The invention relates to a system and method for performing a surgical procedure, and in particular, to a pressure delivery device that provides multiple output ports in a single instrument.
A minimally invasive procedure is a medical procedure that is performed through the skin or an anatomical opening. In contrast to an open procedure for the same purpose, a minimally invasive procedure will generally be less traumatic to the patient and result in a reduced recovery period.
However, there are numerous challenges that minimally invasive procedures present. For example, minimally invasive procedures are typically more time-consuming than their open procedure analogues due to the challenges of working within a constrained operative pathway. In addition, without direct visual feedback into the operative location, accurately selecting, sizing, placing, and/or applying minimally invasive surgical instruments and/or treatment materials/devices can be difficult.
For example, for many individuals in our aging world population, undiagnosed and/or untreatable bone strength losses have weakened these individuals' bones to a point that even normal daily activities pose a significant threat of fracture. In one common scenario, when the bones of the spine are sufficiently weakened, the compressive forces in the spine can cause fracture and/or deformation of the vertebral bodies. For sufficiently weakened bone, even normal daily activities like walking down steps or carrying groceries can cause a collapse of one or more spinal bones. A fracture of the vertebral body in this manner is typically referred to as a vertebral compression fracture. Other commonly occurring fractures resulting from weakened bones can include hip, wrist, knee and ankle fractures, to name a few.
Fractures such as vertebral compression fractures often result in episodes of pain that are chronic and intense. Aside from the pain caused by the fracture itself, the involvement of the spinal column can result in pinched and/or damaged nerves, causing paralysis, loss of function, and intense pain which radiates throughout the patient's body. Even where nerves are not affected, however, the intense pain associated with all types of fractures is debilitating, resulting in a great deal of stress, impaired mobility and other long-term consequences. For example, progressive spinal fractures can, over time, cause serious deformation of the spine (“kyphosis”), giving an individual a hunched-back appearance, and can also result in significantly reduced lung capacity and increased mortality.
Because patients with these problems are typically older, and often suffer from various other significant health complications, many of these individuals are unable to tolerate invasive surgery. Therefore, in an effort to more effectively and directly treat vertebral compression fractures, minimally invasive techniques such as vertebroplasty and, subsequently, kyphoplasty, have been developed. Vertebroplasty involves the injection of a flowable reinforcing material, usually polymethylmethacrylate (PMMA—commonly known as bone cement), into a fractured, weakened, or diseased vertebral body. Shortly after injection, the liquid filling material hardens or polymerizes, desirably supporting the vertebral body internally, alleviating pain and preventing further collapse of the injected vertebral body.
Because the liquid bone cement naturally follows the path of least resistance within bone, and because the small-diameter needles used to deliver bone cement in vertebroplasty procedure require either high delivery pressures and/or less viscous bone cements, ensuring that the bone cement remains within the already compromised vertebral body is a significant concern in vertebroplasty procedures. Kyphoplasty addresses this issue by first creating a cavity within the vertebral body (e.g., with an inflatable balloon) and then filling that cavity with bone filler material. The cavity provides a natural containment region that minimizes the risk of bone filler material escape from the vertebral body. An additional benefit of kyphoplasty is that the creation of the cavity can also restore the original height of the vertebral body, further enhancing the benefit of the procedure.
Typically, kyphoplasty is performed using a bilateral procedure, in which access to the interior of the vertebral body is achieved via pedicular access. Cavities are created in both the left and right halves of the vertebral body interior, and subsequently filled with bone filler material. This bilateral approach can often create a more stable support structure than would be possible using only a unipedicular approach, and can also enhance vertebral body height restoration and maintenance.
However, because conventional cement delivery systems provide only a single delivery output, filling the two cavities can be a cumbersome task. A separate cement delivery system could be used for each cavity, or a single cement delivery system must be moved between the two access cannulas. In either case, the logistics of performing the cement delivery are less than ideal, as the physician performing the procedure is forced to either interact with two separate delivery devices or physically transport a single delivery device between cannulas.
