Patent Application
20210236167
The present disclosure relates to a novel and advantageous delivery device for delivering biologic material. Particularly, the present disclosure relates to a novel and advantageous cannula and hub assembly for delivery of biologic material to a surgical site. More particularly, the present disclosure relates to a novel and advantageous cannula and hub assembly for delivery of biologic material for surgical treatment of subchondral bone defects.
The background description provided herein is for the purpose of generally presenting the context of the disclosure. Work of the presently named inventors, to the extent it is described in this background section, as well as aspects of the description that may not otherwise qualify as prior art at the time of filing, are neither expressly nor impliedly admitted as prior art against the present disclosure.
The surgical repair of subchondral defects, sometimes referred to as subchondroplasty, is a minimally-invasive surgery that targets and treats subchondral defects associated with chronic bone marrow lesions in patients with knee osteoarthritis or insufficiency fractures. Bone marrow lesions, also referred to as subchondral bone marrow edema, are an often-painful defect of the spongy cancellous bone that underlies and supports the cartilage of a joint. In the setting of knee osteoarthritis, patients with subchondral bone marrow edema often undergo faster joint degeneration and experience more pain than those without bone marrow edema. The subchondroplasty procedure may be performed along with arthroscopy for visualization and treatment of findings inside the joint. In some cases, an open or mini-open procedure is necessary for access to the defect.
In patients with knee osteoarthritis, subchondroplasty is most frequently performed to treat bone marrow edema in the medial compartment (i.e., medial tibia plateau, medial femoral condyle, or both for “kissing” contrecoup lesions). Other possible target sites for subchondroplasty include the lateral compartment, patella, and trochlea.
During subchondroplasty, the surgeon injects synthetic bone substitute, such as calcium phosphate, into the region of bone marrow edema to fill the intertrabecular space, thereby providing local mechanical support to the bone at that site. This injection preserves preexisting trabeculae and may induce improved bone remodeling.
Cannula systems have been used to deliver synthetic bone substitute/calcium phosphate or other materials to a variety of bones including, but not limited to: vertebral bodies, distal and proximal tibia, distal and proximal femur. Zimmer, Inc. and Arthrex, Inc. currently have such devices for use in delivering bone substitute material to long bones.
Using currently available systems, it is necessary for a surgeon to visually align the delivery device to ensure proper orientation of a cannula for delivery of biologic material. Further, many of these systems are high profile and portions of the device may catch on materials in the operating room. Further, because of the high profile nature, a further device must be used to pinch tissue away from the device.
Thus, there is a need in the art for low profile subchondroplasty system that provides a tactile indication of positioning of the device within the patient.
The following presents a simplified summary of one or more embodiments of the present disclosure in order to provide a basic understanding of such embodiments. This summary is not an extensive overview of all contemplated embodiments, and is intended to neither identify key or critical elements of all embodiments, nor delineate the scope of any or all embodiments.
The present disclosure, in one or more embodiments, relates to a delivery device for delivering biologic material. The delivery device may comprise a push rod assembly, a cannula assembly, and a connection and alignment piece for detachably connecting the push rod assembly and the cannula assembly. In one embodiment, the cannula assembly comprises a cannula, wherein biologic material may be directed through the cannula and out of an opening provided at or near a distal end of the cannula. The connection and alignment piece may include an alignment mechanism and a connector. The alignment mechanism may be configured to tactilely index a location of the opening. The connector may be configured for engagement with a syringe.
In another embodiment, a further delivery device for delivering a biologic material is provided. The delivery device may include a cannula assembly and a push rod assembly. The push rod assembly may include a push rod and a hub. The cannula assembly may include a cannula, a connection and alignment piece, and a latching mechanism. The cannula may be closed and have a trocar tip. Biologic material may be directed through the cannula and out of an opening provided on a surface of the cannula at or near a distal end of the cannula. The connection and alignment piece may have an alignment ridge and a connector. The alignment ridge may be configured to tactilely index a location of the opening. The connector may be configured for engagement with a syringe. The connection and alignment piece may include a latching mechanism for releasably engaging the push rod assembly.
In yet another embodiment, a method for delivering a flowable material comprising providing a delivery device and using the delivery device to deliver the material. The delivery device may include a push rod assembly, a cannula assembly, and a connection and alignment piece for detachably connecting the push rod assembly and the cannula assembly. In one embodiment, the cannula assembly comprises a cannula, wherein biologic material may be directed through the cannula and out of an opening provided at or near a distal end of the cannula. The connection and alignment piece may include an alignment mechanism and a connector. The alignment mechanism may be configured to tactilely index a location of the opening. The connector may be configured for engagement with a syringe. Using the delivery device may comprise joining the push rod assembly and the cannula assembly, driving the cannula into bone, releasing the push rod assembly from the cannula assembly, engaging the syringe with the connector of the cannula assembly, using the alignment piece to align the opening with an area of bone to be treated, and expelling material from the syringe to the area of bone.
