The above-mentioned and other features and objects of this disclosure, and the manner of attaining them, will become more apparent and the disclosure itself will be better understood by reference to the following description of embodiments of the disclosure taken in conjunction with the accompanying drawings, wherein:
Like reference numerals indicate the similar parts throughout the figures.
The exemplary embodiments of the vertebral treatment device and methods of use disclosed are discussed in terms of medical apparatus and more particularly, in terms of vertebral treatment devices, fluid transfer devices, bone drills, bone drill assemblies and bone cavity drills that can be employed for treating vertebral body and sacral fractures. The vertebral treatment devices may also be employed to treat lytic tumor deposits in bone. It is envisioned that the present disclosure may be employed with a range of applications including vertebral augmentation, vertebroplasty, sacroplasty and osteoplasty. It is further envisioned that the present disclosure may be used with other medical applications such as diagnosis, treatment and surgery.
The following discussion includes a description of the vertebral treatment devices, related components and exemplary methods of operating the vertebral treatment devices in accordance with the principles of the present disclosure. Alternate embodiments are also disclosed. Reference will now be made in detail to the exemplary embodiments of the present disclosure, which are illustrated in the accompanying figures. Turning now to
The components of fluid transfer device 1200 are fabricated from materials suitable for medical applications, such as, for example, polymerics and/or metals, depending on the particular application and/or preference. Semi-rigid and rigid polymerics are contemplated for fabrication, as well as resilient materials, such as molded medical grade polyurethane, etc. It is contemplated that any motors, gearing, electronics and power components employed with fluid transfer device 1200 may be fabricated from those suitable for a medical application. Fluid transfer device 1200 may also include circuit boards, circuitry, processor components, etc. for computerized control. One skilled in the art, however, will realize that other materials and fabrication methods suitable for assembly and manufacture, in accordance with the present disclosure, also would be appropriate.
Detailed embodiments of the present disclosure are disclosed herein, however, it is to be understood that the described embodiments are merely exemplary of the disclosure, which may be embodied in various forms. Therefore, specific functional details disclosed herein are not to be interpreted as limiting, but merely as a basis for the claims and as a representative basis for teaching one skilled in the art to variously employ the present disclosure in virtually any appropriately detailed embodiment.
Referring to
Fluid transfer device 1200 has a body 1202. Body 1202 includes a first section 1204, a second section 1206 and a handle 1208. First section 1204 and second section 1206 are integrally assembled to support components of fluid transfer device 1200. It is contemplated that first section 1204 and second section 1206 may be adhered as a unit, retained by mechanical structure such as, clips, pins, etc., or by other methods known to one skilled in the art. Portions of body 1202 may be monolithically formed. It is further contemplated that sections 1204, 1206 may be symmetric halves, offset, non-symmetric, etc.
Handle 1208 is connected with second section 1206 and facilitates grasping/manipulation of fluid transfer device 1200 by a user. Handle 1208 has a tubular body 1210, which is configured for a user's hand to wrap around. It is envisioned that tubular body 1210 may include a finger grip area. Tubular body 1210 may also be pivotable relative to body 1202 to facilitate manipulation and use of fluid transfer device 1200 for a particular application, as well as protecting a user from radiation during fluoroscopy.
Body 1202 supports a first cylinder, such as, for example, syringe 1212 and a second cylinder, such as, for example, syringe 1214. Syringe 1212 defines a first cavity 1216 and supports a first plunger 1218. First plunger 1218 is disposed for axial movement within first cavity 1216 in a configuration such that a first fluid, such as, for example, body fluid, including blood and/or bone fragments, is drawn into first cavity 1216 from a vertebral cavity of a vertebral body (
Syringe 1212 has a tubular body 1220 that extends from a first end 1222 to a second end 1224. First end 1222 includes a flange 1226, which is releasably mounted with body 1202 via brackets 1228. Flange 1226 has tabs 1230 that can be rotated into and out of position with brackets 1228 for retaining and releasing syringe 1212 from body 1202. It is contemplated that syringe 1212 may also be releasably mounted with body 1202 by other structure such as a spring mechanism, insertion with body 1202, clips, threaded engagement, luer lock, etc. It is further contemplated that syringe 1212 may be permanently fixed with body 1202 via adhesive, locking assembly, monolithically formed components, etc. It is envisioned that tubular body 1220 may be variously configured and dimensioned accordingly to the requirements of a particular application including alternative cross section such as elliptical, polygonal, etc.
