METHODS AND APPARATUS FOR TREATING VERTEBRAL FRACTURES
Methods and apparatus for treating bones, including, in one or more embodiments, methods and apparatus for treatment of vertebral fractures that include an inflation device for cavity creation and an inflation and containment device for maintaining vertebral height and cement containment. Methods for treating a bone comprising: creating a cavity in the bone; inflating a containment jacket in the cavity; inflating a balloon within the containment jacket so that the balloon occupies a first portion of the containment jacket; introducing a first filler material into a second portion of the containment jacket, wherein the second portion of the containment jacket is not occupied by the balloon; removing the balloon from the containment jacket; and introducing a second filler material into the first portion of the containment jacket.
This application is a continuation-in-part application of U.S. patent application Ser. No. 15/355,100, filed on Nov. 18, 2016 (published as U.S. Patent Publication No. 2017-0065309), which is a continuation of U.S. patent application Ser. No. 14/254,614, filed on Apr. 16, 2014 (now issued as U.S. Pat. No. 9,526,550), which is a continuation of U.S. patent application Ser. No. 12/632,325, filed on Dec. 7, 2009 (now issued as U.S. Pat. No. 8,734,458), all of which are incorporated by reference in their entirety herein.
FIELD OF THE INVENTIONThe present disclosure generally relates to treatment of bones. In particular, in one or more embodiments, the present disclosure relates to methods and apparatus for treatment of vertebral fractures that include an inflation device for cavity creation and an inflation and containment device for maintaining vertebral height and cement containment.
BACKGROUNDBones and bony structures are susceptible to a variety of weaknesses that can affect their ability to provide support and structure. Weaknesses in bony structures may have many causes, including degenerative diseases, tumors, fractures, and dislocations. By way of example, weaknesses in vertebrae from lead to compression fractures that involve the collapse of one or more vertebrae in the spine. These vertebral compression fractures may be caused by a number of conditions including osteoporosis, trauma, and tumors. Advances in medicine and engineering have provided doctors with a plurality of devices and techniques for alleviating or curing these weaknesses.
One technique for treating vertebral fractures is vertebroplasty. In vertebroplasty, a physician may use a needle to inject bone cement into a fractured vertebral body to stabilize the fracture. Kyphoplasty is another technique for treating vertebra fractures that involves insertion of a balloon into the fractured vertebra to create a bone cavity in the vertebra. The balloon may then be removed followed by injection of bone cement into the vertebral body to stabilize the fracture. Leakage of the bone cement in both vertebroplasty and kyphoplasty is a common problem that can lead to complications. Another problem associated with these techniques is the potential for inadequate height restoration to the fractured vertebral body.
Thus, there is a need for methods and apparatus that can provide stabilization to a fractured vertebra.
SUMMARYThe present disclosure generally relates to treatment of bones. In particular, in one or more embodiments, the present disclosure relates to methods and apparatus for treatment of vertebral fractures that includes a device for cavity creation, an inflation device and a containment device for maintaining vertebral height and cement containment.
An embodiment of the present invention includes a method for treating a bone. The method may comprise creating a cavity in the bone. The method further may comprise placing a containment jacket in the cavity. The method further may comprise inflating a balloon within the containment jacket so that the balloon occupies a first portion of the containment jacket. The method further may comprise introducing a first filler material into a second portion of the containment jacket, wherein the second portion of the containment jacket is not occupied by the balloon. The method further may comprise removing the balloon from the containment jacket. The method further may comprise introducing a second filler material into the first portion of the containment jacket.
The features and advantages of the present invention will be readily apparent to those skilled in the art. While numerous changes may be made by those skilled in the art, such changes are within the spirit of the invention.
The present disclosure generally relates to treatment of bones. In particular, in one or more embodiments, the present disclosure relates to methods and apparatus for treatment of vertebral fractures that include an inflation device for cavity creation and an inflation and containment device for maintaining vertebral height and cement containment.
