Patent Application
20240398582
Embodiments of the present invention relate generally to graft deployment systems and methods, and in particular instances, to graft deployment systems and methods for rotator cuff repair and reconstruction.
Current graft deployment modalities enable surgeons to provide beneficial treatments to patients in need thereof. Yet still further improvements in graft deployment technology is desired. Embodiments of the present invention provide solutions to at least some of these outstanding needs.
Exemplary graft deployment systems or devices as disclosed herein can be provided as a single use device for the deployment of graft for rotator cuff reconstruction and rotator cuff repair. In some embodiments, the device can include a handle, a trigger, a collapsing feature, and an insertion mechanism. The insertion mechanism can include an outer sheath, a central shaft, and an expansion mechanism. The outer sheath can be made up of a distal sheath and a proximal sheath. The insertion mechanism can be loaded with graft by compressing the expansion mechanism with a loading rod, then loading the graft and distal sheath over the rod, which is then removed, leaving the loaded graft in place and the two parts of the outer sheath joined together. To deploy the graft the trigger is used to draw back the sheath and then expand the expansion mechanism. This presses the graft into position. The expansion mechanism can then be collapsed, and the insertion mechanism can be removed, leaving the graft in position for fixation.
Advantageously, embodiments of the present invention enable the performance of simplified surgical procedures by packaging full functionality into a single-use instrument, reducing cost associated with reprocessing. A simplified loading of the graft with the deployment tool can simplify manual preparation by the surgeon. In some cases, the expansion mechanism maintains rigidity after expansion, allowing for compression of the graft against target tissues, which is difficult with known solutions. In some cases, the expansion mechanism additionally allows for visualization and manipulation of the graft before fixation. Advantageously, in some embodiments the device can enable simplified procedures compared to some known solutions by minimizing need for suture.
Further, according to some embodiments, the semi-rigid nature of the expanded expansion mechanism allows for the ability to apply selective pressure to the graft during the fixation process, giving flexibility to the surgeon in terms of how they place fixation features. In some embodiments, a simple graft loading procedure removes the need for suture preparation, shortening and simplifying procedures. In some embodiments, the insertion mechanism allows for the positioning of the graft with visualization of its depth and location prior to full deployment. In some embodiments, advantages are provided by the configuration of a curved expansion mechanism. In some embodiments, advantages are provided by the use of a nitinol wire that is coiled in a sheet and curled.
In one aspect, embodiments of the present invention encompass systems and methods for deploying a graft for implantation. An exemplary device for deploying a graft for implantation includes a handle, a central shaft, an outer shaft, and an expansion mechanism. The central shaft can be coupled with the handle, and the central shaft can include a central post. The outer shaft can be configured to receive the graft at least partially therein, and the outer shaft can be configured to receive the central post at least partially therein such that the graft is at least partially wrapped around the central post. The expansion mechanism can be in operative association with the central shaft, and the expansion mechanism can include a wire that can be transitioned between a first state and a second state. In some cases, the handle is configured to actuate the outer shaft and the wire. In some cases, the device further includes a spring that operates to force the outer shaft in a proximal direction. In some cases, the device further includes a trigger, and the trigger can be operable to retract the outer shaft in a proximal direction. In some cases, the device includes a first mechanism operable to actuate the wire, and a second mechanism operable to actuate the outer shaft. In some cases, the device further includes a grip that operates to force the outer shaft in a proximal direction. In some cases, the handle is provided as a linear handle. In some cases, the handle is provided as a pistol grip. In some cases, the wire is made of or includes nitinol. In some cases, the outer shaft includes a proximal sheath and a distal sheath. In some cases, the distal sheath is configured to house the graft at least partially therein when the graft is in a curled configuration. In some cases, the distal sheath is configured to couple with the proximal sheath while housing the graft.
