Source: http://www.google.com/patents/US6997941?dq=patent:6144888
Timestamp: 2014-12-28 07:13:14
Document Index: 99525171

Matched Legal Cases: ['application No. 60', 'application No. 60', 'application No. 60', 'application No. 60', 'application No. 60', 'application No. 60', 'application No. 60', 'application No. 60']

Patent US6997941 - Method and apparatus for treating annular fissures in intervertebral discs - Google PatentsSearch Images Maps Play YouTube News Gmail Drive More »Sign inAdvanced Patent SearchPatentsA device is described that may be positioned at a location in an intervertebral disc for diagnosis or treatment of the disc. Treatment may include, for example, applying energy or removing material, and may decrease intradiscal pressure. Radiofrequency energy may be applied. A percutaneous method of...http://www.google.com/patents/US6997941?utm_source=gb-gplus-sharePatent US6997941 - Method and apparatus for treating annular fissures in intervertebral discsAdvanced Patent SearchPublication numberUS6997941 B2Publication typeGrantApplication numberUS 10/388,609Publication dateFeb 14, 2006Filing dateMar 17, 2003Priority dateAug 13, 1996Fee statusPaidAlso published asUS6099514, US6126682, US6261311, US6290715, US6517568, US6547810, US7282061, US7400930, US7647123, US8128619, US8187312, US8226697, US20030181964, US20040102824, US20040111136, US20040111137, US20080039908, US20080039909, US20080051859, US20080058910, US20080091252, US20080262583Publication number10388609, 388609, US 6997941 B2, US 6997941B2, US-B2-6997941, US6997941 B2, US6997941B2InventorsHugh R. Sharkey, John Ashley, Joel Saal, Jeffrey A. Saal, Le Trong LeOriginal AssigneeOratec Interventions, Inc.Export CitationBiBTeX, EndNote, RefManPatent Citations (99), Non-Patent Citations (99), Referenced by (8), Classifications (127), Legal Events (7) External Links: USPTO, USPTO Assignment, EspacenetMethod and apparatus for treating annular fissures in intervertebral discsUS 6997941 B2Abstract A device is described that may be positioned at a location in an intervertebral disc for diagnosis or treatment of the disc. Treatment may include, for example, applying energy or removing material, and may decrease intradiscal pressure. Radiofrequency energy may be applied. A percutaneous method of repairing a fissure in the annulus pulposus comprises placing an energy source adjacent to the fissure and providing sufficient energy to the fissure to raise the temperature to at least about 45-70� C. and for a sufficient time to cause the collagen to weld. An intervertebral fissure also can be treated by placing a catheter with a lumen adjacent to the fissure and injecting sealant into the fissure via the catheter, thereby sealing the fissure. An intervertebral fissure additionally can be treated by providing a catheter having a distal end, a proximal end, a longitudinal axis, and an intradiscal section at the catheter's distal end on which there is at least one functional element. The next step is applying a force longitudinally to the proximal of the catheter which is sufficient to advance the intradiscal section through the nucleus pulposus and around an inner wall of an annulus fibrosus, but which force is insufficient to puncture the annulus fibrosus. Next the functional element is positioned at a selected location of the disc by advancing or retracting the catheter and optionally twisting the proximal end of the catheter. Then the functional unit treats the annular fissure. Optionally, there is an additional step of adding a substance to seal the fissure. An externally guidable intervertebral disc apparatus also is disclosed.
1. A device for treating an intervertebral disc, the device comprising:
an introducer including a needle, the introducer defining an introducer lumen, and the introducer having sufficient rigidity to penetrate an annulus fibrosus of an intervertebral disc; and a catheter configured to be inserted through the introducer lumen and into the intervertebral disc, the catheter having a distal region including a bipolar radiofrequency electrode configuration, the distal region having sufficient column strength to be advanced by blunt dissection through a nucleus pulposus of the intervertebral disc to an inner wall of the annulus fibrosus and sufficient rigidity in a direction out of a disc plane of the intervertebral disc to substantially inhibit bending in the direction. 2. The device of claim 1 wherein the needle comprises a 17-gauge needle.
