HK1107036A

HK1107036A - Spinal diagnostic methods and apparatus

Info

Publication number: HK1107036A
Application number: HK07112540.3A
Authority: HK
Inventors: D．R．米勒; T．阿拉米尼; P．F．坎贝尔
Original assignee: 凯丰股份有限公司
Priority date: 2004-04-16
Filing date: 2005-04-15
Publication date: 2008-03-28

Description

Spinal diagnostic methods and apparatus

Cross Reference to Related Applications

The present application is a continuation-in-part of application 10/825,961 (attorney docket number 022175-.

Technical Field

The present invention relates generally to medical devices and methods. More particularly, the present invention relates to devices and methods for diagnosing and/or treating spinal pain.

Background

Back pain worldwide causes a huge loss in people's health and productivity. According to the american association of orthopedic surgeons, about 80% of americans will experience back pain at some time during their lifetime. In the united states, approximately 2600 million visits to a clinic due to back problems were made in only 2000 for one year. Daily, it is estimated that 5% of the working population in the united states is incapacitated by back pain.

Unfortunately, back pain is not only very common, but also difficult to diagnose accurately and treat effectively. The challenge stems from the fact that: it is often difficult to correctly pinpoint the cause of the patient's pain, or even the origin of the pain. While there are many effective treatments for various types of back pain, many of them are highly invasive and can actually exacerbate the pain or cause pain elsewhere on the back. Accordingly, due to the challenges in diagnosing and treating back pain, and due to the vast number of patients suffering from back pain, improved methods and devices for diagnosis and treatment are constantly being sought.

Back pain can be divided into two major categories: (1) "axial spinal pain" due to pathology or dysfunction of spinal structures such as vertebrae or intervertebral discs between vertebrae; and (2) "root pain", caused by pressure or irritation on nerve roots. Root pain is often easier to diagnose and pinpoint because pain tends to emanate from a stimulated nerve root into the body in a predictable pattern, and nerve root compression is often seen in MRI tests or other spinal radiological tests. Treatment of root pain is often very straightforward, typically involving injection or surgery to reduce radiculitis or to remove structures acting on the affected nerve roots.

Unlike root pain, diagnosis and localization of axial spinal pain is generally much more complex. For example, one type of spinal pain, "discogenic pain," is caused by one or more intervertebral discs (soft tissue structures between vertebrae of the spine), which are particularly difficult to diagnose and precisely localize to one or more specific discs. Physical examination and patient dictation often provide only general clues as to the actual cause and site of origin of the pain, and no radiological tests currently exist to correctly assess which disc, if any, of the patient is causing intervertebral disc pain. Making diagnosis more difficult, a number of different factors can lead to discogenic pain. Moreover, it is often difficult to determine whether treatment of a disc or discs actually alleviates a patient's pain, or whether there are still other potential causes of pain after disc treatment. Thus, diagnosis and treatment of discogenic pain is often incredibly difficult, and there is always a risk of unnecessary surgery or failure to relieve back pain in the patient.

The most commonly performed surgical procedure for treating discogenic pain is spinal fusion, in which the upper and lower adjacent vertebrae of the painful disc are fused together to prevent movement, thereby bypassing the painful disc. Spinal fusion is a very effective treatment, but is costly and invasive, and can lead to prolonged recovery and many potential complications. For example, sometimes fusion can cause accelerated degeneration of one or more discs adjacent to the disc being treated because of increased forces acting on adjacent discs resulting from the fusion. Another possible treatment of discogenic pain involves replacing the disc with an artificial disc (prosthesis). This treatment may provide a patient with better mobility than spinal fusion, but the treatment is still in its infancy. Regardless of the method used to treat discogenic pain, accurate diagnosis is critical to the success of the treatment.

While it is important to obtain a correct and specific diagnosis of discogenic pain, there are a number of deficiencies in the diagnostic techniques currently available. A diagnostic test known as "discography" is the most commonly used and accepted diagnostic technique. Discography involves the insertion of a needle into the disc and the injection of a contrast dye under pressure into the compliant inner core (nucleus pulposus) of the disc. Then, a radiographic (or "X-ray") image of the spine is taken. Sometimes, tissue defects of the disc, such as tears in the fibrous outer layer of the disc (the annulus fibrosis) visible on the radiograph, are indicative of a possible cause of pain. Furthermore, it has been shown that injecting contrast media under pressure into the disc can sometimes cause the patient to feel pain due to the chemical composition of the contrast media and/or the increase in pressure within the nucleus pulposus. Sometimes, this pain is similar to back pain that patients typically feel during daily activities. The physician attempts to determine whether the particular disc causes pain to the patient by combining subjective analysis of the radiographs with subjective description of the patient's back pain. In some cases, multiple discs on a patient are injected during a diagnostic procedure.

Some clinicians believe that if a radiographic image of the intervertebral disc is positive, according to commonly used criteria, then the disc under test is the cause of pain for the patient. However, there is no generally accepted definition of a positive discogram standard. As a result, there has been long held debate over the interpretation of radiographic images of intervertebral discs. Not only does the test rely on subjective feedback, but the results themselves also show high false positive and false negative rates, with up to 30-40% of patients without back pain having positive discograms. Similarly, some patients reported that their usual pain was reproduced during discography, although another non-discogenic cause was later discovered to be the actual source of pain. These facts indicate that conventional intervertebral disc X-ray images are not highly specific.

Many of the epidural catheters and techniques currently available can inject substances (typically anesthetics) into the spinal epidural space. Examples of such epidural catheters are disclosed in us patent 3,885,561; 4,737,146, respectively; 4,973,305, respectively; 5,004,456, respectively; 5,024,655, respectively; 5,084,016, respectively; 5,129,889, respectively; 5,234,406, respectively; 5,344,439, respectively; 5,800,407, respectively; 6,676,643, and 6,368,315. However, these catheters are not suitable for delivery into the intervertebral disc. Furthermore, injection of substances into the epidural space does not help in the diagnosis of discogenic pain.

Due to the prevalence of discogenic pain and other types of back pain, the difficulty of accurately diagnosing and accurately locating discogenic pain, and the invasiveness of typical discogenic pain treatment techniques, such as spinal fusion, improved methods and devices for diagnosing and/or treating discogenic pain are needed. Ideally, these methods and apparatus would improve the ability of the physician to precisely locate one or more discs that cause pain to the patient, thereby facilitating or replacing traditional discography. More desirably, these methods and devices are no longer invasive or less invasive than discography. Even more desirably, in some individuals, various techniques and devices for diagnosing discogenic pain may also be used to treat back pain, thereby providing a less invasive alternative to traditional spinal fusion or other surgical techniques. The present invention will achieve at least some of these objectives.

Summary of The Invention

The methods and devices of the present invention are generally useful for the diagnosis and, in some cases, treatment of discogenic pain. More specifically, the present methods and devices facilitate determining whether one or more intervertebral discs in a patient are actually causing back pain in the patient, and also facilitate accurate positioning of the pain-causing discs. In one embodiment, the distal portion of the catheter device is placed trans-annularly or transosseously in an intervertebral disc believed to be the cause of pain in the patient. One or more anchoring elements are then used to maintain the distal portion in the disc. The patient is allowed to assume a position or perform a task, such as bending over, that typically causes pain in the patient's back. One or more substances, such as an anesthetic or analgesic, are injected into the disc using a catheter device. The patient then reports whether the anesthetic alleviated the pain. Optionally, additional discs may be tested, one or more placebo injections may be used, conventional discography may also be added during the procedure, and/or the like. Based on the patient's response to the substance introduced to the disc, it can be determined whether one or more particular discs cause pain to the patient. Diagnostic and therapeutic decisions may be based on the above-described confirmations.

"intervertebral disc" herein generally refers to the soft tissue between any two adjacent vertebrae. The intervertebral disc typically includes an outer layer of fibers, known as the "annulus fibrosis," and a more compliant inner core, known as the "nucleus pulposus. In various embodiments, the material may be introduced into the annulus fibrosis, nucleus pulposus, or both. To the extent that other soft tissues between two adjacent vertebrae may also be considered part of the intervertebral disc, the introduction of one or more substances into these soft tissues is also contemplated within the scope of the present invention.

In some cases, devices and methods for diagnosing discogenic pain are also used to treat pain. The catheter devices of the present invention typically include one or more anchoring elements to maintain the distal portion of the catheter device in position within the disc. Such a catheter device may be connected, for example, to an implantable pump or an injection inlet for delivering one or more substances, such as an anesthetic or analgesic, to the disc for treating back pain in the patient. As described in detail below, many other substances may be introduced to the disc, and many other modes of treatment are possible, such as Transcutaneous Electrical Nerve Stimulation (TENS).

In one aspect of the invention, a method of introducing one or more substances into an intervertebral disc is provided, the method comprising: positioning the distal portion of the catheter device within the disc, anchoring the distal portion of the catheter device such that the distal portion remains within the disc; and introducing at least one substance into the disc through the conduit means. In various embodiments of the present invention, the distal portion may be positioned using a number of different methods. For example, in one embodiment, the catheter device is passed through a lumen of an introducer device. In one such embodiment, positioning the distal catheter portion comprises: the method includes the steps of passing a catheter device through a lumen of an introducer device over a sharp stylet, piercing the fibrotic annulus of the disc with the stylet, and withdrawing the stylet from the catheter device. In an alternative embodiment, positioning the distal portion comprises: the annulus fibrosis of the disc is pierced into the disc by the tapered distal portion of the catheter device. In some embodiments, the catheter device is passed over a guide wire.

In various embodiments employing an introducer, the introducer may be advanced to a position within the disc, or to a position just outside the disc. In either case, the introducer device may have a configuration that facilitates advancement of the distal end through the distal or distal portion of the annulus fibrosis. In some embodiments, the catheter device is passed over a guide wire. In some cases, the catheter is passed over the over-the-needle guide wire, and in alternative embodiments, the introducer device is removed over the guide wire before the catheter device is passed over the guide wire. In some embodiments, the location of the distal portion can be facilitated by observing the position of the distal portion at or near the distal portion with at least one radiopaque marker or material.

