Patent Application
20090062871
Injured intervertebral discs are generally treated with bed rest, physical therapy, modified activities, and pain medications for substantial treatment durations. There are also a number of treatments that attempt to repair injured intervertebral discs and to avoid surgical removal of injured discs. For example, disc decompression is a procedure used to remove or shrink the nucleus, thereby decompressing and decreasing the pressure on the annulus and nerves. Less invasive procedures, such as microlumbar discectomy and automated percutaneous lumbar discectomy, remove the nucleus pulposus of a vertebral disc by aspiration through a needle laterally inserted into the annulus. Another procedure involves implanting a disc augmentation device in order to treat, delay, or prevent disc degeneration. Augmentation refers to both (1) annulus augmentation, which includes repair of a herniated disc, support of a damaged annulus, and closure of an annular tear, and (2) nucleus augmentation, which includes adding material to the nucleus. Many conventional treatment devices and techniques, including open surgical approaches, involve muscle dissection or percutaneous procedures to pierce a portion of the disc under fluoroscopic guidance, but without direct visualization. Several treatments also attempt to reduce discogenic pain by injecting medicaments or by lysing adhesions in the suspected injury area. However, these devices also provide little in the form of tactile sensation for the surgeon or allow the surgeon to atraumatically manipulate surrounding tissue. In general, these conventional systems rely on external visualization for the approach to the disc and thus lack any sort of real time, on-board visualization capabilities.
Furthermore, accurately diagnosing back pain is often more challenging than many people expect and often involves a combination of a thorough patient history and physical examination, as well as a number of diagnostic tests. A major problem is the complexity of the various components of the spine, as well as the broad range of physical symptoms experienced by individual patients. In addition, the epidural space contains various elements such as fat, connective tissue, lymphatics, arteries, veins, blood, and spinal nerve roots. These anatomical elements make it difficult to treat or diagnose conditions within the epidural area because they tend to collapse around any instrument or device inserted therein. This may reduce visibility in the epidural space, and may cause inadvertent damage to nerve roots during device insertion. Also, the insertion of a visualization device may result in blocked or reduced viewing capabilities. As such, many anatomical elements within the epidural space may limit the insertion, movement, and viewing capabilities of any access, visualization, diagnostic, or therapeutic device inserted into the epidural space.
Some embodiments relate to balloon cannula systems for accessing and visualizing the spine and related methods of treatment, including a forward-looking balloon system for creating a working space and the balloon system having atraumatic dissection capability to allow visualization in spine. The devices and methods described herein may be used, for example, to perform annulus repair, herniated disc excision, and denervation of neurological tissue. The devices and methods may also be used to dispense pharmacological agents and/or cell or tissue therapy agents, to diagnose disc degeneration and bony degeneration, spinal stenosis, and nucleus decompression, and to perform disc augmentation.
In one embodiment, there is provided a method of accessing a portion of the spine including percutaneously approaching a portion of the spine with an instrument having direct visualization capability, providing an access to a portion of the spine using the instrument, and delivering a device into the access provided using the instrument. In a further embodiment, the method includes delivering an expandable structure adjacent a portion of the spine to be accessed and expanding the expandable structure. In another embodiment, the expandable structure is a balloon or an expandable atraumatic element and may contain a material or marker to enhance visualization of the structure using an imaging modality outside of the body. In another embodiment, the device to be delivered is a monitor, a therapy delivery device, a stimulation device or a pharmacological therapy device or, alternatively, the device comprises an electrode, and wherein providing an access to a portion of the spine comprises providing an access to the spinal epidural space. In another embodiment, the method includes implanting the device using the direct visualization capability of the instrument. In still another embodiment, expanding the expandable structure comprises atraumatically deforming a portion of the spinal dura mater to create a sufficient working space. In still other embodiments, a method includes providing an access to a portion of the spine, such as, providing an access to the spinal epidural space, the annulus, the layers of annulus, the disc nucleus, the facet joints, the foramen, or the muscle. In still another embodiment, the method also includes receiving visualization information from an imaging modality outside of the body such as, for example, from fluoroscopy, magnetic resonance imaging, and/or computer tomography. In still other embodiments, the method includes using the direct visualization capability of the instrument to maneuver the instrument between a spinal nerve root, the spinal dura and nerve tissue and other soft tissue, to atraumatically manipulate the spinal nerve root or other soft tissue and/or advancing the instrument while using a portion of the instrument to atraumatically manipulate the spinal nerve root or other soft tissue. In yet another embodiment, the method includes using the subject devices to deliver disc augmentation devices or nucleus augmentation devices or disc excision devices. In another embodiment, the balloon cannula device may be used for diagnostic purposes.
In one embodiment, a balloon cannula system (access system) is fitted with an extrusion (e.g. deflated balloon material) that is terminally bonded. Following positioning of the balloon cannula system at the targeted site to be treated, the balloon may be inflated and may be used as an atraumatic tool for dissection and/or an atraumatic tool to create working space, thereby enhancing visualization of the surrounding structures. In one embodiment, the balloon is a forward-looking structure so that the distal tip of the balloon may push obstructive tissue away from the scope, and the distal tip of the balloon may provide a depth of view between the scope and the targeted sites to be treated.
One embodiment is directed to a balloon cannula device comprising a multi-lumen elongated shaft, a balloon attached at its distal end of the shaft, wherein the proximal end of the balloon and distal end of the balloon are attached to the outer surface of the same elongated shaft, and wherein the balloon is constructed such that following inflation of the balloon, said balloon is forward-looking to create a working space distally to the viewing scope to enhance direct visualization. In another embodiment, the balloon of the balloon cannula system includes at least one portion that is elastically expandable. The expandable balloon may be inflated with air, sterile saline, contrasting agent, or other agents that may be delivered via a syringe or a pump. In some embodiments, the balloon is able to simultaneously undergo radial expansion and keep the forward-looking feature of the balloon cannula system. In one or more of the embodiments described herein, the distance between the points of attachment of the balloon to the same outer shaft of the elongated shaft is between about 1 mm and about 15 mm. In another embodiment, one end of the balloon is attached to a distal end of the balloon catheter in a flipped manner (e.g. everted or inverted), such that the internal surface of the balloon is in contact with the elongated shaft distally, and the outer surface of the balloon is in contact with the same elongated shaft proximally. In yet another embodiment, the balloon includes at least one elastically deformable portion. In yet another embodiment, the deformable portion is constructed of polyurethane.
Some embodiments also provide a balloon catheter having a proximal portion and a distal portion and one or more lumens, wherein said proximal portion contains 3 separate lumens, one of said lumens being suitable for allowing the passage of an endoscope, one of said lumens being suitable for inflation of a balloon, and the other lumen being suitable for allowing passage of therapeutic instruments or injection of medications. The distal portion of the balloon catheter may be a dual-lumen conduit, comprising an inflation lumen in communication with said lumen in the proximal portion and suitable for inflation of the balloon, and a common lumen in communication with the lumens of the proximal portion suitable for passage of the endoscope and the lumen suitable for allowing passage of therapeutic instruments or injection of medications. The balloon may comprise a balloon material attached at its distal end to the outer surface of said distal portion of the balloon catheter, and/or wherein at least part of said distal portion of the balloon catheter is constructed such that following inflation of the balloon, said balloon is forward-looking to create a working space distally to the viewing scope to enhance direct visualization. In another embodiment, the distal portion of the balloon catheter includes at least one portion that is elastically deformable when inflated. In yet another embodiment, at least one elastically deformable portion comprises polyurethane.
In another embodiment, an apparatus and method for treating spinal disorders in a patient in need of such treatment, includes introducing a balloon cannula device having direct visualization capability into the patient, steering the balloon cannula device to a position adjacent an outer surface of the spinal targeted site using visualization information provided by an endoscope or other visualization device in combination with the balloon cannula device, dissecting and/or displacing tissue with the balloon on the balloon cannula device to create a working space, and using the balloon cannula device to deliver a disc augmentation device for treating disc degeneration.
In one embodiment, a method for treating intervertebral disc degeneration in a spine includes introducing a balloon cannula device that permits direct visualization capability into a portion of the spine, inflating the balloon cannula to create a forward-looking capability to enhance visualization and displacement of tissues, and introducing a therapy device into the balloon cannula device to treat disc degeneration.
