Source: http://www.google.de/patents/US9393055
Timestamp: 2017-11-18 10:25:01
Document Index: 517538964

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

Patent US9393055 - Spacer insertion instrument - Google Patentsuche
A percutaneous and minimally invasive instrument for inserting an interspinous process spacer into a patient is disclosed. The insertion instrument includes a first assembly connected to a handle assembly. The first assembly includes an inner shaft located inside an outer shaft and configured for relative...http://www.google.de/patents/US9393055?utm_source=gb-gplus-sharePatent US9393055 - Spacer insertion instrument
Veröffentlichungsnummer US9393055 B2
Anmeldenummer US 14/089,692
Auch veröffentlicht unter CA2701050A1, EP2219538A2, EP2219538A4, US20140081332, US20170128110, WO2009086010A2, WO2009086010A3
Veröffentlichungsnummer 089692, 14089692, US 9393055 B2, US 9393055B2, US-B2-9393055, US9393055 B2, US9393055B2
Patentzitate (677), Nichtpatentzitate (70), Referenziert von (2), Klassifizierungen (13), Juristische Ereignisse (1)
US 9393055 B2
A percutaneous and minimally invasive instrument for inserting an interspinous process spacer into a patient is disclosed. The insertion instrument includes a first assembly connected to a handle assembly. The first assembly includes an inner shaft located inside an outer shaft and configured for relative translational motion with respect to the outer shaft. The relative translational motion causes one of the outer or inner shafts to move with respect to the other and thereby deflect at least one prong formed on one of the inner or outer shafts wherein such deflection causes engagement with a juxtapositioned interspinous spacer. The instrument further includes a driving tool configured for removable insertion into a proximal end of a passageway of the instrument.
1. A method for implanting an interspinous device having a spacer body and first and second wings, the method comprising:
inserting the interspinous device between a first spinous process and a second spinous process of a subject's spine while an instrument is connected to the interspinous device;
deploying the interspinous device by rotating a driving tool of the instrument to rotate the first and second wings relative to the spacer body such that the first and second wings are positioned to hold the first and second spinous processes; and
disconnecting the interspinous device from the instrument by rotating a control of the instrument while the first and second wings are positioned to hold the first and second spinous processes and the control is located outside of the subject.
2. The method of claim 1 wherein deploying the interspinous device includes rotating the driving tool while a prong of the instrument is positioned within a prong receiving portion of the interspinous device such that the prong limits rotation of the spacer body.
3. The method of claim 1 wherein disconnecting the interspinous device from the instrument includes moving prongs of the instrument from a clamping configuration for holding the interspinous device to an open configuration for releasing the interspinous device.
4. The method of claim 1 wherein the instrument includes a clamping assembly and a handle, and wherein rotating the driving tool includes
rotating the driving tool about an axis of rotation defined by the clamping assembly while the driving tool extends through the clamping assembly and extends through the handle positioned outside of the subject.
5. The method of claim 1 wherein the driving tool includes a proximal end with a driver handle and a distal end with an engaging bit, and wherein deploying the interspinous device includes
manually rotating the driver handle positioned proximally of a clamping tool of the instrument while the clamping tool of the instrument holds the spacer body and the engaging bit engages an actuation mechanism of the interspinous device, wherein the actuation mechanism is configured to rotate the first and second wings as the control rotates.
6. The method of claim 1 wherein disconnecting the interspinous device from the instrument includes moving a clamping assembly of the instrument from a clamping configuration for holding the interspinous device to a release configuration for releasing the interspinous device.
the instrument includes
a clamping assembly coupleable to the handle, wherein the clamping assembly includes at least one prong, an outer shaft, and an inner shaft with a passageway for receiving the driving tool; and
disconnecting the interspinous device from the instrument includes moving the at least one prong out of a prong receiving portion of the interspinous device by moving one of the outer and inner shafts.
8. The method of claim 7 wherein disconnecting the interspinous device includes rotating the control to move one of the outer and inner shafts with respect to the other to cause the at least one prong to move toward and/or away from a longitudinal axis of the instrument.
9. The method of claim 1 wherein disconnecting the interspinous device from the instrument includes opening a clamping assembly of the instrument configured to hold the interspinous device.
10. The method of claim 1 wherein the instrument has a distal end that clamps onto the interspinous device, wherein rotation of the control causes the distal end to open and release the interspinous device.
