Patent Application
20220105316
The following background description has been adapted from col. 1, line 38 to col. 3, lines 36 of U.S. Pat. No. 6,749,605 (Ashley et al.) and
Intervertebral disc abnormalities (e.g., morphologic) have a high incidence in the population and may result in pain and discomfort if internal tears develop and impinge on or irritate nerves. Disc abnormalities may be the result of trauma, repetitive use, metabolic disorders, and the aging process and include such disorders but are not limited to degenerative discs (i) localized tears or fissures in the annulus fibrosus, (ii) localized disc herniations with contained or escaped extrusions, and (iii) chronic, circumferential bulging disc.
Disc fissures occur rather easily after trauma or structural degeneration of fibrous components of the annulus fibrosus. Sneezing, bending or just attrition can tear these degenerated annulus fibers, creating a fissure. The fissure may or may not be accompanied by extrusion of nucleus pulposus material into or beyond the annulus fibrosus. The posterior annulus fibrosus is richly innervated and the contents of the nucleus pulposus are pro-inflammatory when they migrate into these tear, so damage to this region causes the majority of low back pain. The fissure itself may be the sole morphological change, above and beyond generalized degenerative changes in the connective tissue of the disc. Even if there is no visible extrusion, biochemicals within the disc may still irritate surrounding structures. Annular fissures can create severe pain and disability for patients and, because of a lack of blood supply, have a poor inherent capacity to heal. Initial treatment is symptomatic, including bed rest, pain killers and muscle relaxants. Spinal fusion with cages has been performed when conservative treatment did not relieve the pain. The fissure may also be associated with a herniation of that portion of the annulus.
With a contained disc herniation, there are no free nucleus fragments in the spinal canal. Nevertheless, even a contained disc herniation is problematic because the outward protrusion can press on the spinal nerves or irritate other structures. In addition to nerve root compression, escaped nucleus pulposus contents may chemically irritate neural structures. Current treatment methods include reduction of pressure on the annulus by removing some of the interior nucleus pulposus material by percutaneous nuclectomy. However, complications include disc space infection, nerve root injury, hematoma formation, instability of the adjacent vertebrae and collapse of the disc from decrease in height.
Another disc problem occurs when the disc bulges outward circumferentially in all directions and not just in one location. Over time, the disc weakens and takes on a “roll” shape or circumferential bulge. Mechanical stiffness of the joint is reduced, and the joint may become unstable. One vertebra may settle on top of another. This problem continues as the body ages, and accounts for shortened stature in old age. With the increasing life expectancy of the population, such degenerative disc disease and impairment of nerve function are becoming major public health problems. As the disc “roll” extends beyond the normal circumference, the disc height may be compromised, and foramina with nerve roots are compressed. In addition, osteophytes may form on the outer surface of the disc roll and further encroach on the spinal canal and foramina through which nerves pass. This condition is called lumbar spondylosis and spinal stenosis.
It has been thought that such disc degeneration creates segmental instability which disturbs sensitive structures which in turn register pain. Traditional, conservative methods of treatment include bed rest, pain medication, physical therapy or epidural steroid injections. Upon failure of conservative therapy, spinal pain (assumed to be due to instability) has been treated by spinal fusion, with or without instrumentation, which causes the vertebrae above and below the disc to grow solidly together and form a single, solid piece of bone. The procedure is carried out with or without discectomy. Other treatments include discectomy alone or disc decompression with or without fusion.
Nuclectomy can be performed by removing some of the nucleus to reduce pressure on the annulus. However, complications include disc space infection, nerve root injury, hematoma formation, and instability of adjacent vertebrae.
These interventions are problematic, because the alleviation of back pain is unpredictable even if surgery appears successful. In attempts to overcome these difficulties, fixation devices have been introduced to the market, including but not limited to pedicle screws and interbody fusion cages. Although pedicle screws provide a high fusion success rate, there is still no direct correlation between fusion success and patient improvement in function and pain. Studies on fusion have demonstrated success rates of between 50% and 67% for pain improvement, and a significant number of patients have more pain postoperatively. Therefore, alternative methods of improving the outcomes of patients with degenerative disc problems need to be explored, particularly through less invasive procedures.