Second end 1224 has a nozzle 1232 configured to receive the body fluid being drawn from the vertebral cavity. Nozzle 1232 is connected to an access tube or the like, discussed below, which is a conduit for the drawn body fluid. It is contemplated that nozzle 1232 and its opening may be variously configured and dimensioned accordingly to the requirements of a particular application including alternative opening sizes to regulate fluid flow.
Syringe 1214 defines a second cavity 1234 and supports a second plunger 1236. Second plunger 1236 is disposed for axial movement within second cavity 1234 in a configuration such that a second fluid, such as, for example, an orthopedic bone filler/cement, or other type of desirable medication/material is, for example, instilled into a fractured bone for treating vertebral and sacral fractures, as will be discussed.
Syringe 1214 has a tubular body 1238 that extends from a first end 1240 to a second end 1242. First end 1240 includes a flange 1244, which is releasably mounted with body 1202 via brackets 1246. Flange 1244 has tabs 1248 that can be rotated into and out of position with brackets 1246 for retaining and releasing syringe 1214 from body 1202. It is contemplated that syringe 1214 may also be releasably mounted with body 1202 by other structure such as a spring mechanism, insertion with body 1202, clips, threaded engagement, luer lock, etc. It is further contemplated that syringe 1214 may be permanently fixed within the body 1202 via adhesive, locking assembly, monolithically formed components, etc. It is envisioned that tubular body 1238 may be variously configured and dimensioned accordingly to the requirements of a particular application including alternative cross section such as elliptical, polygonal, etc.
Second end 1242 has a nozzle 1250 configured to expel the bone filler/cement to the vertebral cavity. Nozzle 1250 is connected to an access tube or the like, discussed below, which is a conduit for the bone filler/cement to the vertebral cavity. It is contemplated that nozzle 1250 and its opening may be variously configured and dimensioned accordingly to the requirements of a particular application including alternative opening sizes to regulate fluid flow.
An actuator 1252 is supported by a rearward portion 1254 of body 1202. Actuator 1252 includes a shaft 1256, which is operatively coupled to a gearing assembly 1258. Gearing assembly 1258 is supported by a forward portion 1260 of body 1202. Actuator 1252 is connected to first plunger 1218 and second plunger 1236 via gearing assembly 1258. It is contemplated that actuator 1252 may be directly connected to plungers 1218, 1236 using, for example, an axial force to move the plungers. It is further contemplated that a plurality of actuator may be employed to facilitate movement of the plungers, such as dedicated actuator for each plunger.
As shown in
Plunger 1218 includes a shaft 1278 having teeth 1280 axially disposed therealong. Teeth 1280 engage pinion gear 1270 to facilitate movement of first plunger 1218 relative to body 1220. For example, as actuator 1252 is manipulated for clockwise rotation, in the direction shown by arrow C, gear 1268 rotates in a clockwise direction. Gear 1268 causes pinion gear 1270 to rotate in a counterclockwise direction. Pinion gear 1270 meshes with teeth 1280 causing shaft 1278 to move first plunger 1218 within first cavity 1216 in a forward axial direction relative to body 1220, in the direction shown by arrow A. Such clockwise rotation of actuator 1252 causes plunger 1218 to expel a fluid, or prepare for drawing fluid, into first cavity 1216. Plunger 1218 includes a gasket 1282 that sealingly engages the inner wall of body 1220. This configuration establishes a vacuum pathway to create suction or expulsion pressure in the communication between first cavity 1216, the vertebral cavity and second cavity 1234, which includes intermediary access lines, tubing or devices.
