1. Technical Field
The present disclosure relates generally to orthopedic spine surgery and in particular to devices and methods for vertebral body aspiration.
2. Background of the Related Art
The present disclosure relates generally to orthopedic spine surgery and in particular to a unique vertebral body aspirator device to collect blood and bone marrow from inside a vertebral body.
The spinal column is a complex system of bones and connective tissues that provides support for the human body and protection for the spinal cord and nerves. The adult spine is comprised of 24 vertebral bodies that are subdivided into three areas including seven cervical vertebrae, twelve thoracic vertebrae and five lumbar vertebrae. An intervertebral disc located between each vertebral body cushions and dampens the various translational and rotational forces exerted upon the spinal column.
A spinal column may experience various disorders, diseases and types of injuries during a lifetime. The problems may include, but are not limited to, scoliosis, kyphosis, excessive lordosis, spondylolisthesis, slipped or ruptured discs, degenerative disc disease, vertebral body fracture and tumors. Persons suffering from any of the above conditions typically experience extreme or debilitating pain and, often, diminished nerve function.
A common solution to the above-mentioned conditions involves a surgical procedure known as spinal fusion. A spinal fusion entails fusing two or more vertebral bodies to eliminate motion at the intervertebral disc or joint. During spinal fusion, natural or artificial bone, along with a spacing device, replaces part or the entire intervertebral disc to form a rigid column of bone, and mechanical hardware is connected to the adjacent vertebrae to stabilize the spine in that area, while the bone grows and the fusion takes place.
The mechanical hardware used to immobilize the spinal column typically involves a series of bone screws and metal rods or plates. When spine surgery is performed using a posterior approach, it is common practice to place pedicle bone screws into the vertebral bodies and then connect a metal rod between the bone screws thus creating a rigid structure between adjacent vertebral bodies. When the spine surgery is performed using an anterior approach, it is common practice to attach a metal plate directly to the vertebral bodies and secure it to each vertebral level using one or more bone screws. Immobilization of the spine allows the bone graft time to grow and form a solid column of bone between the respective vertebral bodies.
A major challenge of spine surgery is achieving the bone growth and subsequent fusion from one vertebral body to the next. Standard spine surgery protocol calls for inserting a rigid body between two vertebral bodies to maintain the disc height. The rigid body or interbody is typically pre-packed with autograft or allograft bone. Autograft bone is generally harvested from the patient's iliac crest and is typically the site of long term post-operative pain and discomfort. Allograft bone can be purchased from a third party vendor but since it is not the patient's own bone, it does not perform as well. Other methods for improving bone growth between the vertebral bodies include blood products, graft extenders and bone-morphogenetic proteins (BMP). These other methods are designed to stimulate bone growth by introducing bone growth factors and can be used as graft replacements.
More recently, progenitor cells have been found to be an effective growth factor for bones. These cells can be harvested from the blood and bone marrow in the patient's vertebral bodies, where they are in abundance, during spine fusion surgery just prior to the bone screw insertion. Aside from serving as a substitute autograft source, progenitor cells effectively eliminate the need for iliac crest bone harvesting. The progenitor cells have been found to be as effective in supporting bone growth as the “gold standard” iliac crest autograft but without the residual pain and discomfort.
Since the use of vertebral body progenitor cells is relatively new, collection instruments are not widely available. Several kinds of bone biopsy needles are available for autograft collection at the iliac crest site but these instruments do not perform as well at the vertebral body site. If a bone biopsy needle or a similar device is used in the vertebral body, the open cannula design draws blood and bone marrow up the tube where it spills out the top. Further, a bone biopsy needle works by wedging a sample of bone in its tube and is not designed to collect a fluid so it has no reservoir.
For at least these reasons, there is a need for a surgical instrument capable of breaking through the hard cortical wall of the vertebral body to gain access to the cancellous bone and marrow in its interior. The instrument must also avoid drawing blood through its cannula prematurely and spilling it out through the proximal end. There is also a need for an instrument capable of stopping and restarting blood and marrow collection to allow a surgeon to change the site of collection or the collection reservoir. By combining all these features in one device, a sufficient amount of progenitor cells can be efficiently collected from a patient's vertebral bodies, and used to promote a successful spine fusion.
The present disclosure is directed to devices, systems and methods for vertebral body aspiration to perform orthopedic spine surgery. These allow the surgeon to find the vertebral body pedicle using a pedicle probe or any other suitable instrument known in the art. By using the pedicle probe or any suitable equivalent, the surgeon can enter the vertebral body where the bone marrow lies. The device has a cannula and may have a disposable cartridge disposed therein. The proximal end of the cartridge may be equipped with a luer lock to which a standard syringe can be attached. Alternatively, the cartridge itself may have a sufficient reservoir to hold the collected bone marrow. Then, by rotating the device's split handle, the inner member of the device will rotate with respect to the outer member thereby opening the distal end. The vacuum created within the cartridge will draw the bone marrow into the opening, up the cannula and into the collection reservoir.
After the desired amount of bone marrow is collected, i.e., approximately 1 cc per aspiration site, the device may be counter-rotated to close the opening at its distal end. Additionally, various styles of cartridge distal tips can be passed down the cannula, including, but not limited to, a bent tip. When using a bent tip cannulated cartridge, the distal tip may be passed through the distal tip opening of the device to access different areas of bone marrow within the vertebral body. Further, the device may be inserted deeper into the vertebral body to collect more bone marrow.