11. A method for implanting an interspinous device having a spacer body and first and second wings using an instrument, the method comprising:
positioning the interspinous device at an interspinous space between a first spinous process and a second spinous process of a subject's spine while the interspinous device is connected to the instrument, wherein the instrument includes a handle, an assembly, a driving tool, and a control;
moving the driving tool relative to the spacer body releasably held by the assembly to cause an actuator mechanism of the interspinous device to drive the first and second wings toward a deployed configuration for holding the first and second spinous process;
after deploying the first and second wings, rotating the control positioned external to the subject to cause the assembly to release the interspinous device; and
after releasing the interspinous device, removing the instrument from the subject while the first spinous process is between elongate arms of the first wing and the second spinous process is between elongate arms of the second wing.
12. The method of claim 11 wherein the driving tool is configured to be rotated independent of rotation of the control to rotate the first and second wings independently of the release of the interspinous device.
13. The method of claim 11 wherein rotating the control of the instrument includes rotating the control a sufficient amount to move prongs of the instrument out of respective prong receiving portions of the interspinous device and thereby release the interspinous device.
the instrument includes a clamping assembly movable from clamping configuration for holding the interspinous device to an open configuration for releasing the interspinous device, and
rotating the control of the instrument includes rotating the control a sufficient amount to move the clamping assembly toward the open configuration so as to release the interspinous device.
15. The method of claim 11 wherein moving the driving tool includes rotating the driving tool about an axis of rotation defined by a clamping assembly of the instrument while the driving tool is positioned within a passageway of the clamping assembly.
the driving tool includes a proximal end with a driver handle and a distal end with an engaging bit, and
moving the driving tool includes manually rotating the driver handle positioned proximally of a clamping assembly of the instrument while the engaging bit engages the interspinous device held by the clamping assembly.
17. The method of claim 11 wherein rotating the control of the instrument causes a clamping assembly of the instrument to move from an clamping configuration for holding the interspinous device to a release configuration for disconnecting from the interspinous device.
the instrument includes a handle and a clamping assembly coupleable to the handle, wherein the clamping assembly includes an outer shaft and an inner shaft with a passageway for receiving the driving tool, and
rotating the control includes moving the control a sufficient amount to move at least one prong out of a prong receiving portion of the interspinous device.
19. The method of claim 18 wherein rotation of the control causes one of the outer and inner shafts to move with respect to the other to cause the at least one prong to move toward or away from a longitudinal axis of the instrument.
20. The method of claim 11 wherein the instrument includes an assembly having a distal end with a clamping assembly, wherein rotation of the control includes moving the clamping assembly between a clamping configuration for holding the interspinous device and an open configuration for releasing the interspinous device independent of rotation of the driving tool.
21. The method of claim 11, further comprising moving the interspinous device along a midline approach to position the interspinous device at the interspinous space.
This application is a continuation of U.S. patent application Ser. No. 12/338,793, now U.S. Pat. No. 8,613,747, filed Dec. 18, 2008, now allowed, which claims priority to and the benefit of U.S. Provisional Patent Application No. 61/008,418 entitled “Spacer Insertion Instrument” filed on Dec. 19, 2007, which also claims priority to and is a continuation-in-part of U.S. patent application Ser. No. 12/205,511, now U.S. Pat. No. 8,123,782, filed on Sep. 5, 2008, entitled “Interspinous Spacer,” which is a non-provisional of U.S. Provisional Patent Application No. 60/967,805, filed on Sep. 7, 2007, and entitled “Interspinous Spacer,” and is a continuation-in-part of U.S. patent application Ser. No. 12/220,427, now U.S. Pat. No. 8,277,488, filed Jul. 24, 2008 and entitled “Interspinous Spacer,” which is a non-provisional of U.S. Provisional Patent Application No. 60/961,741, filed Jul. 27, 2007, and