Source: http://www.patentsencyclopedia.com/app/20150306348
Timestamp: 2018-02-23 17:26:12
Document Index: 74505119

Matched Legal Cases: ['Application No. 60', 'Application No. 60', 'Application No. 60', 'Application No. 60', 'Application No. 60', 'Application No. 61', 'Application No. 61', 'Application No. 61', 'Application No. 61', 'Application No. 61']

DEVICES AND METHODS FOR TREATING TISSUE - Patent application
Patent application title: DEVICES AND METHODS FOR TREATING TISSUE
Inventors: Michael P. Wallace (Pleasanton, CA, US) Robert Garabedian (Mountain View, CA, US) Robert Garabedian (Mountain View, CA, US) Gregory B. Arcenio (Redwood City, CA, US) Gregory B. Arcenio (Redwood City, CA, US) Jeffery L. Bleich (Palo Alto, CA, US) Vahid Saadat (Atherton, CA, US) Winnie Chung (San Francisco, CA, US)
Assignees: AMENDIA, INC.
Patent application number: 20150306348
1. A method for treating target tissue in a patient's spine, the method comprising: advancing a wire into the patient from a first location, through a neural foramen, and out of the patient from a second location; connecting a tissue modification device to the wire; positioning the tissue modification device through the neural foramen using the wire; modifying target tissue in the spine by moving the tissue modification device against the target tissue; and delivering an agent to modified target tissue, wherein the agent is configured to inhibit blood flow from the modified target tissue.
13. A device for delivering an agent to tissue in a patient's spine, the device comprising: a elongate flexible catheter having a proximal end and a distal end, wherein the distal end of the elongate catheter is configured to be advanced into the patient from a first location and toward a neural foramen; a connector coupled to the proximal end of the catheter that remains outside of the patient and is configured to receive a syringe containing an agent; and an aperture at the distal end portion of the catheter configured to deliver the agent to the tissue.
[0001] This application is a division of U.S. patent application Ser. No. 12/911,537 filed on Oct. 25, 2010 entitled "DEVICES AND METHODS FOR TREATING TISSUE". Application Ser. No. 12/911,537 is a continuation-in-part to U.S. patent application Ser. No. 11/251,205, titled "DEVICES AND METHODS FOR TISSUE ACCESS", filed on Oct. 15, 2005, now U.S. Pat. No. 7,918,849 issued on Apr. 5, 2011. U.S. Pat. No. 7,918,849 claims the benefit of U.S. Provisional Patent Application No. 60/619,306, filed Oct. 15, 2004, U.S. Provisional Patent Application No. 60/622,865, filed Oct. 28, 2004, U.S. Provisional Patent Application No. 60/681,719, filed May 16, 2005, U.S. Provisional Patent Application No. 60/681,864, filed May 16, 2005, and U.S. Provisional Patent Application No. 60/685,190, filed May 27, 2005, each of which is incorporated by reference herein in its entirety.
[0002] U.S. patent application Ser. No. 12/911,537 is a continuation-in-part to U.S. patent application Ser. No. 11/468,247, titled "TISSUE ACCESS GUIDEWIRE SYSTEM AND METHOD", filed on Aug. 29, 2006, now U.S. Pat. No. 7,857,813 issued on Dec. 28, 2010. This application is herein incorporated by reference in its entirety.
[0003] U.S. Ser. No. 12/911,537 also claims priority to U.S. Provisional Patent Application No. 61/254,656, titled "TISSUE REMOVAL DEVICES AND METHODS", filed on Oct. 23, 2009; U.S. Provisional Patent Application No. 61/260,012, titled "DEVICES AND METHODS FOR DELIVERING HEMOSTATIC AGENTS", filed on Nov. 11, 2009; U.S. Provisional Patent Application No. 61/289,075, titled "DEVICES AND METHODS FOR STOPPING OR PREVENTING BLEEDING", filed on Dec. 22, 2009; U.S. Provisional Patent Application No. 61/388,601, titled "TISSUE REMOVAL DEVICES AND METHODS", filed on Sep. 30, 2010; and U.S. Provisional Patent Application No. 61/325,753, filed Apr. 19, 2010, title "TISSUE MODIFICATION DEVICES"; each of these applications is herein incorporated by reference in its entirety.
[0006] A significant number of surgical procedures involve modifying tissue in a patient's body, such as by removing, cutting, shaving, abrading, shrinking, ablating or otherwise modifying tissue. Minimally invasive (or "less invasive") surgical procedures often involve modifying tissue through one or more small incisions or percutaneous access, and thus may be more technically challenging procedures. Some of the challenges of minimally invasive tissue modification procedures include working in a smaller operating field, working with smaller devices, and trying to operate with reduced or even no direct visualization of the tissue (or tissues) being modified. For example, using arthroscopic surgical techniques for repairing joints such as the knee or the shoulder, it may be quite challenging to modify certain tissues to achieve a desired result, due to the required small size of arthroscopic instruments, the confined surgical space of the joint, lack of direct visualization of the surgical space, and the like. It may be particularly challenging in some surgical procedures, for example, to cut or contour bone or ligamentous tissue with currently available minimally invasive tools and techniques. For example, trying to shave a thin slice of bone off a curved bony surface, using a small-diameter tool in a confined space with little or no ability to see the surface being cut, as may be required in some procedures, may be incredibly challenging or even impossible using currently available devices.
[0008] For example, as shown in FIG. 1 which shows the lateral aspect of a facet joint complex, there are several arteries that may bleed during a decompression of this spinal region. The facet joint complex includes a superior articular process (SAP) and an inferior articular process (IAP). In some embodiments, it is desirable to remove tissue below (ventral) the SAP and/or the bottom (ventral) portions of the SAP while avoiding the tissue on the lateral side of the SAP (the area labeled SAP in FIG. 1). Although not shown, two nerve roots branching from the cauda equina exit the central spinal canal and extend through intervertebral foramina on either side of the vertebra. Spinal stenosis can occur when the spinal cord, cauda equina and/or nerve root(s) are impinged by one or more tissues in the spine, such as buckled or thickened ligamentum flavum, hypertrophied facet joint (shown as superior articular processes in FIG. 1), osteophytes (or "bone spurs") on vertebrae, spondylolisthesis (sliding of one vertebra relative to an adjacent vertebra), facet joint synovial cysts, and/or collapse, bulging or herniation of an intervertebral disc. Impingement of neural and/or neurovascular tissue in the spine by one or more of these tissues may cause pain, numbness and/or loss of strength or mobility in one or both of a patient's lower limbs and/or of the patient's back.