Conversely, in an example such that actuator 1252 is manipulated for counterclockwise rotation, in the direction shown by arrow CC, gear 1268 rotates in a counterclockwise direction. Gear 1268 causes pinion gear 1270 to rotate in a clockwise direction. Pinion gear 1270 meshes with teeth 1280 causing shaft 1278 to move first plunger 1218 within first cavity 1216 in a rearward direction relative to body 1220, to draw fluid out of the vertebral cavity, facilitating the flow of filler/cement to the vertebral cavity from syringe 1214.
Plunger 1236 of syringe 1214 includes a shaft 1284 having teeth 1286 axially disposed therealong. Teeth 1286 engage pinion gear 1272 to facilitate movement of second plunger 1236 relative to body 1238. For example, as actuator 1252 is manipulated for clockwise rotation, in the direction shown by arrow C, gear 1268 rotates in a clockwise direction. Gear 1268 causes pinion gear 1272 to rotate in a counterclockwise direction. Pinion gear 1272 meshes with teeth 1286 causing shaft 1284 to move second plunger 1236 within second cavity 1234 in a rearward axial direction relative to body 1238, in the direction shown by arrow B. Such clockwise rotation of actuator 1252 causes plunger 1236 to draw a fluid into second cavity 1234. Plunger 1236 includes a gasket 1288 that sealingly engages the inner wall of body 1238. This configuration establishes a preferred vacuum pathway to create suction or expulsion pressure in the communication between first cavity 1216, the vertebral cavity and second cavity 1234, which includes intermediary access lines, tubing or devices.
Conversely, in an example such that actuator 1252 is manipulated for counterclockwise rotation, in the direction shown by arrow CC, gear 1268 rotates in a counterclockwise direction. Gear 1268 causes pinion gear 1272 to rotate in a clockwise direction. Pinion gear 1272 meshes with teeth 1285 causing shaft 1284 to move second plunger 1236 within second cavity 1234 in a forward direction relative to body 1238, in the direction shown by arrow A. Such counterclockwise rotation of actuator 1252 causes plunger 1236 to expel bone filler/cement out of second cavity 1234. Expulsion of the bone filler/cement is facilitated by the sealing engagement of gasket 1288 with the inner wall of body 1238, as discussed. This configuration facilitates a preferred pathway between second cavity 1234 and the vertebral cavity for the flow of filler/cement to the vertebral cavity from syringe 1214. This advantageously reduces the risk of filler/cement flowing out from the vertebral body. The preferred pathway discussed, prevents leakage of filler/cement and undesired filler/cement flow into adjacent structures such as intervertebral disc, spinal canal, neural foramina, and blood vessels.
Fluid transfer device 1200 includes syringes 1212, 1214 such that their respective plungers 1218, 1236 are linked. As plunger 1236 is driven forward, plunger 1218 is driven rearward, as discussed, to create a suction for drawing fluid out of the vertebral cavity of the vertebral body. This advantageous configuration of fluid transfer device 1200 and the methods described, creates a space in the vertebral cavity and a preferred pathway for instilling the bone filler/cement in the vertebral cavity. It is contemplated that alternative to a user manipulated actuator, plungers 1212, 1214 may be moveable via motors, which may include electronic circuitry and microprocessor control. Such control can be employed to monitor and regulate, via adjustment and calibration, the delivery of the bone filler/cement and pressure.