Accordingly, it is desirable to provide surgical tools and techniques that enable user-friendly material delivery during surgical procedures.
By incorporating a diverter element into a pump with multiple outputs, a material delivery system can service multiple surgical target locations from a single control point.
In various embodiments, a material delivery system can include a pressure reservoir, a pressure source for pressurizing the pressure reservoir, and a diverter for selectably coupling the pressure reservoir to one of multiple outputs. In some embodiments, the pressure reservoir can include a pressure release valve for venting the pressure reservoir to a predetermined baseline pressure (e.g., ambient/atmospheric pressure). The diverter can be configured to trigger (open) the pressure release valve whenever switching between different outputs. Alternatively, the diverter can itself vent the pressure reservoir during switching (e.g., by creating a flow path from the pressure reservoir to the baseline pressure). By automatically venting during the switching process, unintended and/or uncontrolled material delivery can be prevented when the pressure reservoir is initially coupled to the new output. In various embodiments, this vent triggering can occur while one or both of the original and destination outputs are coupled to the pressure reservoir.
In various embodiments, the pressure reservoir can contain a hydraulic fluid that transmits the pressure within the pressure reservoir to a remote material dispensing element (e.g., via hydraulic lines/flexible tubing). The material dispending element then dispenses the actual flowable material (e.g., bone filler material) in response to the pressure transmitted via the hydraulic fluid. In various other embodiments, the pressure reservoir can contain the actual flowable material that is expressed from the pressure reservoir through the selected output.
In various embodiments, a surgical procedure (e.g., kyphoplasty) can be performed using a single material delivery system that includes multiple outputs selectably coupled to a single pressure reservoir. The flowable material can be delivered to each the different surgical target locations individually by manually switching between the different outputs. In various embodiments, switching between different outputs automatically vents the pressure reservoir to a baseline pressure. As a result, sudden high pressure output from the new output can be prevented, thereby minimizing the risk of adverse events during the surgical procedure (e.g., cement extravasation during kyphoplasty or vertebroplasty).
As will be realized by those of skilled in the art, many different embodiments of a multi-output material delivery system, along with systems, kits, and/or methods of using such a material delivery system are possible. Additional uses, advantages, and features of such a material delivery system are set forth in the illustrative embodiments discussed in the detailed description herein and will become more apparent to those skilled in the art upon examination of the following.
By incorporating a diverter element into a material delivery system with multiple outputs, the material delivery system can service multiple surgical targets from a single control point.
Pressure source 120 can be any system for pressurizing pressure reservoir 110. In one embodiment, pressure source 120 can be a basic hand pump for driving a piston or plunger (e.g., via a squeeze trigger or crank) to pressurize reservoir 110. In various other embodiments, pressure source 120 can be a powered hydraulic pump or precharged pressure vessel coupled to pressure reservoir 110 by a valve. Any number of additional alternatives will be readily apparent.
Diverter 130 selectably couples pressure reservoir 110 to one of pressure outlets 150A and 150B, and therefore to one of material dispensing elements 155A and 155B, respectively. This pressure application causes the recipient material dispensing system 155 to express a flowable material from its associated dispensing outlet 151. Note that “flowable material” as described herein can be any material capable of being dispensed from material delivery system 100, such as PMMA, granulized or pelletized material such as bone morphongenic protein (BMP) or graft material, or even solid materials that can be forced from material dispensing elements 155A and 155B (e.g., wax or phase-change materials). In various embodiments, pressure reservoir 110 can contain the flowable material itself, such that when diverter 130 couples pressure reservoir 110 to, for example, material dispensing element 155A, the flowable material simply flows from pressure reservoir 110 through diverter 130, through material dispensing element 155A, and out of dispensing outlet 151A.
However, in various other embodiments, pressure reservoir 110 can contain a hydraulic fluid (e.g., water, saline solution, or oil, among others) for driving the flowable material from material dispensing elements 155A and 155B. For example, as shown in
In various hydraulic fluid-based embodiments of material delivery system 100, material dispensing elements 155A and 155B could be coupled to pressure outlets 150A and 150B, respectively, by hydraulic lines (e.g., flexible tubing). This would allow dispensing outlets 151A and 151B to be positioned more remotely than would be typically be feasible if the actual flowable material were being forced directly from pressure reservoir 110.
