Patent Application
20070255172
The present invention relates generally to medical devices and methods, and, more particularly, to medical devices and methods for accessing intervertebral discs and removing tissue therefrom, for example, for accessing and removing tissue from a disc nucleus.
The medical industry is constantly evolving through the adaptation of improved pharmaceutical, biotechnology, and medical device products and procedures. Techniques and technologies are being developed to treat internal areas of the body through less invasive means.
Recently, devices have been developed to explore and therapeutically impact areas inside the spinal canal. These devices are primarily designed to reduce the amount of pain that chronic pain patients are experiencing due to abnormal conditions existing in and around the spinal cord and intervertebral disc. Devices currently used to treat these areas include: spinal injections of anesthetics and anti-inflammatories, RF and cryo neuroablation, epiduroscopes, infusion catheters, spinal stimulation devices, micro endoscopic discectomy instruments, and the like.
The spinal column includes, among other structures, the bony vertebrae which surround the spinal cord, and the intervertebral discs. In a healthy spine, the discs maintain separation between the vertebrae, promote fluid circulation throughout the spine, and provide a cushioning effect between the bony vertebral structures.
Due to the elastic nature of an intervertebral disc, the disc is subject to injury if the disc becomes overstressed, for example, by trauma to the spine, excess body weight or improper mechanical movements. Intervertebral disc injuries and other abnormalities result in serious back pain and physical disability and are often chronic and difficult to treat. Such abnormalities include, but are not limited to, localized tears or fissures in the disc annulus, localized disc herniations with contained or escaped nuclear extrusions, and circumferential bulging discs. Discs also experience degeneration over time which can accelerate these problems.
Disc fissures may result from structural degeneration of fibrous components of the disc annulus (annulus fibrosis). More specifically, fibrous components of the annulus become separated in particular areas, creating a fissure within the annulus. Sometimes the fissure is accompanied by extrusion of material from the disc nucleus (nucleus pulposus), into the fissure. Biochemicals may escape from the disc and irritate surrounding structures. These disc fissures are known to be extremely painful. The fissure may also be associated with herniation of that portion of the annulus wall.
With a contained disc herniation, the nucleus pulposus may work its way partly through the annulus. The outward protrusion of fibrous and nuclear material can press upon the spinal nerves or irritate other body structures.
Another common disc problem occurs when the entire disc bulges circumferentially about the annulus rather than in specific, isolated locations. This may occur for example, when over time, the disc weakens, bulges, and takes on a “roll” shape. The joint may become unstable and one vertebrae may eventually settle on top of another. This problem typically continues to escalate as the body ages, and accounts for shortened stature in old age. Osteophytes may form on the outer surface of the disc and further encroach upon the spinal canal and nerve foramina. This condition is called spondylosis.
Traditional non-surgical treatments of disc degeneration and abnormalities include bed rest, pain and muscle relaxant medication, physical therapy or steroid injection. Such therapies are directed primarily at pain relief and delaying further disc degeneration. In many cases, non-surgical approaches fail and surgical methods of treatment may be applied. Spinal fusion methods are aimed at causing the vertebrae above and below the injured disc to grow solidly together forming a single piece of bone. This procedure is carried out with or without discectomy (surgical removal of the disc). Another procedure, endoscopic discectomy, involves removing tissue from the disc percutaneously in order to reduce the volume of the disc, thereby reducing impingement of the surface of the disc on nearby nerves.
Endoscopic Discectomy is an outpatient surgical procedure to remove herniated disc material. Using local anesthesia with the help of x-ray video image for guidance, an endoscopic probe is inserted between the vertebrae and into the herniated disc space through the skin of the back. Surgical attachments (cutters, lasers, and the like) are then sent down the hollow center of the probe to remove a portion of the offending disc. Sometimes, the surgical attachments can be used to push the bulging disc back into place and for the removal of disc fragments and small bone spurs. This form of discectomy utilizes the same tools used for knee surgery but maneuvers the instruments above the spine. The surgeon introduces the endoscope through a large approximately 10mm or greater, incision into the skin above the spine, then locates the nerve and disc using direct visualization. This surgery can be done through the abdomen for anterior discectomy as well. These procedures are performed under direct endoscopic visualization which increases the incisional space requirement and may require a hemi-laminectomy (surgical removal of part of the lamina).
Summers U.S. Pat. No. 5,383,884, discloses a spinal disc surgical instrument including a rotating cutting shaft including a lateral cutting port for progressively shaving away discrete portions of a herniated disc until the herniated disc is completely removed. The instrument also includes a non-rotating idler shaft for evacuating severed tissue from the surgical site.