In some embodiments, an anchoring catheter device comprises: one or more anchoring elements disposed along the catheter body are expanded. In some embodiments, these anchoring elements may be located at or near the distal portion of the catheter, while in other embodiments, anchoring may occur at a location distal to the distal portion. In some embodiments, anchoring may be accomplished by using a separate anchoring device, such as by applying adhesive, sutures, or the like to anchor the catheter in the desired location on the patient. In one embodiment, the anchoring includes expanding at least a first expandable member of the disc. Optionally, the technique further comprises inflating at least a second inflatable member adjacent the outer surface of the disc such that there is one inflatable member in the disc and another inflatable member just outside the annulus fibrosis.

In an alternative embodiment, anchoring includes expanding at least one mechanism along the distal portion of the catheter device to increase the effective cross-sectional diameter of the catheter at one or more locations. For example, in one embodiment, the cross-sectional diameter is increased by releasing one or more shape memory elements or spring loaded elements from the constraint. In other embodiments, the cross-sectional diameter may be increased by driving one or more mechanical elements, or moving the inner catheter shaft of the catheter device relative to the outer catheter shaft of the catheter device to outwardly buckle one or more anchoring elements. In another embodiment, anchoring includes changing at least a portion of the distal portion from a substantially linear shape to a substantially curved or geometric shape. In yet another embodiment, anchoring includes attaching a portion of the distal portion to the annulus fibrosis of the disc. For example, in various embodiments, the attachment can be screwed, twisted, or pierced into the annulus fibrosis.

In addition to the anchoring mechanisms described above, the access and treatment catheters of the present invention may be modified to promote tissue growth on or into at least selected portions of the catheter. This tissue growth promoting effect may be achieved by modifying the external structure or shape of the outside of the catheter, or by providing additional physical structures that promote tissue ingrowth and adhesion. Alternatively or in addition, the catheter may have osteogenic substances, drugs or chemicals to promote desired tissue attachment. Such tissue attachment may be facilitated in bone, muscle, fibrotic tissue, scar tissue, chondrocytes or other tissue occurring in or around the disc space of the vertebral body. Anchoring by promoting tissue ingrowth is particularly useful when the catheter is implanted for extended periods of time, as often required by therapeutic treatment regimens.

The substance introduced into the disc may be any suitable substance, typically introduced for diagnosing and/or treating discogenic pain, but in other embodiments may be used for any other suitable purpose. Any suitable composition of matter may be introduced simultaneously or sequentially for diagnostic, therapeutic or other purposes. In some embodiments, one or more placebo substances may be introduced into one or more discs, typically to aid diagnosis, but in other embodiments also for research or experimental purposes, etc. For example, in some embodiments, the introduced substances may include, but are not limited to: an anesthetic; an analgesic; (ii) an antibiotic; hydrating agents such as hypotonic, isotonic or hypertonic saline; a supporting agent such as hydrogel, ethylene-vinyl alcohol copolymer, dimethyl sulfoxide or tantalum; prophylactic therapeutic (prolotherapy) agents such as sodium morrhuate, cod liver oil, phenol, minerals or ethanol; and other agents such as collagen, stem cells, osteogenic protein-1, ethanol, alcohol, steroids, radiopaque contrast agents, ultrasound contrast agents, Bone Morphogenetic Protein (BMP), BMP-2, BMP-4, BMP-6, BMP-7, BMP-12, 5-hydroxytryptamine-HT 2A receptor inhibitors, LMP-1, TIMP-1, TGF-2, rofecoxib, ketorolac, glucosamine, chondroitin sulfate, dextrose, DMSO, non-steroidal anti-inflammatory drugs, ibuprofen, naproxen, bucindolol formulation (Bextra), pancreatin (Vioxx), Celebrex (Celebrex), indomethacin, botulinum toxin, capsaicin, vanillyloid (vanilloid) agonists, vanillyl antagonists, VR1, VRL-1, steroids, methylprednisolone, or mulmarigold. These substances can be delivered in biodegradable or time-release vehicles for long-term administration of the substances.

Examples of anesthetics and analgesics include, but are not limited to: lidocaine, chloroprocaine, mepivacaine, ropivacaine, xylocaine, prilocaine, morphine, bupivacaine (bupivocaine), bupivacaine, 2-chloroprocaine, fentanyl, diamorphine, pethidine, methadone, alfentanil, hydromorphone, lofentanyl, sufentanil, buprenorphine, other opiates, adrenergic agonists, somatostatin analogs, calcium channel blockers, N-methyl-D-aspartate receptor antagonists, ketamine, diazepam, clonazepam, tizanidine, midazolam, levorphanol, heterocyclic antidepressants, non-heterocyclic enhanced 5-hydroxytryptamine antidepressants, GABA analogs, spermidine, somatostatin, octreotide, SNX-111, midazolam, methylprednisolone acetate, triamcinolone acetonide (aristopan), ethyl chloride, etidocaine, Lincomycin, triamcinolone diacetate, Asramorph, Duramorph, Dilaudi, Sensorcaine MPF, baclofen (lyolein), clonidine, baclofen, gabapentin (neurontin) and Demerol. Examples of antibiotics include, but are not limited to: penicillin, cephalosporin, tetracycline, erythromycin, clindamycin, vancomycin, bacitracin, doxycycline, ampicillin, levofloxacin (Levaquin), metronidazole, azithromycin, ciprofloxacin, lividin (Augmentin), sulfamethoxine (Bactrim), TMP-SMX, bacteriacide (Rocephin), gentamicin, cephalexin, and nitrofurantoin (Macrobid).

In some embodiments, the method further comprises: prior to introduction of the substance, the patient is placed in a position where significant spinal pain is experienced. In these embodiments, the substance introduced is often an anesthetic or analgesic, and determining whether a patient feels spinal pain after introduction of the substance helps determine whether a particular disc causes pain. The method optionally further comprises positioning a distal portion of a second catheter device in the second intervertebral disc, anchoring the distal portion of the second catheter device to retain the distal portion in the second disc, and introducing at least one substance into the second disc through the second catheter device. The method may further comprise: prior to introducing the at least one substance into the second disc, the patient is placed in a position to experience significant spinal pain, wherein the at least one substance comprises an anesthetic or analgesic. In some embodiments, a method comprises: determining which of the discs into which the at least one substance is introduced causes pain in the patient's spine. The method optionally further comprises: an intervertebral disc angiogram is performed on the intervertebral disc before the distal part of the catheter device is positioned in the disc. Alternatively, in other embodiments, a discography is performed on the intervertebral disc after the introduction of the at least one anesthetic.

In one embodiment of the method, at least one substance is automatically introduced into the disc (or discs) over a period of time. This may include, for example, connecting the catheter device with an automatic injection device, which would allow the patient to rest alone in a doctor's office or hospital room, assume various back pain-causing positions, etc., while introducing various substances into one or more trays. In some embodiments, the method further comprises recording one or more patient input values describing back pain experienced by the patient.

Some embodiments of the method further comprise: the catheter device is retained with the distal portion in place in the disc and at least one substance is administered over a period of time to treat spinal pain. As described above, in some embodiments, the substance may be administered over a period of time through a subcutaneous injection port or an implanted pump, the method further comprising connecting the catheter device to the subcutaneous injection port or implanted pump. In alternative embodiments, the substance may be administered over a period of time by any suitable combination of devices or otherwise.

In another aspect of the invention, a method of identifying a pain-causing intervertebral disc comprises: positioning a distal portion of a catheter device in a disc of a patient, anchoring the distal portion of the catheter device to retain the distal portion in the disc, placing the patient in a position experiencing significant spinal pain, and introducing at least one substance through the catheter into the disc. In this aspect, the method includes any of the features, steps, or variations described above.

In yet another aspect of the invention, a catheter device for introducing one or more substances into an intervertebral disc includes an elongated, flexible catheter body, and at least one anchoring element disposed along the catheter body for anchoring a distal portion of at least a portion of the catheter in the intervertebral disc. The catheter body itself has a proximal portion, a self-introducing distal portion for facilitating penetration of the annulus fibrosis of the disc, and at least one lumen for introducing one or more substances into the intervertebral disc. By "self-introducing" it is meant that the distal portion of the catheter body has at least one structural feature that enables the distal portion to pass through the annulus fibrosis.

In some embodiments, the anchoring element is located at or near the distal portion of the catheter device, while in other embodiments, the anchoring element is distal to the distal portion or may even be a separate device for anchoring the catheter. In various embodiments, the anchoring element (or elements) of the catheter device can be in any of a number of forms. For example, in one embodiment, the anchoring element includes at least one expandable element coupled to the inflation lumen. In alternative embodiments, the anchoring element comprises at least one shape memory, spring loaded or mechanically driven element for increasing the effective cross-sectional diameter of the catheter body at or near the distal portion. Alternatively, the anchoring element may include at least one outwardly bowed portion connected to the inner and outer catheter shafts of the catheter body to bow outwardly as the inner shaft moves axially relative to the outer shaft. In yet another embodiment, the anchoring element includes at least one attachment for attachment to the annulus fibrosis of the disc. For example, such an attachment may include at least one threaded surface, a helical needle, or the like. In another embodiment, the anchoring element includes at least one deformable element to change at least a portion of the distal end portion from a substantially linear shape to a substantially curved or geometric shape.

In various embodiments, the catheter body can have any suitable configuration, size, features, and the like. For example, in one embodiment, the self-introducing distal portion of the catheter body includes at least one pushable portion that is more rigid than the adjacent portion of the catheter body. Optionally, the self-introducing part may further comprise a tapered distal end of the catheter device. In some embodiments, the device may include a sharpened stylet removably positioned within the lumen of the catheter device for piercing the annulus fibrosis of the disc.