Another embodiment of the present disclosure includes a device that can be translationally actuated. In operation, once the device penetrates the pedicle, a surgeon may translate the inner member. The inner member is translated farther into the vertebral body while the device's outer member is maintained in the same position. By translating the inner member along its longitudnal axis, the distal tip opening will be revealed. Once again, a straight or bent cannulated cartridge may be passed down said device for bone marrow collection.
At any time, prior to removing said cannulated cartridge, the device's distal tip opening can be closed via rotation or translation such that blood and bone marrow do not flow up the device and spill out in the proximal end thereof. The vertebral body aspirator device may be packaged as a separate system including a series of disposable cannulated cartridges with various styles of distal tips. Finally, upon successful aspiration of bone marrow from said vertebral body, a pedicle bone screw may be inserted into the hole for subsequent spinal fixation.
Embodiments of the present invention are disclosed herein with reference to the accompanying drawings, wherein:
Embodiments of the presently disclosed vertebral body aspirator are now described in detail or corresponding elements in each of the several views. As used herein, the term “distal” refers to that portion of the vertebral body aspirator, or component thereof, farther from the user while the term “proximal” refers to that portion of the vertebral body aspirator, or component thereof, closer to the user. Terms such as “above,” “below,” “forward,” “rearward,” etc. refer to the orientation of the figures or the direction of components and are simply used for convenience of description.
An embodiment of a rotatably actuated aspirator in accordance with the present disclosure is shown in
Referring now to
In addition, inner member 12 includes a cannula 26 disposed therethrough. Cannula 26 is dimensioned for receiving a cannulated cartridge. Many kinds of cartridges may be used with aspirator 10. For instance, the cartridge may be in the form of a pipette. Further, aspirator 10 may include a pipette pump on the proximal end of the pipette. The cartridge may also be disposable. Aspirator 10, or any other embodiment of the present disclosure, may have other kinds of cartridges, as hereinbelow described in detail. Additionally, a syringe may be attached to a proximal end of the cartridge or directly to a proximal end 22 of inner member 12 to collect blood or bone marrow of a vertebral body. The proximal end of the cartridge and the syringe may be attached to each other by a leur lock or any other suitable locking mechanism known in the art. Alternatively, the cartridge may include a reservoir at its proximal end to collect blood or bone marrow from a vertebral body, as seen in
Referring to
As seen in
To extract bodily fluids using aspirator 10, a surgeon must first find a vertebral body pedicle using a pedicle probe or any other suitable pedicle finder device. Aspirator 10, itself, may be designed to function as a pedicle probe. Alternatively, a separate pedicle probe may be positioned inside inner member 12. After locating the pedicle, the surgeon should introduce and position aspirator 10 in the desired extraction site. Aspirator 10 must be in the closed position before it is introduced into the human body to prevent extraction of unwanted substances. To position aspirator 10 in the closed position, the user must rotate knob 16 until the label 38 is aligned with the “closed” label 42. Once aspirator 10 is located in the desired position, the operator may open opening 34 by rotating knob 16. The operator should rotate knob 16 until label 38 is aligned with “open” label 40 to completely open opening 34. Tactile or audible “clicks” may be utilized to releasably maintain inner knob's 16 position relative to the outer knob 32. As soon as the user opens aspirator 10, negative pressure built up in the cartridge will force blood or bone marrow through opening 34. The blood or bone marrow will then travel through a cartridge and into a barrel of a syringe, a reservoir, or any other suitable collecting device known in the art.
An embodiment of a translationally actuated aspirator according to the present disclosure is referred to in
With reference to
Referring now to
Aspirator 60 may be used to extract blood or bone marrow of vertebral bodies, or other similar bodily fluids. To extract such bodily fluids, a user must first locate a vertebral body pedicle using said device, a pedicle probe or any other suitable pedicle locating device known in the art. Then, while aspirator 60 is in its closed position, the operator must introduce and position aspirator 60 in the desired extraction site. Afterwards, the user must rotate inner member 62 until pins 84 fit into slot 71 and then advance axially inner member 62 by pushing handle 72. Once the user advances inner member 62, opening 80 is exposed and negative pressure will cause blood or bone marrow to travel through opening 80 and into a cartridge, a reservoir or any other suitable collecting device.
As discussed hereinabove, inner members 12, 62 of the the present disclosure are configured to receive a cartridge. Several kinds of cartridges may be placed within inner members 12, 62. For instance, as seen in
Any of the embodiments of the present disclosure may include a casing situated at it proximal end and capable of retaining a syringe. As shown in
In use, aspirator 400 is placed in the desired extraction site. A user must then rotate knob 416 of inner member to open hole 434 of outer member 414. Once hole 434 is opened, an operator may selectively move each pin 418 outwardly to displace syringe plunger 408 proximally and thereby extract a determined amount of vertebral blood or bone marrow. The negative pressure created in barrel 406 will force blood or bone marrow into hole 434 and into barrel 406.
The applications of the present disclosure are not limited to extraction of blood or bone morrow from vertebral bodies, but it may include any number of further extraction applications. It will be understood that various modifications may be made to the embodiments disclosed herein. Therefore, the above description should not be construed as limiting, but merely as exemplifications of various embodiments. Those skilled in the art will envision other modifications within the scope and spirit of the claims appended hereto.
This application claims the benefit of U.S. Provisional Application to Fred Geisler, et al., entitled “Vertebral Body Aspirator,” U.S. Application Ser. No. 60/759,488, filed Jan. 18, 2006.
Number | Date | Country | |
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60759488 | Jan 2006 | US |