It is desirable to diagnose and treat disc abnormalities such as disc degeneration at locations previously not accessible or identifiable via percutaneous approaches and without major surgical intervention or substantial destruction to the disc.
This invention relates to methods and apparatus to treat intervertebral disc problems resulting from pathology in the annulus fibrosus and/or for modifying intervertebral disc tissue. More particularly, this invention relates to percutaneous techniques to avoid major surgical intervention. In one embodiment, annular fissures are treated by the precise delivery of a fluid, e.g., a biologic agent, to damaged intervertebral discs of the lumbar spine. In one embodiment, a medical delivery device and associated method are provided for delivering therapeutic agents directly into the posterior outer annulus fibrosus of a lumbar intervertebral disc.
Embodiments provide a minimally invasive method and apparatus for diagnosing and treating fissures of discs around substantially the entire circumference of the annulus fibrosus of the disc. The cells in the annulus fibrosus of the disc respond well to biologic therapy to stimulate repair. The more precisely cells can be delivered to the damaged areas the better the anticipated clinical outcomes.
Embodiments provide a device which has a distal end that is inserted into the annulus fibrosus of an intervertebral disc and accesses the posterior, posterior lateral and the posterior medial regions between the inner and outer wall of the annulus fibrosus for delivery of a biologic therapy.
Embodiments provide an apparatus which is advanceable and navigable through tissue of and around the inner wall of the annulus fibrosus to provide a geographic biologic treatment to multiple identified and unidentified annular fissures.
Embodiments provide a non-destructive method and apparatus for treating morphologic abnormalities of discs.
Embodiments provide a method and apparatus to treat degenerative intervertebral discs by delivering a biologic to repair selective nerves embedded in the walls of the annulus fibrosus.
Embodiments provide an apparatus to treat degenerative intervertebral discs which is advanceable and navigational between the inner and outer wall of the annulus fibrosus without entry into the nucleus pulposus.
Embodiments of the present invention are designed to stay within the walls of the annulus fibrosus. Embodiments can include a closed end blunt tip or cap, that can be offset, with a side port that is designed to be orientated within the annulus to direct fluid flow during injection from the peripheral annulus toward the center nucleus pulposus. Embodiments can be used to deliver a biologic or, more specifically, an autologous biologic, such as marrow or Platelet Rich Plasma (PRP). When delivering a biologic to tissue, one would not typically heat the delivery catheter or cannula or deliver heat to the tissue, as heat can damage the biologic or render it ineffective. In some embodiments, a removable stylet is provided for placement within the delivery catheter. The removable stylet can be centerless ground to adjust its diameter over its effective length, can also have a pre-set bend, and can be made from a shape memory material such as nitinol. The stylet is removed after the delivery catheter is inserted to the desired position to allow for the injection of the biologic into the disc.
Damage to the annulus fibrosus is a result of a local weakening of the annular fibers. However, it is not possible to visualize the annulus architecture definitively prior to the procedure, and this architecture varies from patient to patient. Therefore, certain embodiments of this device include design elements allowing the stylet and/or catheter the structural flexibility to adapt to the internal tissue integrity of the annulus in a dynamic manner. This flexibility can be achieved through a combination of material choice and stiffness, a preset arc at the tip and potentially along the length of the device, or centerless grinding of the stylet. The resulting flexibility will allow the device to traverse the annulus circumferentially along the path of least resistance (i.e. the path with weaker annular tissue), ultimately allowing for the precise placement of the tip in the area of greatest tissue damage, thereby delivering the therapeutic agent broadly throughout the whole posterior annulus fibrosus.
