This invention relates to devices and methods for use in interventions to restore spinal function. More specifically, the invention removes nucleus pulposus from the intact spine intervertebral disc during surgical therapy to treat herniation or degenerated discs.
Back and spinal ailments trouble thousands of Americans every year. In 2003 approximately 11 million people had impaired movement because of back pain, resulting in $80 billion of lost work and productivity. Back pain is a top cause of health care expenditures, amounting to $50 billion in the USA alone. However, only 2 percent of patients seek current implant therapies that create spinal fusion, and they typically do so only at an advanced stage of disease.
Disc degeneration is part of the natural process of aging and has been documented in approximately 30% of 30 year olds. As the population ages, it is even more common for individuals to have signs of disc degeneration. Disc degeneration is an expected finding over the age of 60.
Many back problems result from failure of the annulus (also called the disc annulus or outer fibrous ring) and from herniation of the nucleus pulposus (also called the disc nucleus) through the annulus of the intervertebral disc to compress the spinal cord or nerve roots. Currently, there are only limited treatments for these ailments. First, if the nucleus is still relatively intact, a physician can remove the herniating portion and leave the remaining nucleus in an effort to maintain the integrity and mobility of that spinal region. Successful surgery depends on integrity of the annulus and involves the assessed risk of additional future herniation. Or, physicians can remove much of the intervertebral disc with the intention of preventing future herniations by facilitating a fusion of adjacent discs.
These interventions are great advancements over treatments that were available just decades ago. But, they introduce several concerns and difficulties. One of the most difficult decisions that physicians face is to determine the amount of nucleus to remove. If too much is removed then mobility can be reduced, too little and the herniation may recur. There is also substantial risk of damage to the annulus that could impair healing. Procedures that remove the complete intervertebral disc, discectomy, damage the vertebral end plate. Due to the similar texture of the ligamentum flavum and the dura there is also concern of cutting into the dura, which could result in neurological complications. Finally, these procedures produce large amounts of scarring, which limits the scope of revision surgeries.
A new treatment uses intervertebral implants to replace the nucleus with materials that restore mobility and avoid adjacent segment deterioration without the risk of herniation. Manufacturers have developed implants to the point that several forms of the prostheses are in clinical trials. Although there are associated problems and difficulties, these implants are poised to be a major breakthrough treatment of failed intervertebral discs, particularly in young people. The implants are placed within the space defined by the annulus after as much of the nucleus as possible has been removed. Because the goal of the surgery is to restore mobility, the annulus, vertebral endplates and other disc structures must be undamaged.
Presently, most disc surgeries involve partial removal of the nucleus pulposus (nuclectomy). Or the nucleus is removed along with the entire intervertebral disc (discectomy). Standard surgical tools, such as curettes, bone nibblers or pituitary rongeurs, and a variety of techniques have been adapted for these procedures. All of these prior art tools were designed for purposes other than spinal surgery and are poorly suited to nucleus removal, especially when other tissues must be spared from injury. Generally, surgeons have experience and training only for procedures that require incremental extraction of small pieces of the nucleus (micro or partial nuclectomy). When applied to complete nuclectomy these tools lack the flexibility and control to remove all of the nucleus and invariably cause damage to the surrounding annulus fibrosus and vertebral end plates. In addition, substantial skill and dexterity is required to produce satisfactory results. Even in the hands of an experienced surgeon, nucleus extraction can be the most prolonged and difficult stage of the newer forms of spinal surgery.
No devices or methods have been developed specifically to remove the entire nucleus while minimizing trauma to other tissues. Maintaining the integrity of surrounding tissue is necessary to hold the implant in place and allow proper support and separation of the surrounding vertebrae. Some the implants will function poorly or risk new herniation if 20% or even as little as 10% of the original nucleus is left behind. A clean bed, free of nuclear material in critical locations, within which to deploy or graft the implants will also be crucial to the success of surgery. As a result, special methods, tools, or procedures are needed that can cleanly remove the nucleus without damaging the fibers of the annulus.