In another embodiment, a method for treating intervertebral disc degeneration in a spine of a body includes making an incision into a skin of the body, introducing a balloon cannula device that permits direct visualization into a portion of the spine, inflating the balloon cannula to create a forward-looking capability that enhances visualization and displacement of tissues, introducing a therapy device into balloon cannula device to treat disc degeneration, and treating the disc degeneration.
In another embodiment, a method for treating intervertebral disc degeneration includes introducing a balloon cannula device that permits direct visualization capability into a portion of the spine, steering the balloon cannula device to a position adjacent to an outer surface of the disc or nervous tissues using visualization information provided by a visualization system, displacing the nervous tissues or other tissues with a portion of the balloon cannula device to create a working area, using the balloon cannula device to deliver a therapy device for treating intervertebral disc degeneration, and treating the disc degeneration. The visualization system may be used in conjunction with the balloon cannula device or may be integrated with the balloon cannula device. In some embodiments, the therapy device is a nucleus decompression device configured to remove a portion of the nucleus, the annulus, or one or more fragmented segments of the vertebral disc. In some embodiments, a therapy device shrinks a portion of the nucleus or the annulus. Treating the disc degeneration may also comprise repairing a herniated disc, supporting a damaged annulus, adding material to the nucleus or annulus, and/or sealing an annulus. In one embodiment, displacing the tissues comprises expanding an expandable structure of the balloon cannula device.
In another embodiment, a system for intervertebral disc augmentation includes a balloon cannula device configured to deliver a disc augmentation device to an intervertebral disc. In one embodiment, the balloon cannula device includes an elongate body, an expandable structure, a direct visualization device, and at least one working channel. The expandable structure may be a mesh, a balloon, an atraumatic element, or a combination thereof. In one or more of the embodiments, the expandable structure may be configured to deform a portion of the spinal dura mater or tissues in the spinal area, and to create a working area. In one or more of the embodiments, the expandable structure comprises a forward-looking balloon. A direct visualization device inserted into the balloon cannula device or integral with the balloon cannula device may provide visualization information from an image generated by a sensor located on the direct visualization device. In some embodiments, the augmentation device comprises at least one mesh, cage, barrier, patch, scaffold, sealing means, hydrogel, silicone, growth factor, or combination thereof. In some embodiments, the augmentation device is an ablation device, a grasper or forceps, or a temperature-controlled energy element, for example. The energy element may be a thermal energy device that delivers resistive heat, radiofrequency, coherent and incoherent light, microwave, ultrasound or liquid thermal jet energies to the nucleus.
In another embodiment, a method of diagnosing disc degeneration in a patient includes introducing a balloon cannula device permitting direct visualization capability into a portion of the spine, steering the balloon cannula device using visualization information provided by the balloon cannula device, displacing the nervous tissues or other tissues with a portion of the balloon cannula device to create a working area, and assessing the condition of targeted site. The balloon cannula device may comprise a material or marker to enhance visualization of the structure using an imaging modality outside of the body. The method may include receiving visualization information from an imaging modality outside of the body. The imaging modality may comprise fluoroscopy and/or magnetic resonance imaging. The visualization information may be provided from an image generated by a sensor located on the visualization device. The balloon cannula device may also include a sensor for collecting diagnostic data.
In another embodiment, a kit for augmenting the intervertebral disc may include at least one disc augmentation device, a balloon cannula device having a forward-looking balloon at its distal tip, an endoscopic mechanism having direct visualization capabilities, and instructions for locating the at least one disc augmentation device using the balloon cannula device. The kit for decompressing the nucleus of an intervertebral disc may also include at least one nucleus decompression device, a balloon cannula device having a forward-looking balloon at its distal tip that permits direct visualization using an endoscope or other visualization device, and instructions for decompressing the nucleus of an intervertebral disc using the balloon cannula device.
In another embodiment, a method for treating intervertebral disc degeneration includes introducing a balloon cannula device permitting direct visualization into a portion of the spine using a visualization mechanism, displacing the spinal column matter with a portion of the balloon cannula device to create a working area, and using the balloon cannula device to deliver a stimulation electrode device for treating intervertebral disc degeneration. In one or more of the embodiments, the balloon cannula device may be steered to a position within the spinal column using the direct visualization of a visualization mechanism positioned within the balloon cannula device. The method may also include introducing a balloon cannula device permitting direct visualization into a portion of the spine using a visualization mechanism, steering the balloon cannula device using visualization information provided by the visualization mechanism, displacing the tissues in spinal area with a portion of the balloon cannula device to create a working area, and using the balloon cannula device to deliver a stimulation electrode device for treating intervertebral disc degeneration. The visualization mechanism, such as an endoscope, may be placed into the balloon cannula device or may be integrally formed with the balloon cannula device.
In another embodiment, a balloon cannula device for assessing a target site within the body may include a multi-lumen elongated shaft and a balloon attached at a distal end of the shaft, wherein the proximal end and distal end of the balloon are attached to the outer surface of the elongated shaft and wherein the balloon is constructed such that following inflation of the balloon, the balloon is forward-looking and create a working space distally to the viewing scope to enhance direct visualization.
In another embodiment, a balloon cannula device for visualizing a target site within body may include a proximal portion and a distal portion, at least three lumens positioned within the proximal portion, wherein at least one lumen is suitable for allowing the passage of endoscope, at least one lumen is suitable for inflation of a balloon, and at least one lumen is suitable for allowing passage of therapeutic instruments or injection of medications. In some embodiments, at least two lumens may be positioned within the distal end, and at least one of the lumens permits visualization of therapeutic instruments or injected medications. A balloon may be attached to an outer surface of the distal portion of the balloon cannula device, and at least part of the distal portion of the balloon cannula device may be constructed such that following inflation of the balloon, the balloon is forward-looking to create a working space distally to enhance direct visualization. In one or more of the embodiments described herein, the balloon is constructed of polyurethane, but in other embodiments may be constructed of a polymer material other than polyurethane.
In another embodiment, a balloon cannula device for visualizing a target site within body may include an elongated shaft having a proximal portion and a distal portion, wherein the proximal portion contains four separate lumens, one of said lumens being suitable for allowing the passage of the endoscope and/or irrigation therethrough, one of said lumens being suitable for allowing the passage for therapeutic instruments and/or aspiration, one of the said lumens being suitable for inflation of the balloon, and one of said lumens for additional aspiration or irrigation. The distal portion of the balloon cannula device may contain three lumens, with one of said lumens being the continuation of the lumen for the endoscope and/or irrigation, one of said lumens being the continuation of the lumen for therapeutic instruments and/or aspiration, and one of said lumens being the continuation of lumen for additional aspiration or irrigation. The balloon may be attached at its distal end of the balloon cannula device, in such a way that one end of the balloon is attached at its distal end in an flipped manner, with the internal surface of said balloon in contact with the catheter shaft distally, and the outer surface of said balloon in contact with the same catheter shaft proximally. The distal portion of the device may be constructed such that following inflation of the balloon, the balloon is able to simultaneously undergo radial expansion and keep the forward-looking aspect. The use of any one lumen need not be limited to a particular instrument or procedure, and may be used differently from the exemplary embodiments disclosed herein. In some embodiments, two or more lumens may be used for the same purpose during a procedure.