A minimally invasive device for delivering a therapeutic agent percutaneously to a target tissue of an intervertebral disc includes an introducer needle and a delivery catheter. The introducer needle can be rigid and includes an elongated cannula having a proximal end and a distal end, the proximal and distal ends forming openings and being in communication along the cannula. A stylet extends through the cannula and has a tip that closes the opening at the distal end of the cannula. The cannula and stylet are configured to allow insertion of the needle percutaneously into tissue. The delivery catheter fits coaxially through the introducer needle when the stylet is removed, is longer than the introducer needle and includes an elongated hollow shaft that has a preset bend. The delivery catheter has a proximal end and a distal end, the proximal and distal ends forming openings and being in communication along the hollow shaft. The distal opening is a side opening to the inside of the preset bend. The distal end of the delivery catheter includes a blunt tip. The delivery catheter is extendable from the distal end of the introducer needle and into a target tissue of an intervertebral disc, the combination of the blunt tip and preset bend allowing the delivery catheter to advance through but not out of an annulus fibrosus of the intervertebral disc.
The blunt tip can be positioned on the shaft at the distal end of the delivery catheter at an angle that is offset from the center line of the delivery catheter. The blunt tip can be welded on the hollow shaft at the distal end of the delivery catheter and made of a material different from the shaft. For example, the hollow shaft of the delivery catheter can be made of nitinol. The blunt tip of the delivery catheter can be made of stainless steel.
The cannula of the introducer needle can have a preset bend at the distal end of the cannula. The preset bend at the distal end of the cannula can be about 3 mm to about 9 mm, preferably about 6.25 mm, from the distal tip with an angle between about 4 degrees and about 6 degrees, preferably with an angle of about 5 degrees.
The introducer needle can include a two-part handle with a first part of the handle attached to the cannula and a second part of the handle attached to the stylet, each part attached at the proximal end of the introducer needle. The second part of the handle and stylet can be selectively removable from the cannula, and the first part of the handle can define a passageway in communication with the opening at the distal end of the introducer needle when the first part of the handle and stylet are removed. The first part of the handle can include a luer hub.
The delivery catheter can include a luer lock connection at the proximal end of the delivery catheter. The luer lock enables delivery of the therapeutic agent from a syringe holding the therapeutic agent and being coupled to the luer lock.
The introducer needle and delivery catheter can have markings on the outside that allow determining the distance of insertion into the target tissue. For example, the delivery catheter can have one or more markings on the proximal end on the outside that allow determining the distance the delivery catheter is inserted beyond the introducer needle or retracted from the target tissue.
The target tissue can be a posterior outer third of the annulus fibrosus of the intervertebral disc.
The introducer needle can be configured to be inserted a pre-determined depth into the annulus fibrosus so that the combination of the starting point where the distal end of the delivery catheter exits the distal end of the introducer needle, the length the delivery catheter extends beyond the introducer needle when the catheter is fully extended beyond the distal end of the introducer needle, the preset bend of the delivery catheter, the blunt tip on the end of the delivery catheter, and stiffness or persistence length of the delivery catheter, results in the delivery catheter exiting into and staying within the tissue of the annulus fibrosus.
The delivery catheter can be configured to be retracted from the target tissue in set intervals, at each interval, a portion of a therapeutic agent being introduced into the annulus fibrosus. The therapeutic agent can be platelet rich plasma, bone marrow aspirate, bone marrow concentrate, adipose-derived cells, autologous or non-autologous fibrin, medications, contrast dye, or energy delivered over a fiber or probe.
The preset bend of delivery catheter can be such that the catheter upon exiting the introducer needle follows an oval path. For example, the preset bend of delivery catheter can be such that the catheter upon exiting the introducer needle follows a path having an initial diameter between about 1.5 cm and about 3.5 cm.
The length that the delivery catheter is extendable past the distal end of the introducer needle can be sufficient to travel at least 75% of the circumference of a circle based on the preset bend of the delivery catheter.