There still exists a need for an apparatus for safely and effectively treating an intervertebral disc, for example, by removing tissue, for example, nucleus pulposus from within the disc.
New apparatus and methods for removing tissue and/or other material from a human or animal spinal column, for example but not exclusively, intervertebral discs, have been discovered. The present invention provides apparatus, for example, micro-invasive apparatus, to remove tissue or other material from a target area of a human or animal intervertebral disc to provide one or more benefits, such as diagnostic benefits, therapeutic benefits and the like.
The apparatus of the invention are useful for removing unwanted, diseased, or even healthy bodily materials, for example, nucleus pulposus within an intervertebral disc, for medical treatment and/or therapeutic purposes. Advantageously, the present invention is suitable for use in many surgical settings and is suitable for performing various material removal procedures using methodologies, for example, in terms of methods of introducing the apparatus into the body and removing the apparatus from the body, which are substantially analogous to conventional surgical techniques. Necessary or desirable adaptations of the apparatus of the present invention for specific medical treatment, e.g., diagnostic, and therapeutic purposes will be readily appreciated by those of skill in the art.
Accordingly, apparatus for removing tissue from an intervertebral disc area of a human or animal spinal column are provided. In one broad aspect, the apparatus comprise a handpiece and a tissue removal element connected or coupled thereto. The tissue removal element includes a cannula, for example, a substantially rigid or flexible cannula, and a rotational element disposed in the cannula. The rotational element is connected to a source of rotational energy, for example, a motor. The rotational element is disposed at least partially in the cannula. The cannula includes an open distal tip, and preferably a proximal end connected, for example, removably connected, to the handpiece. The tissue removal element is structured and effective to draw material from the target area or site, for example, into the open distal tip, in response to, for example, as a result of, rotation of the rotational element relative to the cannula.
In one embodiment, the rotational element and the cannula cooperatively engage to form or create a source of suction sufficient to draw the material into the cannula in response to rotation of the rotational element relative to the cannula. Advantageously, the cannula, in particular the interior hollow space formed or defined by the cannula, and the rotational element are sized and positioned, relative to each other, to create a source of suction or pumping action in response to the rotational element rotating relative to the cannula. Without wishing to limit the invention to any particular theory of operation, it is believed that this functioning of the cannula/rotational element combination is at least somewhat analogous to the functioning of a pump, for example, a pump based on the principles of the “Archimedes screw”, causing the material to be drawn or pulled or pumped into the open distal tip of the cannula and through the cannula in being removed from the target area of the human/animal body.
Preferably, the suction/pumping action created or formed by the cannula/rotational element combination is itself sufficient and effective so that no other, for example, no additional or supplemental, source of suction or pumping action is employed, needed or required to effectively remove material from the intervertebral disc, specifically the nucleus pulposus, in accordance with the present invention.
In one embodiment of the invention, the rotational element includes a shaft and one or more outwardly extending projections, for example threads, for example threading having a substantially helical configuration. Advantageously, the rotational element includes a distal portion with such projections or threads.
The distal portion of the rotational element, in a useful embodiment, extends beyond the open distal tip or inlet of the cannula, for example, by a distance equal to at least about one-half thread spacing. The rotational element distal portion may extend a distance equal to more than about one thread spacing, for example, about two thread spacings or more beyond the open distal tip of the cannula. The rotational element advantageously further includes an elongated shaft having a proximal portion which is substantially smooth to allow sufficient annular space between the shaft and cannula for removal of material.
The cannula may be of any suitable size. However, in order to obtain the reduced invasiveness benefits of the present invention, it is preferred that the cannula size be no larger than about 5 mm, and more preferably about 2 mm, or smaller.
It has unexpectedly been found that the present apparatus including such small size cannulas provide for reduced, or even micro, invasive procedures (which reduce surgical trauma and promote healing) and are effective in removing materials from a spinal column to achieve therapeutic benefits, for example, therapeutic removal of spinal disc nucleus tissue to effect decompression of a herniated disc.
In one embodiment of the invention, the open distal tip of the cannula is angled or is beveled with respect to a longitudinal axis of the cannula. Alternatively, the open distal tip is substantially perpendicular with respect to the longitudinal axis of the cannula.
The present apparatus advantageously includes a tissue collection chamber in communication, for example, fluid communication, with the cannula and structured to collect and contain material, for example, nucleus pulposus, that is drawn from the target site. The collection chamber preferably is structured to facilitate quantification and/or other analysis of the removed material. In one particularly useful embodiment, the collection chamber comprises a substantially transparent conical section removably engaged to a housing of the handpiece and preferably circumscribing a portion, for example, the proximal portion of the shaft of the rotational element.