In another aspect, embodiments of the present invention encompass systems and methods for delivering a graft to a treatment site of a patient. An exemplary method of delivering a graft to a treatment site of a patient can include positioning the graft at least partially within an outer sheath of a graft deployment device, and placing the outer sheath at least partially over a central shaft of the graft deployment device, so that the graft is at least partially wrapped around a central post of the central shaft. The method can further include positioning the outer shaft at the treatment site of the patient while an expansion mechanism wire of the graft deployment device is in a first state, retracting the outer sheath and enabling the expansion mechanism wire to transition to a second state thereby expanding the graft, and pressing the graft against the treatment site of the patient. In some methods, the step of retracting the outer sheath and enabling the expansion mechanism wire to transition to the second state includes actuating a handle of the graft deployment device. In some methods, the step of retracting the outer sheath includes enabling a spring of the graft deployment device to force the outer shaft in a proximal direction. In some methods, the step of retracting the outer sheath includes actuating a trigger of the graft deployment device. In some methods, operating a first mechanism of the graft deployment device is effective to retract the outer sheath and operating a second mechanism of the graft deployment device is effective to enable the expansion mechanism wire to transition to the second state. In some methods, operating a grip of the graft deployment device is effective to force the outer shaft in a proximal direction. In some methods, the handle is provided as a linear handle. In some methods, the handle is provided as a pistol grip. In some methods, the wire is made of or includes nitinol. In some methods, the outer shaft of the graft deployment device includes a proximal sheath and a distal sheath. In some methods, the distal sheath is configured to house the graft at least partially therein when the graft is in a curled configuration. In some cases, methods can further include coupling the distal sheath with the proximal sheath while the distal sheath is housing the graft.
Inventive features of the disclosure are set forth with particularity in the appended claims. A better understanding of the features and advantages of the present disclosure will be obtained by reference to the following detailed description that sets forth illustrative embodiments, in which the principles of the disclosure are utilized, and the accompanying drawings of which:
Specific embodiments of the disclosed device, system and method of use will now be described with reference to the drawings. Nothing in this detailed description is intended to imply that any particular component, feature, or step is essential to embodiments of the invention.
Graft deployment systems disclosed herein can be used to deploy grafts to any of a variety of patient treatment sites. In some cases, a graft deployment system can be used to deploy a graft to a rotator cuff of a patient. In some cases, a graft deployment system can be used to deploy a graft for an Achilles tendon repair, a patella tendon repair, a triceps repair, a quadriceps repair, or the like. In some embodiments, graft deployment systems or methods disclosed herein may incorporate one or more aspects of the systems or methods which are described in U.S. patent application Ser. No. 18/382,899 filed Oct. 23, 2023, the content of which is incorporated herein by reference.
Turning now to the drawings,
In the cross-section side view provided in
The portion 135α of the first collapsible member component 135A that extends between the distal aperture 137d and the distal end 138 can have a length LA-1 when the collapsible member is in the first state and a length LA-2 when the collapsible member is in the second state, where length LA-1 is greater than LA-2. Relatedly, the portion 135% of the first collapsible member component 135A that extends between the distal aperture 137d and the distal end 138 can have an arc height DA-1 when the collapsible member is in the first state and an arc height DA-2 when the collapsible member is in the second state, where the arc height DA-1 is greater than the arc height DA-2. The arc height can refer to the distance between the central post 137 and the maxima of the portion 135α of the first collapsible member component 135A that extends between the distal aperture 137d and the distal end 138. So, for example, the maxima moves between distance DA-1 and DA-2 when the first collapsible member component 135A moves between the first state and the second state.
Likewise, the portion 135β of the second collapsible member component 135B that extends between the distal aperture 137d and the distal end 138 can have a length LB-1 when the collapsible member is in the first state and a length LB-2 when the collapsible member is in the second state, where length LB-1 is greater than LB-2. Relatedly, the portion 135β of the second collapsible member component 135B that extends between the distal aperture 137d and the distal end 138 can have an arc height DB-1 when the collapsible member is in the first state and an arc height DB-2 when the collapsible member is in the second state, where the arc height DB-1 is greater than the arc height DB-2. The arc height can refer to the distance between the central post 137 and the maxima of the portion 135 of the second collapsible member component 135B that extends between the distal aperture 137D and the distal end 138. So, for example, the maxima moves between distance DB-1 and DB-2 when the second collapsible member component 135B moves between the first state and the second state.
Hence, to load the system, a graft 200 can be first prepared per the surgeon's preference. The graft 200 can then be loaded onto the inside of the distal sheath 132D. As discussed elsewhere herein, a loading rod can be placed over an expansion mechanism in order to put the expansion mechanism into a compressed state. The distal sheath 132D and graft 200 can then be inserted or placed over the loading rod until the distal sheath 132D snaps onto a proximal sheath, joining the two sheath components into one outer sheath. The loading rod can then be removed and the device can be loaded. In some embodiments, the graft 200 can be loaded with suture. In some embodiments, grafts can be provided in different sizes. In some cases, devices can be provided in various sizes according to the required sizes of the graft. In some cases, a graft can be trimmed as needed.