3. The device of claim 1 or 2 wherein the introducer comprises a trocar.
4. The device of claim 1 wherein the catheter has a proximal region and the catheter has sufficient torsional strength to transmit rotation applied at the proximal region to the distal region, with the distal region located in the nucleus pulposus of the intervertebral disc.
5. The device of claim 1 wherein the catheter has a total length between 5 and 24 inches.
6. The device of claim 1 or 5 wherein the catheter is configured to be extended from the introducer a maximum distance of no greater than one and one-half times the circumference of the nucleus pulposus.
7. The device of claim 1 or 5 wherein the distal region comprises a biased region that permits advancement of the catheter from the introducer into the intervertebral disc in substantially only one lateral direction relative to a longitudinal axis of the introducer.
8. The device of claim 7 wherein the catheter has a proximal region and the catheter has sufficient torsional strength to transmit rotation applied at the proximal region to the distal region, with the distal region located in the nucleus pulposus of the intervertebral disc.
9. The device of claim 1 wherein the direction out of the disc plane comprises a direction orthogonal to the disc plane.
10. The device of claim 1 wherein the direction out of the disc plane comprises a direction along an axis defined by a spinal column.
11. A kit for treating an intervertebral disc, the kit comprising:
a needle and a trocar; and a catheter configured to be inserted through the needle and into the intervertebral disc, the catheter having a distal region including a bipolar radiofrequency electrode configuration, the distal region having sufficient column strength to be advanced by blunt dissection through a nucleus pulposus of the intervertebral disc to an inner wall of the annulus fibrosus and sufficient rigidity in a direction out of a disc plane of the intervertebral disc to substantially inhibit bending in the direction. 12. The device of claim 1 or 4 wherein the bipolar radiofrequency electrode configuration includes an active electrode and a return electrode, and the catheter further comprises a second active electrode.
13. The device of claim 1 wherein the catheter is further configured to conform sufficiently to the inner wall of the annulus fibrosus to contact multiple locations on the inner wall.
14. The device of claim 1 wherein the distal region of the catheter is configured to provide differential flexibility between the direction and at least one other direction.
15. The device of claim 14 wherein the catheter comprises a mandrel that provides the differential flexibility.
16. The device of claim 15 wherein at least a portion of the mandrel has a rectangular cross-section.
17. The device of claim 15 wherein at least a portion of the mandrel has a D-shaped cross-section.
18. The device of claim 15 wherein at least a portion of the mandrel has an oval cross-section.
19. The device of claim 2 wherein the catheter includes a sheath on at least a portion of an outer surface of the catheter.
20. The device of claim 19 wherein the sheath is formed of a polyimide material.
21. The device of claim 20 wherein the bipolar electrode configuration is disposed distal to a portion of the sheath.
22. The device of claim 21 wherein the catheter is configured to provide preferential localized heating so that water is removed from the nucleus pulposus.
23. The device of claim 21 further comprising a visible marker that is configured to show rotation of the catheter during use.
24. The device of claim 23 wherein the visible marker is disposed on a proximal end of the catheter.
25. The device of claim 2 further comprising a handle attached to a proximal end of the catheter, wherein the catheter includes a bend at the distal region and the handle includes a marker aligned with the bend.
26. The device of claim 25 wherein the catheter is adapted to be twisted at the handle to adjust a position within the nucleus pulposus of one or more electrodes in the bipolar radiofrequency electrode configuration.
27. The device of claim 26 wherein the catheter is adapted to be advanced through the nucleus pulposus and is configured to remove nucleus tissue by application of RF energy.
28. The device of claim 2 further comprising a handle adapted to allow the device to be gripped during a procedure, and wherein (i) the device is configured so that the handle can be used to adjust a position within the nucleus pulposus of one or more electrodes in the bipolar radiofrequency electrode configuration, and (ii) the device is configured to remove nucleus tissue by application of RF energy.
29. The device of claim 28 wherein the device is adapted to provide preferential local heating of the nucleus tissue.
30. The device of claim 29 wherein the preferential local heating of the nucleus tissue is adapted to remove at least water from the disc to decompress the disc.