In one embodiment, a minimally invasive spinal endoscopy system is provided, comprising a tubular shaft with a slotted flexion zone, at least two slidable control wires, a proximal end, a distal end, at least two irrigation channels, an inflation channel, at least one non-circular instrument channel, and a visualization channel. In some examples, the tubular shaft may have an average diameter of less than about 3.5 mm. The system may further comprise a movable actuator attached to at least two slidable control wires, a housing enclosing the proximal end of the tubular shaft and at least a portion of the movable actuator, and an inflatable balloon. The balloon may comprise an extruded tubular polymeric material comprising a folded section and post-extrusion reoriented polymer chains, a proximal attachment to the tubular shaft and a distal attachment to the tubular shaft, wherein the spacing between the proximal attachment and the distal attachment has a fixed distance, a proximal end that is proximal to the distal end of the shaft, a distal end that is distal to the distal end of the tubular shaft, an open-ended common balloon lumen between the distal end of the shaft and the distal end of the inflatable balloon, wherein the open-ended common balloon lumen has a length of at least 1 mm and is in communication with at least two irrigation channels and at least two non-circular instrument channels, and a balloon cavity in communication with the inflation channel of the tubular shaft, wherein the inflatable balloon has a substantially cylindrical uninflated configuration and a substantially toroidal inflated configuration having a diameter that is about three to about six times greater than the longitudinal length of the open-ended common balloon lumen when the inflatable balloon is inflated to at least about 60 psi, wherein the average diameter of the open-ended common balloon lumen decreases by less than about 15% from the uninflated configuration to the inflated configuration at a pressure of at least about 60 psi. The minimally invasive spinal endoscopy system may further comprise an endoscope with a shaft having an average diameter of less than about 1 mm and configured for insertion into the visualization channel. In some examples, the visualization channel may have a smaller cross-sectional area than at least one instrument channel. The minimally invasive spinal endoscopy system may also further comprise a guidewire, a dilator, an introducer sheath, a tissue debrider, a grasper, a coagulation probe, and an infusion cannula configured for insertion into at least one instrument channel.
In another embodiment, a minimally invasive device for use in a body is provided, comprising a tubular body comprising a proximal end, a distal end, a first lumen therebetween, and an inflation lumen, and an inflatable member with an inflation chamber in communication with the inflation lumen of the inflatable member, a proximal end, a distal end, a balloon lumen therebetween that is in communication with the first lumen of the tubular body. The proximal end of the inflatable member may be proximal to the distal end of the tubular body and the distal end of the inflatable member may be distal to the distal end of the tubular body. The inflatable member may also have a base unexpanded configuration and an expanded configuration. The inflatable member may be configured to return toward the unexpanded configuration when deflated from the expanded configuration. In some examples, the inflatable member may comprise a biaxially oriented material, including an extruded polymeric material with post-extrusion reoriented polymer chains. The system may be configured such that the average cross-sectional area of the second lumen changes less than 10 percent between the unexpanded configuration and the expanded configuration. The device may also further comprise a second lumen between the proximal end and the distal end of the tubular body, wherein the second lumen is in communication with the balloon lumen of the inflatable member. The first lumen may also have a non-circular shape. In certain steerable embodiments, the tubular body further comprises at least one deflection wire and a flexion plane. The first lumen of the tubular body comprises a first central axis, the second lumen of the tubular body may comprise a second central axis, and the first central axis and the second central axis are located generally along a plane perpendicular to the flexion plane of the tubular body. The inflatable member may also comprise a toroidal shape. In some further embodiments, the distance between the proximal end of the inflatable member and the distal end of the tubular body may be about three times to about seven times greater than a distance between the distal end of the inflatable member and the distal end of the tubular body, but in other embodiments, may be about four times to about six times greater than a distance between the distal end of the inflatable member and the distal end of the tubular body. The device may also comprise a cannula with a distally extending inflatable member with a through lumen, wherein the inflatable member is sealed to the cannula to withstand an inflation pressure of at least about 40 psi, or even at least about 60 psi.
In one embodiment, a kit for performing a medical procedure may be provided, comprising a cannula comprising a cannula lumen and a distally extending inflatable member with a through lumen, and a rotatable tissue removal device configured for insertion through the cannula and into the through lumen of the distally extending inflatable member. The kit may also further comprise an endoscope configured for insertion into the cannula.
In another embodiment, a method for minimally invasively accessing a body site is provided, comprising providing a tubular body with an inflatable member located at a distal end of the tubular body and protruding distally from the distal end of the tubular body, wherein the inflatable member has a common lumen, an unexpanded configuration and an expanded configuration, inserting the tubular body toward a non-vascular target site in a body, inflating the inflatable member to the expanded configuration while in the body, and visualizing the non-vascular target site from the tubular body and through the common lumen of the distally protruding inflatable member. The method may also optionally comprise inserting an endoscopic device into the tubular body. The endoscopic device may or may not be inserted into the through lumen of the inflatable member. The method may also include advancing the distal end of the tubular body toward a neural structure in contact with a non-neural structure, displacing the neural structure from the non-neural structure using the inflatable member, and/or orienting the common lumen of the inflatable member with the non-vascular target site.
In another embodiment, a method of manufacturing a medical component is provided, comprising providing a first tubular body comprising a proximal end and a distal end, providing a second tubular body comprising a proximal end, a distal end and an intermediate section therebetween, attaching the proximal end of the second tubular body at a first attachment site proximal to the distal end of the first tubular body while positioning the distal end of the second tubular body distal to the distal end of the first tubular body, and attaching the distal end of the second tubular body to the first tubular body so that at least a portion of the intermediate section of the second tubular body is distal to the distal end of the first tubular body. In some embodiments, the second tubular body may be cylindrical and/or may be an extruded tubular body. In some examples, the method may further comprise pressurizing the second tubular body while the second tubular body is heated (e.g. to a temperature of at least 110 degrees F.), which may be followed by cooling the second tubular body while the second tubular body is pressurized. In other examples, the second tubular body may be inserted into a third tubular body before pressurizing the second tubular body. In some instances, the proximal end and the distal end of the second tubular body may be sealed to the first tubular body to withstand an inflation pressure of at least about 40 psi without significant separation of the second tubular body from the first tubular body. The attachment of the distal end of the second tubular body may occur before or after attaching the proximal end of the second tubular body.
Another embodiment comprises a method for treating intervertebral disc degeneration in a spine, which may involve introducing a balloon cannula device having direct visualization capability into a portion of a spine, inflating the balloon cannula to create a forward looking capability to enhance visualization and displacement of tissues, and introducing a therapy device into the balloon cannula device to treat disc degeneration. The therapy device may have a variety of configurations, including to configuration that provide structural support to a disc annulus of the spine, those that can seal a torn annulus, and/or those that add or remove additional material to the nucleus.
In some embodiment, a method for treating intervertebral disc degeneration in a spine of a body may comprise making an incision into a skin of the body, introducing a balloon cannula device having direct visualization component into a portion of the spine, inflating the balloon cannula to create a forward looking capability to enhance visualization and displacement of tissues, introducing therapy device into balloon cannula device to treat disc degeneration, and treating the disc degeneration.
In another embodiment, a method for treating intervertebral disc degeneration may comprise introducing a balloon cannula device having direct visualization capability into a portion of the spine, steering the balloon cannula device to a position adjacent an outer surface of the disc or nervous tissues using visualization information provided by the balloon cannula device, displacing the nervous tissues or other tissues with a portion of the balloon cannula device to create a working area, using the balloon cannula device to deliver a therapy device for treating intervertebral disc degeneration, and treating the disc degeneration. The therapy device may be a nucleus decompression device to remove a portion of the nucleus, annulus, or fragmented segments, or a therapy device shrinks a portion of the nucleus or annulus, for example. More than one therapy device may be provided or used with the balloon cannula device. Treatment of the disc degeneration may comprise repairing a herniated disc, supporting a damaged annulus, sealing an annulus, adding material or removing material with respect to the nucleus or annulus, and/or expanding an expandable structure of the balloon cannula device.
The invention is best understood from the following detailed description when read in conjunction with the accompanying drawings. It is emphasized that, according to common practice, the various features of the drawings may or may not be to-scale. On the contrary, the dimensions of the various features may be arbitrarily expanded or reduced for clarity. Included in the drawings are the following figures:
Conventional systems often rely on external visualization such as fluoroscopy and CT scanning for the approach to the disc, and thus lack any sort of real time, on-board visualization capabilities. Also, existing devices provide little in the form of tactile sensation for the surgeon and do not allow the surgeon to atraumatically manipulate surrounding tissue.
There is a need, therefore, for minimally invasive techniques and systems that provide the capability to diagnose or repair the spine using direct visualization while minimizing damage to surrounding anatomical structures and tissues. There is also a need for a method and device that allows a physician to effectively enter the epidural space of a patient, clear an area within the space to enhance visualization and use the visualization capability to diagnose and treat the disc injury.
