It is often necessary to access a core sample of biological material such as to diagnose defects or ailments. To obtain a sample, an instrument may be used to remove a portion or a “core sample” from surrounding biological material. In some circumstances, the cored material is cancellous bone. For example, it may be desirable for a physician to access decorticated bone and then retrieve cancellous bone for grafting or other purposes.
Aspects of the current subject matter can include a bone coring device, including removable devices that can be adapted to the bone coring device, such as a removable tip device.
In one aspect, a removable tip device is disclosed that can include a bone penetration feature configured to penetrate a layer of bone and a securing feature configured to releasably engage a distal end of a bone coring device.
In another aspect, a method of using the removable tip device can include providing a removable tip device for securing to a distal end of a bone coring device. The removable tip device can include a bone penetration feature configured to penetrate a layer of bone, and a securing feature can be configured to releasably engage a distal end of a bone coring device. In addition, the method can include engaging the securing feature of the removable tip device to the distal end of the bone coring device.
In some variations one or more of the following can optionally be included in any feasible combination. For example, the method can include penetrating a layer of bone with the bone penetration feature, and the layer of bone can include cortical bone. The securing feature can include a push button or tab configured to releasably engage a fenestration along the distal end of the bone coring device. The fenestration can be configured to minimize movement of the engaged securing feature relative to the fenestration for assisting in transmitting torsional loads from the bone coring device to the bone penetration feature.
In addition, the removable tip device can include a deformable element that extends from the securing feature and assists in at least one of engaging and disengaging the securing feature to the distal end of the bone coring device. The deformable element can include an asymmetric cross-sectional geometry that is configured to transmit torsional loads from the bone coring device to the bone penetration feature. Additionally, the removable tip device can include a protective element configured to provide a protective surface for a distal feature of the bone coring device. The protective element can include an o-ring made out of a compliant material. Furthermore, the removable tip device can include an outer sleeve configured to stabilize the removable tip device relative to the bone coring device at least when a torsional load or a longitudinal load is applied to the bone coring device.
The details of one or more variations of the subject matter described herein are set forth in the accompanying drawings and the description below. Other features and advantages of the subject matter described herein will be apparent from the description and drawings, and from the claims.
These and other aspects will now be described in detail with reference to the following drawings.
Like reference symbols in the various drawings indicate like elements.
With reference still to
The first handle component 115 (the proximal component) can be rotated relative to the second handle component 120 (the distal component) to cause relative movement between the outer cutting tube 125 and the inner tube 130 of the coring assembly 110. For example, rotational movement of the first handle component 115 relative to the second handle component 120 causes the inner tube 130 to linearly move or translate relative to the outer cutting tube 125, as described more fully below. In this regard, the inner tube 130 linearly translates along an axis that coincides with the long axis of the coring assembly 110. Various mechanisms can be used to achieve such relative movement of the coring assembly components, some of which are described herein.
For example, as the first handle component 115 is rotated, the engagement of the coupling component (such as pin 505) with the guide track 210 can result in linear and rotational translation of the handle component 115 relative to the second handle component 120. In this manner, the guide track 210 can serve as a linkage and the slip plane coupler 405 (shown, for example, in
The guide track 210 can have one or more features that enable locking of the handle components 115 and 120 into predetermined states, such as open and closed states (described below). For example, at the proximal-most end 230 of the guide track 210, a projecting element or detent feature 235, such as a snap detent, can be located that locks the handle components 115 and 120 relative to one another. Any quantity of detent features 235 can be located along the length of the guide track 210 to reversibly lock the handle components 115 and 120 relative to each other in a variety of positions.
As mentioned, the guide track 210 in the second handle component 120 slidably mates with one or more inwardly projecting elements, or coupling components, associated with the first handle component 115 to form a force coupling therebetween. Rotation of the first handle component 115 relative to the second handle element 120 results in sliding movement of the projecting element(s) within the guide track 210. The guide track 210 can have a detent feature 235, such as a seat or projection, which interferes with movement of the mating projection at the upper and lower ends of the track 210 to impart resistance to movement. In an embodiment, the resistance to movement induces a palpable and/or audible snap, as well as transitional lock in the open and closed states.