[0047] FIGS. 45A-49 illustrate various embodinlents of delivery devices.
[0048] FIG. 50 illustrates a first embodinlent of a kit including a connector, a catheter, and a syringe.
[0052] A hemostatic agent, which may also be an antihemorrhagic (antihaemorrhagic) agent include substances that promote hemostasis (i.e., to stop bleeding). For example, styptics (also spelled stiptics) are one type of antihemorrhagic agent that work by contracting tissue to seal injured blood vessels. Styptic may include astringents. Antihemorrhagic agents used in medicine may have various mechanisms of action, including inhibiting fibrinolysis or promoting coagulation (particularly in systemic agent), causing vasoconstriction or promoting platelet aggregation (particularly in local agents). Examples of such agents include microfibrillar collagen, chitosan, antiliem01Thagic drugs such as antifibrinolytics, vitamin K, fibrinogen, and blood coagulation factors, anhydrous aluminum sulfate, potassium alum, titanium dioxide, styptic powder, etc. These examples are illustrative only, and any appropriate hemostatic agent may be used with the methods, devices and systems described herein.
[0055] In general, the procedure may be used to decompress spinal nerve roots on the unilateral or contralateral side from the access point. A probe or guide may be introduced into the spinal epidural space (or along or just within the ligamentum flavum) at an appropriate spinal level using image guidance and/or tracking (e.g., electromagnetic tracking). Introduction may be either via percutaneous puncture or open laminotomy.
[0059] Once the device is in place as confirmed visually or radiographically, binlanual reciprocating strokes may be utilized to decompress dorsal impinging bone or soft tissue at the nerve root origin. The probe/guide may be reinserted to decompress the ipsilateral or contralateral distal (foraminal) portion of the nerve root, so that the same (or a different) tissue modification device may be used to decompress another region of the spine (or nerve root) using the same access or entry site. As shown in FIG. 3, the devices described herein can used to decompress the ipsilateral or contralateral (not shown), or both, regions adjacent the level proximal to the nerve root (lateral recess). A guide may be deployed in the same access point (location 1810) as described above. As shown in FIG. 3, the guidewire can then be threaded along a path from location 210 to where it exits through the foramen, as shown by arrow 220 (for ipsilateral decompression of the adjacent nerve root origin).
[0060] Described herein are systems including one or more of the following devices: a guidewire and a probe for positioning a guidewire. The guidewire 101 shown in FIG. 4 is typically long (e.g., elongated) and flexible, and may have a sharp (tissue penetrating) distal end 103 and a proximal end 102 that allows it to be coupled to a guidewire coupling member securely. For example, in FIG. 4, the guidewire 101 includes a ball or other shaped end (which may be conical, tubular, ring, etc.) secured to the distal end for coupling to a guidewire coupling member. The proximal end 102 may be configured to lock into a guidewire coupling member I 06 at the distal end of a tissue modification device (such as the one 105 indicated in FIG. 4). A guidewire coupler member is configured to attach to a guidewire (e.g., one end of a guidewire) so that the tissue modification device can be manipulated, at least in part, by pulling on the guidewire after the guidewire has been secured to the device. For example, in some variations a guidewire may be inserted into the body from a first location outside of the body, then passed around the target tissue (e.g., around a spinal foramen) and out of the body from a second position. The distal end of the guidewire may then be coupled to the flexible tissue modification device 105 and pulled through the body until the tissue modifying region of the device, e.g., the portion of the device including cutting edges or blades, is positioned opposite the target tissue. In some variations the distal end of the device may be completely withdrawn from the patient, so that it can be grasped and manipulated. In other variations, the distal end of the tissue-modification device remains coupled to the guidewire, and the guidewire may be grasped to manipulate the distal end of the tissue-modification device. A handle 110 may be attached to the distal end of the guidewire. Similarly, the proximal end of the guidewire may be configured to pass through the probe 109 so that the probe may be removed from over the proximal end of the guidewire during operation. In general, the distal end 107 of the probe 109 described herein may be curved or bent, and/or may be curveable or bendable. The outer distal end may be more or less curved. The inner cannula 108 may be configured to bend as it exits the distal end of the outer cannula, as shown, thereby increasing the ability of the probe to guide a guidewire around a target tissue.
[0062] As shown in FIGS. 6A and 6B the probe 400 may be configured and/or used such that the guidewire is positioned to avoid the tissue (including vascular anatomy) on lateral side of the SAP. As shown, the probe 400 may be passed from outside of a patient's body at a first location 401 and through a spinal neural foramen 402 between a spinal nerve root or ganglia and a facet joint complex 403. As shown in FIG. 6B, the probe is configured such that inner cannula 404 may be advanced through outer cannula 405. The inner cannula advances out of the outer cannula to a position such that the tip 406 of the inner cannula points away from the lateral aspect of the SAP of the joint complex 403. In some embodinlents, as described in more detail below, the inner cannula may include a plunger (610 in FIG. SA) coupled to the inner cannula that is configured to advance the inner cannula through the outer cannula. The outer cannula may include a handle 409 coupled to the outer cannula used to grasp and position the probe. The plunger and the handle may be configured such that the inner cannula may only be advanced within the outer cannula to a point where the plunger hits the handle and cannot be further advanced. In some embodiments, the plunger and the handle may be configured such that the inner cannula may only be advanced to a position such that the tip 406 of the inner cannula points away from the lateral aspect of the SAP of the joint complex 403. Alternatively, the inner cannula may be configured such that it may advance further to a position where it may wrap around the lateral aspect of the SAP, as shown in FIGS. 8A-8C. In this configuration, the plunger may include marking such that a user may only advance the plunger and the inner cannula to the desired position. As shown in FIG. 6A, the plunger 410 has been advanced such that there is an gap X between the plunger and the handle 409. The gap may be any suitable distance such that the tip 406 of the inner cannula points away from the lateral aspect of the SAP of the joint complex 403.