entitled “Insterspinous Spacer,” and is a continuation-in-part of U.S. patent application Ser. No. 12/217,662, now U.S. Pat. No. 8,273,108, filed Jul. 8, 2008, and entitled “Interspinous Spacer,” which is a non-provisional of U.S. Provisional Patent Application No. 60/958,876, filed Jul. 9, 2007, and entitled “Interspinous Spacer,” and is a continuation-in-part of U.S. patent application Ser. No. 12/148,104, now U.S. Pat. No. 8,292,922, filed Apr. 16, 2008, and entitled “Interspinous Spacer,” which is a non-provisional of U.S. Provisional Patent Application No. 60/923,971, filed on Apr. 17, 2007, and entitled “Interspinous Spacer,” and U.S. Provisional Patent Application No. 60/923,841, filed Apr. 16, 2007, entitled “Spacer Insertion Instrument,” all of which are hereby incorporated by reference in their entireties. Patent application Ser. No. 12/338,793 is also a continuation-in-part of U.S. Patent application Ser. No. 11/593,995, now U.S. Pat. No. 8,425,559, filed on Nov. 7, 2006, entitled “Systems and Methods for Posterior Dynamic Stabilization of the Spine,” and a continuation-in-part of U.S. patent application Ser. No. 11/582,874, now U.S. Pat. No. 8,128,662, filed on Oct. 18, 2006, and entitled “Minimally Invasive Tooling for Delivery of Interspinous Spacer” and a continuation-in-part of U.S. patent application Ser. No. 11/314,712, now U.S. Pat. No. 8,152,837, filed on Dec. 20, 2005 and entitled “Systems and Methods for Posterior Dynamic Stabilization of the Spine,” and a continuation-in-part of U.S. patent application Ser. No. 11/190,496, now U.S. Pat. No. 8,409,282, filed Jul. 26, 2005, and entitled “Systems and Methods for Posterior Dynamic Stabilization of the Spine,” and a continuation-in-part of U.S. patent application Ser. No. 11/079,006, now U.S. Pat. No. 8,012,207, filed on Mar. 10, 2005, and entitled “Systems and Methods for Posterior Dynamic Stabilization of the Spine,” which is a continuation-in-part of U.S. patent application Ser. No. 11/052,002, now U.S. Pat. No. 8,317,864, filed Feb. 4, 2005, entitled “Systems and Methods for Posterior Dynamic Stabilization of the Spine,” which is a continuation-in-part of U.S. patent application Ser. No. 11/006,502, now U.S. Pat. No. 8,123,807, filed on Dec. 6, 2004, and entitled “Systems and Methods for Posterior Dynamic Stabilization of the Spine” which is a continuation-in-part of U.S. patent application Ser. No. 10/970,843, now U.S. Pat. No. 8,167,944, filed Oct. 20, 2004, and entitled “Systems and Methods for Posterior Dynamic Stabilization of the Spine,” all of which are hereby incorporated by reference in their entireties.
Turning now to FIGS. 8a-8d , there is shown the outer shaft 22 of the first assembly 12. As seen in the drawings, the outer shaft 22 is substantially cylindrical in shape having a central bore 42 extending from end to end. The outer shaft 22 is sized such that the inner shaft 20 fits inside the outer shaft 22. The distal end includes a pair of flattened portions 44 located substantially opposite from each other. There is a middle portion 46 having a larger cross-section and a threaded proximal portion 48. The threaded proximal portion 48 is configured for threaded connection with the control 24. In one variation, the middle portion 46 includes features such as an octagonal shape as seen in FIG. 16 that serve to align the instrument 10 when inserted into a cannula positioned to an interspinous space of a patient. The features on the middle portion 46 are aligned with similar complementary features on a cannula so that insertion of the instrument into the cannula is limited by the alignment of the features with the result being proper orientation of the instrument relative to the cannula and in turn relative to the patient. The outer shaft 22 includes at least one aperture formed in the sidewall of the shaft to provide access to the inner shaft and the interior of the shaft construct for cleaning purposes.
Turning now to FIGS. 9a-9c , there is shown the control 24 of the first assembly 12. The control 24 includes a user interface such as a finger portion or grip 50. In the variation shown in FIGS. 9a-9c , the user interface 50 is an outer circular or disk shaped portion for easily effecting rotation of the control 24 with a thumb or index finger. The control 24 also includes a connecting portion 52 that connects the control 24 to effect relative translation of the inner shaft 20 with respect to the outer shaft 22. In particular, in the variation shown in the drawings, the connecting portion 52 is a cylindrical portion connected to the user interface 50. The cylindrical portion has a threaded inner surface for engaging the threaded proximal portion 48 of the outer shaft 22 wherein the outer shaft 22 is received inside a threaded bore 54 of the connecting portion 52.