In an effort to address some of these limitations, physicians and researchers are searching for new methods of treatment for the herniated nucleus pulposus. They are looking at treatments that restore the function of the nucleus, regenerate the structure of the annulus, or are implanting artificial discs. Each of these proposed treatments introduces new difficulties and will need additional support mechanisms to prepare for the procedures. One of the most promising therapies is nucleus replacement. It is superior to traditional disc fusion because it restores movement and function to the disc space. It also promises to be superior to artificial disc implantation because much more of the original tissue is preserved, the procedure is faster, and there is less risk of malpositioning. Neither fusion nor artificial disc implantation are likely to ever be compatible with percutaneous access and thus carry a greater risk of infection and damage to other tissues or organs.
Most approaches to nucleus replacement will require removing the entire nucleus. There are few methods of removing the nucleus to prepare for nucleus replacement. These include the use of manual surgical implements such as curettes, bone nibblers, and pituitary rongeurs. The procedure involves incremental extraction of small pieces of the damaged portion until a the surgeon judges that a sufficient amount has been removed.
There are few companies currently looking at methods for removal of the nucleus pulposus, as nucleus replacement is a fairly new treatment modality. Clarus Medical has developed the ‘cut and suction’ method of percutaneous discectomy. Their product is the Nucleotome, a mechanical device with a blunt drill passing through a cannula that enters the disc site. It uses a rounded tip, shaped like a blunt drill to decrease the risk of cutting into the annulus. Stryker Corporation offers another rigid design, the “Dekompressor”, a percutaneous discectomy probe. It has a battery-operated disposable hand piece attached to a helical probe. The cannula allows access to the disc space, and the probe rotates and removes nucleus material through a suction mechanism. Both devices are too stiff to easily remove all of the nucleus
ArthroCare Corporation, has worked on coblation technology, which involves the use of low energy radio-frequency waves. This energy creates an ionic plasma field from the sodium atoms found in the nucleus. A molecular dissociation process occurs due to this low temperature plasma field, which converts this tissue into gases that exit the treatment site. The product is named the Spine Wand. It acts as drill as it is advanced into the disc. The tissue is converted into gas that exits the disc through the cannula. An accessory to the Spinal Wand is the System 2000 Controller. This accessory uses a combination of ablation, resection, coagulation and suction. A bipolar cautery is employed. However, the insertion depth up to the annulus must be predetermined and the wand is difficult to steer to remote parts of the nucleus space.
Laser discectomy employs laser energy to vaporize portions of a diseased disc. It is compatible with through minimally invasive surgery. However, laser techniques are generally useful to remove only small amounts of material because of the heat generated and other limitations. In addition, vaporized material expands to a gaseous phase and must be removed.
This invention proposes devices and methods directed to improving complete removal of the disc nucleus. The new process must be a relatively quick and cost effective alternative to current procedures. In addition, the new method or device must facilitate a complete and clean removal of the disc in a safe manner that does not compromise the integrity of the annulus.
An object of the present invention is to overcome the drawbacks described above and other limitations in existing systems by providing a surgical device to remove almost the entire nucleus from a spinal intervertebral disc.
Another object of the invention is to remove nucleus material with minimal or no damage to surrounding tissues or structures such as the disc annulus, vertebral endplates, spinal nerves or blood vessels.
Another object of the invention is to be minimally invasive and carry a low risk of infection or discomfort to the patient.
Another object of the invention is to provide a system and method that removes the nucleus rapidly.
Another object of the invention is to provide a system and method that allows a surgeon to remove the nucleus without prolonged training, practice or skill.
Another object of the invention is to provide a system and method that removes the nucleus while allowing the surgeon fine control of the procedure.
These and other objects of the invention are accomplished according to various embodiments of the invention.
a is close up view of the shearing type embodiment. This figure shows the present invention in the open position.
b is a view of the shear type embodiment in the closed position.
c is a side view of the shear type embodiment detailing cutting edge angles.
a is a close up view of twist type distal tip. This figure shows the present invention in the open position.
b is a view of the twist type distal tip in the closed position.
c is a side view of the twist type embodiment detailing cutting edge angles.
a and 13b are isometric views of a rotational cutting loop embodiment of the present invention.
c is a phantom isometric view of the rotational cutting loop embodiment of the present invention comprising an auger.
a to 14c are isometric views of a rotational cutting vane embodiment of the present invention.
This invention overcomes various limitations of prior art means to remove nucleus pulposus from spinal intervertebral discs.