[0068] As shown in FIG. 9B, the tissue modification device 711 is pulled by the guidewire along the path established by the guidewire as described above in reference to FIGS. 8A to 8C. The tissue modification device 711 may be pulled from outside of a patient's body at a first location 601 (FIG. 8B), through a spinal neural foramen 702 between a spinal nerve root or ganglia and a facet joint complex 703. As shown in FIG. 9B, the tissue modification device 711 is substantially along the lateral side of the facet joint complex 703 such that there a smaller space 714' (when compared to 714 of FIG. 9A) between the tissue modification device and the lateral aspect of the SAP.
[0069] FIGS. 9A and 9B illustrate the difference in the size of the space 714 and 714' between the tissue modification device and the lateral aspect of the SAP when, as shown in FIG. 6A, the probe and guidewire are inserted such that the tip 406 of the inner cannula points away from the lateral aspect of the SAP of the joint complex 403 (FIG. 9A) versus when, as shown in FIG. 8A, the tip 606 of the inner cannula points up and around the lateral aspect of the SAP of the joint complex 603, respectively. As shown, there is a larger space 714 in FIG. 9A.
[0071] FIGS. 10A and 10B illustrate the difference in the size of the space 814 and 814' between the tissue modification device and the lateral aspect of the SAP. As shown in FIG. 10A, the proximal handle of the tissue modification device and the distal handle are held close together (as shown in FIG. 8B). As shown in FIG. 10B, the proximal handle of the tissue modification device and the distal handle are held a distance from one another (as shown in FIG. 6C). As shown, there is a larger space 814' in FIG. 10B.
[0072] Described herein are systems including a tissue modification device. Various embodiments of tissue modification devices and systems, as well as methods for making and using tissue modification devices and systems, are provided herein. In general, a flexible tissue-modification device as described herein is configured to remove tissue from a patient. In particular, these tissue-modification devices may be configured to decompress spinal stenosis. The tissue modification device may be configured to have a variable stiffness along the length of the device. As shown in FIG. 11, the tissue modification regions 1200, 1201, and 1202 of the devices may have any suitable stiffness. As shown, tissue modification region 1200 that includes "dog bone" rungs, as described below, has a "semi-stiff" modification region. Tissue modification region 1201 includes a radius limiting strap coupled to the device such that the tissue modification region of the device is "stiff". Tissue modification region 1202 is more flexible than regions 1200 and 1201. A more stiff portion of the device will prevent the device from wrapping around the lateral side of the SAP and will therefore not remove tissue (including vascular anatomy) on lateral side of the SAP. In some embodiments, the more stiff portion of the tissue modification device is the tissue modification region. Alternatively, the more stiff portion may be any other suitable portion(s) of the device.
[0079] For example, FIG. 12 illustrates one variation of a tissue modification device having a plurality of rungs. FIG. 12 is a partially exploded, perspective view illustrating enlargements of various regions. The tissue-modification device shown in FIG. 12 is flexible and includes individual rungs that may articulate relative to each other. This device includes two parallel cables 201, 201' and a plurality of rungs 205, 205', 206, 203 extend between the cables. The cables are the connectors that link adjacent rungs. In this example, the two cables are joined at the proximal 233 and distal 235 regions. In some variations, the cable is joined at the proximal and distal ends, or is fomled from a single cable; in some variations the two cables are separate. At least a portion of the cable is flexible. Any appropriate cable may be used, including metal or polymeric cables. Cables may be single-filament or formed of multiple filaments. The portion of the cable towards the distal end of the device, as shown in this example, may be hinged, and the links between distal and proximal sections may be connected in flexible junctions.
[0080] In some embodiments, the links or rungs 205, 205', 206, 203 spanning the cables have different shapes and sizes. The rungs 203 in the central region each include one or more cutting edges 211 projecting from the anterior (target tissue facing) surface. These cutting rungs 203 may form a tissue modifying region of the device. The cutting edges shown are triangular or pointed, although any appropriate shape may be used. Further, these cutting edges may be oriented in any desired manner; the orientation of the cutting edges may help steer or guide the device as it is urged against a target tissue to cut the tissue. In this example the cutting edges are oriented in parallel with the long axis (the distal/proximal axis) of the device.
[0081] In some embodiments, the tissue modification device may be configured to have a variable stiffness along the length of the device. The variable stiffness may be achieved by one of several variations, or a combination thereof. Ina first variation, the geometry of the rungs 211 that make up the tissue modification region has a different geometry than other rungs on the tissue modification device. In a first embodiment, as shown in FIG. 13A, the rungs that make up the tissue modification region 1400 of the tissue modification device 1401 are "dog bone" shaped rungs or "I" shaped rungs. As shown in FIG. 13B, a "dog bone" rung includes rung portions 1402 and 1403 that are coupled to the cables of the device. Rung portions 1402 and 1403 are wider than the center rung portion 1404 thereby creating a "dog bone" geometry. A series of rungs having a "dog bone" geometry is more stiff than a series of rungs having a standard rectangular geometry because the rung portions 1402 and 1403 are wider (or longer, with respect to the entire device) than the standard rectangular geometry. In general, the flexibility of a portion of the device is determined by the number of flex points within the portion. A flex point is a point along the device where two rungs (or a rung and a spacer) may flex and bend with respect to one another. For example, a portion of the device having a length of 1 inch with 10 flex points will be more flexible than a portion of the device having a length of 1 inch with 5 flex points. The wider the rungs are along the cable, the less flex points.
[0085] Returning to FIG. 12, in some embodinlents, cutting rungs 203 are separated by a gap formed by spacing elements 209 between the rungs. These spacing elements are also attached to the connector 201, 201' that flexibly connects the rungs. In FIG. 12 the spacers are threaded on the two parallel cables. The sizes of the connectors and/or spacing elements 209 may be varied to change the spacing between the rungs, and also the longitudinal shape (curvature) of the device, as described in greater detail, below. The sizes of the connectors and/or spacing elements 209 may also be varied indifferent regions along the length of the device to change the stiffness of the device in various regions.