In various other embodiments, material delivery system 100 can also include pressure release valve 140. Pressure release valve 140 is a normally closed valve that, when actuated, vents pressure reservoir 110 to a lower pressure region. Typically, the lower pressure region will be at ambient pressure (e.g., atmospheric pressure), but in various embodiments, the venting can be to a predetermined baseline pressure other than atmospheric pressure. In some embodiments, pressure release valve 140 can vent outside of the pressure system (i.e., an open system) as indicated by the solid arrow, and in other embodiments, pressure release valve 140 can vent back into the pressure system (i.e., a closed system) as indicated by the dotted arrow returning to pressure source 120.
When present, pressure release valve 140 can be triggered by the action of diverter 130. Specifically, switching diverter 130 between outputs can open pressure release valve 140, thereby ensuring that the newly coupled material dispensing element 155 does not receive a sudden high pressure surge. This automatic pressure “reset” prevents unexpected and/or uncontrolled material delivery from the newly selected material dispensing element 155, which can be a critical safety factor during a medical procedure (as described in greater detail below).
For example, in
Once a desired amount of flowable material has been expressed from dispensing outlet 151A, diverter 130 can be switched to a new position to couple pressure reservoir 110 to material dispensing element 155B. In one embodiment, as indicated in
In various embodiments, pressure release valve 140 remains open as diverter 130 couples pressure reservoir 110 to material dispensing element 155B, as shown in
Note that for exemplary purposes diverter 130 is depicted as creating discrete connections between pressure reservoir 110 and material dispensing element 155A and between pressure reservoir 110 and material dispensing element 155B. However, in various other embodiments, diverter 130 can exhibit a mode in which pressure reservoir 110 is simultaneously coupled to both material dispensing elements 155A and 155B. Opening pressure release valve 140 during such a mode would simultaneously equalize pressures at pressure reservoir 110 and material dispensing elements 155A and 155B.
When diverter 130 is fully switched to its new position, pressure release valve 140 is closed, as shown in
Note that while flow path 131 is depicted as a hollowed-out portion of diverter 130 for exemplary purposes, in various other embodiments, flow path 131 can take any configuration or shape. For example, in various embodiments, flow path 131 can be a passageway within diverter 130. Note further that while diverter 130 is depicted and described as a rotational element for exemplary purposes, diverter 130 can exhibit any mode of operation that enables output switching capability. For example, in various embodiments, diverter 130 can be a push-pull element, a rotating ball or cylinder valve, or a movable lever, among others.
For exemplary purposes, pressure generator 120 is depicted as a simple piston 121 that pressurizes pressure reservoir 110 through a one-way check valve 122. Such an embodiment is particularly conducive to pressure generation in a hand-held device. For example, pressure generator 120 can include a trigger 122 that, in response to pressure (e.g., squeezing) by the operator, drives piston 121 inward to pressurize pressure reservoir 110.
Likewise, for exemplary purposes, pressure release valve 140 is depicted as a simple one-way check valve with an actuator 142. Note that in various other embodiments, pressure release valve 140 can incorporate any pressure release mechanism. Raising actuator 142 vents pressure reservoir 110 to ambient pressure (although as described above with respect to
Diverter 130 also includes a triggering feature 132 that is configured to actuate (open) pressure release valve 140 as diverter 130 is rotated. For exemplary purposes, triggering feature 132 is depicted as a raised element on diverter 130 that can slip under actuator 142. Note, however, that in various other embodiments, triggering feature 132 can be any system for actuating pressure release valve 140, including a magnetic switch, a proximity sensor, and/or a mechanical linkage.