A number of features facilitate passage of the catheter body through the introducer device. For example, in one embodiment, the catheter body includes an anti-friction outer surface. In some embodiments, the outer diameter of the catheter body is less than 2 millimeters. And in some embodiments, the catheter body has a cross-sectional diameter near the proximal end of the body that is larger than a cross-sectional diameter near the distal end of the body. Optionally, the catheter body may further comprise an outer surface having one or more different markings for indicating the depth of insertion of the catheter device into the patient. In alternative embodiments, the catheter body may include an outer surface having two or more different colors for indicating the depth to which the catheter terminates insertion into the patient. The catheter body may further include at least one radiopaque marker or material to facilitate viewing of the catheter device in the patient.

In one embodiment, the catheter apparatus includes a syringe tube extending through at least a portion of the lumen of the catheter body for introducing one or more substances into the disc, and an inflation tube extending through at least a portion of the lumen for inflating the expandable anchor element. The syringe may be made of any suitable material or combination of materials, such as, but not limited to: stainless steel, tempered stainless steel, annealed stainless steel, polymers, and superelastic alloys. In some embodiments, a syringe tube and an inflation tube extend from the proximal end of the catheter body, and at least one adapter (adapter) is removably attached to provide for injection or inflation. In some embodiments, the injection tube and the inflation tube extend coaxially through at least a portion of the catheter body lumen. Alternatively, the injection tube and inflation tube may extend side-by-side through at least a portion of the catheter body lumen. In other embodiments, the injection tube and inflation tube may extend coaxially through a portion of the catheter body lumen and extend side-by-side through another portion of the lumen. In an alternative embodiment of the catheter device, the catheter body does not include a syringe tube and an inflation tube, but rather includes a single extrusion having a syringe lumen for introducing one or more substances into the disc and an inflation lumen for inflating the at least one anchoring element.

In various embodiments, the catheter device may have any suitable proximal end configuration for connection to one or more injection, dilation, aspiration, irrigation or other devices to provide a guidewire pathway and/or the like. For example, in one embodiment, the proximal end of the proximal portion of the catheter body is bifurcated to form two separate catheter body proximal ends. In some embodiments, each of the two proximal ends is removably connected to an adapter to facilitate injection or inflation through each end. Some embodiments of the device further include a guide wire having a distal end shaped to retain the distal end within the disc. The distal end may include, for example, a double guide wire, a wrap around coil (coil), or a pigtail (pigtail). The guide wire may be constructed of any conventional guide wire material, including stainless steel and superelastic materials such as nickel-titanium alloys. Generally, a superelastic guidewire is preferred because other materials, such as stainless steel, may inadvertently tangle at a location remote from the catheter tip when the guidewire is advanced. If the guide wire becomes tangled, it becomes difficult to remove the guide wire from the catheter, preventing the rest of the procedure.

In some cases, it is also preferable to provide the guide wire with a radiopaque marker. The guide wire has a small diameter and a superelastic material, such as nitinol (nitinol), has low visibility under fluoroscopic visualization. The radiopacity of the guide wire may be increased by incorporating radiopaque materials in various conventional ways. For example, a guide wire may be wrapped with a radiopaque material, a radiopaque core may be provided within the guide wire, the guide wire may be braided with a radiopaque material, or the material may be provided as a ring-like marker. These wrapped guidewires having improved radiopacity can be made by a number of methods, including sputtering, electroplating, electroless plating, and the like.

In another aspect of the invention, a system for introducing one or more substances into an intervertebral disc includes an introduction device and a catheter device passable through the introduction device. The catheter device includes an elongated, resilient catheter body and at least one expandable anchoring element disposed along the catheter body for anchoring at least a portion of the distal catheter portion in the disc. The catheter body includes a proximal portion, a self-introducing catheter portion for facilitating passage through the annulus fibrosis of the disc, and at least one lumen for introducing one or more substances into the intervertebral disc. In various embodiments, the catheter device may include any of the above features, configurations, or combinations.

In some embodiments, the system further comprises a sharp stylet removably positioned within the lumen of the catheter device for piercing the annulus fibrosis. In some embodiments, the system includes a guide wire over which the catheter device can be passed within the introduction device. The catheter device and the introducer device can have any suitable dimensions, but in one embodiment the outer diameter of the catheter body is less than 2 millimeters. In some embodiments, the inner diameter of the needle is about 0.1-0.01 mm larger than the outer diameter of the catheter body.

In some embodiments, the system further comprises an automatic injection device removably connected to the catheter device for automatically introducing the at least one substance into the tray. These or other embodiments may optionally further comprise recording means for recording patient input values describing the patient's pain perception.

In another aspect of the invention, a kit for introducing one or more substances into an intervertebral disc is provided, the kit comprising: a catheter device; at least one implantable device removably connected to the conduit means for introducing one or more substances into the disc over a period of time; and instruments for using the catheter device and the implantable device. The catheter device includes: an elongate, flexible catheter body having a proximal portion, a self-introducing distal portion for facilitating passage through the annulus fibrosis of the disc, and at least one lumen for introducing one or more substances into the intervertebral disc; and at least one anchoring element disposed along the catheter body for anchoring at least a portion of the catheter distal portion within the disc. The catheter device may have any of the features described above.

In various embodiments, the implantable device comprises any number of suitable devices. For example, in some embodiments, the implantable device comprises a pump. In other embodiments, the implantable device comprises an injection port.

In various embodiments, the kit further comprises one or more additional devices, such as, but not limited to: an introducer device to facilitate positioning of the catheter device in the disc, a sharp stylet removably positioned within the lumen of the catheter device for penetrating the annulus fibrosis and/or a guide wire passable through the needle.

These and other aspects and embodiments of the present invention will be described more fully hereinafter with reference to the accompanying drawings.

Brief description of the drawings

Figures 1A-1K illustrate a method of positioning a catheter device, shown in cross-section from the spinal column, for introducing a substance into an intervertebral disc, according to one embodiment of the invention.

Fig. 1L and 1M show a catheter introducer needle with a pointed tip (fig. 1L) and an atraumatic tip (fig. 1M).

Fig. 1N shows a catheter introducer needle having an axial slot and a frangible cover to facilitate removal of the needle from the catheter after implantation.

Figures 2A and 2B illustrate a portion of a method of positioning a catheter device to introduce a substance into an intervertebral disc using a sharpened stylet, according to one embodiment of the invention.

Figure 2C shows a catheter device in place and a split introduction device for introducing a substance into an intervertebral disc according to another embodiment of the invention.

Fig. 2D and 2E show a catheter and stylet with a modified distal end to facilitate connection during introduction of the catheter and stylet assembly.

Fig. 3A and 3B are perspective and cross-sectional views, respectively, of the distal end of a catheter device according to an embodiment of the present invention.

Fig. 4A and 4B are cross-sectional views of the distal end of a catheter device with the anchoring elements in unexpanded and expanded states, respectively, according to one embodiment of the present invention.

Fig. 5A and 5B are cross-sectional views of the distal end of another catheter device with the anchoring elements in unexpanded and expanded states, respectively, according to another embodiment of the present invention.

Fig. 6A and 6B are cross-sectional views of the distal end of another catheter device with the anchoring elements in unexpanded and expanded states, respectively, according to another embodiment of the present invention.

Fig. 7A and 7B are perspective views of the distal end of another catheter device with the anchoring element in unexpanded and expanded states, respectively, according to another embodiment of the present invention.

FIG. 8 shows a catheter device having a deformed anchoring distal portion, according to one embodiment of the present invention.

FIG. 9 shows a catheter device having a deformed anchoring distal portion, according to another embodiment of the present invention.

FIG. 10A shows a longitudinal cross-section of a spinal column with a catheter device having radially symmetric anchors, according to one embodiment of the present invention.

FIG. 10B shows a longitudinal cross-section of a spinal column with a catheter device having radially asymmetric anchors, according to another embodiment of the present invention.

FIG. 10C shows a longitudinal cross-section of a spinal column and catheter device with an elliptical anchor, according to another embodiment of the present invention.

FIG. 10D shows a longitudinal cross-section of a spinal column and catheter device with non-spherical anchors, in accordance with another embodiment of the present invention.

FIG. 11 illustrates a spinal anchor for use in connecting the annulus fibrosis of an intervertebral disc, according to one embodiment of the invention.

FIG. 12 shows the distal end of a catheter device having a threaded portion for attaching the annulus fibrosis of an intervertebral disc, in accordance with one embodiment of the invention.

FIG. 13 shows a catheter device having two anchoring elements for anchoring inside and outside of a cellularized annulus of an intervertebral disc, according to one embodiment of the invention.

Figure 14 illustrates a catheter device coupled to an implantable device for facilitating delivery of a substance to an intervertebral disc, according to one embodiment of the invention.

Fig. 14A and 14B illustrate the introduction of a therapeutic or other access catheter into the disc space using a trans-osseous approach.

FIG. 15A shows a catheter device being passed over a guidewire having a helical distal end, according to one embodiment of the present invention.

FIG. 15B shows a catheter device passed over a guidewire having a curved shaft-shaped distal end, according to another embodiment of the present invention.

Figures 16A and 16B illustrate a two-wire guidewire in unexpanded and expanded states, respectively, according to one embodiment of the present invention.

Fig. 17A and 17B show perspective and cross-sectional views, respectively, of a proximal end adapter for use with a catheter device, according to an embodiment of the present invention.

Detailed Description

The methods, devices and systems of the present invention generally provide for the introduction of one or more substances into an intervertebral disc to facilitate diagnosis and/or treatment of discogenic pain (i.e., back pain caused by one or more intervertebral discs). The methods, devices, and systems may be used alone or in combination with other methods or devices now known or later developed, such as discography, radiology, physical examination, and/or the like. In alternative embodiments, the methods and devices of the present invention may be used for purposes other than diagnosis or therapy, such as research or experimental purposes, and the like. Thus, while the following description focuses on diagnostic and therapeutic applications, the various embodiments may be used in any other suitable applications.