[0086] The proximal end 233 of the device shown in FIG. 12 includes a handle 231 which may be pemlanently or removeably attached to the proximal end. The distal end 235 shown in FIG. 12 includes a guidewire coupler 237 that is flexibly attached to the distal end of the device. A guidewire coupler is configured to attach to a guidewire (e.g., one end of a guidewire) so that the device can be manipulated, at least in part, by pulling on the guidewire after the guidewire has been secured to the device. For example, in some variations a guidewire may be inserted into the body from a first location outside of the body, then passed around the target tissue (e.g., around a spinal foramen) and out of the body from a second position. The distal end of the guidewire may then be coupled to the flexible tissue modification device (such as the one shown in FIG. 12) and pulled through the body until the tissue modifying region of the device, e.g., the portion of the device including cutting rungs 203, is positioned opposite the target tissue. In some variations the guidewire used includes a tip region that is enlarged and may engage the guidewire coupler. For example, the guidewire may have a proximal end with a flange or ball. This enlarged region may be configured to fit into an opening on the guidewire coupler 242 so that the guidewire can be pulled distally from outside of the patient. In some variations the distal end of the device may be completely withdrawn, so that it can be grasped and manipulated. In other variations, the distal end of the tissue-modification device remains coupled to the guidewire, and the guidewire may be grasped to manipulate the distal end of the tissue-modification device. A handle may be attached to the guidewire.
[0088] In some embodiments, the tissue modification device may be configured to have a variable stiffness along the length of the device. The variable stiffness may be achieved by one of several variations, or a combination thereof. In some embodiments, the tissue modification device may include a radius limiter. The radius limiter is configured to allow flexibility of elongate body while limiting the radius of curvature that the tissue modification region may achieve in at least one direction (e.g. concave or convex curvature). The radius limiter may be one of several variations. FIGS. 16A and 16B illustrate the difference in the size of the space 1714 and 1714' between the tissue modification device and the lateral aspect of the SAP. As shown in FIG. 16A, the tissue modification device does not include a radius limiting strap. As shown in FIG. 16B, the tissue modification device does include a radius limiting strap. As shown, there is a larger space 1714' in FIG. 16B.
[0090] As shown in FIGS. 18A and 18B, the radius limiting strap 1901 is coupled to the elongate body of the tissue modification device 1900 at points 1903 and 1904. As shown in FIG. 18B, the strap 1901 is positioned on the posterior side of the device such that it does not interfere with the cutting edges on the front (anterior) side of the device. Connection points 1903 and 1904 are located on the front (anterior) side of the device, as shown in FIG. 18A, however they may be located on the back side or any combination thereof. In this variation, the radius limiting strap is a flat strap. The radius limiter may be coupled at at least one point along the length of the strap. In some embodiments, the radius limiter may be allowed to move with respect to the elongate body. The radius limiter is positioned toward the center of the elongate body, but may alternatively be positioned in any other suitable position on the elongate body.
[0092] FIGS. 20A-25 show various configurations where the tissue modification device includes some variation of a flexible or compressible blade guard. In some embodiments, the tissue modification device may be configured to avoid cutting or damaging the soft tissue laterally from the facet joint and neural foramen (such as the foraminal vasculature and other healthy or non-target tissue). For example, the tissue modification device may be configured to be soft tissue sparing. In these examples, as the tissue modification device is moved against soft tissue, the blade guards will cover the blade. However, as the tissue modification device is moved against bone or a harder tissue (e.g. tissue, such as ligament, on top of bone), the blade guards will bend, flex, or compress, and allow the blade to enter into the target tissue to cut, or otherwise modify the target tissue. As shown in FIG. 20A, a blade 2100 may be surrounded by a flexible or compressible material 2101. For example, the material may be a foam, rubber, silicone, or other flexible or compressible material. As shown in FIG. 20B, the blade guards 2102 may include a plastic or metal spring adjacent to the blade 2100. As shown in FIG. 21 a substrate having flexible or rigid atraumatic ridges 2103 may be placed adjacent to the elongate body 2104. In some embodinlents, the ridges may be placed between the rungs 2105 of the elongate body. In some embodiments, the ridges 2103 may be spring loaded so that they may be raised or lowered between the rungs of the device.
[0095] FIGS. 26-27 show various configurations where the tissue modification device cuts when it is reciprocated in a first direction and does not cut when it is reciprocated in the second direction. In some embodiments, the tissue modification device may be configured to avoid cutting or damaging the soft tissue laterally from the facet joint and neural foramen (such as the foraminal vasculature and other healthy or non-target tissue) by being configured to cut when the device is moved across the tissue in a first direction (medially, for example) and not cut when the device is moved across the tissue in a second direction (laterally toward the non-target tissue, for example). As shown in FIG. 26, the rungs 2105 may each have a flexible cover 2110 that can be moved over the blade 2100 to expose the blade in a first direction and a rigid back 2111 that holds the cover fixed when the device is moved in the opposite direction. As shown in FIG. 27, the substrate or elongate body 2104' may have a zig zag configuration with blades 2100 only positioned on the sides facing in a first direction. Therefore, the device can cut when the blades are moved in a first direction and cannot cut when the blades are moved in a second direction.
[0096] FIGS. 28-30B show various configurations wherein a substrate or shield bends to move the blades toward or away from the tissue. As shown in FIG. 28, the tissue modification device 2800 may include a shield 2801 that covers a portion of the device. For example, the shield may cover the distal blades 2802 such that the device cannot cut as far laterally beyond the facet joint and the neural foramen. The shield may be fixed at the distal end, and as the device is bent into a curved configuration around the facet joint, the shield may pop up to cover the blades.
[0097] As shown in FIGS. 29A and 29B, rather than having a curved shield, the blades 2900 may be coupled to a curved substrate 2901. For example, due to the curvature of the substrate, the blades toward the center of the device will perform the majority of the cutting, while the blades toward the proximal and distal ends of the device will not cut as much. The configuration in FIG. 29B is coupled to a wire 2902 at the distal end so that as the distal wire is pulled, the blades will be pulled further into a curved configuration. FIG. 30A and FIG. 30B illustrate an embodiment where the blades 3000 of the tissue modification device 3002 are coupled to a substrate 3001. In some portions of the substrate, the substrate may be configured to bend up (like a "tape measure") such that the blades can engage into the target tissue, while in other portions, the blades will be on a straight substrate and will be lower in the tissue modification device and will not cut, or will not cut as deeply.