The embodiments disclosed herein will be more clearly understood and appreciated with respect to the following Detailed Description, when considered in conjunction with the accompanying Drawings.
The shaft 102 of the balloon cannula device 100 may include one or more working channels. In
Proximally, one or more of the lumens or channels 126, 128, 130 and 132 of the tubular shaft 102 may be in communication with one or more ports 108, 110, 112 and 114. In the embodiment depicted in
Distally, the visualization channel 128 may terminate about the distal end 106 of the shaft 102. The visualization channel 128 may be used as a passage for insertion/removal of illumination, visualization, and/or imaging components to provide direct visualization capabilities at the distal end 106 of the balloon cannula device 100. In some embodiments, a visualization channel 128 may house or may be integral with one or more illumination, visualization, analytical, and/or imaging components, including but not limited to one or more fiber-optic strands used to transmit light from a light source or to optically visualize the anatomy about the distal end 106 of the shaft 102.
As noted in the embodiment depicted in
In the particular embodiment depicted in
Embodiments of the balloon cannula device 100 may facilitate the positioning of an instrument in a targeted area. For example, the instrument may be steered using information, such imaging or physiological data, generated by a data device located on the instrument. The image may come from a data device such as a camera placed on the distal end of the instrument, or from a sensor or combination of sensors. In one embodiment, the sensor utilizes light to generate the image. In another embodiment, the sensor is adapted to see through the bloody field as presented in the spinal region by selecting at least one infrared wavelength transparent to blood or other bodily fluids. In some embodiments, at least one infrared wavelength transparent to blood presented in the spinal field may have a wavelength of about 1 micron to about 15 microns. In another embodiment, the at least one infrared wavelength transparent to blood presented in the spinal field has a wavelength between about 1.5 micron to about 6 microns. In yet another embodiment, the at least one infrared wavelength transparent to blood presented in the spinal field has a wavelength between about 6 microns to about 15 microns. In yet another embodiment, the at least one infrared wavelength transparent to blood presented in the spinal field has a wavelength between about 1.0 microns to about 1.5 microns, about 1.5 microns to about 1.9 microns, about 2.0 microns to about 2.4 microns, about 3.7 microns to about 4.3 microns, or about 4.6 microns to about 5.4 microns. In yet another embodiment, the wavelength is selected or adapted for use in distinguishing nervous tissue from surrounding tissue and/or minimally vascularized nervous tissue. In yet another embodiment, the wavelength is selected to distinguish nervous tissue from muscle. Wavelength selection information and characterization and other details related to infrared endoscopy are found in U.S. Pat. No. 6,178,346; US Patent Application Publication No. 2005/0014995, and US Patent Application Publication No. 2005/0020914, each of which is hereby incorporated by reference in its entirety for all purposes.
The visualization channel 128 or the distal end 106 of the device 100 may include a sensor used to generate images or identify tissue. In one example, the sensor utilizes acoustic energy to generate the image, similar to diagnostic ultrasound. In another example, the sensor utilizes an electrical characteristic to generate the image or other types of structural or physiological information. In yet another example, the sensor distinguishes the type of tissue adjacent to the sensor. Some properties used by the sensor to differentiate adjacent structures or tissue include resistance, capacitance, impedance, membrane voltage, acoustic, and optical characteristic of tissue adjacent the sensor or probe. Additionally, the sensor or image may be used to distinguish different types of tissue to identify neurological tissue, collagen, or portions of the annulus, for example. It is to be appreciated that the sensor may be a multi-modal or multi-sensor probe that can distinguish bone, muscle, nerve tissue, fat, etc. to help position the probe in the proper place.
In some embodiments, a trocar may be guided using fluoroscopic or other external imaging modality to place the trocar in proximity to a treatment area. In contrast to conventional procedures that attempt to fluoroscopically navigate a trocar tip around nerves and other tissue, the trocar may remain safely positioned away from sensitive structures and features. In one embodiment, the trocar tip remains about 1 to about 2 cm or more from vulnerable nerve tissue. In another embodiment, the last about 1 to about 2 cm of travel to a therapy site is performed using direct visualization provided by a visualization mechanism in the balloon cannula device.
In some embodiments, the trocar is removed and the balloon cannula device 100 is inserted into the pathway formed by the trocar. In other embodiments, a tubular trocar may be used. From the final trocar position, the balloon cannula device 100 may be passed through a channel or lumen of the trocar and along the remaining distance to the therapy or treatment site using the onboard visualization capabilities. The onboard visualization may be used alone or in combination with the balloon 116 or other type of atraumatic tip to identify, atraumatically displace, and/or maneuver around nerves and other tissue as needed. An optional steering mechanism may be provided on the balloon cannula device 100 to manipulate surrounding tissue and structures, and/or to traverse the remaining distance to one or more therapy or treatment sites. In other embodiments, the balloon cannula device 100 may have a rigid or fixed configuration, and may be manipulated by optionally manipulating the trocar to reach a desired location. In an alternative embodiment, the trocar may house the balloon cannula device during trocar insertion and thus utilize the direct visualization capabilities of the visualization mechanism within the balloon cannula device to guide trocar positioning. In still another embodiment, the trocar may be provided with a separate imaging system from the imaging device or component provided in the balloon cannula device for use during trocar insertion. In still another embodiment, the trocar may be configured with a lumen to house only the imaging component from the balloon cannula device 100. After the desired trocar position is reached, the trocar is removed and the imaging component is removed from the trocar and reinserted into the balloon cannula device 100. In yet another alternative embodiment, both external imaging may be used to position the trocar distal end, either alone or in combination with direct imaging.
As mentioned previously, one or more embodiments of the balloon cannula device may be provided with any of a wide variety of steering configurations, such as the steering mechanism 120 depicted in
The dimensions of the balloon cannula device may be sized and selected based on the particular therapy being provided. For example, one embodiment of the balloon cannula device may be dimensioned for navigation to a spinal region for diagnostic evaluation and/or to apply a therapy thereto. In another embodiment, the balloon cannula device may be sized to fit within the epidural space. Other embodiments may be configured for use in the chest cavity (e.g. pleural biopsy or pleuracentesis) or abdominal-pelvic cavity (e.g. bladder neck suspension), or for non-spinal procedures such as breast biopsy and transvaginal oocyte retrieval, for example. In some embodiments, the balloon cannula device 100 may have a diameter of about 5 mm or less, while in other embodiments, the diameter may have a diameter of about 3 mm or less, or even 2.5 mm or less. In another embodiment, one or more of the working channels 124, 126 and 128 of the balloon cannula device 100 may have a diameter of about 5 mm or less, about 3 mm or less, about 2 mm or less, about 1 mm or less, or about 0.8 mm or less.
As mentioned previously, the cannula device may comprise a balloon or other type of structure that may be used as an atraumatic tip structure to reduce the risk of inadvertent injury to surrounding structures during a procedure. The atraumatic tip may be configured to provide tactile feedback to the user of the rigidity, pliability or feel of the tissue or structures in contact with the tip. In one embodiment, the atraumatic tip also provides dissection or retraction capabilities and/or the ability to displace surrounding tissue. The overall shape of the atraumatic tip may allow manipulation of the nerves as the balloon cannula device is advanced without harming the nerve or causing pain. In one embodiment, the atraumatic tip may have a curved shape and no sharp edges, burrs or other features that may pierce, snag, tear or otherwise harm tissue that comes into contact with the atraumatic tip. The shape, surface contours and/or overall finish of the atraumatic tip may be selected to reduce or minimize impact forces when the tip comes into contact with structures such as nerves, muscle and the spinal dura, among others.
As mentioned previously, the atraumatic tip may also be controllably inflatable or expandable, or otherwise comprise two or more surfaces or structures that are independently controllable. One potential use of such an embodiment comprises contacting the tip against tissue and then inflating, expanding or separating to deform or move the tissue. The tip may be a balloon that is inflated to create a working space in the surrounding tissue as well as provide a clearing for improved visibility. The balloon cannula device may then be advanced into the working space. The balloon may be inflated again to create another working space and so forth to advance the balloon cannula device in a spinal space. In addition, the balloon cannula device may be used to provide saline or another type of cleaning solution to the working area for enhancing visualization. In another embodiment, the distal balloon 116 may be moveable or articulated such that it may be used to displace, nudge or prod surrounding tissue or structures. The nudge action is felt by the user and also provides a more tactile sense of tissue movement. The nudge may result from active movement of the tip under control of the user, movement caused by releasing the tip from a bias position or from other conventional techniques for manipulation of surgical implements.