Referring now to fig. 1A-1K, a method of introducing a substance into an intervertebral disc is schematically depicted. As seen in FIG. 1A, the intervertebral disc D comprises a fibrotic annulus AF surrounding the nucleus pulposus NP that is located adjacent to the spinous process of vertebra V. Anatomically, the disc D is sandwiched between two vertebrae of the spine (not shown), which are above and below the disc.

In one embodiment, the introduction device 2 and the sharp filling body 4 are introduced together through the skin S of the patient' S back with the distal part thereof positioned in the vicinity of the intervertebral disc D. The introduction device 2 and the filling body 4 may have any suitable dimensions, but in one embodiment, the introduction device 2 is about 18-22 gauge (gauge) and the filling body 4 is about 20-25 gauge.

As shown in fig. 1B, the filling body 4 is then removed, leaving the lead-in device 2 in place. As shown in fig. 1C, the injection needle 6 is then passed through the introducer device 2 and through the annulus fibrosis AF, with its distal tip positioned in the nucleus pulposus NP. The position of the introducing means 2 and/or the injection needle 6 can be confirmed by X-ray, fluoroscopic or other suitable means. In some embodiments, the visualization dye is injected through the injection needle 6 while the injection needle 6 is located within the nucleus pulposus NP, and the appearance of the visualization dye in the disc and the patient's response to the injection is monitored. This part of the procedure is generally known as discography. In alternative embodiments, discography may or may not be performed at a later time.

After the needle 6 is positioned, a guide wire 8 is passed through the needle 6 into the disc, as shown in fig. 1D. The needle 6 is then removed as shown in fig. 1E and the catheter device 10 is passed over the guide wire 8 through the introducer device 2 as shown in fig. 1F. The catheter device 10 will be described in further detail below, but in one embodiment the catheter device 10 may comprise two or more conduits, such as a guidewire conduit 11 and an injection or inflation conduit 12, each individually proximally attached to a plurality of adapters or the like. Once the catheter device 10 is in place, the introducer device 2 can be removed, as shown in FIG. 1G, and adapters 13 and 14 attached to the proximal ends of the tubes 11 and 12. The adapters 13, 14 may facilitate passage of a guidewire, expansion of an expandable member, injection of one or more substances into the disc, and the like.

Referring to fig. 1I, one or more anchoring elements 16 along catheter 10 are expanded to maintain the distal portion of catheter 10 within the disc. In one embodiment, the anchoring element 16 comprises an inflatable balloon, but as described in more detail below, many other types of anchoring elements may be used in various embodiments. Once the anchoring element 16 is expanded, the guide wire 8 may be removed, as shown in fig. 1J. In some embodiments, as shown in fig. 1K, the marker expandable member 17 can be expanded outside the patient. When the anchoring element 16, and thus the distal end of the catheter 10, is in place within the disc, one or more substances may be introduced into the disc through the catheter 10.

Sometimes, it is necessary to leave the needle 6 in place to introduce the catheter into the disc space to facilitate advancement and retraction of the catheter. However, as shown in fig. 1L, the use of a conventional needle having a sharp tip risks damaging the catheter, especially when the catheter is retracted proximally through the needle. Thus, it is preferred to use an introduction "needle" having a blunt or otherwise atraumatic head, as shown in FIG. 1M. In one embodiment, the atraumatic head may be square cut and edge rounded to form a smooth surface that does not damage the catheter when advanced or retracted through the lumen of the needle. The head may also be constructed of a softer, more resilient material, wrapped with a lubricious material or otherwise modified to reduce the risk of damaging the catheter. When using a needle with an atraumatic tip, a stylet with a sharp tip may be used to introduce the needle.

When introducing a catheter through a needle, either a sharp-tipped needle as shown in fig. 1L or an atraumatic needle as shown in fig. 1M, it is often necessary to remove the needle. If the catheter has a proximal hub or other enlarged structure, the needle will not be pulled proximally over the enlarged structure. In this case, it is often necessary to use a needle 6 with an axial slot 6A, optionally wrapped with a frangible outer sleeve, covering or tube 7. The slot 6A is wide enough to allow passage of a catheter, and the outer tube or sleeve 7 prevents accidental passage of the catheter through the slot 6A when the catheter is introduced. Thus, the material of the tube 7 should be strong enough to accommodate the catheter during delivery, but still be susceptible to longitudinal tearing when it is desired to withdraw the needle over the catheter. Suitable materials include: polyester, PET, FEP, PTFE, polyolefin, nylon, PVC, neoprene, and other materials. Many materials can shrink on the needle shaft when exposed to heat. The needle shaft is typically metal, such as stainless steel or nickel, but may also be composed of a polymer of sufficient strength, such as polycarbonate, polyethylene, PEEK, nylon, polypropylene, and the like. The axial slot 6A may be formed in the needle by cutting and machining an opening, typically for a metal needle shaft, or by extruding a material having a C-shaped cross-section, typically for a polymer. Although generally linear, the longitudinal opening 6A may have other geometries, such as a spiral, a curved rod, or any other shape. The outer tube 7 may be opened by tearing, shearing, etc., and may also be pre-scored, pre-perforated or otherwise weakened to aid in separation. In addition to shrinking upon exposure to heat, the outer tube may be attached to the needle shaft by heat fusion, adhesives, or the like.

The above-described method is but one embodiment of a technique for positioning and anchoring the distal portion of a catheter within a disc and introducing a substance therein. In various alternative embodiments, any suitable changes to the techniques, such as the addition or deletion of several steps, the use of various devices, etc., may be made without departing from the scope of the present invention.

Fig. 2A and 2B illustrate a portion of an alternative embodiment of a method of feeding a catheter device 20 into a tray for introducing one or more substances. In this embodiment, rather than using a guide wire through the needle, a sharp stylet 24 extending through the catheter lumen 20 and out of its distal tip is used to pass the catheter device 20 through the introducer device 22. Stylet 24 enables catheter 20 to be passed through tough fibrotic ring AF without the aid of guidewires and needles. The stylet 24 is then removed, leaving the catheter 20 in place for expansion of the anchor and introduction of material, as shown in fig. 2B.

Generally, the stylet shown in fig. 2A and 2B is much stiffer in the axial and bending directions than when advancing the catheter. The catheter is free to slide relative to the stylet. There is a risk that the catheter will be differentially deflected and exit the stylet. To prevent such deviation, the stylet head and the head of the catheter may be modified to bring them together. For example, the distal end of the stylet 24 can have a step or other geometry to match a complementary shape formed on the inside of the distal tip of the catheter 20, as shown in FIG. 2D. Alternatively, the stylet 24 may have a tapered or tapered distal end to match the type of shape in the distal end of the catheter 20, as shown in fig. 2E. The distal ends of the catheter and stylet may also be modified to have matching threaded ends for more secure but simultaneously releasable attachment.

Optionally, the distal tip of the stylet may be made radiopaque to enhance fluoroscopic visualization. For example, at least the distal portion of the stylet 24 can be at least partially constructed of, or plated with, a radiopaque material, such as platinum, iridium, or gold. The remainder of the stylet may be constructed of stainless steel, nickel, or other material having the desired column strength and flexibility to provide "pushability" of the stylet 24 in combination with the catheter 20. By providing a stylet that is inherently radiopaque, the number of components and the profile or cross-section of the combined device (including stylet 24 and catheter 20) can be reduced. Reducing the profile is advantageous because it facilitates access to the disc space through the annulus fibrosis.

Referring now to FIG. 2C, in one embodiment, the method of introducing catheter device 21 into a tray for injecting one or more substances is facilitated by the use of split introduction device 23. A split introducer device 23 may be used as described above. However, rather than removing split introducer 23 by sliding it out of the proximal end of catheter device 21, split introducer 23 is split along its length for removal from catheter device 21. The split introducer 23 may be constructed of any suitable material to tear, break, split, stretch, or separate along the length of the needle 23. The splitting may be achieved by, for example, perforations, thin sections or other weak links along the length of the needle 23.

Typically, once the catheter device is in place with the distal portion left in the disc, the one or more anchoring elements are expanded to maintain the position of the catheter, the patient is instructed to place in a position that often causes pain to the patient or to perform a task, such as bending over to pick up something, etc. The substance is then introduced into the disc and the patient is asked if the pain is reduced, eliminated, unchanged, etc. In various embodiments, the patient is asked to score the pain experienced on a scale of 1-10, either before or after introducing the substance to the disc. In one embodiment, the introduced substance is an anesthetic or analgesic, and thus relieves the patient of pain when the actual pain-causing disc is injected. In some cases, multiple injections are performed, and one or more of the injected substances may be a placebo to verify the accuracy of the test results. Moreover, such tests can be performed alone or before or after conventional discography. In some embodiments, multiple trays of a patient may be accessed and tested. In some embodiments, the test is performed over an extended time frame to test multiple discs and/or to improve the accuracy or certainty of the test results.

In various embodiments, any number of different substances may be introduced into the tray. Different substances can be introduced for different purposes, such as diagnosis and treatment of discogenic pain, for research purposes or for experimental purposes, etc. Examples of possible substances that may be introduced into the disc include, but are not limited to: an anesthetic; an analgesic; (ii) an antibiotic; hydrating agents such as hypotonic, isotonic or hypertonic saline; a supporting agent such as hydrogel, ethylene-vinyl alcohol copolymer, dimethyl sulfoxide or tantalum; prophylactic therapeutic (prolotherapy) agents such as sodium morrhuate, cod liver oil, phenol, minerals or ethanol; and/or other agents such as collagen, stem cells, osteogenic protein-1, ethanol, alcohol, steroids, radiopaque contrast agents, ultrasound contrast agents, Bone Morphogenetic Protein (BMP), BMP-2, BMP-4, BMP-6, BMP-7, BMP-12, 5-hydroxytryptamine-HT 2A receptor inhibitors, LMP-1, TIMP-1, TGF-2, rofecoxib, ketorolac, glucosamine, chondroitin sulfate, dextrose, DMSO, non-steroidal anti-inflammatory drugs, ibuprofen, naproxen, bucindolol formulations, pancreatin, Celebrex (Celebrex), indomethacin, botulinum toxin, capsaicin, vanilloid (vanilloid) agonists, vanilloid antagonists, VR1, VRL-1, steroids, methylprednisolone, or mulukinase. These substances are delivered in biodegradable or time-release vehicles for long-term administration of the substances.