The cannula and/or the rotation element, preferably both, advantageously are manually deformable, for example, to enable the physician to alter the normal configuration, for example, the normal substantially straight configuration, thereof to create a curved configuration if desired, for example, to better access the disc or specific locations within the disc.
Advantageously, the apparatus of the present invention may be structured as a self-contained hand-held device which requires no external wiring or conduits for operation. The apparatus conveniently requires only single hand operation and is sufficiently lightweight so as to be easily maneuverable by a physician.
The present invention further provides methods for treating and/or monitoring the status of an intervertebral disc by measuring and/or monitoring pressure in the intervertebral disc before, during and/or after a disc treatment procedure, for example, in order to achieve a safe and successful patient outcome. The methods preferably are used in conjunction with surgical procedures, wherein at least a portion of a disc nucleus is removed, or otherwise modified in order to benefit the spinal column, for example, to effect decompression of a herniated disc.
It is known that an intervertebral disc nucleus has an intrinsic pressure. In the event the disc pressure becomes elevated, due to injury or trauma for example, the disc itself may bulge, or nucleus material from the center of the disc may extrude through fissures in the annulus and impinge on nearby nerves, causing severe pain and physical disability.
As described elsewhere herein, various surgical techniques are known which are directed at reducing the extent to which an intervertebral disc presses against nearby nerve structures. The present invention provides an effective method for determining an initial disc pressure prior to such a surgical technique and a comparable post surgery disc pressure.
Also included within the scope of the present invention are methods for monitoring the intrinsic pressure in the disc nucleus during a surgical procedure, for example a surgical procedure directed at reducing disc size or disc pressure. Such a medical procedure may utilize aspiration alone, or in conjunction with cutting or ablation to reduce the volume of nucleus material within the disc. The use of enzymes suitable for dissolving the gelatinous nucleus material may be employed as part of the surgical procedure.
A method in accordance with the present invention generally comprises the step of measuring the intrinsic pressure within an intervertebral disc nucleus before, during and/or after medical treatment of the disc. The step of monitoring may be performed intermittently, periodically, or on a substantially continuous real-time basis. The methods of the present invention allow a physician to utilize the pressure information obtained from the disc in diagnosing a problem, determining potential or actual effectiveness of a treatment, and/or determining the degree of treatment necessary to achieve a desired result.
The present invention will be more clearly understood and appreciated by the following detailed description and accompanying drawings of which:
Turning now to
The handpiece 14 is preferably sized and contoured to fit comfortably within a palm of a surgeon, and includes for example a molded plastic housing 22. As shown in
Turning now as well to
In a preferred embodiment of the invention, such as shown in
Although the threading 56 is only shown as a single thread located on the distal portion 52 of the rotational element 34, it is to be appreciated that in some embodiments of the invention, the threading 56 may involve multiple threads, and/or may be disposed on more proximally located portions of the rotatable element shaft 50. Furthermore, although only about 4.5 turns of threading 56 are shown, it is to be appreciated that in some embodiments of the present invention, fewer or more than 4.5 turns of threading 56 may be provided. It is also contemplated by the present invention that rather than continuous threading 56, the shaft 50 may be provided with discontinuous threading. It is contemplated that with appropriate modifications and the like, these and other structures may be provided which would operate in a manner similar to the pumping action provided by the structure shown.
Preferably, the cannula 30 is structured to be insertable into an intervertebral disc, for example by means of a pre-inserted rigid stylet, and has an outer diameter of less than about 5 mm, for example, an outer diameter of about 2 mm or less. It is contemplated and considered within the scope of the invention that the cannula can be made to be percutaneously insertable into a disc without first introducing a stylet therein. That is, the cannula itself may be made of a suitable material and structure to be sufficiently rigid and strong to effectively puncture the skin, underlying fatty tissue, muscle and disc annulus in order to directly access the disc nucleus. However, the present invention is oftentimes used in conjunction with a stylet, as the back muscles overlying and connected to the spinal column are particularly dense and strong and therefore may be difficult to penetrate without the use of a sharp stylet.
The cannula 30 is made of any suitable, medical grade material or materials, but is preferably somewhat rigid and bendable or manually deformable.