In an embodiment, the track 210 has a recess or seat on the lower surface of the proximal-most end 230 of the track 210. A compressive load (imparted with downward or distal-directed pressure on the proximal first handle component 115 during introduction of the bone harvester into the bone) causes the mating projection of the first handle component 115 to nest into the recess. This results in coupled rotational movement of the first (proximal) handle component 115 and the second (distal) handle component 120 when a distal-directed load is applied to the first handle component 115. As a result, the second lower handle component 120 and first handle component 115 can rotate in unison when both a distally-directed force and rotation is applied to the first handle component 115 (or the associated cap 122).
The depth of the recess can be less than the diameter of the mating projection such that when the distal-directed force is reduced and/or the rotational force of first handle component 115 relative to second handle component 120 increases the mating projection rides up over the recess and along the spiral tract. This terminates the coupled rotation between the first and second handle components 115, 120 and results in linear movement of the inner tube 130 relative to the outer cutting tube 125 such as toward a closed position. This mechanism permits the operator to effectively rotate both the first and second handle components 115 and 120 while applying distal pressure on the first handle component 115 or cap 122, and also while maintaining the relationship of inner slit tube 130 relative to the outer cutting tube 125 with the device in an open state (described below). The operator can then relax the distal-directed force and rotate the first handle component 115 relative to the second handle component 120 to transition from the open locked position to the locked closed position, which can linearly advance the slit tube 130 relative to the outer cutting tube 125.
A similar but reverse oriented mechanism, such as a recess on the upper portion of the distal-most end of the guide track 210, can be used to lock the instrument in a closed position during withdrawal of the instrument. Additionally or alternatively, a snap detent feature may be employed for the same purpose. For example, when a proximal-directed force is applied to the first handle component 115, the mating projection of the first handle component 115 can nest into the recess of the distal-most end of the guide track 210 such that coupled rotational movement of the first (proximal) handle component 115 and the second (distal) handle component 120 is achieved.
Linear movement of the cap 122 (along the longitudinal axis of the device) is translated into corresponding linear movement of the inner tube 130. Thus, linear or rotational movement of the first handle component 115, which is secured to the cap 122, translates to corresponding linear movement of the inner tube 130. In addition, the slip plane coupler 405 is rotationally coupled to the second handle component 120 in a manner that permits longitudinal translation of the slip plane coupler 405 and the inner tube 130 relative to second handle component 120. This can result from rotational and translational movement of the first handle component 115 and slip plane mating feature of the cap 122 relative to the second handle component 120.
An exemplary manner in which linear translation of the inner tube 130 is achieved is now described with reference to
A pair of pins 505 or another coupling structure extend through the first handle component 115 and into the guide tracks 210 (
As mentioned, rotation of the first handle component 115 relative to the second handle component 120 results in linear translation of the inner tube 130 in a proximal direction relative to the longitudinal axis of the device. Thus, in the open state, the distal edge of the inner tube 130 is positioned in a proximal position relative to the longitudinal axis of the device. When in the open state, the device can harvest a sample of tissue, as described more fully below. The linear translation is the result of the linkage (via the guide track 210) between the first handle component 115 and the second handle component 120 via the inclined guide track 210 (as shown in
The configurations of the outer cutting tube 125 and the inner tube 130 are now described in more detail.
A distal edge 605 of the outer cutting tube 125 is adapted for cutting or otherwise penetrating through the material being cored, such as through bone. In this regard, the distal edge 605 can be sharpened.