The second balloon 30 may be located on a distal end or proximal end of the interior fill tube 28, in accordance with embodiments of the present invention. In certain embodiments, the second balloon 30 and interior fill tube 28 may be an inflatable bone tamp. While not illustrated, the second balloon 30 is deflated when the inflation and containment device 24 is inserted into the vertebral body 10. After insertion into the cavity 22, the second balloon 30 may then be inflated. In general, inflation of the second balloon 30 should provide pressure on the walls of the cavity 22 to prevent (or reduce) loss of vertebral height. It may be desirable, in certain embodiments, for expansion of the second balloon 30 to further increase the height of the vertebral body 10. In certain embodiments, inflation of the second balloon 30 may restore some vertebral height lost after removal of the first balloon 20. As illustrated, the second balloon 30 generally may be enclosed within the containment jacket 32. The volume of the second balloon 30 generally should be smaller than the volume of the containment jacket 32, in accordance with embodiments of the present invention. Furthermore, when inflated, the second balloon 30 generally should not occupy the entire volume of the containment jacket 32. By way of example, the second balloon 30 may occupy from about 10% to about 90% by volume of the containment jacket 32.
The containment jacket 32. may be located on a distal end of the exterior tube 26, in accordance with embodiments of the present invention. As illustrated, the containment jacket 32 may be attached to the distal end of the exterior tube 26 such that the containment jacket 32 encloses the distal end of the exterior tube 26. While not illustrated, the containment jacket 32 may be deflated when the inflation and containment device 24 is inserted into the vertebral body 10. After insertion into the cavity 22, the containment jacket 32 may be inflated as the second balloon within the containment jacket is inflated. As illustrated, the containment jacket 32 may conform to the shape of the cavity 22. In certain embodiments, the volume of the containment jacket 32 may be larger than the volume of the cavity 22. It may be desirable, in certain embodiments, for the containment jacket 32 to be a compliant balloon (e.g., polyurethane) that can contain the filler material to prevent leakage. Accordingly, the containment jacket may permit interdigitation of the filler material with the cancellous bone, in accordance with embodiments of the present invention.
As illustrated by
While the preceding description of
The preceding description describes the use of a first cement volume 34 and a second cement volume 36 in accordance with embodiments of the present invention. Those of ordinary skill in the art will appreciate that the first cement volume 34 and the second cement volume 36 may comprise any of a variety of bone cements suitable for use in orthopedic applications. An example of a suitable bone cement comprises polymethyl methacrylate (PMMA). In addition, while the preceding description describes the use of cement, embodiments of the present invention also may encompass a variety of different filler materials that may be utilized to, for example, fill and stabilize the cavity 22 in the vertebral body 10. Examples of suitable materials may include human bone graft and synthetic derived bone substitutes.
In the exemplary embodiment, a first balloon is used to create a cavity in the vertebral body. However, any device that can be used to create cavity may be applied. For example, mechanical devices such as stents, drills, and vacuums may be used to create a cavity in the vertebral body. After the cavity is created, a containment jacket and the second balloon can be introduced according to the present invention. It should also be noted that various different methods of deploying the second balloon within the containment jacket may be used. For instance, the second balloon may be positioned in any position to maximize the efficiency and ease for inserting the cement into a particular position in the vertebral cavity.
In another exemplary embodiment of the present invention,
A central guide wire 58 is used to initially insert the containment jacket 50 within the vertebral body. Once the containment jacket 50 is positioned within the vertebral body as illustrated in
In another embodiment of the present invention, a cavity creation balloon and a height restoration balloon may be configured within a containment jacket attached to a vertebral body insertion device. In one step of the present invention, containment jacket, the cavity creation balloon and the height restoration balloon are inserted into a fractured vertebral body. Next, the cavity creation balloon and the height restoration balloon are inflated simultaneous, thereby inflating the containment jacket within the vertebral body. Once the cavity is created and the height restoration balloon is inflated, the cavity creation balloon is deflated and removed. After removal of the cavity creation balloon, a bone filler material insertion device is inserted into the containment jacket and filled with a bone filler material in a first portion of the containment jacket. Once the bone filler material is cured, the height restoration balloon is removed and a second bone filler material is inserted into the second portion of the containment jacket, Next, the second bone filler material is cured and the insertion devices are removed, leaving the containment jacket containing the first and second bone filler material in the vertebral body.
In addition, the preceding description is directed, for example, to treatment of vertebral fractures that includes an inflation device for cavity creation and an inflation and containment device for maintaining vertebral height and cement containment. It should be understood that the present technique also may be used in other suitable bone treatments were maintenance of vertebral height and/or cement containment may be desired. By way of example, embodiments of the present invention may be used to treat tibia plateau fractures, distal radius fractures, and cancellous fractures.