As noted above, in some embodiments, the method further comprises retaining the catheter device in place to provide treatment of the patient's back pain, such as with an anesthetic or analgesic or other substance. In some embodiments, the catheter device may be connected to an implanted pump, injection port, or other device to provide such treatment.

Referring now to fig. 3A and 3B, there are shown a perspective view and a cross-sectional view, respectively, of a distal portion of a catheter device 30, according to one embodiment of the present invention. The catheter device 30 suitably includes a catheter body 32 having an expandable anchoring element 36, the catheter body 32 housing an expandable tube 34 and a syringe 38, and having radiopaque markers 33 disposed along its distal end. Anchoring element 36 maintains the distal portion of catheter device 30 in place within the disc. An inflation tube 34 is used to inflate the anchoring element 36, and in the illustrated embodiment, the inflation tube 34 comprises an inflatable balloon. One or more fluids are introduced into the nucleus pulposus of the disc using a syringe 38. The radiopaque markers 33 facilitate visualization of the distal portion of the catheter device 30 so that its position can be assessed before, during, or after diagnostic and therapeutic procedures.

In various embodiments, the distal portion of the catheter device 30 may have one or more structural features that facilitate advancement of the distal portion through the annulus fibrosis of the intervertebral disc. A distal portion having one or more of these structural features is often referred to as "self-introducing". Thus, "self-introducing" simply means that the distal portion has one or more structural features that facilitate its passage through the annulus fibrosis tissue. These structural features include, for example, one or more segments on the catheter shaft that are stiffer than adjacent segments. Another structural feature may include a tapered or sharpened distal tip for piercing the annulus fibrosis. In some embodiments, the catheter device 30 may be connected to a removable sharpened stylet. These or any other suitable structural features may be included in the distal portion of the catheter device 30 to facilitate passage through the annulus fibrosis.

In various embodiments, the various components of catheter device 30 may be constructed from any suitable materials and may have any suitable shape, size, dimensions, etc. For example, in one embodiment, the cross-sectional diameter of the catheter body 32 decreases along its length from the proximal end to the distal end. This tapered configuration allows for easy passage of the catheter device 30 through the introducer. Typically, the outer diameter of the catheter body 32 is also slightly smaller than the inner diameter of the introducer device. For example, in one embodiment, the catheter body 32 has an outer diameter along at least a portion of its length of about 2 millimeters or less.

In various embodiments, the catheter body 32 may comprise a single rigid polymer or a composite of reinforced metal or polymer components. The metal component may include, for example, stainless steel, nickel, or other superelastic alloys. Polymers may include, but are not limited to: polyether ether ketone (PEEK), Polyether block amide (PEBAX), nylon, polyester, polyolefin, polyamide, polyimide, polycarbonate, polypropylene, Fluorinated Ethylene Polymer (FEP), Perfluoroalkoxy (PFA), tetrafluoroethylene-perfluoromethylvinylether (MFA) -containing, polyurethane, or Low Density Polyethylene (LDPE). In some embodiments, these materials may be reinforced by wrapping or braiding. The inner or outer sides of these materials may also be coated with an anti-friction material such as Teflon (polytetrafluoroethylene), hydrophilic materials, parylene, etc.

In various embodiments, the catheter shaft may include one or more radiopaque markers 33 and/or be constructed of one or more radiopaque materials to facilitate visualization. These radiopaque markers/materials may include, but are not limited to: gold, platinum, iridium, tungsten, Tantalum (Tantalum), barium sulfate-containing resin, bismuth trioxide or tungsten, and the like.

According to various embodiments, the anchoring element 36 may also be constructed of any suitable now known or later discovered material. For example, the expandable anchoring element 36 may comprise elastic polyvinyl chloride (PVC), polyethylene, polyether block amide (PEBAX), polyethylene terephthalate (PET), polyester, nylon, polyurethane, polyether block amide (PEBAX), polyolefin, or any suitable combination thereof. An adhesive may be used to bond the anchoring element 36 to the catheter shaft 32 or for any other suitable purpose. Any suitable adhesive may be used, such as, but not limited to: photosensitive acrylates, photosensitive cyanoacrylates, photosensitive silicones, heat sensitive adhesives, room temperature curing adhesives, cyanoacrylates, epoxy adhesives and/or polyurethane adhesives. Other means, such as friction fit, snap fit, screw fit, application of energy such as heat or radio frequency energy, etc., may also be used to attach the various portions of the catheter device 30.

Referring now to fig. 4A and 4B, in another embodiment, the catheter device 40 includes an outer shaft 42, an inner shaft 44, and an anchoring element 46 connected to the outer shaft 42 and the inner shaft 44. The shafts 42, 44 are axially slidable relative to each other such that when the inner shaft 44 is moved proximally relative to the outer shaft 42, the anchoring elements 46 are flexed outwardly to perform their anchoring function, as shown in FIG. 4B. In this embodiment, the inner shaft 44 functions as an infusion lumen and also as a guide wire lumen, without the need for an inflation lumen. In one embodiment, the anchoring element 46 may be configured as a cylinder with a slot or other shape cut therein to form a cylindrical buckling structure. The components of this embodiment may be composed of the same or different materials as described above.

Another embodiment of a catheter device 50 is shown in fig. 5A and 5B. Here, the catheter device 50 includes an outer shaft 52, an inner shaft 54, an anchoring element 56 connected to the outer shaft 52 and the inner shaft 54, and a cannula 58 slidable over the outer shaft 52. When the sleeve 58 is positioned over the anchoring element 56, as shown in FIG. 5A, the anchoring element 56 is maintained in an unexpanded state suitable for delivery into the disc. When the cannula 58 is retracted and/or the outer shaft 52 is advanced, the anchor elements 56 may expand, as shown in FIG. 5B. In some embodiments, the anchoring element 56 may be expanded by buckling or by expansion, as described above. In other embodiments, the anchoring element 56 may be self-expanding, e.g., expandable upon release from the sleeve 58 if constructed of a shape memory or spring loaded material.

Referring now to fig. 6A and 6B, in another embodiment, a catheter device 60 includes an outer shaft 62 having an expandable anchoring portion 66 and an inner shaft 64. The expandable anchoring portion 66 generally comprises a warped portion of the outer shaft 62 and may include a plurality of structural features, such as small cutouts 68 and larger openings 67. When the proximal end portion 62a of the outer shaft is moved toward the distal end portion of the outer shaft 62b, the anchoring element 66 buckles due to the structural features 67, 68, thereby providing an anchoring function.

Referring now to fig. 7A and 7B, another embodiment catheter device 70 is shown having a catheter shaft 72 and a retractable tip anchor 76. The tip anchor 76 is expandable from a retracted state (shown in FIG. 7A) to an expanded state (shown in FIG. 7B). The tip anchors 76 may be pre-bent so that they readily form a predetermined shape when expanded from the catheter shaft 72, and the anchors 76 may be constructed of a metal, such as stainless steel, or a shape memory metal such as nitinol, a polymer, or any other suitable material. In various embodiments, the tip anchor 76 is expanded by pushing the tip anchor 76 out of its containment lumen, or by releasing them from a constrained state so that they self-expand.

In other embodiments, referring now to fig. 8 and 9, the distal portion of the catheter device may be deformed to anchor the distal portion within the disc D. In one embodiment, as shown in fig. 8, catheter device 80 has a distal portion 82 that is deformed into a helical configuration. In another embodiment, as shown in fig. 9, the catheter device has a distal portion 86 that deforms to a curved rod configuration. In various embodiments, the distal portion may take any other suitable shape. Deformation of the distal portion may be accomplished by any suitable means, such as by using a shape memory or spring loaded material, by deforming the distal portion using a pull string, tendon, stylet, or other actuator, or the like.

Fig. 10A-10D illustrate that in various embodiments, the anchoring element of the catheter device can have any suitable shape, size, configuration, orientation relative to the catheter shaft, and the like. For example, in the embodiment of fig. 10A, a cross-sectional view of the anchoring element 100 of the catheter device is shown in the disc D between two vertebrae V. In this embodiment, the anchoring element 100 has a circular cross-sectional shape, concentrically located on the catheter shaft 102 of the catheter device. In the embodiment shown in fig. 10B, the anchor element 104 is asymmetrically attached to the catheter shaft 106, having a non-circular, asymmetric shape. In the embodiment shown in fig. 10C, the anchor element 108 is concentrically located on the catheter shaft 110, having an elliptical cross-sectional shape. Fig. 10D shows a longitudinal view of the catheter device 112 with an approximately conical anchoring element 114. This embodiment shows that in various embodiments, the anchoring element 114 has not only various cross-sectional shapes, but also various longitudinal shapes.

Referring now to fig. 11, there is shown yet another embodiment catheter device 116 advanced over a guide wire 120, which includes an anchoring element 118 attached to the annulus fibrosis AF of the disc to maintain the distal portion of the device 116 within the disc D. Here, the anchoring element 118 comprises a helical needle that can be screwed, twisted or driven into the annulus fibrosis AF.

Fig. 12 shows another embodiment of a catheter device 122, in this embodiment a catheter shaft with threads 126 to anchor in the annulus fibrosis. In various embodiments, any other suitable structure may be employed to anchor in the annulus fibrosis, such as hooks, anchors, barbs, T-tags (T-tags), and the like.

Referring now to fig. 13, in another embodiment, the catheter device 128 includes an outer anchoring member 130 for anchoring outside the annulus fibrosis AF, and an inner anchoring member 132 for anchoring inside the disc D, typically in the nucleus pulposus NP. As shown, the anchoring elements 130, 132 may comprise an expandable element, such as an expandable balloon. In other embodiments, other anchoring elements may be employed, more than two anchoring elements may be employed, etc. The use of two anchoring elements 130, 132 further ensures that the distal portion of the catheter device 128 remains in place in the disc.