Turning now to FIGS. 10a and 10b , there is shown the proximal end cap 18 of the present invention. The end cap 18 is configured to cap the proximal end of the handle assembly 14. The handle assembly 14, if made of multiple parts, is held together, in part, by the end cap 18, capturing at least a portion of the first assembly 12 therein. The end cap 18 includes a central bore 56 providing a passage through the instrument 10 end to end. Also, apertures 58 are formed in the end cap 18 for receiving fasteners (not shown) therein for attachment to the handle assembly 14.
Jumping now to FIGS. 15a, 15b and 15c , there is shown a driving tool 66 according to the present invention. The driving tool 66 includes a handle 74 at the proximal end and a spacer engaging bit 76 at the distal end. The handle 74 and bit 76 are interconnected by a middle shaft portion 78. The driving tool 66 is configured and sized to be inserted into the central passageway 67 of the instrument 10 such that the bit 76 at the distal end operatively connects with a spacer loaded and locked into the prongs 28 of the instrument 10. The distal bit 78 includes features 80 for engaging with the operative portion of the spacer 32 in order to effect deployment or undeployment of the spacer 32. A driving tool 66 may have a different distal bit 76 in order to mate with a complementarily different member on the spacer. For example, the driving tool 66 shown in FIG. 15 includes features 80 comprising two oppositely located projections which are configured to mate with complementary features on the spacer. In another variation of the driving tool 66, the distal bit 66 may simply be a hexagonally shaped or other polygonal shaped member that fits inside a complementary member or hex socket on the spacer. In essence, different driving tools 66 having different distal bits 76 may be employed depending on the design of the spacer with which it is to be used. The instrument is advantageously configured such that torque placed on the handle 74 of the driving tool 66 while arranging the spacer is countered by grasping the handle assembly 14 to provide a counter-torque preventing twisting or misalignment of the instrument relative to the implantation site.
The spacer insertion instrument 10 functions to engage with, insert and deploy an interspinous spacer. Illustrative examples of interspinous spacers that are compatible with the insertion instrument are described in applicant's co-pending U.S. patent application Ser. No. 12/217,662 entitled “Interspinous spacer” filed on Jul. 8, 2008 incorporated herein by reference in its entirety, U.S. patent application Ser. No. 12/220,427 entitled “Interspinous spacer” filed on Jul. 24, 2008 incorporated herein by reference in its entirety, U.S. patent application Ser. No. 12/205,511 entitled “Interspinous spacer” filed on Sep. 5, 2008 incorporated herein by reference in its entirety, and U.S. Provisional Patent Application Ser. No. 61/011,199 entitled “Interspinous spacer” filed on Jan. 15, 2008 incorporated herein by reference in its entirety. Examples of such interspinous spacers 32 are shown in FIGS. 12-14 wherein like reference numerals are used to describe like parts. In general, each spacer 32 includes a body portion 68 with at least one prong receiving portion 36 for connecting with the instrument 10, at least one wing 70 rotatably connected to the body portion 68 and an actuator shaft 72 housed in the body portion 68 and configured to arrange the at least one wing 70 from at least one undeployed configuration (see FIGS. 12a, 13a and 14a ) to at least one deployed configuration (see FIGS. 12b, 13b and 14b ) and vice versa. The at least one wing serves as a body portion 68 stabilizer with respect to at least one adjacent spinous process of a patient's spine and is configured in one variation to cradle an adjacent spinous process on both sides and in another variation forming a seat for an adjacent spinous process.
If a cannula is employed in the operative site, the insertion instrument 10 with the attached spacer 32 in an undeployed configuration is sized to fit through a cannula and is passed through the cannula to the interspinous process space. Once in position inside the patient, a driving tool 66 is inserted into the proximal opening of the central passageway 67 of the instrument and passed until the distal spacer engaging bit 76 of the driving tool 66 connects with the spacer 32. The connection of the driver 66 to the spacer is signaled via tactile feedback of the bit engaging the spacer. Depending on the spacer design, the connection of the driving tool 66 with the spacer 32, in particular the engaging features 80, 82, will be different. In general, however, the driving tool 66 connects to the spacer 32 such that movement, such as rotation and/or translation, of the driving tool 66 effects deployment of the at least one wing 70 of the spacer 32. Such deployment of the wings is continuous with the rotation and/or translation of the driving tool. As a result, the deployment may be stopped by stopping such rotation making the deployment incremental. Such incremental deployment allows the surgeon to observe incremental deployment progress via fluoroscopic observation inbetween rotations to help properly position the instrument. Hence, the spacer and instrument combination provides incremental and continous deployment unlike other spacer/installment combinations that only have one deployed configuration and one undeployed configuration with no intermediate configurations or means provided by the instrument to gradually arrange the spacer therebetween. In particular and with respect to the spacer embodiments shown in FIGS. 12-14, movement, such as rotation and/or translation, of the driving tool effects translation of the actuator shaft 72 which in turn is connected to the at least one wing 70 causing it to deploy into an expanded configuration.