A method for minimally invasive delivery of a therapeutic agent percutaneously to target tissue of an intervertebral disc includes advancing a delivery catheter into target tissue of an intervertebral disc through an introducer needle placed in the intervertebral disc. The delivery catheter is longer than the introducer needle and has a proximal end and a distal end, the proximal and distal ends forming openings and being in communication along the delivery catheter. The distal opening of the catheter is a side opening. The distal end of the delivery catheter includes a blunt tip such that when the distal end of the delivery catheter is extended from the distal end of the introducer needle, the blunt tip allows the delivery catheter to advance through but not out of an annulus fibrosus of the intervertebral disc. The method further includes delivering a therapeutic agent through the distal side opening to the target tissue.
The delivery catheter can have a preset bend and the side opening can be to the inside of the preset bend. The location of the side opening facilitates delivery of the therapeutic agent to the target tissue, which can be a posterior outer third of the annulus fibrosus of the intervertebral disc.
Delivering the therapeutic agent can include retracting the delivery catheter from the target tissue in set intervals and, at each interval, delivering a portion of the therapeutic agent to the target tissue. The therapeutic agent being delivered can include platelet rich plasma, bone marrow aspirate, bone marrow concentrate, adipose-derived cells, autologous or non-autologous fibrin, medications, contrast dye, or energy delivered over a fiber or probe.
The method can further include inserting the introducer needle with a stylet positioned coaxially within the introducer needle to a pre-determined depth into the annulus fibrosus, and removing the stylet prior to advancing the delivery catheter. Advancing the delivery catheter into the target tissue can include guiding the delivery catheter with a blunt stylet positioned coaxially within the delivery catheter.
The foregoing will be apparent from the following more particular description of example embodiments, as illustrated in the accompanying drawings in which like reference characters refer to the same parts throughout the different views. The drawings are not necessarily to scale, emphasis instead being placed upon illustrating embodiments.
A description of example embodiments follows.
The terms “delivery catheter” and phrase “cannula of the delivery needle” are used in this disclosure to describe the hollow, longer catheter that fits coaxially through the shorter introducer needle.
An oval (from Latin ovum, “egg”) is a closed curve in a plane which “loosely” resembles the outline of an egg. Many distinct curves are commonly called ovals or are said to have an “oval shape.” Generally, to be called an oval, a plane curve should resemble the outline of an egg or an ellipse. In particular, these are common traits of ovals: 1. they are differentiable (smooth-looking), simple (not self-intersecting), convex, closed, plane curves; 2. their shape does not depart much from that of an ellipse, and 3. an oval would generally have an axis of symmetry, but this is not required. (Source: Oval, Wikipedia, https://en.wikipedia.org/wiki/Oval, accessed Jan. 30, 2019.)
In mathematics, an ellipse is a curve in a plane surrounding two focal points such that the sum of the distances to the two focal points is constant for every point on the curve. As such, it is a generalization of a circle, which is a special type of an ellipse having both focal points at the same location. (Source: Ellipse, Wikipedia, https://en.wikipedia.org/wiki/Ellipse, accessed Jan. 30, 2019.)
The persistence length is a basic mechanical property quantifying the stiffness of a polymer. (Source: Persistence length, Wikipedia, https://en.wikipedia.org/wiki/Persistence_length, accessed Jan. 30, 2019.)
The intervertebral disc is composed of a gelatinous central core (the nucleus pulposus) which is contained by 10-20 circumferentially oriented collagen fiber rings (the annulus fibrosus). There is a transition zone from the nucleus pulposus to the annulus fibrosus, whereby the outer fibers of the annulus fibrosus are generally stronger than the inner fibers.
Centerless grinding is a term that refers to selectively removing material from a solid wire to have a variable outer diameter (OD) along its length.
There are numerous prior approaches that use an introducer needle with a stylet to penetrate through the annulus fibrosus. The introducer needle when the stylet is removed creates a working channel to introduce a second longer needle or needles or probe into the nucleus pulposus. These double needle systems generally are either straight, curved, or a combination of straight and curved. These systems are designed to access a particular targeted treatment zone or multiple zones. Some of the approaches allow the shape of the combined channel created by the assembled cannulas of the device to access the target zone by traversing through both sides of the annulus fibrosis, across the nucleus pulposus, and through the inner wall of the annulus fibrosus distal to where the first puncture was made. Some approaches use curved needles.