In some repair embodiments, a graft can have a size of about 20-25 mm by about 25-30 mm and 1-3 mm thick, and an outer sheath can have an outer diameter of about 10 mm. In some reconstruction embodiments, a graft can have a size of about 40 by 75 mm and 3-5 mm thick, and an outer sheath can have an outer diameter of about 12 mm or more.
In some embodiments, a graft deployment system 50 includes a graft deployment device 100, a loading rod 140, and a graft (not visible). The graft deployment device 100 can include a handle 110, a trigger 120, a collapsing feature or mechanism 136, and an insertion mechanism 130. The insertion mechanism 130 can include an outer sheath having a proximal section 132P and a distal section 132D, a central shaft (not visible), and an expansion mechanism (not visible). In some cases, the outer sheath is made up of a proximal sheath that has a snap feature capable of joining with a corresponding snap feature on the distal sheath. The central shaft and the outer sheath can be fixated in the handle 110, with the central shaft rigidly fixed and the outer sheath spring loaded but otherwise free to move axially when not blocked by the trigger 120. The trigger 120 can be attached to the handle 110 such that it can be pulled comfortably with the same hand holding the handle, and such that it initially blocks the movement of the outer sheath. The expansion mechanism can be located on the distal end of the central shaft. In some cases, a collapsing mechanism can include or be provided as a switch or a knob. In some cases, a collapsing mechanism could be used in place of a loading rod.
Hence, the deployment device 100 can be used by situating the distal end of the outer sheath at the location where the graft is desired, then pulling the trigger 120. The outer sheath is drawn back, revealing the graft 200 and expansion mechanism. The expansion mechanism flattens the graft onto the surface (e.g. surface of tissue) for grafting. The graft 200 can then be fixated as desired. Once ready, the collapsing mechanism can be used to collapse the expansion mechanism. For example, with reference to
Hence, use of a graft deployment system can involve advancing an insertion mechanism through a portal, toward the desired or proper position. The insertion mechanism can be inserted to a desired depth of the graft and positioned so that the center of the graft is at the center of the desired graft location. Once the desired location is reached, the trigger can be pulled, retracting the outer sheath. In some cases, the trigger can be pulled a second time to expand the expansion mechanism. The expansion mechanism, now expanded, can be used to tamp down the graft, and to hold the graft in place while fixation is applied to the graft (e.g. to a distal end of the graft). Once sufficient fixation is applied, the lever can be used to compress the expansion mechanism, and the graft deployment system can be removed from the patient.
Although the preceding description contains significant detail in relation to certain preferred embodiments, it should not be construed as limiting the scope of the invention but rather as providing illustrations of the preferred embodiments.
Embodiments of the present invention encompass kits having one or more components of a system as disclosed herein. In some embodiments, the kit includes one or more system components, along with instructions for using the component(s) for example according to any of the methods disclosed herein.
All features of the described systems and devices are applicable to the described methods mutatis mutandis, and vice versa.
In addition, each reference provided herein in incorporated by reference in its entirety to the same extent as if each reference were individually incorporated by reference. Relatedly, all publications, patents, patent applications, journal articles, books, technical references, and the like mentioned in this specification are herein incorporated by reference to the same extent as if each individual publication, patent, patent application, journal article, book, technical reference, or the like was specifically and individually indicated to be incorporated by reference.
While preferred embodiments of the present disclosure have been shown and described herein, it will be understood to those skilled in the art that such embodiments are provided by way of example only. Numerous variations, changes, and substitutions will now occur to those skilled in the art without departing from embodiments of the present invention. It should be understood that various alternatives to the embodiments of the invention described herein may be employed in practicing the invention. It is intended that the following claims define the scope of the invention and that methods and structures within the scope of these claims and their equivalents be covered thereby.
This application claims the benefit of U.S. Provisional Patent Application No. 63/469,652 filed May 30, 2023, the disclosure of which is incorporated herein by reference.
| Number | Date | Country | |
|---|---|---|---|
| 63469652 | May 2023 | US |