It is envisioned that fluid transfer device 1200 includes a pressure monitoring gauge (not shown), which is connected to the preferred pathway discussed. The pressure monitoring gauge is employed to monitor pressure in the preferred pathway and is connected to an automatic stop mechanism (not shown). The automatic stop mechanism can be activated to discontinue operation of fluid transfer device 1200 to advantageously prevent buildup of excessive pressure in the targeted bone to minimize the likelihood of filler/cement leak. It is further envisioned that such a pressure monitoring gauge may be connected at other locations of the preferred pathway such as with tubing or other devices employed.
In one method of using fluid transfer device 1200, a bore may be created in bone of a vertebral or sacral body, to introduce and temporarily leave a tube, tubular sheath or the like. A tubular sheath may be used, which is configured to allow an instrument, component, tool or the like to pass therethrough and provide access to an area at or adjacent to the vertebral cavity of the vertebral body. Fluid transfer device 1200 may include radiolucent and radio opaque materials. Fluid transfer device 1200 may also include radio opaque markers for aligning components such as tubing, cannulas, needles, sheaths, etc., during a procedure for treating a vertebral body.
In another particular embodiment, in accordance with the principles of the present disclosure, a vertebral treatment system is provided. The vertebral treatment system includes components such as a bone drill, forceps, a cavity drill and a fluid transfer device for treating fractured bone of a vertebral body and/or a sacral body. It is envisioned that the vertebral treatment system may include one or all of the components discussed herein. It is further envisioned that the vertebral treatment system may include other components applicable to a vertebral treatment procedure and in accordance with the present disclosure.
The vertebral treatment system employs, for example, a bone drill 410, as shown in
In operation of the vertebral treatment system, bone drill 410 is employed with a method for treating fractured bone of a vertebral body or a sacral body. The components of bone drill 410 are fabricated, properly sterilized and otherwise prepared for use. Bone drill 410 is provided with handle portion 414, drive portion 416 and head portion 418 in a configuration that provides a safe distance between a physician and radiation emitted during the procedure.
Head portion 418 includes radioopaque markers 464 disposed in a configuration to facilitate alignment of sheath 457 with bone of the vertebral body (
Forceps 1300 is provided to stabilize and guide bone drill 410 during drilling of bone of the vertebral body. Forceps 1300 includes radioopaque arms 1324, 1326 having jaws 1328, 1329. The exposure of radiation to forceps 1300 and radioopaque arms 1324, 1326 allows the user to identify the location of jaws 1328, 1329 relative to sheath 457 and drill bit 458 of bone drill 410. This configuration facilitates guidance for drilling and protects the user from radiation by maintaining the hands of the user a safe distance therefrom.
Arms 1324, 1326 are moveable between a closed position and an open position, as discussed above. When jaws 1328, 1329 are in the open position, sheath 457 is free to rotate. To grasp sheath 457 for guidance and stabilization of bone drill 410 during the vertebral drilling procedure, the user grasps handle 1302 and squeezes on actuator 1304. Shaft 1308 moves to the extended position and jaws 1328, 1329 move to the closed position to grasp sheath 457. Cylindrical cavity 1330 is configured to snugly fit and snap onto sheath 457. Sheath 457 is firmly held in position by forceps 1300, which advantageously operates as a drill guide.
Drill bit 458 engages the bone and rotates via motor 498 to bore a cavity in the bone. Sheath 457 is driven into engagement with the bone to further define the cavity in the bone. After drill bit 458 has reached a desired depth within the targeted bone, according to the requirements of a particular procedure, actuator 1304 of forceps 1300 can release jaws 1328, 1329 from sheath 457. Sheath 457 is free to rotate. If desired, forceps 1300 may be removed from sheath 457.
Cavity drill 610, which is an alternate embodiment of bone drill 410, is provided for enlarging and/or further defining the cavity bored in the bone by bone drill 410. Cavity drill 610 includes a knob 620, which is manipulated for rotation to drive a bone curette 622, which reams the targeted bone and cavity. Cavity drill 610 also includes a knob 632, which is manipulated for rotation to cause relative axial translation of bone curette 622. Knobs 620, 632 are rotated, in cooperation to ream the targeted bone area and further define the targeted bone cavity. It is contemplated that cavity drill 610 may include radioopaque markers to facilitate alignment thereof with the targeted bone.