[0098] FIGS. 31-32 show various configurations wherein the rungs of the tissue modification device are movable. As shown in FIG. 31, the tissue modification device includes multiple blades sections or rungs 3100. Each section may be coupled to the adjacent section via a cam 3101. The cam may be configured such that it can bend or rotate the blade sections. For example the curved section 3102 as shown, the cam in this curved configuration may bend or rotate the sections such that the blades 3103 are facing up toward the target tissue. Alternatively, the cams may rotate or push the blades out of the substrate or shield (not shown). In the straight section 3104, the cams may rotate the bladed sections such that blades are not exposed to the tissue and will not cut or otherwise modify (or modify to a less degree) the non-target tissue located in these positions. As shown in FIG. 32, the blade sections 3200 are rotatable about a pivot joint 3200 such that in some configurations, the blades 3203 are rotated up, while in other configurations, the blades are 3203 are rotated down and away from the tissue. For example, the rungs toward the distal and proximal ends may be exposed, while the rungs at the center of the device may be rotated such that the blades are exposed and the blades may cut tissue.
[0099] FIG. 33 shows a configuration wherein the tissue modification device 3300 includes a shield 3301 that covers the distal end of the device. In some embodiments, the shield may be fixed such that the tissue modification device may move into and out of the shield, while the shield covers the distal cutting blades as they moved through the lateral portion of the spine.
[0100] FIGS. 34-36B show configurations wherein the travel of the tissue modification device 3400 within the body of a patient is limited in at least one direction. As shown in FIG. 34, the tissue modification device 3400 includes a physical stop 3401 at the proximal end of the device. This stop will prevent the device from entering too far into, or beyond, the facet joint or neural foramen, such that it will not cut the healthy tissue lateral to the superior articular process of the spine. As shown in FIG. 35, the tissue modification device 3500 may be coupled to the guidewire 3501 via a spring 3502. In this configuration, the tissue modification device may be reciprocated in a unimanual fashion. For example, the distal handle 3503 may be held in place, while the proximal handle 3504 is pulled and then released. When the proximal handle is released the spring will return the tissue modification device to position. The length of the guidewire may determine the distance that the tissue modification device may be moved laterally through the spine. In some embodiments, the distal guidewire may be a rigid element, holding the distal portion of the tissue modification device (e.g. the distal end of the spring) in place.
[0101] As shown in FIGS. 36A and B, the tissue modification device 3600 may include a physical stop 3601 outside of the patient that may prevent the blades 3602 device from being moved too far laterally (toward the right in the figure) in the spine. In some embodiments, the stop may be fixed to a frame within the operating room. For example, the stop may be coupled to a METRX frame. The stop may be adjustable along the proximal end of the device.
[0102] Described herein are systems including a delivery device. Various embodiments of delivery devices and systems are provided herein. In general, a delivery device as described herein is configured to deliver a hemostatic agent, tissue sealant analgesics, anti-inflammatories, or any other suitable agent to a desired surgical site. In particular, these delivery devices may be configured to deliver an agent to a surgical site for a spinal decompression procedure. The hemostatic agents may be delivered to an artery or other vessel that has been damaged or ruptured or is otherwise bleeding. The agent will promote hemostasis and stop or prevent unwanted and/or excessive bleeding.
[0103] In some embodiments, the agent(s) may be delivered to the surgical site via an agent deliver device. The delivery device may be any suitable device having any suitable configuration such that the agent may be delivered to the desired tissue and/or area within the surgical site. In some embodiments, the tissue modification device may be configured to deliver an agent to the surgical site. In alternative configurations, the delivery device may be a catheter that may be pulled into position within the surgical site via a guidewire. In further alternative configurations, a probe or cannula may be configured to deliver an agent to the surgical site.
[0104] In some embodiments, the tissue modification device may be configured to receive and deliver an agent to tissue and/or a surgical site. For example the agent may be selected to stop or slow bleeding, such as a haemostatic agent. FIGS. 37A-38B show configurations wherein the tissue modification device 3700 includes a channel 3701 to direct an agent, such as a haemostatic agent toward a tissue or surgical site. As shown in FIG. 37A-B, the distal end 3702 of the tissue modification device may include a channel 3701. As shown in cross section FIG. 37B, the rungs 3703 toward the distal end portion of the device include a recess to form a channel 3701. Once the blades 3702 of the tissue modification device have been used to cut tissue (or during or before tissue modification), the device may be pulled proximally (i.e. at least paltially out of the patient) such that a user may couple a catheter 3704 or syringe to the channel 3701 and deliver an agent to the channel, as shown in FIG. 37C. The tissue modification device may be used to directly deliver the agent to the desired location. For example, the agent may travel through the channel from the catheter to the desired location or the agent may be placed in the channel, and the device may be moved such that the channel is adjacent to the bleeding tissue. In some embodiments, a user may pull up on the distal and proximal ends of the tissue modification device to pull the device up against the target tissue and deliver the agent from the channel. As shown in FIGS. 38A and 38B, the channel 3801 may be configured to receive a shaped catheter 3804. The catheter may be placed into the channel either before, during, or after the device is used to modify tissue. The shaped catheter may then be used to deliver the agent to the desired location.
[0105] FIGS. 39-40B show configurations wherein a catheter 3903 (FIG. 40A) or bladder 3901 (FIG. 39) may be coupled to a tissue modification device 3900 or to a guidewire 3902 directly. As shown in FIG. 39, rather than the tissue modification device 3900 including a channel, a bladder 3901 or catheter (not shown) may be removably coupled to the tissue modification device. In some embodiments, the device 3900 may coupled to a guidewire 3902 via a guidewire coupler 3905 at the distal end of the device. The device may then be pulled distilling into position within a spine of the patient with the guidewire and may then be reciprocated to cut target tissue within the spine. The device may then be pulled back proximally, at least partially out of the spine of the patient. Then the bladder 3901 may be hooked on via hooks 3904, or otherwise coupled, to the tissue modification device 3900, and the guidewire 3902 may be used to pull the device and bladder distally into position. An agent may then be delivered through the bladder. In some embodiments, the bladder may be configured to function as a shield and cover the blades 3906 of the device, such that the blades cannot cut while an agent is being delivered from the bladder 3901.
[0106] In some embodiments, as shown in FIGS. 40A and 40B, after cutting as described above, the tissue modification device (not shown) may be pulled back proximally and removed from the spine and then removed from the guidewire 3902. A catheter 3903 with a guidewire coupler 3905 at its distal end may then be coupled to the guidewire. The guidewire may then be used to pull the catheter into position within the patient and the agent may be delivered. In some embodiments, the agent may be delivered via apertures 3907 in the guidewire coupler, the catheter, or any other suitable location.