For example, U.S. Pat. No. 9,113,950 to Schultz et al. teaches a therapeutic delivery device and associated method that includes a needle assembly. According to Schultz, the needle assembly can include either: 1) an introducer needle that internally constrains an advanceable cannula or 2) an introducer needle having the advanceable cannula and further includes an advanceable catheter internally constrained within the cannula. Schultz describes aspects of the needle assembly allow the cannula and catheter to be independently advanced by a user from the introducer needed to exact distances and with exact arch.
Some of the known approaches deliver therapy inside the nucleus pulposus by targeting the inner wall of the annulus fibrosus through a curved probe that conforms to the curved shape of the nucleus pulposus. Energy in the form of heat can be delivered over a second cannula or probe introduced into the nucleus pulposus through a first cannula. The heat can be sufficient to coagulate tissue as a means to seal the disc. The probe used to deliver the energy can be delivered over a guide wire that is introduced through a cannula of an introducer needle. See, for example, U.S. Pat. No. 6,749,605B2 to Ashley et al., U.S. Pat. No. 6,007,570 to Sharkey et al., and U.S. Pat. No. 6,878,155 to Sharkey et al.
Some art describes the use of needles to transverse the pedicle bone to access the marrow space of the vertebral body. See, for example, Pakter et al. U.S. Pat. No. 8,747,359, McGuckin et al. U.S. Pat. No. 8,784,382. Cook Medical sells a device called the Pakter needle system comprised of two needles, one introducer needle and a second delivery needle. The second delivery needle has a pre-set bend, is made of nitinol, fits coaxially through the introducer needle, and bends to access the inside of the nucleus pulposus.
Shah et al. describe a double needle system to deliver narcotic to nerves in the spine following failed back surgery. (Shah et al. Targeting the spinal nerve via a double-needle. transforaminal approach in failed back surgery syndrome: Demonstration of a technique. Pain physician. 7. 93-7. February 2004)
Kumar et al. describe a double needle technique to access the nucleus pulposus. (Kumar, Naresh & Agorastides, Ioannis (2000). The curved needle technique for accessing the L5/S1 disc space. The British journal of radiology. 73. 655-7.
101259/bjr.73.870.10911790.)
However, painful tears and herniations occur across and around the posterior circumference of the disc of the spine. These tears are not always easily identified, can be diffuse, and do not always communicate with the inner nucleus pulposus. Therefore, therapeutic agents delivered through entry of the nucleus pulposus do not necessarily flow throughout all of the painful tears. Prior needle systems are typically designed to access an individual zone or zones and often miss entire areas of damage, thereby limiting the potential therapeutic benefits of the injectate. In addition, the blood supply of the intervertebral disc is limited to the outer third of the annulus fibrosus. Delivery of fluids, e.g., biologic agents, to stimulate perivascular repair cells needs to be as close to the posterior annulus as possible.
There currently exists no device to reliably deliver therapeutic agents precisely throughout the entire posterior annulus fibrosus. Therefore, a better means of delivering therapy to the entire posterior circumference of the disc of the spine is needed. It will be appreciated that a device with the features described herein can also be used for the delivery of other materials (i.e. contrast agent or anesthetics) useful in the diagnosis and/or treatment of annular tears and fissures.
As illustrated in
As illustrated in
In use, the introducer needle 200 is inserted with the stylet 205 through the skin and into the annulus fibrosus of the intervertebral disc. The annulus is the fibrous outer tissue that surrounds the softer nucleus of the disc. The stylet 205 is removed and the catheter 300 is inserted through the introducer needle 200 into the annulus. Unlike prior approaches, the catheter 300 does not enter the nucleus but stays within the annulus.