As described above, referring now to fig. 14, in some embodiments, a catheter device 134 having an anchoring element 136 can be used to treat intervertebral disc pain. In some embodiments, the catheter device 134 may be coupled to an implantable device 138 to provide therapy, the implantable device 138 being positioned beneath the patient 'S skin S or at any other suitable location within the patient' S body. For example, in various embodiments, implantable device 138 may comprise an implantable pump with or without a drug reservoir, an implantable drug introduction/injection port, a Transcutaneous Electrical Nerve Stimulation (TENS) device, or any other suitable device. The substance introduced to disc D by catheter device 134 and implantable device 138 may include any of the substances listed above, such as an anesthetic or analgesic to relieve pain. The implantable device 138 can be left in the patient for any suitable length of time to provide treatment.

In one embodiment, the implantable device 138 can include an implantable pump 139. In some embodiments, the pump may be programmed to deliver drug from an attached reservoir into the nucleus pulposus at a constant rate at set intervals once triggered by the patient or physician using an external device in communication with the pump, including but not limited to: magnetic reed switches, electromagnetic wave communication means such as visible light, radio waves, microwaves or short waves, or wireless communication protocols such as bluetooth. In some embodiments, the patient may control pump-mediated drug delivery by physically manipulating a switch, trigger, or other similar device connected to the pump. Optionally, the implantable pump can be configured to store data relating to a patient's drug usage pattern. The information may be downloaded for analysis by wireless communication with an external device, such as those listed above. In embodiments with a reservoir, the implantable pump may further comprise an injection port to refill the reservoir percutaneously.

The distance between the disc D and the skin surface may vary as the patient moves. To prevent the distal portion of the catheter device 134 and the anchoring element 136 from pulling out of the nucleus pulposus, a mechanism may be provided for providing strain relief in the connection between the catheter device 134 and the implantable device 138. For example, in one embodiment, the catheter device 134 may extend between the implantable device 138 and the disc D in a circular, helical, curved, serpentine, or other non-linear path, thereby providing an amount of slack (shown in phantom) in the catheter device to account for movement between the disc D and the implantable device 138 with patient movement.

An implantable catheter device, such as catheter device 134, has an anchoring element 136, typically an inflatable balloon or other structure. Preferably, the catheter device 134 has an integral balloon inflation lumen, or has a separate balloon inflation tube to allow the balloon anchor 136 to inflate once the catheter is in place. Rather than using a stopcock or other valve structure to inflate the balloon, a catheter device 134 is provided having a self-sealing diaphragm structure at the end of the inflation lumen. Optionally, the catheter device 134 may further include a substance delivery lumen, also terminating at the proximal end in a self-sealing septum to allow for delivery of drugs and substances after implantation of the device. Suitable diaphragm materials include silicone, rubber, latex rubber, isoprene rubber, polyisoprene rubber and many other known materials.

Alternatively, sutures, clips, loops of filaments, or any of a number of other external closure elements may be employed to close a balloon-expanding lumen or a separate balloon-expanding tube on the catheter device 134. The clips or crimps may be formed of a spring-like material that is pre-formed to collapse (collapse) the expansion tube. Alternatively, the clips or crimps may be deformable so that they may be secured over the balloon inflation lumen to effect closure. In both cases, multiple closure elements may be provided at different locations along the balloon inflation lumen to facilitate closure. Also, the closure element may be removed during or after implantation to allow for balloon deflation and re-inflation, as desired.

As a further alternative, the balloon inflation lumen may be sealed using heat, adhesives, or ultrasonic energy to cause the lumen to melt or melt. Heat may be provided by a number of sources, including resistive heaters, conductive heaters, and the like.

To facilitate delivery of the distal portion of the catheter device into the disc D, referring now to fig. 15A, some systems include a shaped guide wire 146 configured to maintain the distal portion of the guide wire 146 within the disc during delivery of the catheter device. As shown in fig. 15A, a guide wire 146 is delivered through the injection needle 142 that has passed through the introduction device 140. When the distal portion 146a of the guide wire is pushed out of the distal end of the injection needle 142, it is shaped, in this embodiment a spiral, to secure the distal portion 146a within the disc. The guide wire 146 may be formed of any suitable material to provide such a shape change, such as, but not limited to, a shape memory material, such as nitinol, spring stainless steel, or the like. In some embodiments, the distal tip of the guide wire includes one or more radiopaque markers, wound coils, or the like, or is constructed of one or more radiopaque materials.

In another embodiment, as shown in fig. 15B, the guide wire 148 has a distal portion 148a that swings in a curved rod shape when advanced beyond the distal end of the needle. In various embodiments, the guidewire may have a distal portion of any suitable shape for anchoring in the disc D.

Referring now to fig. 16A and 16B, in one embodiment, guide wire 150 has a double-wire configuration to improve its ability to maintain position in disc D. The two-wire guide wire 150 comprises two wires joined together at their distal ends, the connection being achieved by welding, soldering, gluing, folding a single wire, or any other suitable technique. As shown in fig. 16A, the distal end portion 150a of the guide wire may be delivered into the disc D in a substantially straight, unexpanded configuration. The two-wire guidewire 150 is then expanded by differentially pushing or pulling one of the wires of the two-wire guidewire to deform the distal portion 150a, as shown in fig. 16B. In its expanded state, the two-wire guide wire 150 is less likely to dislodge or pull out of the disc D than a single wire guide wire.

As described so far, a trans-annular approach is employed to reach the disc space. However, as shown in fig. 14A and 14B, in some embodiments, it is preferred to access the nucleus pulposus NP through the adjacent vertebral body V in a trans-osseous approach, i.e., trans-osseous. Using the trans-osseous approach avoids the need to perform an annulotomy (annulotomy), thereby avoiding puncture and potentially damaging the annulus fibrosis AF. In the trans-osseous approach, a catheter 134 is passed through the vertebral body V into the disc space. As shown in fig. 14A, the catheter 134 may be passed through a single vertebral body into the adjacent disc space. However, in some cases it may be desirable to pass the catheter 134 through multiple disc spaces, as shown in FIG. 14B, to expand the anchoring element 136 in the distal-most disc space, or optionally in one of the vertebral bodies. This approach is advantageous because it allows for the simultaneous treatment of multiple disc spaces. The disc space or spaces can be accessed from the superior or inferior vertebral body. The trans-osseous approach may be accomplished by drilling or chiseling a passageway through the vertebral body using twist drills (twist drill bits), abrasive burrs (abrasive burrs), sharp chisels (sharp chips) or other tools known in the surgical field. The tool for making the passage in the bone can be introduced separately or through an introduction needle. In some cases, it is necessary to pre-bend the introducer needle or tool to obtain the correct angle for the access hole in the vertebral body.

Referring to fig. 17A and 17B, an embodiment is shown that includes one or more adapters 160 for removable connection to the proximal end of one or more catheters 162. Typically, adapter 160 is connected to catheter device 162 after the distal end of catheter 162 is in place within the disc and after the introducer device, stylet, etc. is removed, although in alternative embodiments adapter 160 may be connected to catheter device 162 at any other suitable time. Adapter 160 may comprise or resemble a Touhy Bourst adapter, compression fitting, instant tube fitting, or other similar adapter or connector. In one embodiment, the adapter includes a distally-closed connector 164, a proximally-closed connector 166 having an injection port 167, an anchoring element inflation port 168, and a stopcock 169 for controlling the flow of liquid through inflation port 168. Injection port 167 is in fluid communication with the lumen of catheter device 162 and may be used for injecting a substance into the disc and/or for passage of a guide wire. Injection port 167 and inflation port 168 may include luer fittings, press fittings, barbs, or any other suitable tubing connection method. The proximal 166 and distal 164 closed connectors may be activated by rotating the closed connectors on threads, automatic press activation, spring actuation, or any other suitable method.

In addition to the implantable device and the proximal end adapter, in some embodiments, the catheter device may be connected to one or more automatic injection devices. These injection devices facilitate testing of one or more discs over an extended time frame, requiring only periodic monitoring by a physician, nurse or other clinician. For example, a patient may be left in a doctor's office or ward while introducing a series of substances into the tray, the patient may be placed in different positions to test for pain response, the substances may be injected into multiple trays via multiple catheter devices, and so forth. Such an automated system may facilitate and enhance diagnosis of discogenic pain by allowing for a wider range of tests. In some embodiments, such a system may further comprise means for recording a patient's pain response, such as an instrument that allows the patient to record the pain sensations before and after injection on a scale of 1-10 and/or correlate the pain sensations with the patient's general back pain.

While the foregoing is a full and complete description of the invention, many modifications, additions, variations, and the like can be made to the various embodiments without departing from the scope of the invention. Accordingly, the description is intended primarily for purposes of illustration and should not be construed to limit the scope of the invention, which is defined by the claims that follow.

Claims

1. A method of introducing one or more substances into an intervertebral disc, the method comprising:

positioning a distal portion of a catheter device in the disc;

anchoring a distal portion of a catheter device to retain the distal portion in a disc; and

at least one substance is introduced into the tray by a conduit means.

2. The method of claim 1, wherein the step of positioning the distal portion comprises positioning an introducer device through the skin and passing a catheter device through a lumen of the introducer device.

3. The method of claim 1, wherein the positioning step comprises piercing a annulus fibrosis.

4. The method of claim 1, wherein the positioning step comprises piercing a vertebra.

5. The method of claim 1, wherein the catheter is positioned in the two or more discs by advancing the catheter through the intermediate vertebrae.

6. The method of claim 2, wherein the step of positioning a catheter device comprises:

passing the catheter device through the lumen of the introducer device over the sharp stylet; and

piercing the annulus fibrosis or the vertebrae of the disc with a stylet; and

the stylet is withdrawn from the catheter device.