[0107] FIGS. 41A-41B show a configuration wherein the cable or tube 4100 connecting the rungs 4101 of the elongate body 4102 is configured to deliver an agent, such as a haemostatic agent. As described above the tissue modification device may be a flexible runged device. As shown, the rungs may be connected via a cable 4100. As shown in FIGS. 41A and 41B, the cable may be a hollow tube configured to receive and deliver an agent. As shown, the tip geometry of the tissue modification device may be modified such that the agent may be delivered from the tube through apertures 4103 in the device and into the desired location within the patient.
[0108] FIGS. 42A-44B show configurations wherein the tissue modification device further comprises a bladder, disposed along the length of the device, or other device to deliver an agent, such as a haemostatic agent. As shown in FIG. 42A and in an end view in FIG. 42B, the rungs 4200 may be modified such that they have a hole 4201 through their width to receive a tube or bladder 4202. As shown, the rung 4200 may also include a hole 4206 to receive a cable. As described above, the cable may be configured to connect the multiple rungs of the device. A tube or bladder 4202 may be disposed along the length of the device such that it exits the distal end 4203 of the device as shown in FIGS. 42A-42C. The device may include multiple holes 4204 or simply an opening 4205 for the distal open end of the tube, through which the agent may be delivered.
[0109] As shown in FIG. 43A, the bladder or tube may run proximally through the device to the proximal handle 4300 of the device. The proximal handle of the device may include a coupler 4301 configured to connect to a syringe 4302, as shown in FIG. 43A, or, as shown in FIG. 44B, the proximal handle 4300 may alternatively include a syringe or chamber 4303 within the proximal handle. As shown in FIGS. 43B and 44A, rather than running through the center of the device, the bladder (4400 and 4401 respectively) may be coupled to the back, non-abrasive, side of the tissue modification device 4402. As shown in FIG. 43C, the bladder 4400 of FIG. 43B may include apertures 4404 positioned between the rungs 4405 of the device. As shown, the agent will be delivered via the apertures 4404 between the rungs of the device to the target tissue or surgical site.
[0110] In alternative configurations, the delivery device may be a catheter that may be pulled into position within the surgical site via a guidewire. As shown in FIG. 45A, a guidewire 101 has been threaded along a path from an access location (such as through an interlaminar window 501) to where it exits through a foramen 502 of the spine 500. A distal guidewire handle 110 is coupled to the distal end of the guidewire. In this embodiment, the delivery device includes a catheter 505 and a connector 506. Catheter 505 preferably has a length such that the proximal end may be accessed outside of the patient and the distal end (not visible) is positioned within the surgical site adjacent to the necessary anatomical structures, such as blood vessels for example. In some embodiments, the catheter may be sized and configured to be fed through a METRX tube (Medtronic) or other minimally invasive surgical access device. The outer diameter of the catheter is about 1 mm to about 10 mm. In one specific embodiment, the catheter is a 14 gauge catheter.
[0111] As shown, the connector may be a Y-tube such as a "Tuey" valve. The connector includes a first branch 507 that is sized and configured to receive the guidewire 101. Branch 507 may include a locking mechanism such that the connector can lock down on the guidewire and prevent further motion of the guidewire through the connector. The lock may also prevent agent from escaping out of the connector through branch 507. The connector also includes a second branch 508 that is sized and configured to receive a syringe. The syringe preferably contains an agent 510, such as a hemostatic agent. Alternatively, the syringe may be coupled, over the guidewire, to branch 507 and an irrigation and/or suction source may be coupled to branch 508. In some embodiment, an additional two-way connector may be coupled to branch 508 such that the connector 506 becomes a three-way connector.
[0112] In an alternative variation, as shown in FIG. 45B, the delivery device also includes a catheter 505 and a connector 506, however as shown, the connector may include three branches 507, 508, and 512. The connector may be a three-way valve, for example. The connector includes a first branch 507 that is sized and configured to receive the guidewire 101. Branch 507 may include a locking mechanism such that the connector can lock down on the guidewire and prevent further motion of the guidewire through the connector. The lock may also prevent agent from escaping out of the connector through branch 507. The connector also includes a second branch 508 that is sized and configured to receive a syringe. The syringe preferably contains an agent 510, such as a hemostatic agent. Alternatively, the syringe may be coupled, over the guidewire, to branch 507. In some embodiments, branch 512 and 508 may be configured to provide suction and irrigation to the surgical site. For example, branch 512 may be configured to couple to a suction device. Apertures 513 are in fluid communication with branch 512 and the suction device. Apertures 513 may be positioned within the surgical site, and may be configured to remove fluids such as blood or flushing fluids, such as saline, from the surgical site. Branch 508 may be configured to couple to an irrigation device. Apertures 514 are in fluid communication with branch 508 and the irrigation device. Apertures 514 may be positioned within the surgical site, and may be configured to deliver fluids such irrigation or flushing fluids, such as saline, to the surgical site. These fluids may then be received by apertures 513 and removed as described above. As shown, catheter 505 includes three lumens. Any one of the branches and their respective lumens or apertures may be configured to couple to the guidewire 101, couple to an agent delivery syringe and deliver the agent to the surgical site, couple to a suction device and provide suction to the surgical site, and/or couple to an irrigation device and provide irrigation to the surgical site. The delivery device, as shown in FIG. 45B, may also include a marker 515. Marker 515 is positioned near the distal end of the catheter 505, and in some embodiments marks the position of apertures 513 and 514 and/or the distal end of the catheter. Marker 515 may be radiopaque such that it can be visualized fluoroscopically or by any other suitable visualization modality. The catheter may include a plurality of markers that may be positioned at any suitable location along the length of the delivery device. Alternatively, the entire delivery device, or a portion thereof, may be made of a radiopaque material, or a material treated to become radiopaque.