Advantageously, as will be appreciated by those of skill in the art, the apparatus 10 of the present invention is minimally invasive to the patient. For example, the cannula 30 can be introduced into the target area of the spinal column by means of a conventional, rigid stylet (not shown) disposed through the cannula 30 (detached from the handpiece 14). The cannula/stylet are introduced percutaneously through the skin, underlying muscle/fatty tissue and into the target area, for example through the fibrous annulus of an intervertebral disc, such that the inlet 42 is positioned within or closely adjacent the nucleus pulposus. The stylet is then removed and the cannula 30 is left in place. The rotational element 34, attached to the handpiece 14, is then introduced into the cannula 30. Preferably, in order to minimize invasiveness of the procedure, this procedure is facilitated through the use of fluoroscopy and x-ray imaging techniques as known in the art, which do not require endoscopic or direct viewing of the target tissue.
Advantageously, unlike prior art surgical tissue removal devices, the action of the tissue removal mechanism 16 urges tissue such as nucleus pulposus into the cannula 30 in many instances a substantially continuous cohesive segment rather than in relatively smaller, distinct portions of the tissue. Generally, the cannula 30 and rotational element 34 are structured to cooperatively function in a manner that will form a source of suction within the cannula 30 when the rotational element 34 is rotated while the cannula inlet 42 is disposed within the target tissue. It has been found that the level of suction so created is sufficient to gently and effectively draw soft tissue, for example gelatinous, viscous, or any suitable spinal column tissue that can be drawn by the action of the present invention into the cannula without need for any other, for example, supplemental, source of suction applied to the inlet 42. For example, the suction formed or created is sufficient to pull or soft tissues into the open tip without causing damage to other structures such as the inner wall of a disc annulus.
The tissue removal mechanism 16 can be left to remain in substantially the same position within the target area during the tissue removal procedure, or alternatively may be advanced or withdrawn during the procedure, for example in a direction along the longitudinal axis of the cannula in order to facilitate tissue removal.
As shown in
Generally, the collection chamber 70 is structured to contain material that is drawn from the surgical site. The removed material enters the collection chamber 70 as shown by arrows 74 in
It is further contemplated that in many applications of the present invention, the cannula 30 may alternatively or additionally be used as a passageway for introducing disc replacement material, medication, and/or other agents into the target region before or after the tissue removal, if desirable.
It can be appreciated that the present apparatus is less invasive in comparison to other percutaneous tissue removal devices in the art. Despite its simplicity, the present device is designed to be highly efficient in removing soft tissue or materials, for example, gelatinous tissue material (such as within an intervertebral discs). Because there is no external suction source or supplemental aspiration required of the present invention to pull material into the cannula, it can further be appreciated that the apparatus is smaller, safer and requires less monitoring than devices that include a separate or external source of suction or additional idler shafts for removing material.
It is also to be appreciated that the apparatus of the present invention may be modified to include a connector for enabling the handpiece to be connected to an external aspiration source. In this case, means for monitoring the vacuum level in the cannula is preferably provided in order to indicate and prevent buildup of excess vacuum in the event the cannula becomes clogged for example. Preferably however, the apparatus is self-contained and requires no external wiring, conduits, tubing or the like.
The present invention further provides a method for treating an intervertebral disc, comprising measuring an intrinsic pressure within an intervertebral disc nucleus and treating the disc based at least in part in the measured pressure within the disc. The step of measuring the pressure is preferably performed before and/or during the step of treating. In addition, the step of measuring comprises monitoring the pressure in a substantially continuous basis over a selected period of time.
In some cases, it may be desirable to introduce material into the disc, for example, artificial nucleus material. The present methods can be easily adapted for such situations.
Accordingly, in one embodiment of the present invention, a method for treating an intervertebral disc comprises the steps of percutaneously removing material, for example nucleus pulposus, from an intervertebral disc through a cannula, and introducing, preferably subsequently introducing a material, for example, a disc replacement material through the same cannula.
The material introduced into the disc may comprise for example, an artificial disc replacement material known in the art, such as a hydrogel, foam or other compressible material, an expandable inflatable element such as a balloon, or any other suitable disc replacement material.
It is to be appreciated that the step of removing material through a cannula is not limited to removing material by means of the apparatus elsewhere described and shown herein but may encompass any suitable means of percutaneously removing the material through a cannula which is then utilized as a passageway for introducing another material, such as an artificial disc replacement material into the disc.
The following specific examples are for purposes of example only, and are not to be considered as limiting the scope of the present invention. As will be appreciated by those of skill in the art, other arrangements and sequencing of steps are possible and are considered to be within the spirit and the scope of the present invention.
Turning now to
The catheter 106 may be mounted to a substantially rigid access device, or may be passed through a substantially rigid access device such as needle 105 shown, to provide direct access to the disc nucleus 104. The needle 105 or access device has a working length, preferably a working length of about 8 inches or less.