7. The method of claim 6, wherein the distal end of the stylet is removably connected to a catheter when the stylet pierces the annulus fibrosis or bone.

8. The method of claim 2, wherein the step of positioning the distal portion further comprises piercing the tapered distal end of the catheter through the annulus fibrosis of the disc.

9. The method of claim 8, wherein the step of positioning the distal portion further comprises passing a catheter device over a guide wire.

10. The method of claim 2, wherein the distal end of the introducer device is advanced to a position in the disc prior to the catheter device passing through the introducer device.

11. The method of claim 10, wherein the step of positioning the distal portion further comprises passing a catheter device over a guide wire.

12. The method of claim 11, wherein the catheter device is passed over a guide wire through an introducer device.

13. The method of claim 11, wherein the introducing means on the guide wire is removed before passing the catheter means over the guide wire.

14. The method of claim 1, wherein the step of positioning the distal portion comprises observing at least one radiopaque marker or material at or near the distal portion to estimate the position of the distal portion.

15. The method of claim 1, wherein the anchoring step comprises expanding an anchoring element of at least one catheter device.

16. The method of claim 15, wherein the at least one anchoring element is expanded at or near a distal portion of the catheter device.

17. The method of claim 16, wherein the anchoring step includes expanding at least the first expandable member in the disc.

18. The method of claim 17, further comprising expanding at least the second expandable member adjacent the outer surface of the disc.

19. The method of claim 1, wherein the anchoring step comprises expanding at least one mechanism at or near the distal portion of the catheter device to increase the effective cross-sectional diameter of the catheter at one or more locations.

20. The method of claim 19, wherein the step of increasing the cross-sectional diameter comprises releasing one or more shape memory or spring-loaded elements from restraint.

21. The method of claim 19, wherein the step of increasing the cross-sectional diameter comprises activating mechanical elements of one or more catheters.

22. The method of claim 19, wherein the step of increasing the cross-sectional diameter comprises moving an inner catheter shaft of the catheter device relative to an outer catheter shaft of the catheter device to outwardly buckle the one or more anchoring elements.

23. The method of claim 1, wherein the anchoring step comprises changing at least a portion of the distal portion from a substantially straight shape to a substantially curved or geometric shape.

24. The method of claim 1, wherein the anchoring step comprises attaching a portion of the distal portion to the annulus fibrosis of the disc.

25. The method of claim 24, wherein the step of attaching the portion of the distal portion to the annulus fibrosis comprises at least one of screwing, twisting, or piercing the portion of the attachment into the annulus fibrosis.

26. The method of claim 1, wherein the step of introducing at least one substance comprises introducing at least one of: an anesthetic; an analgesic; (ii) an antibiotic; hydrating agents such as hypotonic, isotonic or hypertonic saline; a supporting agent such as hydrogel, ethylene-vinyl alcohol copolymer, dimethyl sulfoxide or tantalum; prophylactic and therapeutic agents such as sodium morrhuate, cod liver oil, phenol, minerals or ethanol; and other agents such as collagen, stem cells, osteogenic protein-1, ethanol, alcohol, steroids, radiopaque contrast agents, ultrasound contrast agents, Bone Morphogenetic Protein (BMP), BMP-2, BMP-4, BMP-6, BMP-7, BMP-12, 5-hydroxytryptamine-HT 2A receptor inhibitors, LMP-1, TIMP-1, TGF-2, rofecoxib, ketorolac, glucosamine, chondroitin sulfate, dextrose, DMSO, non-steroidal anti-inflammatory drugs, ibuprofen, naproxen, bucindolol formulation, pancreatin, celecoxib, indomethacin, botulinum toxin, capsaicin, vanillyl agonist, vanillyl antagonist, VR1, VRL-1, steroids, methylprednisolone, or mulumarin.

27. The method of claim 26, wherein at least two different substances are introduced into the tray.

28. The method of claim 1, wherein the step of introducing at least one substance comprises introducing a placebo into the tray.

29. The method of claim 1, further comprising maintaining the patient in a position experiencing significant spinal pain prior to introducing the at least one substance, wherein the at least one substance comprises an anesthetic or analgesic.

30. The method of claim 29, further comprising:

positioning a distal portion of a second catheter device in a second intervertebral disc;

anchoring a distal portion of a second catheter device to retain the distal portion in the second disc; and

at least one substance is introduced into the second tray by second conduit means.

31. The method of claim 30, further comprising: prior to introducing the at least one substance to the second disc, the patient is placed in a position to experience significant spinal pain, wherein the at least one substance comprises an anesthetic or analgesic.

32. The method of claim 31, further comprising determining which of the discs into which the at least one substance is introduced causes pain to the spine of the patient.

33. The method of claim 29, further comprising performing a discography on the intervertebral disc prior to positioning the distal portion of the catheter device in the disc.

34. The method of claim 29, further comprising performing discography on the intervertebral disc after introducing the at least one anesthetic or analgesic.

35. The method of claim 1, wherein the at least one substance is introduced automatically over a period of time.

36. The method of claim 35, further comprising recording one or more patient input values describing back pain experienced by the patient.

37. The method of claim 1, further comprising:

holding the catheter device in position with the distal portion in the disc; and

at least one substance is administered over a period of time to provide treatment for spinal pain.

38. The method of claim 37, wherein the at least one substance is administered over a period of time via a subcutaneous injection port or an implanted pump, the method further comprising connecting a catheter device to the subcutaneous injection port or implanted pump.

39. A method of identifying a pain-causing intervertebral disc, the method comprising:

positioning a distal portion of a catheter device in a disc of a patient;

anchoring a distal portion of the catheter device to retain the distal portion in the disc;

the patient is placed in a position experiencing significant spinal pain; and

at least one substance is introduced into the tray through a conduit.

40. The method of claim 39, wherein the step of positioning the distal portion comprises passing a catheter device through a lumen of an introducer device.

41. The method of claim 40, wherein the step of positioning the catheter device comprises:

passing the catheter device through the lumen of the introducer device over the sharp stylet;

piercing the annulus fibrosis of the disc with a stylet; and

the stylet is withdrawn from the catheter device.

42. The method of claim 40, wherein the step of positioning the distal portion further comprises piercing the annulus fibrosis of the disc with the tapered distal end of the catheter device.

43. The method of claim 42, wherein the step of positioning the distal portion further comprises passing a catheter device over a guide wire.

44. The method of claim 40, wherein the distal end of the introducer device is advanced to a position within the disc prior to passing the catheter device through the introducer device.

45. The method of claim 44, wherein the step of positioning the distal portion further comprises passing a catheter device over a guide wire.

46. The method of claim 45, wherein the catheter device is passed through the introducer device over a guidewire.

47. The method of claim 45, wherein the introducing means on the guide wire is removed before passing the catheter means over the guide wire.

48. The method of claim 39, wherein the step of positioning the distal portion comprises observing at least one radiopaque marker or material at or near the distal portion to estimate the position of the distal portion.

49. The method of claim 39, wherein the anchoring step comprises expanding an anchoring element of at least one catheter device.

50. The method of claim 49, wherein the at least one anchoring element is expanded at or near a distal portion of the catheter device.

51. The method of claim 50, wherein the anchoring step includes expanding at least the first expandable member in the disc.

52. The method of claim 51, further comprising expanding at least the second expandable member adjacent the outer surface of the disc.

53. The method of claim 39, wherein the anchoring step comprises expanding at least one mechanism along the distal portion of the catheter device to increase the effective cross-sectional diameter of the catheter at one or more locations.

54. The method of claim 39, wherein the anchoring step comprises changing at least a portion of the distal portion from a substantially linear shape to a substantially curved or geometric shape.

55. The method of claim 39, wherein the anchoring step comprises attaching a portion of the distal portion to the annulus fibrosis of the disc.

56. The method of claim 39, wherein the step of introducing at least one substance comprises introducing at least one of: an anesthetic; an analgesic; (ii) an antibiotic; hydrating agents such as hypotonic, isotonic or hypertonic saline; a supporting agent such as hydrogel, ethylene-vinyl alcohol copolymer, dimethyl sulfoxide or tantalum; prophylactic and therapeutic agents such as sodium morrhuate, cod liver oil, phenol, minerals or ethanol; and other agents such as collagen, stem cells, osteogenic protein-1, ethanol, alcohol, steroids, radiopaque contrast agents, ultrasound contrast agents, Bone Morphogenetic Protein (BMP), BMP-2, BMP-4, BMP-6, BMP-7, BMP-12, 5-hydroxytryptamine-HT 2A receptor inhibitors, LMP-1, TIMP-1, TGF-2, rofecoxib, ketorolac, glucosamine, chondroitin sulfate, dextrose, DMSO, non-steroidal anti-inflammatory drugs, ibuprofen, naproxen, bucindolol formulation, pancreatin, celecoxib, indomethacin, botulinum toxin, capsaicin, vanillyl agonist, vanillyl antagonist, VR1, VRL-1, steroids, methylprednisolone, or mulumarin.

57. The method of claim 39, wherein the step of introducing at least one substance comprises introducing a placebo into the tray.

58. The method of claim 39, wherein the introducing at least one substance significantly reduces spinal pain.

59. The method of claim 39, wherein the introducing at least one substance does not significantly reduce spinal pain.

60. The method of claim 39, further comprising:

61. The method of claim 60, further comprising: prior to introducing the at least one substance to the second disc, the patient is placed in a position to experience significant spinal pain, wherein the at least one substance comprises at least one of an anesthetic or an analgesic.

62. The method of claim 61, further comprising determining which of the discs into which the at least one substance is introduced causes pain to the spine of the patient.

63. The method of claim 39, further comprising performing a discography on the intervertebral disc.

64. The method of claim 39, further comprising:

65. The method of claim 64, wherein the at least one substance is administered over a period of time via a subcutaneous injection port or an implanted pump, the method further comprising connecting a catheter device to the subcutaneous injection port or implanted pump.