31. The device of claim 2 wherein (i) the catheter includes a tube that provides stiffness to the catheter, (ii) the catheter includes a sheath disposed on at least a portion of the catheter, and (iii) a part of the radiofrequency electrode configuration is disposed distal to the sheath.
32. The device of claim 2 wherein an outer diameter of the catheter is between approximately 0.2 mm and approximately 5 mm.
33. The device of claim 32 wherein a total length of the catheter is between approximately 10 cm and approximately 60 cm.
34. The device of claim 33 wherein the total length of the catheter is between approximately 10 cm and approximately 30 cm.
35. The device of claim 34 wherein the catheter comprises a round metallic tube.
36. The device of claim 35 wherein one or more electrodes in the bipolar radiofrequency electrode configuration is disposed distal to the metallic tube.
37. The device of claim 36 wherein the catheter includes a polyimide sheath in addition to the metallic tube.
38. The kit of claim 11 wherein the catheter includes a sheath on at least a portion of an outer surface of the catheter.
39. The kit of claim 38 wherein the sheath is formed of a polyimide material.
40. The kit of claim 39 wherein the bipolar electrode configuration is disposed distal to a portion of the sheath.
41. The kit of claim 40 wherein the catheter is configured to provide preferential localized heating so that water is removed from the nucleus pulposus.
42. The kit of claim 41 wherein the catheter includes a visible marker that is configured to show rotation of the catheter during use.
43. The kit of claim 42 wherein the visible marker is disposed on a proximal end of the catheter.
44. The kit of claim 11 further comprising a handle attached to a proximal end of the catheter, wherein the catheter includes a bend at the distal region and the handle includes a marker aligned with the bend.
45. The kit of claim 44 wherein the catheter is adapted to be twisted at the handle to adjust a position within the nucleus pulposus of one or more electrodes in the bipolar radiofrequency electrode configuration.
46. The kit of claim 44 wherein the catheter is adapted to be advanced through the nucleus pulposus and is configured to remove nucleus tissue by application of RF energy.
47. The kit of claim 11 further comprising a handle attached to the catheter that is adapted to allow the catheter to be gripped during a procedure, and wherein (i) the catheter is configured so that the handle can be used to adjust a position within the nucleus pulposus of one or more electrodes in the bipolar radiofrequency electrode configuration, and (ii) the device is configured to remove nucleus tissue by application of RF energy.
48. The kit of claim 47 wherein the catheter is adapted to provide preferential local heating of the nucleus tissue.
49. The kit of claim 48 wherein the preferential local heating of the nucleus tissue is adapted to remove at least water from the disc to decompress the disc.
50. The kit of claim 49 wherein (i) the catheter includes a tube that provides stiffness to the catheter, (ii) the catheter includes a sheath disposed on at least a portion of the catheter, and (iii) a part of the radiofrequency electrode configuration is disposed distal to the sheath.
REFERENCES TO PARENT AND CO-PENDING APPLICATIONS The present application is a continuation of U.S. patent application Ser. No. 09/707,627, filed Nov. 6, 2000, now U.S. Pat. No. 6,547,810 which is a continuation of U.S. patent application Ser. No. 09/236,816, filed Jan 25, 1999, now U.S. Pat. No. 6,290,715, and a continuation-in-part of U.S. patent application Ser. No. 09/162,704, filed Sep. 29, 1998, now U.S. Pat. No. 6,099,514, U.S. patent application Ser. No. 09/153,552, filed Sep. 15, 1998, now U.S. Pat. No. 6,126,682, U.S. patent application Ser. No. 08/881,525, filed Jun. 24, 1997, now U.S. Pat. No. 6,122,549, U.S. patent application Ser. No. 08/881,692, filed Jun. 24, 1997, now U.S. Pat, No. 6,073,051, U.S. patent application Ser. No. 08/881,527, filed Jun. 24, 1997, now U.S. Pat. No. 5,980,504, U.S. patent application Ser. No. 08/881,693, filed Jun. 24, 1997, now U.S. Pat. No. 6,007,570, U.S. patent application Ser. No. 08/881,694, filed Jun. 24, 1997, now U.S. Pat. No. 6,095,149, and which claims priority to provisional application No. 60/047,820, filed May 28, 1997, provisional application No. 60/047,841, filed May 28, 1997, provisional application No. 60/047,818, filed May 28, 1997, provisional application No. 60/047,848, filed May 28, 1997, provisional application No. 60/045,941, filed May 8, 1997, provisional No. 60/029,734, filed Oct. 23, 1996, provisional application No. 60/029,735, filed Oct. 23, 1996, provisional application No. 60/029,600, filed Oct. 23, 1996, and provisional application No. 60/029,602, filed Oct. 23, 1996, each of which are incorporated herein by reference.