[0113] In use, the delivery device may be thread over the guidewire 101 at any point during a surgery --before tissue modification, during tissue modification, after tissue modification, and/or any combination thereof. The catheter 505 is thread over the guidewire such that the catheter is positioned into a desired position within the surgical site. As shown in FIG. 45A, the delivery device may be coupled to the proximal end of the guidewire and delivered to the surgical site by way of an interlaminar window. Alternatively, the delivery device may be coupled to the distal end of the guidewire (in addition to or instead of the distal handle 110). In this variation, the delivery device may be delivered to the surgical site by way of a spinal foramen. Once in the desired position, the locking mechanism of branch 507 may be clamped down on the guidewire. The catheter, in some embodiments, is made from a material that is stiff enough such that the catheter will not buckle or be pushed back along the guidewire by the spinal anatomy as the catheter is inserted into position. The catheter may include a hole at the distal end of the catheter through which the agent may be delivered. Alternatively (or additionally) the catheter may include holes or fenestrations along a portion of the length of the catheter. The catheter, in some variations, may be thin and flexible and ribbon shaped. For example, in variations in which the delivery device has an elongated ribbon shape that is long and flat with a width greater than the thickness, the device includes a first major surface (e.g., a front) and a second major surface (a back), and has edges (minor surfaces) between the first and second major surfaces. The first major surface may be referred to as the anterior or front surface and the second major surface may be referred to as the posterior or back surface. The anterior surface of the catheter may be positioned such that it faces toward the back of the patient, i.e. toward the facet joint, for example. The catheter may have holes for the agent along only the anterior surface, or may have holes on both the anterior surface and the posterior surface.
[0114] In an alternative variation (not shown), the syringe (coupled to a catheter, or independently) may be fed over the guidewire directly, rather than coupling to a connector. In this variation, the syringe may have a lumen disposed along the length of the catheter through which the guidewire may be fed. The guidewire may be used to guide the syringe (or other suitable agent receptacle) into the correct position within the surgical site. The syringe or delivery device may include a grommet or o-ring to seal the space between the guidewire and the syringe to prevent any leakage of the agent to be delivered.
[0115] In another alternative variation, similar to the variation of FIGS. 40A and 40B, the guidewire may be coupled to the end of the delivery device. The proximal shaped end of the guidewire may be coupled to the distal end of the catheter (or other portion of the delivery device) and may be used to pull the catheter into location. In this variation, the catheter may have a guidewire coupler at the distal end of the catheter and a hole or a plurality of holes on the catheter proximal to the guidewire coupler. In another alternative variation, the catheter or other portion of the delivery device may include a rapid exchange lumen. In this variation, the catheter includes a lumen that runs substantially along the length of the catheter, fluidically connecting ng an injection port (into which the agent is delivered, via a syringe for example) to the holes through which the agent is delivered to the surgical site. The catheter includes a second "rapid exchange" lumen that is sized and configured to receive the guidewire. This lumen does not run the length of the catheter but functions to couple the catheter to the guidewire.
[0116] As shown in FIGS. 46A and 46B, the delivery device may include a ribbon 600 and at least one port 601 fluidically coupled to the ribbon. As shown, the ribbon 600 includes at least one lumen along the length of the ribbon through which the guidewire 602 may run. As described above, the ribbon 600 may be coupled to the guidewire by being fed over the guidewire (as shown) or may include a guidewire coupler at its distal end and be coupled to the guidewire in an end-to-end configuration. The port(s) 601 may be fluidically connected to the same lumen through which the guidewire runs, or may be connected to an additional lumen. That lumen is also fluidically connected to holes 603 in the ribbon through which the agent may flow to the desired surgical location. As shown in FIG. 46B, in use, the surgeon or other user may grasp the distal handle 604 (coupled to the distal end of the guidewire 602) and the proximal end of the guidewire (which may be coupled to a proximal handle or other device) in one hand, while delivering an agent through a syringe 605 into port 601 with a second hand. Alternatively, a second user may operate the syringe. As the agent is delivered through the delivery device the user may pull up (i.e. away from the patient) on the distal and proximal ends of the guidewire to position the ribbon directly against the tissue to be treated.
[0117] As described above, in this variation, in which the delivery device has an elongated ribbon shape, the device includes a first major surface (e.g., a front, shown) and a second major surface (a back, not shown). The first major surface may be referred to as the anterior or front surface and the second major surface may be referred to as the posterior or back surface. The anterior surface of the catheter may be positioned such that it faces toward the back of the patient, i.e. toward the facet joint, for example.
[0118] In some embodiments, as shown in FIG. 47, the delivery device, similar in most respects to the delivery devices described above, may also include a balloon 700. The balloon may be a low-pressure, high-volume balloon. The balloon may contain the agent and may function to deliver the agent through holes 701 upon inflation.
[0119] In some embodiments, as shown in FIG. 48, the delivery device may include a two sided applicator. In this embodiment, the applicator 800, as shown in cross section in FIG. 48, has an elongated ribbon shape having a first major surface (e.g., a front, shown as 801) and a second major surface (a back, not shown). The delivery device includes two lumens: a front lumen 802 and a back lumen 803 that fluidically couple front holes 804 and back holes (not shown) to a front injection port and a back injection port, respectively. The holes are located toward the middle or distal end of the delivery device and the injection ports are location at the proximal end of the delivery device which remains outside of the patient. When the delivery device is positioned within the surgical site, the anterior surface of the device may be positioned such that it faces toward the back of the patient, i.e. toward the facet joint, for example; and the posterior surface of the device may be positioned such that it faces toward the front of the patient, i.e. toward the nerves and other non-target tissue. Different agents with different functions may be injected into the different lumens and delivered to different anatomy having different requirements. For example, a hemostatic agent may be delivered to the surgical site and tissue removal area while an analgesic may be delivered to a nerve on the opposite side of the device. Other possible agents are listed in FIG. 48.
[0120] As shown in FIG. 49, a ribbon shaped delivery device may include larger edges 900, 901 along at least a portion of the length of the ribbon. The injected material seems more likely to remain at the target site, as shown in FIG. 49 as the edges may function to act as a barrier and keep the injected agent toward the center of the delivery device. In some embodiments, as shown the edges 900 and 901 may include lumens 902 and 903. The lumens may couple injection ports to the holes through which the agent is delivered. For example, lumen 903 is fluidically connected to holes 904. The holes connected to lumen 902 may be located on the top side of edge 900 or may be located on the opposite side of the device from holes 904.
[0121] In some alternative embodiments, a tissue modification device, as described above, or a neural localization device may further include agent injection ports and/or holes to deliver the agents. For example, the tissue modification device may deliver hemostatic agent or analgesics to the surgical site while the tissue modification device is also modifying and/or removing target tissue.