The intervertebral disc functions somewhat like a water bed to allow articulation of the spine. When a person is upright substantial hydrostatic pressure is developed within the disc 24 and this pressure increases at lower portions of the spine, particularly the lumbar and sacral region. The annulus 21 serves to contain nucleus 20 that is under pressures in the range of 690 to 2000 kPa (100 to 300 psi). Articulation of the spine is accommodated by displacement of nucleus material from one side of the nucleus space to another. In a normal, healthy spine the vertebrae are prevented from contacting each other even at maximal angles of articulation.
In young adults the intervertebral disc 24 is approximately 7 to 9 mm thick. With age and disease the hydration level of the nucleus 20 decreases. This thickens the nucleus from a soft gel-like consistency to become relatively stiff. Further degeneration with age and disease can occur to both the nucleus 20 and the annulus 21. This may allow the thickness of the disc 24 to decrease until, in the final stages, the vertebrae are in contact during some or all postures and movement. Contact between vertebrae damages these bony structures and generates substantial pain. Disc thickness greater than approximately 4 mm is presently considered suitable for nucleus replacement therapy. At lesser thickness treatment will usually involve removal of the disc 24 for spinal fusion or implantation of an artificial disc.
Because the nucleus 20 is avascular there are no living cells and exchange of fluids is through the cartilaginous endplates (not shown) covering the vertebral body. The endplates are a thin layer of primarily hyaline cartilage. The endplates are important to proper function of the intervertebral disc. In traditional therapies of fusion and disc replacement the endplates are not preserved so surgical techniques generally disregarded protection of the endplates. With motion restoration implantation of nucleus replacements the endplates must be protected from damage.
Similarly, with age and disease the annulus 21 may become weakened. This is a frequent cause of herniation, as illustrated in
A first embodiment 50 of the present invention is illustrated in
To aid in accessing and navigating the annulus space of the intervertebral disc the tubes 53 and 54 of the invention 50 may be formed of a partially elastic material that can bend through an angle up to approximately 20 degrees in the range of force that may be conveniently be applied by hand. Further, the most distal portion (e.g., a tip) of the collection tube 54 preferably comprises a material with a hardness in the same range as annulus 21, or softer. It may also be formed with a rounded or blunted surface. These will aid in protecting the annulus and vertebral surfaces from iatrogenic damage. The length of the tubes 53 and 54 is chosen to allow for use in less invasive or minimally invasive surgery. The tubes 53 and 54 are preferably manufactured of material with relatively high strength, such as stainless steel braid or polycarbonate, that resists fracture when manipulated by the operator. One or both of the tubes 53 and 54 may be formed of transparent material, depending on operator preference to observe the removal of nucleus material 20.
The collection container 56 is also preferably formed of transparent material and is sealed except for the outlet and inlet ports connected respectively to the vacuum source 51 and collection tube 53. The container 56 preferably is formed of two or more pieces or an access port that may be used to remove and preserve collected nucleus material 20; and markings or other means to allow estimation of the volume of nucleus material collected in the container. The container 56 also serves to prevent nucleus material 20 and other tissue from contaminating the vacuum source 51.
The two-piece hand control 52 is comprised of two arms 52a and 52b able to pivot at a pin joint 57. The shorter portion of the distal hand control arm 52a is attached to the cutting tube 53 while the proximal arm 52b is attached to the collection tube 54. Operating the hand control to bring the long portions of the arms together causes the cutting tube to move so that it substantially covers the distal portion of the collecting tube. The handle may further comprise a spring mechanism (not shown) that separates the arms once a force applied to bring the arms together is removed. Alternatively, the hand control may be arranged and connected to the tubes 53 and 54 so that bringing the longer portion of the arms together causes the cutting tube 53 to move proximally. Optionally, the tubes 53 and 54 may be manipulated directly or with gripping regions (not shown) without the aid of the hand control.