Thus, as diverter 130 is rotated, as shown in
Then, as switching is completed as shown in
Note that in various embodiments, diverter 130 can couple pressure reservoir 100 to both pressure outlets 150A and 150B (as shown in
For example, in
Then, as diverter 130 is moved in the direction indicated by the solid arrow in
Note further that for exemplary purposes, pressure release valve 140 is depicted as a simple one-way check valve. However, as noted above, in various other embodiments, pressure release valve 140 can incorporate any pressure release mechanism. Note further that for exemplary purposes, triggering feature 132 is depicted as a raised element on diverter 130 that can actuate pressure release valve 140. However, in various other embodiments, triggering feature 132 can be any system for actuating pressure release valve 140, including a magnetic switch, a proximity sensor, and/or a mechanical linkage.
As switching is completed as shown in
For example, in
Then, as diverter 130 is rotated about its longitudinal axis as indicated in
Continuing to rotate diverter 130 as indicated in
After desired material dispensing from material delivery element 155B, diverter 130 can be further rotated to cause flow path 131B to connect with bleed port 141B (while still connecting pressure reservoir outlet 111 to outlet 150B), as shown in
Next, cavity-creation tools such as inflatable bone tamps 320A and 320B are placed into cannulas 310A and 310B, respectively, to position expandable members (e.g., balloons) 321A and 321B, respectively, within cancellous bone 300-C. Expandable members 321A and 321B are then expanded as shown in
Inflatable bone tamps 320A and 320B are then removed and replaced with material delivery elements 155A and 155B, respectively, coupled to material delivery system 100 (as described with respect to
For exemplary purposes, material dispensing elements 155A and 155B are depicted as including storage chambers 157A and 157B, respectively, and long, thin dispensing outlets (nozzles) 151A and 151B, respectively, that are sized to fit through cannulas 310A and 310B, respectively. Storage chambers 157A and 157B hold an amount of bone filler material that can be delivered to cavities 325A and 3256, respectively, via elongate nozzles 151A and 151 B, respectively.
For exemplary purposes, diverter 130 is initially positioned to couple pressure reservoir 110 to material delivery element 155A. However, diverter 130 can be switched to the opposite position (i.e., coupling pressure reservoir 110 to material delivery element 155B) or can even be in the mid-point position (i.e., coupling pressure reservoir 110 to both material delivery elements 155A and 155B and opening release valve 140), before switching to a desired one of material delivery elements 155A and 155B.
To begin filling cavity 325A, pressure source 120 is used to pressurize pressure reservoir 110, thereby forcing bone filler material 305 from material dispensing element 155A, as shown in
Once a sufficient amount of bone filler material 305 is delivered to cavity 325A, diverter 130 can be used to switch the output of material delivery system 100. As described with respect to
Upon completion of the switching operation of diverter 130, material dispensing element 155A is isolated from, and material dispensing element 1556 is coupled to, pressure reservoir 110, as shown in
Note that a sequential two-step bone filler material delivery operation (i.e., fill cavity 325A, and then fill cavity 325B) is described for exemplary purposes only. In various other embodiments, cavities 325A and 325B can be filled in any order, using any number of discrete filling operations. For example, cavity 325A could be partially filled via material dispensing element 155A, diverter 130 could be used to switch the output of material delivery system 100 to material dispensing element 155B to allow partial filling of cavity 325B. Diverter 130 could then switch the output back to material dispensing element 155A, to enable additional material delivery to cavity 325A. The filling process could continue alternating between cavities 325A and 325B until a desired amount of bone filler material 305 is delivered to each.
Once the filling operation is complete, delivery nozzles 151A and 151B, and cannulas 310A and 310B are removed from vertebra 300 (and the patient's body) as shown in
While various embodiments of the invention have been described above, it should be understood that they have been presented by way of example only, and not limitation. Where methods and steps described above indicate certain events occurring in certain order, those of ordinary skill in the art having the benefit of this disclosure would recognize that the ordering of certain steps may be modified and that such modifications are in accordance with the variations of the invention. Additionally, certain steps may be performed concurrently in a parallel process when possible, as well as performed sequentially as described above. Thus, the breadth and scope of the invention should not be limited by any of the above-described embodiments, but should be defined only in accordance with the following claims and their equivalents. While the invention has been particularly shown and described with reference to specific embodiments thereof, it will be understood that various changes in form and details may be made.