In some embodiments, the balloon component may be formed such that its base configuration is an uninflated shape, an inflated shape, or an intermediate shape therebetween. In some embodiments, a balloon with its base configuration in the uninflated shape may lie flatter against the tubular shaft of the balloon cannula device in comparison to a balloon with its base configuration in the inflated shape. In other embodiments, balloons having a base configuration in their inflated shape may have ripples, wrinkles or folds when collapses or constricted for insertion into the body. In other embodiments, such as the balloon 160 in
Although both the proximal and distal mounting sites 150 and 152 may be located on the same tubular shaft 102, in some embodiments the mounting sites 150 and 152 may be located on different tubular shafts have a coaxial sliding relationship. In this latter embodiment, the two tubular shafts may be manipulated to alter the balloon shape. For example, the proximal and distal mounting sites 150 and 152 may be brought closer together to permit a greater radial expansion range. In another example, the proximal mounting site 150 may be moved more proximally, which in some embodiments, may shift the balloon proximally to elongate the balloon configuration and/or to reduce the degree of forward positioning of the balloon.
In some embodiments, the balloon or tubular structure may be attached to the tubular shaft by adhesives or by heat bonding, for example. In some embodiments, bonding structures or processes may be used, which may improve the sealing between the balloon and the tubular shaft to support the use of higher inflation pressures without separating the balloon from the tubular shaft. For example, crimp rings or heat shrink tubing may be used to augment the bonding or attachment process. In some embodiments, the crimp rings or shrink tubing may be applied temporarily to facilitate setting of other bonding processes, and are later removed. In other embodiments, the crimp rings or shrink tubing may be incorporated into the final assembled product.
In some embodiments, after inflation, the balloon may not fully revert to its uninflated state upon relief the inflation pressure. Due to stretching or other types of deformation, the balloon may fold, wrinkle or crease upon deflation, which may affect the ability to withdraw the balloon cannula device from an introducer or guide into which the balloon cannula device was inserted. In some embodiments, where the balloon material comprises a polymeric material, the deflation characteristics of the balloon may be improved providing at least some polymer chains that are circumferentially oriented with respect to the tubular shaft. In embodiments where the balloon 116 originates as a thermoplastic tube, the thermoplastic tube may be an extruded polymeric tube, which typically provides longitudinally oriented polymer chains due to the extrusion process used to form the tube. In some embodiments, some of the longitudinally oriented polymer chains may be reoriented toward a circumferential orientation by heating the tube while in an expanded state.
In one example, a thermoplastic tube is provided, comprising an outer diameter that is less then the final assembled diameter of the balloon, and a thickness that is greater than the final thickness of the balloon. The thermoplastic tube is placed into a molding tube or cavity having an inner diameter that is approximate to the final assembled balloon outer diameter. The thermoplastic tube is pressured and expanded until the outer surface of the tube is constrained by the inner diameter of the modeling tube or cavity for a period of time at an elevated temperature. The thermoplastic tube is then cooled while pressurized to set the new diameter and to set the circumferentially reoriented polymer chains. The temperature, pressure and treatment period of the thermoplastic material may vary, depending upon the particular balloon material and the balloon configuration. In one particular example wherein the thermoplastic material comprises polyurethane with a durometer in the range of about 80 A to about 95 A and a thickness of about 0.005″ to about 0.01″, sometimes about 0.006″ to about 0.009″, and other times about 0.007″ to about 0.008″. The setting temperature may be about 120° F. to about 250° F., depending upon the particular material used. The setting period may be in the range of about 5 seconds to about 2 hours or more, sometimes about 30 seconds to about 30 minutes, and other times about 1 minute to about 2 minutes.
The balloon may be made of a flexible material such that the balloon is inflatable upon introduction of a fluid or gas. In one embodiment, the flexible material has sufficient rigidity such that it may effectively maintain the tubular shape when uninflated. As shown in
The atraumatic balloon 116 may be used to manipulate surrounding tissue in one or more ways. First, by transitioning the balloon 116 from a stowed to deployed configuration, the outer walls 142 of the balloon 116 will be urged outward against the surrounding tissue. Second, whether or not the device 100 is deployed or stowed, the balloon cannula device 100 may be maneuvered using the steering mechanism 120 to manipulate tissue. Third, the atraumatic balloon 116 may cycled between the stowed and deployed configuration to assist in the advancement of the steerable balloon cannula device 100. For example, the balloon 116 may be deflated to facilitate insertion of the device 100 through a wall of tissue, and may be reinflated after traversing the wall. Fourth, the practitioner may advance the balloon cannula device 100 and manipulate surrounding tissue and push tissue away by creating space under direct visualization. As the balloon 116 of the balloon cannula device 100 expands, a work space or opening may be created in the surrounding tissue, thereby easing the advancement or atraumatic maneuverability of the balloon cannula device 100. Thereafter, the atraumatic balloon 116 may be deployed or otherwise used to deform surrounding tissue and/or to make space available for the balloon cannula device 100 or other therapy or treatment device provided by working channel 126 (e.g.,
In the embodiment illustrated in
Exemplary embodiments of the tip structure(s) may include any of a variety of balloons or other shaped inflatable structures. There are a great many different shapes, sizes and functionality readily available in such balloons and many are well suited and easily adaptable for use in endoscopic spinal procedures. In one embodiment, the balloon, when in a stowed configuration, is dimensioned to translate through a lumen, working channel, trocar or introducer in an embodiment of the balloon cannula device described herein. The atraumatic balloon may be shaped in virtually any shape desired to further balloon cannula. For example, the balloon may be elongated, rounded, or other pre-formed shape. In one specific embodiment, the balloon has an elongate shape that follows the shape of an adjacent spinal structure. In one specific embodiment, the balloon is adapted to follow a portion of the dura mater. In another specific embodiment, the balloon is adapted to follow a portion of the annulus. In another embodiment, the atraumatic balloon includes a marker or other feature(s) making all or a portion of the balloon perceptible using external imaging modalities. In another embodiment, the atraumatic balloon is donut shaped to create a forward-looking design. In one embodiment, the marker or feature is a radio opaque marker. In other embodiments, including the balloon cannula device 430 in
Atraumatic balloon embodiments are not limited to closed surface, inflatable embodiments. Open surface structures such as mesh, scaffold structures, polymer stent-like structures, for example, may also be used to atraumatically deform spinal tissues. One example of an open surface structure is a coronary stent. Many of the delivery techniques used to deliver stents into the vasculature are applicable here for delivery into the spinal space. The stent may also be a polymer stent or a stent with a coating to improve the atraumatic qualities of the stent to spinal tissues and structures. In another embodiment, a suitable scaffold includes the collapsible scaffold structures used to deform and support tissue, and to maintain spacing between a radioactive source and the tissue being treated prior to and during brachytherapy.
In one embodiment, the surfaces of the atraumatic balloon are expandable. For example, the atraumatic balloon might be expanded using mechanical mechanisms, pneumatic mechanisms, or hydraulic mechanisms. In addition, the atraumatic balloon 116 may also contain sensing and/or monitoring devices such as a temperature thermo-couple. In an alternative embodiment, the atraumatic balloon may include multiple layers and provide insulation or shielding to surrounding tissue by changing thermal and/or insulating properties either alone or in combination with expansion and contraction between the multiple layers. The change in properties could be accomplished by electrical, chemical, or mechanical properties of the layers, spaces between layers or through the use of a liquid, gas or other material inserted between layers or into a layer.