This application is related to the following applications and the applications to which they claim priority: �Method and Apparatus for Treating Intervertebral Discs with Thermal Energy�, by the same inventors as named for this application, filed on Jun. 24, 1997, and identified as Ser. No. 08/886,525; �Method and Apparatus for Treating Intervertebral Discs with Electrothermal Energy�, by the same inventors as named for this application, filed on Jun. 24, 1997, and identified as Ser. No. 08/881,692; �Method and Apparatus for Delivering and Removing Material from the Interior of an Intervertebral Disc�, by the same inventors as named for this application, filed on Jun. 24, 1997, and identified as Ser. No. 08/881,527; and �Method and Apparatus for Treating Intervertebral Disc Degeneration�, by the same inventors as named for this application, filed on Jun. 24, 1997, and identified as Ser. No. 08/881,694. The above applications are incorporated by reference.
FIGS. 1(a) and 1(b) illustrate a cross-sectional anatomical view of a vertebra and associated disc and a lateral view of a portion of a lumbar and thoracic spine, respectively. Structures of a typical cervical vertebra (superior aspect) are shown in FIG. 1(a): 104�lamina; 106�spinal cord; 108�dorsal root of spinal nerve; 114�ventral root of spinal nerve; 116�posterior longitudinal ligament; 118�intervertebral disc; 120�nucleus pulposus; 122�annulus fibrosus; 124�anterior longitudinal ligament; 126�vertebral body; 128�pedicle; 130�vertebral artery; 132�vertebral veins; 134�superior articular facet; 136�posterior lateral portion of the annulus; 138�posterior medial portion of the annulus; and 142�spinous process. In FIG. 1(a), one side of the intervertebral disc 118 is not shown so that the anterior vertebral body 126 can be seen. FIG. 1(b) is a lateral aspect of the lower portion of a typical spinal column showing the entire lumbar region and part of the thoracic region and displaying the following structures: 118�intervertebral disc; 126�vertebral body; 142�spinous process; 170�inferior vertebral notch; 110�spinal nerve; 174�superior articular process; 176�lumbar curvature; and 180�sacrum.
The presence of the spinal cord and the posterior portion of the vertebral body, including the spinous process, and superior and inferior articular processes, prohibit introduction of a needle or trocar from a directly posterior position. This is important because the posterior disc wall is the site of symptomatic annulus tears and disc protrusions/extrusions that compress or irritate spinal nerves for most degenerative disc syndromes. The inferior articular process, along with the pedicle and the lumbar spinal nerve, form a small �triangular� window (shown in black in FIG. 1(c)) through which introduction can be achieved from the posterior lateral approach. FIG. 1(d) looks down on an instrument introduced by the posterior lateral approach. It is well known to those skilled in the art that percutaneous access to the disc is achieved by placing an introducer into the disc from this posterior lateral approach, but the triangular window does not allow much room to maneuver. Once the introducer pierces the tough annulus fibrosus, the introducer is fixed at two points along its length and has very little freedom of movement. Thus, this approach has allowed access only to small central and anterior portions of the nucleus pulposus. Current methods do not permit percutaneous access to the posterior half of the nucleus or to the posterior wall of the disc. Major and potentially dangerous surgery is required to access these areas.