With reference again to
An exemplary use of the device is now described. The device is first placed in the “open” state such that the inner tube 130 is retracted into the outer tube 125, as was shown in
A cortical defect or pathway can first be formed using a separate, but associated, device. The physician inserts the distal end of the coring assembly 110 through the pathway and into the cancellous bone. The tapered outer walls of the outer cutting tube 125 can reduce the potential for penetrating cortical walls of bone with glancing or low angle contact. A physician grasps the device by the handle 105 and applies a forward pressure through the distal edge 605 of the outer tube 125 against the cancellous bone. The physician can impart an oscillating rotational movement to the distal edge 605 by reciprocal rotation the handle 105. As mentioned, the handle 105 can be configured to lock into the open position so that the device does not inadvertently transition to the closed position during this step. The oscillating rotation of the device effects micro-fracturing of the cancellous trabeculae. The sharpened distal edge 125 of the outer tube 125 and the teeth 610 facilitate such micro-fracturing. In this manner, a distal region of the coring assembly 110 penetrates into the cancellous bone. A plug of cancellous bone is now positioned within the distal region of the coring assembly 110 as a result of the coring assembly's penetration into the bone. That is, a plug or piece of cancellous bone that substantially conforms to the inner shape of the coring assembly is positioned within the inner tube 130. The piece can have various shapes.
After a desired depth of cancellous penetration is achieved, the physician/surgeon can stabilize the second handle component 120 with a first hand while rotating the first handle component 115 with the second hand, transitioning the device into the closed state. Any portion of the coring assembly 110, such as the outer cutting tube 125, can have one or more indicia to assist in identifying the depth of penetration. In an embodiment, an audible and/or tactile detent 235 can be associated with the device being moved to a fully closed position. As discussed above, when the device moves to the closed state, the distal edge of the inner tube 130 moves toward the distal edge of the outer cutting tube 125. The internal taper of the outer cutting tube 125 interferes with the outer diameter of the inner tube 130 to cause the inner tube 130 to annularly constrict or reduce in diameter a distal region of the inner tube 130. The reduction in diameter or annular constriction of inner tube 130 creates a compressive force on the sample of cancellous bone that is present within tube 130.
The compressive force secures or stabilizes the cored cancellous bone. The instrument is then rotated and/or tensioned to shear the bone at the terminus of the instrument. The device is subsequently withdrawn from the bone while the bone sample remains within the inner tube 130. The withdrawal of the device from the bone can be performed with or without continued rotation of the handle 105.
As mentioned, the outer cutting tube 125 has fenestrations 615 that align with a slot 620 in the inner tube 130. The cancellous bone accumulated within the inner tube 130 (which can be one or more plugs of bone) can be observed through the fenestrations 615 and the slot 620. It should be appreciated that the procedure can be performed multiple times to collect a plurality of samples within the inner tube 130 wherein the samples are positioned in sequence within the inner tube 130. The operator can visually verify the quantity of samples within the inner tube by looking through the fenestrations in the outer tube.
Once a sample or samples are collected within the inner tube 130, the cored and sheared material can be extracted. In an embodiment, this is accomplished by using a tamp or plunging member 1005 that interfaces with the cored material within the device (see
In at least some cases it may be beneficial to remove or create a defect in the cortical bone prior to using a bone coring device. For example, cancellous bone, which is located deep to cortical bone, may be acquired for diagnostic or bone grafting purposes. As such, penetrating the bone in order to remove or create a defect in some of the overlaying cortical bone can assist with accessing underlying cancellous bone tissue for coring.
The bone penetration feature 1102 can include a variety of features, including a sharp distal cutting tip that can allow the removable tip device 1100 to penetrate bone by displacing and removing portions of the cortical surface. In addition, the bone penetration feature 1102 can create a variety of defects or bone removal formations, such as creating an approximately circular hole through the cortical bone layer. Some bone penetration features 1102 may have features similar to a trephine surgical instrument. Additionally, the bone penetration feature 1102 can be made out a medical grade material that is durable enough to withstand penetrating and creating defects in bone, such as various steel alloys, ceramics or structural plastics.