In some embodiments, the atraumatic balloon may not be circular in cross section or may not be generally cylindrical as the balloons suited for use in the vasculature. In one embodiment, the atraumatic balloon may be irregular in shape and may be designed to accommodate tissues, endoscopes, and therapeutic devices to avoid potential injury to the tissues during treatment options. In one embodiment, the atraumatic balloon is adapted to conform to a portion of the spinal anatomy when in a deployed configuration. In another embodiment, the atraumatic balloon is sized and adapted to conform to the shape of the annulus. In another specific embodiment, the atraumatic balloon may have a preformed shape, such as a rounded shape, an elongated shape or combinations thereof. In one specific embodiment, the folded wall thickness of the atraumatic balloon is about 6 to about 40 thousandths of an inch. In another specific embodiment, the folded wall thickness of the atraumatic balloon may be about 12 to about 30 thousandths of an inch. In another specific embodiment, the folded wall thickness of the atraumatic balloon is about 20 to about 30 thousandths of an inch. Other sizes are possible and may be selected based on the channel size of the balloon cannula device as well as the physical parameters of the patient's spinal area.
In some embodiments wherein the atraumatic tip comprises a balloon structure, the balloon structure may be inflated with an optically transparent fluid that is selected to reduce distortions through the balloon and/or cavity, and/or reflections at the balloon/cavity interface. An optional bubble removal filter may be provided with the cannula system or the fluid injection system to reduce the number of bubbles inflated into the balloon. In some embodiments, visibility through the balloon structure may be different between the uninflated state and inflated state. In some embodiments, where the curvature of the inflated balloon may reduce the visual clarity through the balloon, the balloon may be configured to limit the amount of curvature or expansion in one or more areas. In
Although the embodiment depicted in
In some embodiments, the distal segment may comprise a different material from the proximal balloon material. The distal segment may be attached to the balloon in any of a variety of ways, including but not limited to the use of adhesives or heat bonding. In other embodiments, such as the cannula device 230 depicted in
The distal segment or tip 232 in
In other embodiments, the forward-mounted balloon or expandable structure may be provided with one or more support elements. The support elements may be oriented longitudinally, radially, and/or circumferentially along the balloon to support the uninflated and/or inflated balloon configurations. The configuration of a support element may be complementary to the shape or configuration of the balloon. In one embodiment, the support element may comprise a helical configuration, for example. In some embodiments, the support elements may be located about the balloon lumen. Support elements about the balloon lumen may resist involution of the balloon lumen in the inflated configuration, particularly at higher inflation pressures. The support elements may comprise any of a variety of materials, including but not limited to a metal and/or polymeric material. The support element maybe rigid, semi-rigid or flexible, and at least a portion of the support element may be attached or coupled to the shaft, the inner or outer surface of the balloon, and/or embedded in the balloon wall.
Although the balloon 116 may be generally circumferentially symmetrical about the longitudinal axis of the shaft 102, in other embodiments, the balloon may be asymmetrical. In
In some embodiments, the balloon may have semi-circular, hood-like configuration that is open along at least one perimeter of the balloon working space.
Referring back to
During use, the balloon cannula device may be moved or may remain in place while an inserted therapy device is manipulated to perform the desired function. Once the working or therapy area has been created or accessed using the atraumatic balloon, the atraumatic balloon may be removed thereby allowing working channel or trocar or introducer to be used for another instrument or therapy device or to provide support for a procedure. For example, the therapy device may comprise a mechanical debrider or other type of tissue disrupting device that may be introduced via the working channel to assist in removal of tissue. Various examples of mechanical tissue disrupting devices that may be used with a balloon cannula device are described in U.S. patent Ser. No. 12/035,323, filed Feb. 21, 2008, which was previously by incorporated by reference in its entirety. In yet another example of the flexibility of the balloon cannula device, one or more the working channels or ports may be used to provide access for the delivery of pharmacological agents to the access site either for application onto or injection into tissue. In some embodiments, the therapeutic agents may be directed injected into the channel or port, but in other embodiments, an infusion catheter may be inserted into a channel or port and used to provide additional control of the therapy. The infusion catheter may have any of a variety of configurations and features, including but not limited to its own optional steering mechanism separate from the balloon cannula device, and a needle tip for injecting therapeutic agents into the tissues or structures. In some embodiments, the needle tip may be retractable and extendable to protect against inadvertent puncture of the balloon cannula device and/or the tissues or structures accessible from the balloon cannula device. Examples of injection catheters that may be used with embodiments of the balloon cannula device include U.S. patent Ser. No. 10/820,183, which is hereby incorporated by reference in its entirety.
The therapy device may be supplied with energy from a source external using a suitable transmission mode. For example, laser energy may be generated external to the body and then transmitted by optical fibers for delivery via an appropriate therapy device. Alternately, the therapy device may generate or convert energy at the therapy site, for example electric current from an external source carried to a resistive heating element within the therapy device. If energy is supplied to the therapy device, transmission of energy may be through any energy transmission means, such as wire, lumen, thermal conductor, or fiber-optic strand. Additionally, the therapy device may deliver electromagnetic energy, including but not limited to radio waves, microwaves, infrared light, visible light, and ultraviolet light. The electromagnetic energy may be in incoherent or laser form. The energy in laser form may be collimated or defocused. The energy delivered to a disc may also be electric current, ultrasound waves, or thermal energy from a heating element. Moreover, it is to be appreciated that embodiments of the balloon cannula devices described herein may also be used to dispense a compound, compounds or other pharmacological agents to reduce, diminish or minimize epidural neural tissue scarring.
The balloon cannula device may also be used to perform denervation procedures using direct visualization from the balloon cannula device. The denervation procedure may be physical, chemical or electrical denervation, for example. The approaches used may be similar those described herein to access the posterior or posterolateral annulus. It is to be appreciated that the denervation procedures may be performed to relieve discogenic pain and/or before the disc damage has progressed to a herniated disc or torn annulus.
Referring back to
Referring still to
The control members 192 may comprise wires, threads, ribbons or other elongate structures. The flexibility and/or stiffness of the control member 192 may vary depending upon the particular steering mechanism. In further embodiments, the characteristics of the control member 192 may also vary along its length. In embodiments comprising two or more control members, the control members need not be configured symmetrically, e.g. having the same length, cross-sectional area or shape, or opposite attachment sites with respect to the longitudinal axis of the tubular shaft. Also, individual control members need not have the same configuration along their lengths. For example, although the proximal end of the control members 192 depicted in
The bending range of tubular shaft may vary depending upon the particular design. The cannula device may be configured with a one-sided or a two-sided bending range with respect to the neutral position of the tubular shaft. The bending range is from about 0 degrees to about 135 degrees, while in other embodiments, the bending range is from about 0 degrees to about 90 degrees, and sometimes about 0 degrees to about 45 degrees, and still other times about 0 degrees to about 15 or about 20 degrees. The bending range of the other side, if any, may be less than, equal to, or greater than the first side. In some embodiments, increased bending angles may cause creasing or telescoping of the tubular shaft, which may obstruct one or more channels within the tubular shaft.
In some embodiments, to enhance the bending range of the tubular shaft, one or more flexion slots may be provided on the shaft.
As noted in
In some embodiments, the number of slots per slot region may be anywhere from about 1 slot to about 100 slots or more, sometimes about 12 slots to about 50 slots, and other times about 24 slots to about 48 slots. In some embodiments, the length of the flex region may be anywhere from about 1 inch to about 20 inches, sometimes from about 4 inches to about 10 inches, and other times about 5 inches to about 8 inches in length. In some embodiments, the outer diameter of the flex region may be about 0.05 inches to about 0.3 inches, sometimes about 0.08 inches to about 0.15 inches, and other times about 0.1 inches to about 0.12 inches. The wall thickness of the flex region may be in the range of about 0.001 inches to about 0.01 inches, sometimes about 0.002 inches to about 0.006 inches, and other times about 0.003 inches to about 0.004 inches. The slots 272 may have an average slot width in the range of about 0.004 inches to about 0.02 inches, some times in the range of about 0.005 inches to about 0.015 inches, and other times about 0.006 inches to about 0.008 inches. The spacing between the slots 272 may be in the range of about 0.015 inches to about 0.1 inches, sometimes about 0.020 inches to about 0.050 inches, and other times about 0.025 inches to about 0.04 inches. The spacing between the ends of the slots may be in the range of about 0.004 inches to about 0.05 inches, sometimes about 0.006 inches to about 0.02 inches, and other times about 0.004 inches to about 0.01 inches. The maximum transverse dimension of a slot end may be in the range of about 0.004 inches to about 0.008 inches, other times about 0.004 inches to about 0.03 inches, and other times about 0.01 inches to about 0.04 inches.