As illustrated in
As illustrated in
The devices and methods described are improvements on prior approaches that use a double needle assembly to treat disc disease. Other approaches, for example, use needles to access single points on the annulus fibrosus by entering the nucleus pulposus and then traversing inner and outer walls of the annulus of the disc to access sites that are thought to be diseased or damaged. These needle delivery systems then deliver a therapeutic to the narrowly identified site. The shortcomings of these devices are that they do not treat the entire annulus fibrosus or substantially the entire circumference of the posterior annulus fibrosus. The current device addresses these and other shortcomings by assembling a novel combination of introducer needle and delivery catheter with specific preset bends and depth markings so that a clinician can reliably deliver therapy to inside a substantial portion of the circumference of the posterior annulus fibrosus of the disc space. The pre-set curve of the cannula can take on multiple different arches so that when the cannula is fully extended through the introducer cannula the shape of the cannula takes on an oval or elliptical shape and not a circular shape. An optional stylet can be assembled into the cannula to vary the persistence of length of the cannula. Various materials can be used to create the novel combination of depth of entry, curvature, persistence of length, to allow for delivery of a therapeutic through a catheter around a circular path within a boundary of tissue that resides subcutaneously, such as the annulus fibrosus. Different materials and combinations are described but are not meant to be limiting with respect to other such suitable materials that could be substituted.
In an embodiment, a minimally invasive intradiscal device is provided for delivering a therapeutic agent percutaneously to a target tissue. The device includes a rigid introducer needle with an elongated hollow rigid cannula having a first end and a second end, the first and second ends forming openings and in communication along the hollow shaft and a sharp stylet that protrudes from the distal end of the cannula, the shaft and stylet tip configured to allow insertion of the needle through the body and into a target tissue, the tip of the introducer needle can have a pre-specified bend or can be straight. A longer delivery catheter that fits coaxially through the introducer cannula when the stylet is removed, the delivery catheter having an elongated hollow cannula that also has a preset bend, the cannula having a first end and a second end, the first and second ends forming openings and in communication along the hollow shaft of the cannula and a blunt tip welded on the distal end of the cannula such that when the distal end of the delivery catheter exits the distal end of the introducer needle into the target tissue, the combination of the depth of the introducer needle into the tissue, the blunt tip catheter and preset bend allow the delivery catheter to be maneuvered through but not out of the target tissue. The blunt tip cap can be welded onto the distal end of the delivery cannula at an offset to improve the angle of attack to further facilitate the delivery catheter circumnavigating the inside of the target tissue. The target tissue can be, for example, the posterior outer annulus fibrosus. Nitinol is contemplated for the material of the delivery catheter. Stainless steel or Nitinol are contemplated for the welded tip. Alternatively, the cap can be from the Nitinol catheter by closing the end with a laser weld or other known means.
Other materials such as a polymer or a wire coil in the shape of a cannula are contemplated for the cannula of the delivery needle. The cannula of the delivery needle can have an open end and blunt stylet that protrudes past the end of the cannula. Additionally, the delivery cannula can be flexible without a preset bend and the curvature being provided by a nitinol stylet. The preset bent nitinol stylet is internally deployed in the delivery cannula, such a configuration causing the outer flexible cannula to take the shape of the internally deployed stylet. For example, a minimally invasive device for delivering a therapeutic agent subcutaneously comprised of a rigid introducer needle with an elongated hollow rigid cannula having a first end and a second end, the first and second ends forming openings and in communication along the hollow shaft and a sharp stylet that protrudes from the distal end of the introducer cannula, the shaft and stylet tip configured to allow insertion of the needle through the body and into a target tissue, and a longer delivery needle and cannula that fits coaxially through the introducer needle and cannula when the stylet is removed, the delivery needle has an elongated hollow flexible cannula formed from a wire coil or polyether ether ketone (PEEK), the coil or PEEK cannula having a first end and a second end, the first and second ends forming openings and in communication along the hollow shaft of the coil or PEEK cannula and a blunt stylet that protrudes from the distal end of the coil or PEEK cannula, the blunt tip stylet having a pre-set bend such that when the distal end of the delivery needle exits the distal end of the introducer needle into the target tissue, the combination of the internally deployed, preset bent blunt tip stylet allows the delivery cannula to advance in a circular trajectory to pass through but not out of the target tissue. The stylet is made of nitinol and can have a pre-set bend. Other material capable of maintaining a pre-set bend are also suitable. The internally deployed stylet inside the flexible coil or PEEK cannula causes the cannula to take on the same pre-set bend as the stylet. A closed end cap with at least one side port can be welded to the tip of the wire coil or PEEK cannula. The internally deployed stylet of the delivery cannula fits coaxially and dead ends against the cap on the distal end and can extend beyond the opening of the cannula on the proximal end. Pushing on the stylet advances the flexible wire or PEEK cannula forward. The combination of adjusting/setting the depth of the introducer needle along with the pre-set bend of the delivery cannula will allow the curved delivery needle to circumvent a large geography of the circular annular fibrosus of the disc without exiting into the nucleus pulposus or exiting outside the annular fibrosus. Any of the delivery cannulas disclosed can have a standard liter connection on the proximal end to allow for injection of the therapeutic as the cannula is withdrawn from the body.