As shown in
Hub 2206 is shown in greater detail in
In another configuration, balloon implant 2202 may be releasably attached to shaft 2204. In
While it is apparent that the invention disclosed herein is well calculated to fulfill the objects stated above, it will be appreciated that numerous modifications and embodiments may be devised by those skilled in the art.
Claims
1. A method for repairing a vertebral body, said method comprising:
- accessing the vertebral body via a cannula;
- creating a cavity within cancellous bone of the vertebral body;
- inserting an implantable device into the cavity via the cannula, wherein the implantable device comprises: a balloon implant having a neck portion and configured to receive bone cement, wherein the balloon implant has a larger size than the cavity; a shaft rigidly attached to the neck portion at a distal end; a hub attached to shaft at a proximal end; and a filler needle disposed inside the shaft and configured to provide bone cement to the balloon implant;
- delivering bone cement to the balloon implant;
- detaching the balloon implant from the shaft via a detachment device, wherein the detachment device has two or more jaws configured to radially cut the balloon implant when rotated within the shaft.
2. The method of claim 1, wherein the balloon implant and the shaft are bonded together.
3. The method of claim 1, wherein the hub is configured to attach to a handle of the cannula.
4. The method of claim 3, wherein the hub is configured to prevent at least one of rotation and axial movement of the implantable device.
5. The method of claim 4, wherein the hub contains one or more wings to overlap the handle.
6. The method of claim 1, wherein the jaws of the detachment device are driven open by a mandrel inserted in a cannulated portion of the detachment device.
7. The method of claim 1, wherein the filler needle includes markings indicating a depth of the needle into the balloon implant.
8. The method of claim 1, wherein the filler needle is configured to provide a clearance between the filler needle and the shaft to provide venting for air while maintaining liquid within the balloon implant.
9. An implantable device for repairing a vertebral body, said implantable device comprising:
- a balloon implant having a neck portion and configured to receive bone cement, wherein the balloon implant has a larger size than the cavity;
- a shaft rigidly attached to the neck portion at a distal end;
- a hub attached to shaft at a proximal end; and
- a filler needle disposed inside the shaft and configured to provide bone cement to the balloon implant;
- a detachment device having two or more jaws configured to radially cut the balloon implant when rotated within the shaft.
10. The device of claim 9, wherein the balloon implant and the shaft are bonded together.
11. The device of claim 9, wherein the hub is configured to attach to a handle of the cannula.
12. The device of claim 11, wherein the hub is configured to prevent at least one of rotation and axial movement of the implantable device.
13. The device of claim 12, wherein the hub contains one or more wings to overlap the handle.
14. The device of claim 9, wherein the jaws of the detachment device are driven open by a mandrel inserted in a cannulated portion of the detachment device.
15. The device of claim 9, wherein the filler needle includes marking indicating a depth of the needle into the balloon implant.
16. The device of claim 9, wherein the filler needle is configured to provide a clearance between the filler needle and the shaft to provide venting for air while maintaining liquid within the balloon implant.
17. An implantable device for repairing a vertebral body, said implantable device comprising:
- a balloon implant having a neck portion and configured to receive bone cement, wherein the balloon implant has a larger size than the cavity;
- a shaft attached to the neck portion at a distal end;
- a hub attached to shaft at a proximal end; and
- a filler needle disposed inside the shaft and configured to provide bone cement to the balloon implant.
18. The device of claim 17, wherein the shaft further comprises a pair of steel tubes and the neck portion is disposed between the steel tubes and wherein the balloon implant is released from the shaft by retracting one of the pair of steel tubes.
19. The device of claim 17, wherein the shaft is attached to the neck portion via threaded connection.
20. The device of claim 19, wherein the shaft is configured to rotate to release the balloon implant from the threaded connection.
Type: Application
Filed: Oct 10, 2017
Publication Date: Mar 29, 2018
Inventors: Damien O'Halloran (Conshohocken, PA), David C. Paul (Phoenixville, PA), Sean Suh (Morganville, NJ), Stephen Cicchini (North Wales, PA), Robert Doran (Eagleville, PA)
Application Number: 15/728,581