a is an expanded view of one embodiment of the distal portion of the invention 50. The collection tube 54 comprises a side opening 60 defined by edges 64 and end cap 62. The cutting tube 53 slides over the collection tube 54, as described above, and substantially or completely covers the side opening, as shown in
The distal edge of the cutting tube 53 in the embodiment of
To remove nucleus material 20 from the intervertebral disc space 24 the distal end of collection tube 54 is inserted through an opening formed in the annulus 21. Once inside the annulus the opening 60 collection tube 54 is pushed into the nucleus material 20 so that material enters the opening 60. The cutting tube 53 is then moved forward, slicing through the nucleus material 20 and entraining a discreet quantity of nucleus material within the collection tube 54. Suction provided from the vacuum source through a lumen in the collection tube causes the entrained nucleus material to be pulled proximally and into the collection container 56. The cutting tube may be returned to a distal position immediately to re-expose opening 60 in the collection tube 54 and the collection tube repositioned to ‘pack’ more nucleus material 20 into the collection tube 54. This may aid in forming a plug of nucleus material across the entire cross-section of the lumen in the collection tube 54 so that maximum suction pressure may be developed to move the nucleus material proximally to the collection container 56. A further technique to aid in mobilizing nucleus material 20 proximally involves manipulating the cutting tube 53 across the opening 60 in the collection tube 54 to occlude air passages that may exist proximally of the nucleus material. The steps of engaging, cutting and removing nucleus material by positioning the invention 50 and moving the cutting tube 53 relative to the collection tube 54 are repeated until the desired amount of nucleus material is removed.
The operator may remove the invention from the intervertebral disc as needed to permit visualization of the annular space and then reinserted to continue the procedure. Alternatively, one or more optical fibers may be incorporated into the invention to permit visualization during nucleus removal and to aid in positioning the collection tube opening 60 for the most efficient and complete removal of nucleus material 20.
a shows another embodiment of the present invention wherein the cutting tube 53 is rotated around collection tube 54 to sever and entrain nucleus material 20 within opening 60.
b shows this embodiment with the tubes 53 and 54 in a configuration forming the closed position. The angle 72 forming the end of the cutting tube 53 is preferably 10 to 40 degrees. This smaller angle permits a larger opening 60 and a longer shearing edge. A further embodiment may combine these two modes of operation between the tubes 53 and 54: distal/proximal translation and rotation.
All of the preceding embodiments of the invention rely on force developed by suction pressure to pull entrained nucleus material 20 to the proximal end of the collection tube 54 and into the collection container 56. As described above, nucleus material becomes stiffer and is composed of increasing quantities of discreet, rigid components with age or the progress of disease. Consequently, additional features may be needed to disrupt the nucleus material and bring it out of the disc space and toward the collection container 56.
The control rod 102 is manipulated by an operator from outside the intervertebral disc 24 to move the loop 101. The control rod 102 may pass through a second lumen of the collection tube 54 or a lumen 103 within a capture tube 105 located within the collection tube. Alternatively, the control rod may move freely within the main lumen of the collection tube 54. In this latter configuration the loop 101 may be withdrawn through the lumen of the collection tube 54 to assist in bringing nucleus material proximally through the collection tube. The loop 101 is used in the configuration with the capture tube 105 to bring nucleus material into the distal opening of the capture tube so that suction pressure will draw the nucleus material to the container 56 which is connected in this configuration to the capture tube instead of the collection tube 54. Alternatively, the loop 101 can trap a quantity of nucleus material 20 against the capture tube 105 and the combination withdrawn through the collection tube 54.
The embodiment of the present invention 120 shown in
a shows an embodiment of the present invention comprising a loop 131 formed on the end of a rotational control rod and located in the opening 60 of the collection tube 54. The control rod passes through a lumen of the collection tube 54 near the center line of the opening 60. Alternatively, the lumen 103 guiding the control rod may be within the wall of a capture tube 105 located within the collection tube 54, as illustrated in
c shows an auger 106 located within a lumen of capture tube 105. The auger comprises and central rod and one or more flutes or vanes 107 that serve to move stiffened and granular nucleus material 20 proximally for removal. Similar auger features may be incorporated within the collection tube 54 and in any of the embodiments of the invention described herein.
a, 14b and 14c illustrate an embodiment of the present invention 140 with vanes 141 formed on the a rotatable control rod 142. The control rod passes through a lumen 103 formed in the wall of collection tube 54. When rotated, the vanes serve to disrupt or sever nucleus material 20 that enters an opening at the end of the collection tube 54. The length of the vanes is preferably selected to be able to substantially or completely occlude the opening in the collection tube through rotation and an opening 144 that approximates the cross section of the opening to permit the maximum amount of nucleus material 20 to enter the opening. As shown in
This utility application claims the benefit of U.S. Provisional Patent Application Ser. No. 60/747,089, filed May 11, 2006, incorporated by reference herein in its entirety.
Number | Date | Country | |
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60747089 | May 2006 | US |