U.S. Pat No. 5,201,729 (the �'729 patent�) discloses use of an optical fiber that is introduced into a nucleus pulposus. In the '729 patent, the distal end of a stiff optical fiber shaft extends in a lateral direction relative to a longitudinal axis of an introducer. This prevents delivery of coherent energy into the nucleus pulposus in the direction of the longitudinal axis of the introducer. Due to the constrained access from the posterior lateral approach, stiff shaft and lateral energy delivery, the device of the '729 patent is unable to gain close proximity to seelected portion(s) of the annulus (i.e., posterior, posterior medial and central posterior) requiring treatment or to precisely control the temperature at the annulus. No use in treating an annular fissuer is disclosed. The device of the '729 patent describes ablating the nucleus pulposus.
SUMMARY OF THE INVENTION Accordingly, one aspect of the invention features a minimally invasive method and apparatus for diagnosing and treating fissures of discs at selected locations within the disc.
Methods for manipulating a disc tissue with a fissure or tear in an intervertebral disc, the disc having a nucleus pulposus and an annulus fibrosus, the annulus having an inner wall of the annulus fibrosus, employs employ an externally guidable intervertebral disc apparatus, or catheter. The procedure is performed with a catheter having a distal end, a proximal end, a longitudinal axis, and an intradiscal section at the catheter's distal end on which there is at least one functional element. The catheter is advanced through the nucleus pulposus and around an inner wall of an annulus fibrosus by applying a force to the proximal end, but the applied force is insufficient for the intradiscal section to puncture the annulus fibrosus. The next step is positioning the functional element at a selected location of the disc by advancing or retracting the catheter and optionally twisting the proximal end of the catheter. Then the functional unit treats the annular fissure.
In addition to the methods, there is provided an externally guidable intervertebral disc apparatus for diagnosis or manipulation of the disc tissue present at a selected location of an intervertebral disc, the disc having a nucleus pulposus, an annulus fibrosus, an inner wall of the annulus fibrosus, the nucleus pulposus having a diameter in a disc plane between opposing sections of the inner wall. The apparatus comprises a catheter having a distal end, a proximal end, and a longitudinal axis, and an intradiscal section at the catheter's distal end, which is extendible into the disc, has sufficient rigidity to be advanceable through the nucleus pulposus and around the inner wall of the annulus fibrosus under a force applied longitudinally to the proximal end, has sufficient flexibility in a direction of the disc plane to be compliant with the inner wall, and has sufficient penetration ability to be advanceable out through the annulus fibrosus under the force; and a functional element located at the intradiscal section for adding sufficient thermal energy at or near the fissure.
FIG. 5(a) is a cross-sectional view of the intervertebral segment of the embodiment of the invention shown in FIG. 3(a) taken along the line 5(a)�5(a) of FIG. 3(a).
The catheter is adapted to slidably advance through the introducer lumen, the catheter having an intradiscal section at the distal end of the catheter, the intradiscal section being extendible through the distal opening at the terminus of the introducer into the disc. Although the length of the intradiscal portion can vary with the intended function as explained in detail below, a typical distance of extension is at least one-half the diameter of the nucleus pulposus, preferably in the range of one-half to one and one-half times the circumference of the nucleus pulposus.
As with any medical instrument and method, not all patients can be treated, especially when their disease or injury is too severe. There is a medical gradation of degenerative disc disease (stages 1-5). See, for example, Adams et al., �The Stages of Disc Degeneration as Revealed by Discograms, � J. Bone and Joint Surgery, 68, 36-41 (1986). As these grades are commonly understood, the methods of instrument navigation described herein would probably not be able to distinguish between the nucleus and the annulus in degenerative disease of grade 5. In any case, most treatment is expected to be performed in discs in stages 3 and 4, as stages 1 and 2 are asymptomatic in most patients, and stage 5 may require disc removal and fusion.
