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GLOBUS MEDICAL INC

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Patent Application Titled “Inflatable Multi-Chambered Devices And Methods Of Treatment Using The Same” Published Online (USPTO 20190224018): Globus Medical Inc.

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08/14/2019 | 05:04pm EDT

2019 AUG 14 (NewsRx) -- By a News Reporter-Staff News Editor at Health & Medicine Business Daily -- According to news reporting originating from Washington, D.C., by NewsRx journalists, a patent application by the inventors Wirtel, III, Anthony (Malvern, PA); Borden, Mark (Collegeville, PA), filed on April 1, 2019, was made available online on July 25, 2019.

The assignee for this patent application is Globus Medical Inc. (Audubon, Pennsylvania, United States).

Reporters obtained the following quote from the background information supplied by the inventors: “The intervertebral disc (IVD) permits articulation between adjacent elements of the spine. The disc includes an outer annulus fibrosis and an inner nucleus pulposus. In a healthy disc, the nucleus is a gel that transmits load and absorbs shock. Loads are constrained axially by the annulus fibrosis. Through degenerative processes and/or trauma, the annulus may fail and release the nucleus, which is then free to flow.

“The posterior annulus is typically thinner than the anterior annulus, thus, making failures of the posterior annulus more common. When these failures occur, a variety of problems may arise. For example, the contents of the disc may impinge onto nerve roots and/or the spinal cord, resulting in pain and/or neurological deficits. IVD failures in the lumbar region of the spine are most common, but failures can occur at any level.

“When disc failure occurs and pain is present, discectomy may be indicated to remove the impinging material. A 5-10% recurrence of painful extrusion may occur. Loss of the nucleus leads to kinematic changes to the segment and can accelerate weakening of the annulus and development of osteophytes at the vertebral endplates. This development of ectopic bone may lead to stenosis of the vertebral canal and detrimental changes to other articulating elements.

“Injected liquids and implants have been proposed for insertion into a spinal disc space for different purposes. For example, some proposed systems include inflated balloons to distract disc space to restore lost height as preparation for an injected biomaterial or as an implant. Other systems include injecting liquids that harden or thicken in situ or hydrogel systems that expand upon exposure to water. The use of such devices, however, shares a common weakness, in that a failure of the device would tend to lead to rapid expulsion of the filler material, for example, through a pre-existing defect in the annulus. Such expulsion may create impingement in the same area that created a need for surgical intervention in the first place. For example, failure of such a device may lead to loss of material from the disc space which may then impinge on neural elements. The loss of any material from such devices may lead to loss of disc height and detrimental changes to segment kinematics. Further, the arrangement of many of these devices would tend to lead to expulsion of the device itself, if deflated. Additionally, for devices constructed from a single chamber, the uneven compression of the disc in flexion and extension can result in improper loading of the disc space.”

In addition to obtaining background information on this patent application, NewsRx editors also obtained the inventors’ summary information for this patent application: “Example devices are generally directed to multi-chambered devices, which may be useful as intervertebral disc nucleus pulposus augmentation or replacement devices, as inflation devices to distract neighboring vertebral elements, as cushioning devices for joint replacement, or for cosmetic augmentation, reconstruction or restoration. Examples may further include devices that may be useful in mechanical systems where damping is required, or to position or maintain the position, or isolate machinery or structures. Example devices may include inflatable balloon devices, which include at least two chambers and a filling manifold. Example devices are adapted such that at least one of the chambers, and preferably multiple chambers, may be filled with a filler material, for example after insertion of the device into a patient.

“Example embodiments are also directed to kits and systems that include inflatable devices. Such kits and systems may further include various other items, including, but not limited to filler material, tools or devices for inserting the inflatable devices into a patient, and/or tools or devices for inserting the filler material into at least one chamber of the inflatable devices, such as a high pressure gun.

“Example embodiments are further directed to methods of treating a patient in need of treatment, by inserting into the patient a deflated device, and then inserting at least one filler material into at least one chamber of the inflatable balloon device. Such methods may also include prior removal of all or part of a disc or other material at or around the location in the patient where the device is to be inserted.”

The claims supplied by the inventors are:

“1. A system comprising: a multi-chambered inflatable implant having a deflated configuration and an inflated configuration, the multi-chambered inflatable implant having a plurality of chambers and a single filling manifold having a plurality of holes and a rotatable valve, each of the plurality of holes being aligned with a corresponding opening in a respective one of the plurality of chambers; and a pressure detector configured to detect pressure within at least one of the chambers.

“2. The system of claim 1, wherein the implant is inflatable until a filling end point is reached based on a pressure reading from the pressure detector.

“3. The system of claim 1, wherein the pressure detector transmits a signal to a remote device to indicate when the chambers have been filled to a desired amount.

“4. The system of claim 1, wherein the inflation stops automatically upon a pressure range reaching a pre-set level.

“5. The system of claim 1, wherein the pressure detector is positioned within at least one of the chambers.

“6. The system of claim 1, wherein the chambers are sealed after inflation to prevent leakage of filling material out of the chambers.

“7. The system of claim 1, wherein the chambers are independent chambers in which filling material does not pass therebetween.

“8. The system of claim 1, wherein the chambers are interrelated chambers in which filling material passes therebetween.

“9. The system of claim 1, wherein the implant comprises three chambers arranged side-by-side.

“10. The system of claim 1, wherein the chambers are formed of a flexible polymer.

“11. A system for repairing or replacing spinal discs, the system comprising: a multi-chambered inflatable implant having a deflated configuration and an inflated configuration, the multi-chambered inflatable implant having a plurality of chambers; and a pressure detector configured to detect pressure within at least one of the chambers.

“12. The system of claim 11, wherein the implant is inflatable until a filling end point is reached based on a pressure reading from the pressure detector.

“13. The system of claim 11, wherein the pressure detector transmits a signal to a remote device to indicate when the chambers have been filled to a desired amount.

“14. The system of claim 11, wherein the inflation stops automatically upon a pressure range reaching a pre-set level.

“15. The system of claim 11, wherein the pressure detector is positioned within at least one of the chambers.

“16. The system of claim 11, wherein the chambers are sealed after inflation to prevent leakage of filling material out of the chambers.

“17. The system of claim 11, wherein the chambers are independent chambers in which filling material does not pass therebetween.

“18. The system of claim 11, wherein the chambers are interrelated chambers in which filling material passes therebetween.

“19. The system of claim 11, wherein the implant comprises three chambers arranged side-by-side.

“20. The system of claim 11, wherein the implant includes a filling manifold having a rotating ball valve.”

For more information, see this patent application: Wirtel, III, Anthony; Borden, Mark. Inflatable Multi-Chambered Devices And Methods Of Treatment Using The Same. Filed April 1, 2019 and posted July 25, 2019. Patent URL: http://appft.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PG01&p=1&u=%2Fnetahtml%2FPTO%2Fsrchnum.html&r=1&f=G&l=50&s1=%2220190224018%22.PGNR.&OS=DN/20190224018&RS=DN/20190224018

(Our reports deliver fact-based news of research and discoveries from around the world.)

Copyright © 2019 NewsRx LLC, Health & Medicine Business Daily, source Health Newsletters

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