This application is a continuation of application Ser. No. 12/771,812, filed on Apr. 30, 2010, the contents of which are herein incorporated by reference in their entirety.
Number | Name | Date | Kind |
---|---|---|---|
1845479 | Carpenter | Feb 1932 | A |
2469362 | Bashark | May 1949 | A |
2635620 | Deardorff | Feb 1951 | A |
2811852 | Shuck | Nov 1957 | A |
2847678 | Opuszenski | Aug 1958 | A |
3259077 | Wiley | Jul 1966 | A |
3447479 | Rosenberg | Jun 1969 | A |
3515127 | Reymond | Jun 1970 | A |
3817247 | Mills | Jun 1974 | A |
4103229 | Gear | Jul 1978 | A |
4174473 | Brenneman | Nov 1979 | A |
4328827 | Enjolras | May 1982 | A |
4447226 | Mayoral | May 1984 | A |
4546767 | Smith | Oct 1985 | A |
4563175 | LaFond | Jan 1986 | A |
4615469 | Kishi et al. | Oct 1986 | A |
4730638 | Hazelton | Mar 1988 | A |
4781687 | Wall | Nov 1988 | A |
4828545 | Epstein | May 1989 | A |
4979944 | Luzsicza | Dec 1990 | A |
5014715 | Chapolini | May 1991 | A |
5071547 | Cazer | Dec 1991 | A |
5282573 | Reimer | Feb 1994 | A |
5305793 | Cencula | Apr 1994 | A |
5360320 | Jameson et al. | Nov 1994 | A |
5466128 | Brown et al. | Nov 1995 | A |
5484354 | Vukovich et al. | Jan 1996 | A |
5567122 | Schulte | Oct 1996 | A |
5643218 | Lynn et al. | Jul 1997 | A |
5670048 | Davison et al. | Sep 1997 | A |
5695720 | Wade | Dec 1997 | A |
5814015 | Gargano | Sep 1998 | A |
5915313 | Bender et al. | Jun 1999 | A |
6086594 | Brown | Jul 2000 | A |
6264436 | Edwards et al. | Jul 2001 | B1 |
6428702 | Berger et al. | Aug 2002 | B1 |
7025079 | Einar | Apr 2006 | B1 |
7371241 | Evans et al. | May 2008 | B2 |
7967783 | Rebours | Jun 2011 | B2 |
8235256 | Green | Aug 2012 | B2 |
20030091741 | Schmoyer | May 2003 | A1 |
20040181206 | Chiu et al. | Sep 2004 | A1 |
20050180806 | Green | Aug 2005 | A1 |
20050209602 | Bowman et al. | Sep 2005 | A1 |
20070027230 | Beyar | Feb 2007 | A1 |
20070039866 | Schroeder | Feb 2007 | A1 |
20070161943 | Lidgren et al. | Jul 2007 | A1 |
20070213660 | Richards et al. | Sep 2007 | A1 |
20070219445 | Liebschner | Sep 2007 | A1 |
20080125330 | Cady | May 2008 | A1 |
20080249530 | Truckai et al. | Oct 2008 | A1 |
20110301535 | Takayama | Dec 2011 | A1 |
20120035471 | Lee-Sepsick et al. | Feb 2012 | A1 |
20120191101 | Roth | Jul 2012 | A1 |
Number | Date | Country |
---|---|---|
2022426 | Feb 2009 | EP |
EP 2022426 | Feb 2009 | IT |
EP 2022426 | Jul 2009 | IT |
2002349959 | Dec 2002 | JP |
Entry |
---|
International Search Report, W02011137062, Nov. 3, 2011. |
Number | Date | Country | |
---|---|---|---|
20150018834 A1 | Jan 2015 | US |
Number | Date | Country | |
---|---|---|---|
Parent | 12771812 | Apr 2010 | US |
Child | 14502200 | US |