Referring now to the figures, FIGS. 3(a) and 3(b) illustrate one embodiment of a catheter 14 of the invention as it would appear inserted into an introducer 12. The apparatus shown is not to scale, as an exemplary apparatus (as will be clear from the device dimensions below) would be relatively longer and thinner; the proportions used in FIG. 3(a) were selected for easier viewing by the reader. The distal portion of an intervertebral apparatus operates inside an introducer 12 having an internal introducer lumen 13. A flexible, movable catheter 14 is at least partially positionable in the introducer lumen 13. Catheter 14 includes a distal end section 16 referred to as the intradiscal section, which is designed to be the portion of the catheter that will be pushed out of the introducer lumen and into the nucleus pulposus, where movement of the catheter will be controlled to bring operational portions of the catheter into the selected location(s) within the disc, such as, for example, the annular tear. In FIG. 3(a), dashed lines are used to illustrate bending of the intradiscal portion of the catheter as it might appear under use, as discussed in detail later in the specification. FIG. 3(b) shows an end view of handle 11 at the proximal end of the catheter, with the handle 11 having an oval shape to indicate the plane of bending, also discussed in detail later in the specification. Other sections and properties of catheter 14 are described later.
Specific mechanical characteristics of particular designs will be described later in the examples that follow. Generally, however, the necessary design features can be selected (in an interrelated fashion) by first providing the intradiscal section of the catheter with sufficient column strength to be advanceable through normal human nucleus pulposus and around the inner wall of the annulus fibrosus without collapse. Here �collapse� refers to bending sufficient to inhibit further advancement at the tip. Advancement of the tip is restricted by 1) sliding through the normal gelatinous nucleus pulposus, 2) contacting denser clumps of nucleus pulposus, and 3) curving and advancing along the inner wall of the annulus. Column strength can be increased in many ways known in the art, including but not limited to selecting materials (e.g., metal alloy or plastic) with a high resistance to bending from which to form the catheter, forming the structure of the catheter with elements that add stiffening (such as bracing), and increasing the thickness of the structural materials. Column strength can be decreased to favor bending by selecting the opposite characteristics (e.g., soft alloys, hinging, and thin structural elements).
Particularly preferred for locations, such as, for example, annular tears, at the posterior of the annulus, the tip 28 of intradiscal section 16 is biased or otherwise manufactured so that it forms a pre-bent segment prior to contact with the annulus fibrosus as shown in FIG. 3(a). The bent tip will cause the intradiscal section to tend to continue to bend the catheter in the same direction as the catheter is advanced. This enhanced curving of a pre-bent catheter is preferred for a catheter that is designed to reach a posterior region of the nucleus pulposus; however, such a catheter must have sufficient column strength to prevent the catheter from collapsing back on itself.
Catheter 14 is not always pre-bent as shown in FIG. 3(a), but optionally can include a biased distal portion 28 if desired. �Pre-bent� or �biased� means that a portion of the catheter (or other structural element under discussion) is made of a spring-like material that is bent in the absence of external stress but which under selected stress conditions (for example, while the catheter is inside the introducer), is linear. Such a biased distal portion can be manufactured from either spring metal or superelastic memory material (such as Tinel� nickel-titanium alloy, Raychem Corp., Menlo Park Calif.). The introducer (at least in the case of a spring-like material for forming the catheter) is sufficiently strong to resist the bending action of the bent tip and maintain the biased distal portion in alignment as it passes through the introducer. Compared to unbiased catheters, a catheter with a biased distal portion 28 encourages advancement of intradiscal section 16 substantially in the direction of the bend relative to other lateral directions as shown by the bent location of intradiscal section 16 indicated by dashed lines in FIG. 3(a). That is, biased distal portion 28 permits advancement of intradiscal section 16 substantially in only one lateral direction relative to the longitudinal axis of introducer 12. More generally, embodiments of the intradiscal section may resist bending in at least one direction. Biasing the catheter tip also further decreases likelihood that the tip 29 will be forced through the annulus fibrosus under the pressure used to advance the catheter.
