a minimum number of parts so that they are light, reliable and can be manufactured at a relatively low cost.
Embodiments of the invention are illustrated in
The operation of the drive mechanism will now be described as illustrated in
As can be seen in
If the operator completely depresses lever 1, first wheel 11 will rotate exactly one complete revolution. If the operator relaxes his grip before complete depression, lever 1 reverses under influence of spring 30 and rotates counterclockwise, as viewed in
If first wheel 11 has made one complete revolution and the operator releases his grip, surface 4 can rotate completely around slot 5 in the counterclockwise direction as viewed in
Mainspring 10, as seen in
Link 16 is a ‘U’-shaped link having a right hand arm, as viewed in
As can be seen in exploded view of
Compound link 20 is arranged to pivot on ‘U’-shaped link 16, and may then cause strut arm 22 to lift sprag link 14 clear of notch 13, thus releasing wheel 12 to rotate.
As wheel 12 revolves, after release, cam 25 lifts cam follower arm 21 of compound link 20, in turn moving strut arm 22 in the counterclockwise direction, as viewed in
Every time one revolution of first wheel 11 occurs, even though it may take considerable time to complete the one revolution, second wheel 12 will snap one revolution under influence from mainspring 10. Furthermore, for each time second wheel 12 revolves, the mainspring 10 unwinds one turn, and every time the first wheel 11 revolves one turn, the mainspring 10 is wound up one turn. Mainspring 10 can be pre-wound, for example 3 turns at assembly and then the spring will cycle between 4 and 3 turns as the device is actuated.
As second wheel 12 revolves, crown wheel 26 (attached to second wheel 12) drives shaft 28 through pinion 27. The ratio between crown wheel 26 and pinion 27 can be selected to give shaft 28 the desired number of turns needed to drive one fastener for each complete pull of lever 1. By simply altering the gear ratio between crown wheel 26 and pinion 27, the delivery device may provide one or more additional turns of the fastener for each instance of delivery device actuation. Fasteners are driven by the rotation of shaft 28 that can engage fasteners by a number of methods. By example shown in
One alternate embodiment does not include the one-way clutch 7. In this embodiment first wheel 11 rotates freely with lever 1 in both directions. In this manner energy is only stored in the spring 10 while the handle lever 1 is depressed, and if lever 1 is released, the inputted energy is also released, as mainspring 10 unwinds.
Another alternate embodiment,
In another embodiment, one stroke of lever 1 wind spring 10 is sufficient for multiple fastener deployments. Each fastener may then be deployed by separate actuations of trigger 37. Using the separate trigger arrangement allows for pre-winding the spring for multiple fastener deployments, so that the user would not have to wind spring 10 with the action of lever 1 in between each fastener.
Numerous other embodiments and modifications will be apparent to those skilled in the art and it will be appreciated that the above description of a preferred embodiment is illustrative only. It is not intended to limit the scope of the embodiments contained herein, which are defined by the following claims. Without further elaboration the foregoing will so fully illustrate our invention that others may, by applying current or future knowledge, adopt the same for use under various conditions of service.