66. The method of claim 39, wherein the at least one substance is introduced automatically over a period of time.

67. The method of claim 67, further comprising recording one or more patient input values describing back pain experienced by the patient.

68. A catheter device for introducing one or more substances into an intervertebral disc, the device comprising:

an elongate, flexible catheter body having a proximal portion, a self-introducing distal portion for facilitating penetration of the annulus fibrosis of the disc, and at least one lumen for introducing one or more substances into the intervertebral disc; and

at least one anchoring element disposed along the catheter body for anchoring at least a distal portion of the catheter in the intervertebral disc.

69. The device of claim 68, wherein the at least one anchoring element is located at or near the distal portion along the catheter body.

70. The device of claim 68, wherein the at least one anchoring element comprises at least one expandable element connected to the inflation lumen.

71. The device of claim 68, wherein the at least one anchoring element comprises at least one shape memory, spring loaded, or mechanically driven element for increasing the effective cross-sectional diameter of the catheter body at or near the distal portion.

72. The device of claim 68, wherein the at least one anchoring element includes at least one outwardly bowed portion connected to an inner catheter shaft of the catheter body and an outer catheter shaft of the catheter body to bow outwardly upon axial movement of the inner shaft relative to the outer shaft.

73. The device of claim 68, wherein the at least one anchoring element comprises at least one attachment to a fibrotic ring of the disc.

74. The device of claim 73, wherein the attachment member includes at least one threaded surface.

75. The device of claim 73, wherein the attachment comprises at least one helical needle.

76. The device of claim 68, wherein the at least one anchoring element comprises at least one deformable element to change at least a portion of the distal portion from a substantially linear shape to a substantially curved or geometric shape.

77. The apparatus of claim 68, wherein the self-introducing distal end portion comprises at least one advanceable portion that is more rigid than the attachment portion of the adjacent catheter body.

78. The device of claim 77, wherein the self-introducing portion further comprises a tapered distal end of the catheter device.

79. The device of claim 68, further comprising a sharpened stylet removably positioned within the lumen of the catheter device for piercing the annulus fibrosis of the disc.

80. The apparatus of claim 68, wherein the stylet and catheter have self-connecting distal ends to limit differential deviation.

81. The device of claim 68, wherein the catheter body comprises an anti-friction outer surface.

82. The device of claim 68, wherein the catheter body has an outer diameter of less than 2 millimeters.

83. The device of claim 68, wherein the cross-sectional diameter of the catheter body decreases from the proximal end to the distal end along its length.

84. The device of claim 68, wherein the catheter body comprises an outer surface having one or more markers for indicating the depth of insertion of the catheter device into the patient.

85. The device of claim 68, wherein the catheter body comprises an outer surface having two or more different colors for indicating the depth of insertion of the catheter device into the patient.

86. The device of claim 68, wherein the catheter body includes at least one radiopaque marker or material to facilitate visualization of the catheter device in the patient.

87. The apparatus of claim 68, further comprising:

a syringe extending through at least a portion of the catheter body lumen for introducing one or more substances into the disc; and

an inflation tube extending through at least a portion of the lumen for inflating the expandable anchoring element.

88. The device of claim 87, wherein the inflation tube comprises a proximal diaphragm to allow inflation with a needle.

89. The apparatus of claim 87, further comprising: the syringe may be formed of a material selected from the group consisting of: stainless steel, tempered stainless steel, annealed stainless steel, polymers, and superelastic alloys.

90. The apparatus of claim 87, further comprising: the injection tube and inflation tube extend from the proximal end of the catheter body, and at least one adapter is removably connected to provide injection or inflation.

91. The apparatus of claim 87, further comprising: the injection tube and inflation tube extend coaxially through at least a portion of the catheter body lumen.

92. The apparatus of claim 87, further comprising: the injection tube and inflation tube extend in parallel through at least a portion of the catheter body lumen.

93. The apparatus of claim 87, further comprising: the injection tube and inflation tube extend coaxially through a portion of the catheter body lumen and extend side-by-side through another portion of the lumen.

94. The device of claim 68, wherein the proximal end of the proximal portion of the catheter body is bifurcated to form two separate proximal catheter body ends.

95. The device of claim 94, wherein the two proximal ends are each removably connected to an adapter to facilitate injection or inflation through each end.

96. The device of claim 68, further comprising a guide wire having a distal end shaped to retain the distal end within the disc.

97. The device of claim 96, wherein the distal end comprises at least one of a double wire guide wire, a wound coil, or a braided wire.

98. A system for introducing one or more substances into an intervertebral disc, the system comprising:

an introducing device; and

a catheter device for passing through an introducer device, said catheter device comprising:

an elongate, flexible catheter body comprising a proximal portion, a self-introducing distal portion for facilitating passage through the annulus fibrosis of the disc, and at least one lumen for introducing one or more substances into the intervertebral disc; and

at least one expandable anchoring element disposed along the catheter body for anchoring at least a portion of the distal portion of the catheter in the disc.

99. The system of claim 98, further comprising a sharp stylet removably positioned within the lumen of the catheter device for piercing the annulus fibrosis.

100. The system of claim 98, further comprising a guide wire over which the catheter device may be passed within the needle.

101. The system of claim 98, wherein the introducing means comprises an axially split shaft body covered with a frangible sleeve.

102. The system of claim 98, wherein the at least one anchoring element is located along the catheter body at or near the distal end.

103. The system of claim 98, wherein the at least one anchoring element comprises at least one expandable element.

104. The system of claim 98, wherein the at least one anchoring element comprises at least one shape memory, spring loaded, or mechanically driven element for increasing the effective cross-sectional diameter of the catheter body at or near the distal portion.

105. The system of claim 98, wherein the at least one anchoring element includes at least one outwardly bowed portion connected to an inner catheter shaft and an outer catheter shaft of the catheter body to bow outwardly upon axial movement of the inner shaft relative to the outer shaft.

106. The system of claim 98, wherein the at least one anchoring element comprises at least one attachment for attachment to the annulus fibrosis of the disc.

107. The system of claim 106, wherein the attachment member includes at least one threaded surface.

108. The system of claim 106, wherein the attachment comprises at least one helical needle.

109. The system of claim 98, wherein the at least one anchoring element comprises at least one deformable element to change at least a portion of the distal portion from a substantially linear shape to a substantially curved or geometric shape.

110. The system of claim 98, wherein the self-introducing distal portion comprises at least one advanceable portion having a stiffness greater than a stiffness of an adjacent portion of the catheter body.

111. The system of claim 111, wherein the self-introducing portion further comprises a tapered distal end of a catheter device.

112. The system of claim 98, wherein the catheter body comprises an anti-friction outer surface.

113. The system of claim 98, wherein the catheter body has an outer diameter of less than 2 millimeters.

114. The system of claim 113, wherein the inner diameter of the needle is about 0.1 mm to about 0.01 mm larger than the outer diameter of the catheter body.

115. The system of claim 98, wherein the catheter body includes an outer surface having one or more markers for indicating a depth of insertion of the catheter device into the patient.

116. The system of claim 98, wherein the catheter body includes an outer surface having two or more different colors for indicating the depth of insertion of the catheter device into the patient.

117. The system of claim 98, wherein the catheter body includes at least one radiopaque marker or material to facilitate visualization of the catheter device in the patient.

118. The system of claim 98, further comprising:

119. The system of claim 118, wherein the infusion lumen comprises a material selected from the group consisting of: stainless steel, tempered stainless steel, annealed stainless steel, polymers, and superelastic alloys.

120. A system as in claim 118, wherein the injection tube and inflation tube extend from the proximal end of the catheter body and are removably connectable to two separate adapters, respectively, to facilitate injection or inflation.

121. The system of claim 118, wherein the injection tube and inflation tube extend coaxially through at least a portion of the catheter body lumen.

122. The system of claim 118, wherein the injection tube and inflation tube extend side-by-side through at least a portion of the catheter body lumen.

123. The system of claim 118, wherein the injection tube and inflation tube extend coaxially through a portion of the catheter body lumen and extend side-by-side through another portion of the lumen.

124. The system of claim 98, wherein the proximal end of the proximal portion of the catheter body is bifurcated to form two separate proximal catheter body ends.

125. The system of claim 124, wherein the two proximal ends are each removably connected to an adapter to facilitate injection or inflation through each end.

126. The system of claim 98, wherein the guidewire includes a curved head to retain a distal portion of the guidewire within the disc.

127. The system of claim 98, wherein the guide wire includes at least one attachment to the annulus fibrosis of the intervertebral disc to retain the distal portion of the guide wire within the disc.

128. The system of claim 98, further comprising an implantable pump for connection to the catheter device to introduce the one or more substances into the disc over a period of time.

129. The system of claim 98, further comprising an implantable injection port for coupling with a catheter device for introducing one or more substances into the disc over a period of time.

130. The system of claim 98, further comprising an automatic injection device removably coupled to the conduit device for automatically introducing the at least one substance into the tray.

131. The system of claim 130, further comprising recording means for recording patient input values describing pain experienced by the patient.

132. A kit for introducing one or more substances into an intervertebral disc, the kit comprising:

a catheter device, the catheter device comprising:

an elongate, flexible catheter body having a proximal portion, a self-introducing distal portion for facilitating passage through the annulus fibrosis of the disc, and at least one lumen for introducing one or more substances into the intervertebral disc; and

at least one anchoring element disposed along the catheter body at or near the distal end for anchoring at least a portion of the catheter distal portion within the disc;

at least one implantable device removably connected to the catheter device for introducing one or more substances into the disc over a period of time; and

instructions for using the catheter device and the implantable device.

133. The kit of claim 132, wherein the implantable device comprises a pump.

134. The kit of claim 132, wherein the implantable device comprises an injection port.

135. The kit of claim 132, further comprising an introducer device to facilitate positioning the catheter device in the tray.

136. The kit of claim 135, further comprising a sharpened stylet removably positioned within the lumen of the catheter device for piercing the annulus fibrosis.

137. The kit of claim 135, further comprising a guide wire that can be threaded through the needle.