The flexion of the cannula system may facilitate access to the target site and/or reduce the degree of tissue disruption in achieving access to the target site. For example, in some procedures, the angle for approaching the target site through the skin may be different from the angle that provides the visibility or viewing angle to treat or diagnose a particular abnormality. Referring to
In some embodiments, during bending, one or more components inserted a channel of the balloon cannula device may exhibit different degrees of relative displacement. The degree of relative displacement may be affected by the degree of bending, the fixation or coupling site, if any between the component and the balloon cannula device, and/or the degree of displacement from the neutral position of the balloon cannula device. Referring to
In some embodiments, the steering mechanism may also be coupled to an endoscope adjustment mechanism so that manipulation of the steering mechanism also provides at least some position adjustment which may reduce if not eliminate the degree of displacement. In other embodiments, the endoscope may be coupled to the balloon cannula device about a distal region of the tubular shaft so that, during flexion, the proximal portions of the endoscope exhibit the displacement rather than the distal portions. In still other embodiments, a spring or other type of bias member may bias the endoscope distally against an interference structure (not shown) located at the distal end of the tubular shaft to maintain the endoscope position during flexion. In some further embodiments, the interference structure may be rotated or moved out of its interfering position to permit endoscope positioning more distally, as desired.
Although the embodiment shown in
As mentioned previously, an endoscope or working instrument (e.g. graspers or tissue debrider) may be inserted into one or more channels of the cannula device through a proximal port. The proximal port, endoscope, and/or working instrument may be optionally configured with one or more features to lock and/or adjust the position of the inserted component. In other embodiments, one or more components of the endoscope or working instrument may be an integrally formed component of the cannula device and is not configured for removal.
For example, in
Referring now to
The balloon cannula devices may be used, for example, in systems for treating disc degeneration that include nucleus decompression devices. The balloon cannula device may be used for accessing the nucleus and delivering a nucleus decompression device. For example, a decompression device may be advanced from one of the working channels of the balloon cannula device and into the nucleus of a disc. A nucleus decompression device may be used to removed the disc nucleus tissue either by dissection, suction, dissolving, or by shrinking the nucleus. Various types of thermal energy are known to shrink the nucleus such as resistive heat, radiofrequency, coherent and incoherent light, microwave, ultrasound or liquid thermal jet energies. Mechanical tissue removal devices may also be used. Decompression of the disc nucleus may result in the protruded disc material collapsing toward the center of the disc. This may reduce the pressure on the spine nerve roots, thereby minimizing or reducing the associated pain, weakness and/or numbness in the lower extremities, upper extremities, or neck region. One or more devices that may be used to strengthen and/or support the weakened disc wall may also be used with a balloon cannula device.
The combination of a balloon cannula device and a decompression device results in increased tactile sensation for the surgeon thereby allowing the surgeon to atraumatically manipulate surrounding tissue to accurately deliver the decompression device. The decompression device may be any of a wide variety of devices suited for decompressing the nucleus. By utilizing the subject balloon cannula device, nucleus decompression devices well-known in the art may be improved as a result of the real time, on-board visualization capabilities and the creation of a working area.
In additional to spinal applications, the atraumatic cannula system may also be used for a variety of other procedures. The atraumatic cannula system, including the balloon cannula systems, may be used to provide direct visualization to a variety of both bedside and surgical procedures that were previously performed blind and/or with indirect visualization. Such procedures include but are not limited to pleural biopsy, pleuracentesis, paracentesis, renal biopsy, and joint aspiration, for example. In another example, the cannula system may be used in the emergency room or trauma centers to perform peritoneal taps to diagnosis blunt abdominal trauma.
In some embodiments, the balloon cannula device may be used for diagnostic purposes. Because of the complexity of the spine, it may be more difficult to diagnose an injury than for other medical conditions. As such, the direct visualization capabilities of the subject devices may be able to accurately identify any instability or deformity in the spine. For example, the subject device may offer direct visualization of any tumors, fractures, nerve damage, or disc degeneration. In addition, the subject devices may include sensors for collecting diagnostic data, for example, sensors that measure flow, temperature, pressure, or oxygen concentration. The subject devices may also be used to remove fluid, tissue or bone samples to be used for external diagnostic tests. Additionally, the subject devices may deliver testing reagents or additional instruments for diagnosing disc degeneration and bony degeneration, for example, the subject devices may deliver electrodes for diagnosis and treatment.
In one embodiment, the balloon cannula device may be used to perform discectomy. In this particular embodiment, the patient is prepped and draped in usual sterile fashion and in a lateral decubitis or prone position. General, regional, or local anesthesia is achieved and a rigid guidewire may be inserted percutaneously to the epidural space. Guidewire placement may be performed under fluoroscopic guidance or other types of indirect visualization including ultrasound. In some instances, a small skin puncture or incision is made about 2 to 5 inches from the midline of the patient's lumbar region to facilitate guidewire insertion. A needle may also be used to facilitate guidewire passage through some tissues. The guidewire may introduced on the ipsilateral side from which the nerve impingement has been identified and at an angle of about 25 degrees to about 45 degrees to the patient's back, but in other procedures, a contralateral approach and/or a different angle may be used. After confirmation of the guidewire location, a dilator may be inserted over the guidewire to enlarge the guidewire path to the epidural space. An introducer with a releasable lock may be inserted over the dilator to maintain access so that the dilator and guidewire may be removed. An endoscope or other type of direct visualization may be inserted into the scope channel of the balloon cannula device. An irrigation fluid source is connected to the irrigation port on the balloon cannula and activated to provide continuous flushing. A passive or active aspiration port or outlet port is checked for patency. The balloon cannula is inserted into the introducer and advanced toward the epidural space. Direct visualization of the epidural space may be performed with the endoscope as the balloon cannula nears the epidural space. As the balloon cannula enters the epidural space, the balloon may be manipulated (e.g. flexed and/or rotated) to orient the user and to identify the spinal nerve and for any disc or foraminal pathology. The balloon cannula device may then be inflated with about 0.5 cc of contrast material and then advanced closer to the treatment site. Where the treatment site is abutting or impinging upon a nerve, the inflated balloon may be used to separate the treatment site and the nerve and to create a working space at the treatment site. In some embodiments, a guidewire may be reinserted into a channel of the balloon cannula and advanced past the tip of the balloon toward the treatment site. For example, the guidewire may be inserted into a bulging region of the annular wall at the site of impingement. Insertion may occur before or after balloon inflation, and before or after a nerve is separated from a bulging disc surface. A tissue disrupting instrument is then inserted in the balloon cannula device and activated to mince or disrupt the tissue at the treatment site. The disrupted material may be swept away by the continuous irrigation and flush system, or may be removed from the treatment site by an aspiration assembly on the tissue disrupting instrument. A coagulation probe, if needed, may be inserted into the balloon cannula to achieve hemostasis and/or to shrink tissue. In some embodiments, the treated disc surface may self-seal due to the small size of the tissue disrupting instrument and/or the reduced pressure in that portion of the disc following removal of disc material. In other embodiments, the treated disc may be further treated to reduce any extrusion of disc material from the treatment site. A forceps or grasper instrument may also be used with the balloon cannula device to remove any extra-discal fragments. In some instances where fragments may have migrated through a foramen of the vertebrae, the size of the balloon cannula may permit advancement of the balloon cannula into or even through the foramen. Thus, the balloon cannula may be inserted into the central spinal canal from the foramen to retrieve any migrated fragments.