Referring now to FIG. 5(a), a guiding mandrel 32 can be included both to add rigidity to the catheter and to inhibit movement of catheter 14 in the inferior and superior directions while positioned and aligned in the disc plane of a nucleus pulposus 120. This aids the functions of preventing undesired contact with a vertebra and facilitating navigation. The mandrel can be flattened to encourage bending in a plane (the �plane of the bend�) orthogonal to the �flat� side of the mandrel. �Flat� here is a relative term, as the mandrel can have a D-shaped cross-section, or even an oval or other cross-sectional shape without a planar face on any part of the structure. Regardless of the exact configuration, bending will preferentially occur in the plane formed by the principal longitudinal axis of the mandrel and a line connecting the opposite sides of the shortest cross-sectional dimension of the mandrel (the �thin� dimension). To provide sufficient resistance to the catheter bending out of the desired plane while encouraging bending in the desired plane, the minimum ratio is 1.25:1 (�thickest� to �thinnest� cross-sectional dimensions along at least a portion of the intradiscal section). The maximum ratio is 20:1, with the preferred ratio being between 1.5:1 and 16:3, more preferably between 2:1 and 3.5:1. These ratios are for a solid mandrel and apply to any material, as deflection under stress for uniform solids is inversely proportional to the thickness of the solid in the direction (dimension) in which bending is taking place. For other types of mandrels (e.g., hollow or non-uniform materials), selection of dimensions and/or materials that provide the same relative bending motions under stress are preferred.
It is not necessary that the guiding mandrel 32 be flattened along its entire length. Different mandrels can be designed for different sized discs, both because of variations in disc sizes from individual to individual and because of variations in size from disc to disc in one patient The bendable portion of the mandrel is preferably sufficient to allow intradiscal portion 16 of the catheter to navigate at least partially around the circumference of the inner wall of the annulus fibrosus (so that the operational functions of the catheter can be carried out at desired location(s) along the inner wall of the annulus fibrosus). Shorter bendable sections are acceptable for specialized instruments. In most cases, a flattened distal portion of the mandrel of at least 10 mm, preferably 25 mm, is satisfactory. The flattened portion can extend as much as the entire length of the mandrel, with some embodiments being flattened for less than 15 cm, in other cases for less than 10 cm, of the distal end of the guide mandrel.
The guide mandrel can also provide the function of differential flexibility by varying the thickness in one or more dimensions (for example, the �thin� dimension, the �thick� dimension, or both) along the length of the mandrel. A guide mandrel that tapers (becomes gradually thinner) toward the distal tip of the mandrel will be more flexible and easier to bend at the tip than it is at other locations along the mandrel. A guide mandrel that has a thicker or more rounded tip than more proximal portions of the mandrel will resist bending at the tip but aid bending at more proximal locations. Thickening (or thinning) can also occur in other locations along the mandrel. Control of the direction of bending can be accomplished by making the mandrel more round, i.e., closer to having 1:1 diameter ratios; flatter in different sections of the mandrel: or by varying the absolute dimensions (increasing or decreasing the diameter). Such control over flexibility allows instruments to be designed that minimize bending in some desired locations (such as the location of connector of an electrical element to avoid disruption of the connection) while encouraging bending in other locations (e.g., between sensitive functional elements). In this manner, a catheter that is uniformly flexible along its entire length, is variably flexibility along its entire length, or has alternating more flexible and less flexible segment(s), is readily obtained simply by manufacturing the guide mandrel with appropriate thickness at different distances and in different orientations along the length of the mandrel. Such a catheter will have two or more different radii of curvature in different segments of the catheter under the same bending force.
Returning now to FIG. 5(a), the guiding mandrel 32 is generally located in the interior of catheter 14, where it shares space with other functional elements of the catheter. For example and as shown in FIG. 5(a), thermal energy delivery device lumen 34 can receive any of a variety of different couplings from an energy source 20 to a thermal energy delivery device (functional element) further along the catheter, including but not limited to a wire or other connector between thermal energy elements. Alternatively or concurrently, hollow lumen(s) 36 for delivery and/or removal of a fluid or solid connectors for application of a force to a mechanical element can be present, so no limitation should be placed on the types of energy, force, or material transporting elements present in the catheter. These are merely some of the possible alternative functional elements that can be included in the intradiscal portion of the catheter. Accordingly, a general description will now be given of some of the possible functional elements.