[0122] In some alternative embodiments, a delivery device, a tissue modification device, and or a neural localization device may be configured to deliver energy to the surgical site, such that the bleeding may be stopped or prevented with cautery rather than by delivering a chemical agent to the surgical site. For example, the device may be configured to deliver heat and/or electricity (such as a bipolar or monopolar signal) to the surgical site. For example, the bleeding could be stopped or prevented with electrocauterization and/or ligation, which is the process of destroying tissue to stop or prevent bleeding using heat conduction from a metal probe or electrode heated by electric current. Alternatively, the tissue could be ablated (i.e. heated) using high frequency alternating current, such as radiofrequency waves, to stop or prevent bleeding.
[0123] As shown in FIG. 50, the delivery device may be packaged and provided to a user in a kit 1100. In some embodiments, the kit includes connector 1002 and a catheter 1003. As described above, the connector 1002 may include two branches, as shown, or alternatively, the connector may include a single branch or more than two branches. As described above, the catheter may be sized and configured (for example, having a suitable length) to be fed through a METRX tube (Medtronic) or other minimally invasive surgical access device. The outer diameter of the catheter 1003 may be about 1 mm to 10 mm. In one specific embodiment, the catheter is a 14 gauge catheter. Kit 1100 may further include syringe. Syringe may include a hemostatic delivery agent, or may be filled upon removal from the kit by the user. The components of the kit are preferably packaged in a single unit. The package and each of the components are preferably sterilized and packaged in sterilized packaging. Alternatively, the components along with the packaging may be sterilized once assembled. In some embodiments, the kit 1100 may further comprise a guidewire, a guidewire delivery probe, a neural localization device, and/or a tissue modification device.
[0124] In further alternative configurations, a probe or cannula may be configured to deliver an agent to the surgical site. As described above with respect to the access probes, for example, in FIGS. 5A and 5B, a probe or cannula configured to deliver an agent to the surgical site may be positioned within the spine of a patient in a similar fashion. For example, the distal end of the probe may be advanced through and interlaminar window or laminotomy and advanced toward or through a neural foramen. The distal end of the probe delivery device may then be places in the surgical site adjacent to the target tissue. As described above, the probe may include an outer cannula and an inner cannula, slideable disposed within the outer cannula. Alternatively, as shown in FIGS. 51A to 51C, the delivery device probe 5100 may only include a single outer cannula. As shown, the distal end portion of the probe may be curved 5101 such that it may better access the desired tissue within the spine. Furthermore, the distal end of the delivery device may have an atraumatic end S 102 such that the probe may be advanced within the spine without damaging tissue such as never or vascular tissue. In some embodiments, the atraumatic tip may include a curved tip, as shown. In some embodiment, an extrusion may be molded around the distal tip of the catheter. Alternatively, the atraumatic tip may be a cap pressed into or welded to the end of the probe. In some embodiments, the distal end portion of the probe may be molded as two halves ("clam shell") that are then welded or snapped together. In this embodiment, the end may be closed and the probe may have apertures on the top and or bottom portion of the probe through which to deliver the agent. In some embodiments, as shown in FIGS. 51A and 51B, the delivery device may further include a connector S103 toward the proximal end of the cannula. The connector may a luer connector to receive a catheter and/or a syringe. In some embodiments, the delivery device may include a syringe or plunger suitable to deliver the agent through the device. The probe 5100 may be metal, plastic, or any other suitable material. In some embodiments, the material is rigid and/or has column strength such that the probe may be advanced into the spine without buckling.
[0125] In some alternative embodiments, the probe or delivery device of FIG. 5A to 5B or 51A to 51C may be configured to include an electrode or electrodes toward the distal end of the probe. In some embodiments, the electrode may be configured to deliver electricity. In some embodiments, the electricity may be used to stimulate nerve to determine the position of the nerve with respect to the probe. Alternatively, the energy may be used to ablate or cauterize the tissue adjacent to the electrode of the probe. In some embodiments, the entire metal tip of the probe may be electrified, however the majority of the tip may be insulated (with PEBAX for example) such that only a portion of the metal probe tip is exposed and able to delivery energy.
[0126] Although much of the description and accompanying figures generally focuses on surgical procedures in spine, in alternative embodiments, devices, systems and methods of the present invention may be used in any of a number of other anatomical locations in a patient's body. For example, in some embodiments, the flexible tissue modification devices of the present invention may be used in minimally invasive procedures in the shoulder, elbow, wrist, hand, hip, knee, foot, ankle, other joints, or other anatomical locations in the body. Similarly, although some embodiments may be used to remove or otherwise modify ligamentum flavum and/or bone in a spine to treat spinal stenosis, in alternative embodiments, other tissues may be modified to treat any of a number of other conditions. For example, in various embodiments, treated tissues may include but are not limited to ligament, tendon, bone, tumor, cyst, cartilage, scar, osteophyte, inflammatory tissue and the like. Non-target tissues may include neural tissue and/or neurovascular tissue in some embodiments or any of a number of other tissues and/or structures in other embodiments. In one alternative embodiment, for example, a flexible tissue modification device may be used to incise a transverse carpal ligament in a wrist while inhibiting damage to the median nerve, to perform a minimally invasive carpal tunnel release procedure. Thus, various embodiments described herein may be used to modify any of a number of different tissues, in any of a number of anatomical locations in the body, to treat any of a number of different conditions.
[0127] Although various illustrative embodiments are described above, any of a number of changes may be made to various embodiments without departing from the scope of the invention as described by the claims. For example, the order in which various described method steps are perfomled may often be changed in alternative embodiments, and in other alternative embodiments one or more method steps may be skipped altogether. Optional features of various device and system embodiments may be included in some embodiments and not in others. Therefore, the foregoing description is provided primarily for exemplary purposes and should not be interpreted to limit the scope of the invention as it is set forth in the claims.
[0128] The examples and illustrations included herein show, by way of illustration and not of limitation, specific embodiments in which the subject matter may be practiced. Other embodiments may be utilized and derived there from, such that structural and logical substitutions and changes may be made without departing from the scope of this disclosure. Such embodiments of the inventive subject matter may be referred to herein individually or collectively by the term "invention" merely for convenience and without intending to voluntarily limit the scope of this application to any single invention or inventive concept, if more than one is in fact disclosed. Thus, although specific embodiments have been illustrated and described herein, any arrangement calculated to achieve the same purpose may be substituted for the specific embodinlents shown. This disclosure is intended to cover any and all adaptations or variations of various embodiments. Combinations of the above embodiments, and other embodiments not specifically described herein, will be apparent to those of skill in the art upon reviewing the above description.
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