In another embodiment, a balloon cannula system may be utilized for any of a variety of cardiothoracic procedures, including but not limited to bronchoscopy, pleural biopsy, pleuracentesis pericardiocentesis, and pericardial biopsy. Pericardial biopsy, for example, is indicated for the investigation of a pericardial effusion. The procedure may be performed under fluoroscopic guidance or using endoscopic instruments, but is still associated with substantial morbidity, including but not limited to risks of a pneumothorax and myocardial rupture. A minimally invasive, direct visualization alternative may improve the risk/benefit profile of the procedure. In one particular embodiment, the patient is prepped and draped in usual sterile fashion. Local anesthesia is achieved in the subxiphoid region of the patient. In other embodiments, other entry points into the thoracic cavity may be used instead. In other embodiments, regional or general anesthesia may be used instead. In some embodiments where a pericardial drainage catheter was already in place, the guidewire may be inserted into the catheter and the catheter may be removed, leaving the guidewire in place. The guidewire may be a straight guidewire or a J-tip guidewire, for example. In embodiments where an initial entry into the pericardial space is made by the guidewire, a catheter may be inserted over the guidewire and one or more pericardial fluid samples may be taken for chemistry, histology, and/or culture, for example, before continuing the procedure. One or more dilators may be inserted over the guidewire and removed to widen the tissue pathway from the skin to the pericardial space. After widening the guidewire pathway, the balloon cannula system may be inserted over the guidewire. In some embodiments, as the balloon cannula system is inserted, a sampling of the parietal pericardial tissue (i.e. the outer pericardial surface) may be taken before or after the placement of the balloon cannula system into the pericardial space. In some embodiments, the balloon may be inflated and pressed against the parietal pericardial surface. A grasper may be used to take one or more tissue biopsies of the parietal pericardial surface. A coagulation probe may be used to provide hemostasis following the biopsy or biopsies. The balloon cannula may be deflated and advanced distally over the guidewire toward the pericardial space. Once in the pericardial space, the guidewire is optionally removed from the balloon cannula system. The pericardial fluid may be drained and replaced with saline or a gas to facilitate viewing. In patients with a hemorrhagic effusion, additional irrigation and/or drainage may be used to improve the clarity of the viewing field. The balloon may be inflated and the pericardial space may be explored by flexing and/or rotating the balloon cannula device. In some embodiments, the balloon cannula may be flexed in a retrograde fashion and the inflated balloon tip of the balloon cannula is used to atraumatically tent up the pericardial tissue to reduce the tissue laxity and increase the success of the biopsy. Unlike traditional endoscopic procedures, which are sometimes contraindicated when there is insufficient fluid or loculated fluid in the pericardial sac, use of the balloon cannula system may facilitate tissue separation between the pericardium and the epicardium to safely perform the biopsy in those situations. Tissue biopsies of the visceral pericardium and/or the epicardium may be taken using graspers or other endoscopic biopsy tools. Using a tissue debrider and/or a coagulation probe, one or more windows or fenestrations may be formed in the pericardium to provide ongoing drainage of the pericardial effusion. Pericardial windows or fenestrations, if any, may be performed before or after entry into the pericardial space. The balloon cannula may then be removed and an x-ray may be taken to check for a pneumothorax. If needed, chest tube drainage may be provided until the pneumothorax has resolved.
In another embodiment, the balloon cannula system may be used to perform any of a variety of genitourinary and OB/GYN procedures, including but not limited to cystoscopy (with or without bladder biopsy), renal biopsy, prostate biopsy and surgery, fetoscopy (including optional fetal blood draws), and bladder neck suspension procedures. In one particular example, cystoscopy may be performed using a flexible balloon cannula system with a forward-positioned inflatable balloon, but in other embodiments, a rigid balloon cannula system may also be used. In one embodiment, a cystoscopy procedure may be performed by draping a patient in the usual fashion and prepping the urethral orifice with a sterilizing agent and a topical anesthetic. In patients where ureteroscopy may be performed in addition to cystoscopy, regional or general anesthesia may be used instead. A topical anesthetic is optionally applied to the exterior of the balloon cannula system as the balloon cannula system is inserted into the urethral orifice and advanced to the bladder cavity. In some embodiments, the bladder may be filled with a gas or a liquid to expand the bladder wall for viewing. Once in the bladder, the balloon cannula system may be flexed and rotated to view the bladder cavity. Biopsies may be taken as indicated by inserting a biopsy instrument (e.g. graspers) into a channel of the balloon cannula device, actuating the biopsy instrument and withdrawing the biopsy instrument. The ureteral orifice may be identified and the balloon cannula may be inserted into the ureter. A guidewire may be optionally inserted through the balloon cannula system and into the ureteral orifice to facilitate passage of the balloon cannula system into the ureter. In some embodiments, the balloon of the balloon cannula system may be at least partially expanded during entry and/or advancement of the device, to reduce the risk of ureteral perforation. Depending upon the length of the balloon cannula system, the balloon cannula system may also be advanced into the intrarenal collecting system. If a stone is encountered during the procedure, a basket or other type of capturing instrument may be inserted into the balloon cannula system to remove the stone. For stones that are too large to be withdrawn through a channel of the balloon cannula system, a burr or other type of disrupting structure may be used to break up the stone. Once the biopsies and/or stone break-up or removal is completed, the balloon cannula system may be withdrawn.
It is to be understood that this invention is not limited to particular exemplary embodiments described, as such may, of course, vary. It is also to be understood that the terminology used herein is for the purpose of describing particular embodiments only, and is not intended to be limiting, since the scope of the present invention will be limited only by the appended claims.
Where a range of values is provided, it is understood that each intervening value, to the tenth of the unit of the lower limit unless the context clearly dictates otherwise, between the upper and lower limits of that range is also specifically disclosed. Each smaller range between any stated value or intervening value in a stated range and any other stated or intervening value in that stated range is encompassed within the invention. The upper and lower limits of these smaller ranges may independently be included or excluded in the range, and each range where either, neither or both limits are included in the smaller ranges is also encompassed within the invention, subject to any specifically excluded limit in the stated range. Where the stated range includes one or both of the limits, ranges excluding either or both of those included limits are also included in the invention.
Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. Although any methods and materials similar or equivalent to those described herein can be used in the practice or testing of the present invention, some potential and preferred methods and materials are now described. All publications mentioned herein are incorporated herein by reference to disclose and describe the methods and/or materials in connection with which the publications are cited. It is understood that the present disclosure supersedes any disclosure of an incorporated publication to the extent there is a contradiction.
It must be noted that as used herein and in the appended claims, the singular forms “a”, “an”, and “the” include plural referents unless the context clearly dictates otherwise. Thus, for example, reference to “a blade” includes a plurality of such blades and reference to “the energy source” includes reference to one or more sources of energy and equivalents thereof known to those skilled in the art, and so forth.
The publications discussed herein are provided solely for their disclosure. Nothing herein is to be construed as an admission that the present invention is not entitled to antedate such publication by virtue of prior invention. Further, the dates of publication provided, if any, may be different from the actual publication dates which may need to be independently confirmed.
The preceding merely illustrates the principles of the invention. It will be appreciated that those skilled in the art will be able to devise various arrangements which, although not explicitly described or shown herein, embody the principles of the invention and are included within its spirit and scope. Furthermore, all examples and conditional language recited herein are principally intended to aid the reader in understanding the principles of the invention and the concepts contributed by the inventors to furthering the art, and are to be construed as being without limitation to such specifically recited examples and conditions. Moreover, all statements herein reciting principles, aspects, and embodiments of the invention as well as specific examples thereof, are intended to encompass both structural and functional equivalents thereof. Additionally, it is intended that such equivalents include both currently known equivalents and equivalents developed in the future, i.e., any elements developed that perform the same function, regardless of structure. The scope of the present invention, therefore, is not intended to be limited to the exemplary embodiments shown and described herein. Rather, the scope and spirit of present invention is embodied by the appended claims. For all the embodiments described herein, the steps of the method need not be performed sequentially.
The present application claims priority under 35 U.S.C. §119(e) to U.S. Provisional Application Ser. No. 60/968,086, filed Aug. 27, 2007, and U.S. Provisional Application Ser. No. 61/045,919, filed Apr. 17, 2008, all of which are hereby incorporated by reference in their entirety.
| Number | Date | Country | |
|---|---|---|---|
| 60968086 | Aug 2007 | US | |
| 61045919 | Apr 2008 | US |