Instead of PEEK, other suitable polymers may be used for the cannula.
As illustrated in
In one embodiment of the invention, the delivery catheter does not have a pre-set bend, is highly flexible, and can have a blunt cap (tip) with a side port formed or welded onto the distal end. In this embodiment, a stylet provides the stiffness to advance the catheter, and has a pre-set curve, to allow the assembled stylet and catheter to travel through the annulus after passing coaxially through the introducer cannula. In this embodiment, the catheter is a slave to the bend of the stylet. The stylet can have varying degrees of stiffness based on changing the OD through centerless grinding the stylet. This can then change the persistence length of the assembled stylet and catheter as the assembly passes through the annulus after passing coaxially through the introducer cannula.
The stylet can be made from, for example, Nitinol. The catheter can be made from, for example, PEEK or a wire wound tube. The blunt cap with side port can be formed onto the end of the PEEK tube or a blunt cap with a side port can be made of steel and can be welded onto the end of the wire wound tube. Multiple different stylets having varying persistence length and curves can be placed in a kit. If one stylet does not have the appropriate rigidity to navigate the annulus fibrosus, it can be removed and a second stylet with either less or more rigidity can be inserted. In this embodiment, one size cannula can be used with multiple stylets available to customize the curve or stiffness of the cannula based on the particular needs of the individual patient. The different stylets can be switched out during the procure based on what the clinician encounters. The pre-set curve of the stylet can take on multiple different arches so that when the assembled catheter and stylet is fully extended through the introducer cannula the shape the catheter takes is an oval or elliptical shape and not a circular shape. The stylet can be removed leaving just the catheter in place. Fluids can be injected through the catheter as it is retrieved after removing the stylet.
It is contemplated that the introducer cannula can be made from various materials to include both polymers and metals including nitinol and that the introducer cannula can have a pre-set bend. It is contemplated that a stylet can be used for the injection catheter and introducer cannula in any of the embodiments and that the stylet for the injection catheter can have varying angles of bend along its length and varying OD so that a unique persistence of length can be established.
Embodiments of the invention provide an intervertebral disc apparatus that includes an introducer needle and cannula and a delivery catheter and cannula. The delivery catheter is at least partially positioned in the introducer needle. The delivery catheter is configured to be advanceable around the annulus within the inner and outer walls. A biologic (i.e. autologous platelet rich plasma, bone marrow aspirate, bone marrow concentrate, fibrin, or non-autologous fibrin or cells, or a combination) is contemplated to be injected through the delivery catheter. Energy such as laser energy delivered over a fiber is also contemplated to be delivered through the delivery catheter.