During attachment of the removable tip device 1100 to the coring assembly 110 of the core sample device, the securing feature 1104 can be inserted into the distal end of the coring assembly 110 and an outer sleeve 1110 of the removable tip device 1100 can slide over an outer surface of the coring assembly 110. The securing feature 1104 can continue to advance into the coring assembly until the securing feature 1104 engages a fenestration 615, as shown in
Once the removable tip device 1100 is secured or locked to the end of the coring assembly 110, a user can position the bone penetration feature 1102 in contact with bone for creating a cortical surface defect. The outer sleeve 1110 can engage the outer surface of the coring assembly 110 and assist in securing the position of the removable tip device 1100 relative to the coring assembly 110. This can assist in efficiently translating applied forces, such as rotational and translational forces, from the handle 105 and coring assembly 110 to the bone penetrating feature 1102, which can efficiently either remove or create a defect in bone layers. The outer sleeve 1110 can be configured to provide stabilization of the removable tip device 1100 relative to the coring assembly 110 during use and when applying various loads (i.e., torsional loads, such as angular displacing loads, longitudinal loads, etc.) to at least the coring assembly 110 and removable tip device 1100.
The removable tip device 1100 can be released from the coring assembly 110 by activating the securing feature 1104, which can disengage the securing feature 1104 from the coring assembly 110. For example, the user can push down on the securing feature 1104 that is extending through the fenestration 615 and concurrently withdraw the removable tip in the distal direction until the removable tip device 1100 is completely disengaged, as shown in
In addition, the securing feature 1104 can be configured to engage the fenestration 615 such that movement between the securing feature 1104 and the fenestration 615 is minimized. For example, the securing feature 1104 can engage the fenestration 615 such that when either a torsional or longitudinal force is applied to the core sample device there is minimal movement experienced between the securing feature 1104 and the fenestration 615. This can assist in efficiently transmitting either the torsional and/or longitudinal force applied to the core sample device to the bone penetration feature 1102 for efficiently either removing or creating a defect in bone layers.
Some embodiments of the removable tip device 1100 can include a deformable and/or deflectable element 1106 that can extend from the securing feature and assist in engaging and disengaging the securing feature 1104 to the distal end of the bone coring device. For example, the deformable/deflectable element 1106 can deform or deflect in response to a force applied to the securing feature 1104, which can allow the securing feature 1104 to disengage from the fenestration 615 and remove the removable tip device 1100 from the distal end of the coring assembly 110.
In addition, some embodiments of the deformable/deflectable element 1106 can assist in transmitting torsional loads from the coring assembly 110 to the bone penetrating feature 1102. This can allow rotational forces that have been applied to the core sample device, via manipulation of the handle 105, to be efficiently transmitted to the bone penetrating feature 1102, such as for either removing or creating a defect in bone, such as cortical bone.
For example, the deformable element 1106 can have an asymmetric cross-sectional geometry, or I-beam configuration, that has a thickness (i.e., a linear dimension associated with its cross section in the plane of deflection) that is smaller than its width (i.e., a linear dimension associated with a plane perpendicular to its plane of deflection). This I-beam configuration can provide sufficient rigidity for transmitting torsional loads from the rotation of the coring assembly 110 (i.e., via the securing feature 1104 engaged with the fenestration 615) to the bone penetrating feature 1102, while also requiring relatively low loading requirements to disengage the securing feature 1104 from the fenestration 615.
Some embodiments of the removable tip device 1100 can include a protective element 1108 configured to provide a protective surface for a distal feature(s) of the bone coring device, such as the teeth 610 or the distal edge 605. As shown in
The protective element 1108 can provide a protective surface for the distal feature during use of the core sample device, such as when either a longitudinal or torsional load is applied to the core sample device for deforming or removing one or more layers of bone. In addition, the protective element 1108 can be made out of a compliant material that can allow the distal feature to contact and displace portions of the protective element 1108, such as during the applied loads, without causing damage to the distal feature(s), which would otherwise blunt or deform sharp, thin, distal features.
For example, the protective element 1108 can have an o-ring configuration, as shown in
The removable tip device 1100 can include a variety of features for assisting a user in either deforming or removing a layer of bone. Additionally, the removable tip device 1100 can include one or more features that can assist with mitigating unintended excessive penetration of the removable tip device 1100 into bone, such as a collar or shoulder stop adjacent the proximal end of the removable tip device 1100 or bone penetration feature 1102.