After the cavity is created in the targeted vertebral bone, according to the requirements for the particular fracture and treatment procedure, the targeted vertebral body or sacral body is treated. See, for example, the description of methods of use in co pending and commonly owned U.S. application Ser. No. ______, filed on Apr. 20, 2007 under Express Mail Label No. ER 550793142 US, U.S. application Ser. No. ______, filed on Apr. 20, 2007 under Express Mail Label No. ER 550793139 US and U.S. application Ser. No. ______, filed on Apr. 20, 2007 under Express Mail Label No. ER 550793156 US. It is contemplated that one or a plurality of cavities may be created to allow for access tubing, cannulas, etc. in the targeted area. It is further contemplated that balloon catheters, etc., may be inserted through the access tubing, cannulas, etc. into the targeted fractured vertebral body. Bone fillers/cement may then be instilled into the bone. It is envisioned that the access tubing, cannulas, etc. may be fabricated from radiolucent material and/or radioopaque material.
A fluid transfer device 1200 is provided for treating a fracture of a vertebral body 1400 having a vertebral cavity 1402, as shown in
Tubing 1412, 1414 are connected with access cannulas 1408, 1410. Tubing 1412 is connected to nozzle 1232 and tubing 1414 is connected to nozzle 1250. Syringes 1212, 1214, tubing 1412, 1414, cannulas 1404, 1406 and vertebral cavity 1402 are in fluid communication to establish a preferred vacuum pathway to create suction and expulsion pressure between syringes 1212, 1214 and vertebral cavity 1402 for treating a fracture of vertebral body 1400.
To instill an orthopedic bone filler/cement such as PMMA (Polymethyl methacrylate) into vertebral cavity 1402, fluid transfer device 1200 draws body fluid out of vertebral cavity 1402 and instills PMMA therein. Actuator 1252 is manipulated for counterclockwise rotation, in the direction shown by arrow G. First plunger 1218 is caused to move within first cavity 1216 in a rearward direction, in the direction shown by arrow H, discussed above. Accordingly, body fluid is drawn out of vertebral cavity 1402, in the direction shown by arrows I.
As actuator 1252 is rotated counterclockwise, second plunger 1236 is caused to move within second cavity 1234 in a forward direction, in the direction shown by arrow J. Accordingly, plunger 1236 expels PMMA out of second cavity 1234, in the direction shown by arrows K, and into vertebral cavity 1402. This advantageous configuration removes body fluid and instills bone filler/cement simultaneously, as facilitated by the preferred communication pathway between syringe 1212 and syringe 1214. This design of the vertebral treatment system and fluid transfer device 1200 has several benefits including increased patient safety by reducing the risk of leakage of bone filler/cement and undesired flow of filler/cement into adjacent structures such as the intervertebral disc, spinal canal, neural foramina, and blood vessels.
The PMMA instilled in vertebral cavity 1402 hardens to provide strength and stability to the vertebra. It is envisioned that the vertebral treatment system employing fluid transfer device 1200 may be continuously monitored using fluoroscopy guidance. It is further envisioned that the vertebral treatment system may be employed with various treatment procedures such as vertebral augmentation, vertebroplasty, sacroplasty, osteoplasty, etc.
While the invention has been illustrated and described in detail in the drawings and foregoing description, the same is to be considered as illustrative and not restrictive in character, it being understood that embodiments have been shown and described and that all changes and modifications that come within the spirit of this invention are desired to be protected.
This patent application claims the benefit of U.S. Provisional Patent Application Ser. No. 60/809,945, filed on Jun. 1, 2006, the contents of which being incorporated herein by reference in its entirety.
Number | Date | Country | |
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60809945 | Jun 2006 | US |