With particular reference now to FIGS. 12a and 12b , the driving tool 66 that is configured to connect with the spacer shown in FIGS. 12a and 12b will have a spacer engaging bit 76 that has a hexagonally shaped member that is sized to fit inside the complementarily hexagonally shaped interior 84 of the actuator shaft 72. With the instrument 10 operatively positioned inside the patient and with the driving tool engaged to the actuator shaft 72, rotation of the driving tool 66 distally advances the actuator shaft 72 to deploy the wings 70 into the configuration shown in FIG. 12b . Of course, any polygonal or other shape may be employed. Reverse rotation of the driving tool 66 will proximally retract the actuator shaft 72 to undeploy the wings 70.
With particular reference now to FIGS. 13a, 13b and FIGS. 17-20, the driving tool 66 that is configured to connect with the spacer 32 shown in FIGS. 13a and 13b will have a configuration of the like shown in FIGS. 15a, 15b and 15c wherein the spacer engaging bit 76 includes two projecting features 80. The two projecting features 80 engage complementary features 88 on a spindle 86 located inside the body portion 68 of the spacer 32 as shown in FIG. 18. Once engaged to the spindle 86 (see FIG. 17), rotation of the driving tool 66 rotates the spindle 86 which in turn advances the actuator shaft 72 to deploy the wings 70 into the configuration shown in FIGS. 13b , 19 and 20. As can be seen in these figures, when in the deployed configuration, the actuator shaft 72 is distally translated with rotation of the driving tool. Reverse rotation of the driving tool 66 will turn the spindle 86 in an opposite direction and proximally translate the actuator shaft 72 to undeploy the wings 70 into position shown in FIGS. 13a and 17.
With particular reference now to FIGS. 14a and 14b , the driving tool 66 that is configured to connect with the spacer shown in FIGS. 14a and 14b will have a spacer engaging bit 76 that has a hexagonally shaped member that is sized to fit inside the complementarily hexagonally shaped interior 84 of the actuator shaft 72. With the instrument 10 operatively positioned inside the patient and with the driving tool engaged to the actuator shaft 72, rotation of the driving tool 66 proximally advances the actuator shaft 72 to deploy the wings 70 into the configuration shown in FIG. 14b . Of course, any polygonal or other shape may be employed and reverse rotation of the driving tool 66 will distally advance the actuator shaft 72 to undeploy the wings 70.
Furthermore, the driving tool may be activated by rotation and translation of the driving tool to deploy the spacers of the like shown in FIGS. 12a, 12b, 14a and 14b . Activation of the driving tool to deploy the spacer that involves translation of the driving tool advantageously provides the user with a degree of deployment information. This feature is particularly important because positioning and deployment of the instrument and spacer may result in the wings 70 abutting tissue, bone or other obstructions within the patient that would signal to the user to either reposition the instrument and spacer or clear any obstructions. An example of a degree of deployment information feature includes translation of the driving tool. For example, if translation of the driving tool is less than a specific marker or distance, the user will know that the spacer is not fully deployed or that there is some obstruction and further movement of the driving tool, repositioning or removal of an obstruction is required for full deployment. In one variation, the handle 74 of the driving tool 66 rests a certain distance from the proximal end of the handle assembly 14 and with rotation, the driving tool 66 advances until the handle 74 of the driving tool contacts the proximal end of the handle assembly 14. In another variation, the middle shaft 78 of the driving tool 66 includes markings that indicate to the user the distance that the driving tool has moved distally or proximally to provide a degree of deployment information.
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Internationale Klassifikation A61B17/70, A61B17/02, A61B17/68, A61B17/00, A61F2/00
Unternehmensklassifikation A61B17/7062, A61B17/025, A61B2017/00004, A61B17/7065, A61F2/0077, A61B17/7067, A61B17/7074, A61B2017/0256