A proximal end of the transducer catheter 106 is connected to a cable terminating at a controller/monitor 112. The controller/monitor 112, of generally conventional configuration, includes a DC output with a ring tip sleeve differential female phone plug. The controller 112 provides excitation voltage to produce a calibrated DC output which provides a readout allowing conversion of voltage to psi (pounds per square inch).
A disc decompression procedure is begun. A tool for drawing or suctioning disc nuclear material is inserted through the disc annulus 102a and into the disc nucleus 104. The tool is preferably an embodiment of the nucleotomy apparatus 10 in accordance with the present invention described and shown elsewhere herein. It is to be appreciated that the tool may be passed through the same needle holding the transducer catheter or, alternatively, through a percutaneous incision at a different location within the disc 102, such as shown in
The pressure transducer tip 108 remains near the center of the disc 102 during the decompression procedure. Alternatively, the pressure transducer may be positioned to measure pressure within a protruding portion of the nucleus pulposus adjacent an affected nerve root for example, or may be positioned within or adjacent any other portion of the intervertebral disc where monitoring pressure is desirable.
The disc pressure is monitored at least once before the decompression procedure and subsequently, at selected time intervals, for example, of about 15 seconds apart, during the procedure. In this specific example, pressure in a lumbar disc is reduced from an initial reading of about 8 psi to about 4 psi after about two minutes of decompression treatment.
In a related example, the pressure monitoring is performed on a thoracic disc which is undergoing a decompression procedure. In this example, pressure is observed on a real time basis as material is removed from the disc. The pressure within the disc decreases from an initial reading of 20 psi to a negative pressure or below atmospheric pressure (i.e. vacuum).
The examples herein are presented for purposes of example only, and are not to be considered as limiting the present invention. Various modifications can be made to the examples without departing from the scope and spirit of the invention.
For instance, pressure may be monitored both before and after the procedure in order to determine the need for the treatment procedure and/or the effectiveness or lack of effectiveness of the procedure. A pressure measurement may be taken as a diagnostic tool to determine whether excessive pressure in the disc may be a cause of pain experienced by a patient. If disc pressures appear normal, a physician may choose to select a different pain management therapy. It can also be appreciated that the apparatus and specific techniques for performing a method in accordance with the invention can vary from the examples presented herein without departing from the scope of the invention. The pressure measurement transducer may be designed as a piezoelectric transducer or an optically measured diaphragm transducer. Other options are available as well. The device is preferably connected to a monitor that displays real-time pressures to the physician such that the physician can determine how the surgical procedure is proceeding and when to stop.
The methods of the present invention may further include the step of controlling decompression of the disc, for example by responsively increasing or decreasing the cutting/aspiration power of the decompression device, e.g. tissue removal device, for example in response to a pre-selected disc pressure being detected. In a related example, the methods may include the step of controlling the rate at which the disc is decompressed by causing the tissue removal device to be turned off, or reduced or increased in power, in response to a detected variation in pressure.
In summary, it can be appreciated that the present invention facilitates spinal surgical procedures by providing useful, real-time, pertinent information to a physician before, during and/or after a surgical procedure. For example, the method of the present invention enables a physician to make a calculated determination as to whether to continue or terminate a procedure.
In other words, one significant advantage of the present invention over conventional spinal surgical procedures which do not employ pressure monitoring, is that the present invention allows a more informed diagnosis and a more informed determination of treatment options and the potential effectiveness thereof. In addition, by monitoring pressure in a disc which has previously been treated, a determination can be made as to whether the treatment was successful and whether the condition of the disc has remained stable over time or requires additional treatments.
While this invention has been described with respect to various specific examples and embodiments, it is to be understood that the invention is not limited thereto and that it can be variously practiced within the scope of the following claims.
This application is a continuation of Ser. No. 10/093,774, filed Mar. 8, 2002, which claims the benefit of U.S. provisional applications Ser. No. 60/281,848, filed Apr. 5, 2001 and Ser. No. 60/305,178, filed Jul. 13, 2001 and Ser. No. 60/322,909, filed Sep. 17, 2001 and Ser. No. 60/342,436, filed Dec. 21, 2001, the disclosure of each of which is incorporated in its entirety herein by reference.
| Number | Date | Country | |
|---|---|---|---|
| 60278128 | Mar 2001 | US | |
| 60281848 | Apr 2001 | US | |
| 60305178 | Jul 2001 | US | |
| 60322909 | Sep 2001 | US | |
| 60342436 | Dec 2001 | US |
| Number | Date | Country | |
|---|---|---|---|
| Parent | 10093774 | Mar 2002 | US |
| Child | 11810552 | Jun 2007 | US |