Some embodiments have an interior infusion lumen 36. Infusion lumen 36 is configured to transport a variety of different media including but not limited to electrolytic solutions (such as normal saline), contrast media (such as Conray meglumine iothalamate), pharmaceutical agents, disinfectants, filling or binding materials such as collagens or cements, chemonucleolytic agents and the like, from a reservoir exterior to the patient to a desired location within the interior of a disc (i.e., the fissure). Further, infusion lumen 36 can be used as an aspiration lumen to remove nucleus material or excess liquid or gas (naturally present, present as the result of a liquefying operation, or present because of prior introduction) from the interior of a disc. When used to transport a fluid for irrigation of the location within the disc where some action is taking place (such as ablation, which generates waste materials), the infusion lumen is sometimes referred to as an irrigation lumen. Infusion lumen 36 can be coupled to medium reservoir 21 through the catheter (see FIG. 3(a)).
Included in the particular embodiment shown in FIG. 5(a) is one or more sensor lumens 42. An example is a wire connecting a thermal sensor at a distal portion of the catheter to control elements attached to a connector in the proximal handle 11 of the catheter.
In one preferred embodiment, thermal energy delivery device 18 is a resistive heating device. As illustrated in FIG. 6. a heating coil 46 is positioned around an exterior of catheter 14. The heating element 46 need not be in the shape of a coil. For instance, the heating element can be in the form of a thin flexible circuit which is mountable on or in substantially one side of the intradiscal portion of the catheter. Heating element 46 is powered by a direct current source 20 (and less preferably a source of alternating current). Heating element is made of a material that acts as a resistor. Suitable materials include but are not limited to stainless steel, nickel/chrome alloys, platinum, and the like.
Referring now to the embodiment shown in FIG. 10, thermal energy delivery device 18 comprises one or more resistive heating elements 46 coupled to a resistive heating energy source. Resistive heating elements 46 are positioned along intradiscal section 16 at locations where they controllably deliver thermal energy to selected structures, including granulation tissue in a fissure 44 and the annulus surrounding the fissure. Resistive heating elements 46 can be segmented and multiplexed so that only certain resistive heating elements, or combinations of resistive heating elements are activated at any one particular time. Thermal sensor 48 can be positioned between resistive heating elements 46 and/or at an exterior or interior location of catheter 14. In the embodiment illustrated in FIG. 10, catheter 14 can be prepared with a wound helical structural element 49 to increase flexibility and minimize kinking. However, other structures and geometries are suitable for catheter 14, including but not limited to a substantially smooth surface (and specifically including the device using an internal guide mandrel as previously described). For example, a sheath can be provided over the heating element, and the guiding mandrel inside the coil can be encapsulated in silicone potting material. The tubing flexibility and the silicone potting material prevent kinking. Additionally, sheath 40 can be positioned around catheter 14 and also around resistive heating elements 46 to afford a substantially smooth surface. Resistive heating element 46 can be at least partially covered by a thermally insulating material, for example, along one side of the catheter, to selectively heat disc tissue on the opposite side.
Tensile Geometry (height, Strength % Conductivity Resistivity Melt temp. width, and/or dia.) Component in MPa Elongation cal/cm2/cm/sec/� C. nΩ * m � C. in mm Mandrel 600-2000 5-100 N/A N/A N/A height 0.2-2.3 width 0.05-0.5 Heating Element 300 min. 20 (min.) .025-0.2 500-1500* N/A 0.05-0.5 dia. Conductor N/A N/A .2-1.0 150 max.* N/A 0.1-0.5 dia. Wire Plastic sheath N/A 25 (min.) N/A N/A 80� (min.) 0.05-0.2 thickness Another preferred characteristic is that the minimum ratio of heating element resistivity to conductor wire resistivity is 6:1; the preferred minimum ratio of guiding mandrel height to guiding mandrel width is 2:1. Tensile strength and % elongation can be measured according to ASTME8 (tension test of metallic materials). Conductivity and resistivity can be determined by procedures to be found in ASTM Vol. 2.03 for electrothermal properties.
In some embodiments, inside the bands, coil, hypodermic tube, and both the polyimide sheath and internal polyimide tube is a guiding mandrel that extends from a proximal handle to the catheter tip. In one embodiment, this mandrel is 0.15 mm 0.5 mm and formed from 304 stainless steel. In another embodiment, it is a 0.3 mm diameter 304 stainless steel wire, with the distal 2.5 cm flattened to 0.2 mm by 0.5 mm.
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