Embodiments include providing an externally guidable intervertebral disc apparatus, the disc having a nucleus pulposus, an annulus fibrosus, and an inner and outer wall of the annulus fibrosus, the nucleus pulposus having a first diameter and the surrounding annulus and nucleus pulposus having a second bigger diameter. Access to the annulus between the inner and outer walls being provided by an introducer needle and the delivery catheter being deployed between opposing sections of the inner and outer wall of the annulus. The delivery catheter comprises an internal lumen with an opening at a terminus, comprising a hollow shaft having a distal end and a proximal end having a longitudinal access, the hollow shaft being adapted to slide through the introducer lumen, the catheter having an intradiscal curved section at the distal end of the catheter, the intradiscal curved section being extendable through the opening of the introducer and having sufficient rigidity to be advanceable through the tissue of the annulus of the disc between the inner and outer wall of the annulus fibrosus. Under a force applied longitudinally to the proximal end of the delivery catheter, such catheter under force having a bend and insufficient penetration ability to be advanceable through the wall of the outer annulus fibrosus but sufficient curvature and persistence of length to travel through the annulus fibrosus. The delivery catheter has depth markings on the proximal end. The delivery cannula is retracted from the disc in set intervals based on the depth markings. At each interval, a therapeutic agent is delivered to the disc, allowing for delivery of said agent broadly along the entire posterior circumference of the disc. Such agents contemplated can be platelet rich plasma, bone marrow aspirate or concentrate, adipose derived cells, fibrin autologous or non-autologous, laser energy delivered over a fiber optic that coaxially fits through the delivery catheter or other types of energy delivered through a probe that coaxially fits through the delivery catheter. The depth markings on the delivery cannula can be for instance every half centimeter.
A particular benefit of the device is that it allows for delivery of the biologic from both a posterior and anterior angle of attack when delivering a biologic or fluids to a disc.
The following is a step by step description of how the device can be used in practice.
The procedure is to be performed in an outpatient surgical suite or ambulatory care center under strict sterile conditions. It is to be performed under fluoroscopic guidance with intravenous sedation. The disc levels treated will be determined pre-procedure by the patient's history, physical examination, pain drawing and radiological testing.
The patient is placed in a prone position on the fluoroscopy table. After the usual sterile skin preparation, sterile draping of the treatment area, and local anesthesia a 17-gauge introducer needle is place using the standard extra-pedicular approach into the anterior lateral annulus fibrosus. Both anterior-posterior and lateral fluoroscopic images confirm proper needle placement. The stylet of the introducer needle is removed and then the semi-rigid catheter is manually advanced under fluoroscopic guidance into the anterior annulus fibrosus using the preset curved blunt tip to navigate. The catheter is slowly and gently advanced parallel to the end plates under lateral fluoroscopic imaging to the contralateral anterior annulus fibrosus and then to the contralateral posterior annulus fibrosus, across the posterior central annulus fibrosus, and finally to the ipsilateral posterior annulus fibrosus. Proper catheter placement is confirmed by both anterior-posterior and lateral fluoroscopic images.
The desired fluid is then injected slowly while the catheter is withdrawn in predictable increments to deliver the fluid throughout the whole posterior outer annulus fibrosus. Typical injected volumes would be 0.5-1.0 cc of fluid every 0.5-1.0 cm of movement. During this part of the procedure the side port is directed toward the inner disc as to not put abnormal force on the outer annulus fibrosus in order to not worsen the disc protrusion. A marker on the end of the disc catheter will notify the interventionalist as to the direction of the side port. Once the entire posterior annulus fibrosus has been bathed in fluid, the catheter is withdrawn back through the introducer needle and both the introducer needle and the catheter are removed manually from the disc. A sterile dressing is the applied to the wound and the patient is taken to the post-procedure recovery area to monitor for any adverse events.
The teachings of all patents, published applications and references cited herein are incorporated by reference in their entirety.
While example embodiments have been particularly shown and described, it will be understood by those skilled in the art that various changes in form and details may be made therein without departing from the scope of the embodiments encompassed by the appended claims.
This application claims the benefit of U.S. Provisional Application No. 62/800,215, filed on Feb. 1, 2019. The entire teachings of the above application are incorporated herein by reference.
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/US2020/016167 | 1/31/2020 | WO | 00 |
| Number | Date | Country | |
|---|---|---|---|
| 62800215 | Feb 2019 | US |