Although embodiments of various methods and devices are described herein in detail with reference to certain versions, it should be appreciated that other versions, embodiments, methods of use, and combinations thereof are also possible. Therefore the spirit and scope of the tissue (e.g. bone) coring device should not be limited to the description of the embodiments contained herein.
This application is a national stage application, filed under 35 U.S.C. § 371, of International Application No. PCT/US2014/068222, filed on Dec. 2, 2014, entitled “Removable Bone Penetrating Device and Methods,” which claims priority to U.S. Provisional patent application No. 61/911,977, filed on Dec. 4, 2013, entitled “Removable Bone Penetrating Device and Methods,” the contents of which are hereby incorporated by reference in its entirety.
Filing Document | Filing Date | Country | Kind |
---|---|---|---|
PCT/US2014/068222 | 12/2/2014 | WO | 00 |
Publishing Document | Publishing Date | Country | Kind |
---|---|---|---|
WO2015/084881 | 6/11/2015 | WO | A |
Number | Name | Date | Kind |
---|---|---|---|
3628524 | Jamshidi | Dec 1971 | A |
3893445 | Hofsess | Jul 1975 | A |
4403617 | Tretinyak | Sep 1983 | A |
4789547 | Song et al. | Dec 1988 | A |
4793363 | Ausherman et al. | Dec 1988 | A |
4951690 | Baker | Aug 1990 | A |
5040542 | Gray | Aug 1991 | A |
5106364 | Hayafuji et al. | Apr 1992 | A |
5341816 | Allen | Aug 1994 | A |
5505210 | Clement | Apr 1996 | A |
5526822 | Burbank et al. | Jun 1996 | A |
5649547 | Ritchart et al. | Jul 1997 | A |
5730752 | Alden et al. | Mar 1998 | A |
5769086 | Ritchart et al. | Jun 1998 | A |
5807277 | Swaim | Sep 1998 | A |
5833628 | Yuan | Nov 1998 | A |
6063037 | Mittermeier et al. | May 2000 | A |
6139509 | Yuan et al. | Oct 2000 | A |
6248081 | Nishtalas et al. | Jun 2001 | B1 |
6383145 | Worm | May 2002 | B1 |
6554778 | Fleming, III | Apr 2003 | B1 |
7033324 | Giusti et al. | Apr 2006 | B2 |
7179232 | Sutton et al. | Feb 2007 | B2 |
9192396 | Marino | Nov 2015 | B2 |
10039601 | Kim | Aug 2018 | B2 |
20010005778 | Ouchi | Jun 2001 | A1 |
20010009978 | Krueger et al. | Jul 2001 | A1 |
20010014778 | Worm | Aug 2001 | A1 |
20030229293 | Hibner et al. | Dec 2003 | A1 |
20040049128 | Miller | Mar 2004 | A1 |
20040059252 | Giusti | Mar 2004 | A1 |
20040077973 | Groenke et al. | Apr 2004 | A1 |
20050107800 | Frankel et al. | May 2005 | A1 |
20050251063 | Basude | Nov 2005 | A1 |
20060247653 | Akerfeldt et al. | Nov 2006 | A1 |
20070282220 | Abernathie | Dec 2007 | A1 |
20070293788 | Entrekin et al. | Dec 2007 | A1 |
20080161720 | Nicoson | Jul 2008 | A1 |
20100152616 | Beyhan et al. | Jun 2010 | A1 |
20130144188 | Fiebig et al. | Jun 2013 | A1 |
Number | Date | Country |
---|---|---|
2001-521406 | Nov 2001 | JP |
WO-9106246 | May 1991 | WO |
WO-9739685 | Oct 1997 | WO |
Entry |
---|
“Trap It.” HS Hospital Service. Web. Sep. 2, 2016. http://www.hshospitalservice.com//prod.php?id=116. |
International Search Report issued in PCT/US2014/068222 dated Feb. 24, 2015. |
Number | Date | Country | |
---|---|---|---|
20160302777 A1 | Oct 2016 | US |
Number | Date | Country | |
---|---|---|---|
61911977 | Dec 2013 | US |