While multiple embodiments are disclosed, still other embodiments of the present disclosure will become apparent to those skilled in the art from the following detailed description, which shows and describes illustrative embodiments of the invention. As will be realized, the various embodiments of the present disclosure are capable of modifications in various obvious aspects, all without departing from the spirit and scope of the present disclosure. Accordingly, the drawings and detailed description are to be regarded as illustrative in nature and not restrictive.
While the specification concludes with claims particularly pointing out and distinctly claiming the subject matter that is regarded as forming the various embodiments of the present disclosure, it is believed that the invention will be better understood from the following description taken in conjunction with the accompanying Figures, in which:
The present disclosure relates to a novel and advantageous delivery device for biologic material. Particularly, the present disclosure relates to a novel and advantageous cannula and hub assembly for delivery of biologic material, such as bone cement, for surgical treatment of subchondral bone defects. It is to be appreciated that all dimensions and materials suggested herein are exemplary only and not intended to be limiting.
Delivery Device for Delivering Biologic Material
In the embodiment shown, the push rod assembly 20 comprises a push rod 22 and a hub 24, the hub having a receptacle 19. The cannula assembly comprises a connection and alignment piece 32 and a cannula 34. The connection and alignment piece 32 may have complementary cross sections such that at least a portion of the connection and alignment piece 32 is received by the receptacle 19. These may connect via a male-female connection or via any other suitable shape or connection. The shape of the hub 24 may be selected such that it is generally easy to determine the orientation of the device using only touch In one embodiment, the connection and alignment piece 32, the receptacle 19, and the hub 24 may have a tear dropped cross section.
The connection and alignment piece 32 may include an alignment mechanism configured to tactilely index a location of an opening in the cannula. For example, the connection and alignment piece may include an alignment ridge 35 that indexes openings 37 (shown in
The delivery device 10 has a proximal end 11 and a distal end 12. During use, the proximal end 11 is generally towards the surgeon and the distal end 12 is towards the patient. A wire piece 22 may be providing extending proximally from the hub 24. The distal end 12 of the delivery device 10 may be the distal end of the cannula assembly 30. The distal end 12 may be open or may be closed and have openings, described more fully below. Biologic material for delivery by the delivery device 10 may flow through the delivery device and out at or proximate the distal end, either by way of an open end or by way of openings in the distal end. A radiopaque marker 36 may be provided at or near the distal end 12. In one embodiment, the radiopaque marker 36 is a tantalum bar. The radiopaque marker 36 may facilitate proper indexing and visualization under x-ray examination/fluoroscopy.
In one embodiment, the total length of the delivery device is approximately 8.3 inches with the proximal extension of the push rod from the hub being approximately 4.8 inches. In other embodiments, the total length of the delivery device may range from approximately 6 inches to approximately 11 inches, with the proximal extension of the push rod from the hub ranging from approximately 2 inches to approximately 7 inches. In alternative embodiments, any suitable length may be used.
Biologic material, such as synthetic calcium phosphate, is directed through the cannula 34 and generally out of or proximate to the distal end 39. The distal end 39 thus may be configured to allow the biologic material to escape from the delivery device. This may be done by providing an open distal end or by providing openings in the distal end. The embodiment of
In an embodiment wherein the distal end 39 of the cannula 34 is open, the viscous material flows out of the open distal end. The push rod of the push rod assembly may be provided with a trocar tip to pierce bone.
The proximal end 31 of the cannula may be fixed to the inside of the connection and alignment piece 32. This may be done by overmolding the connection and alignment piece 32 onto the proximal end 31 of the cannula.
In various embodiments, each of the push rod assembly and the cannula assembly comprise a plastic piece over-molded onto a stainless steel piece. In alternative embodiments, the push rod assembly and cannula assembly may be otherwise formed.
Using the Delivery Device
Surgeons can use the delivery device to deliver a flowable material to subchondral lesions in human bone. In summary, a distal end of the delivery device is inserted into subchondral bone. This may be done using a powered wire driver, for example. The push rod assembly is removed, allowing the surgeon to fix a syringe of flowable material onto the cannula portion of the device. The flowable material is then injected into the subchondral lesion. The procedure augments areas of soft bone to reestablish a foundation for the hard bone and cartilage that sit on the bone. This staves off the need for larger surgeries. A more detailed description is provided below.
Use of the delivery device will now be described in more detail. In treatment of subchondral defects, a surgeon assembles the delivery device by inserting the connection and alignment piece 32 of the cannula assembly 20 into the receptacle 19 of the hub 24 of the push rod assembly 10. In one embodiment, the cannula assembly 20 and push rod assembly 10 are latched together by engaging the toggle 40 of the connection and alignment piece 32 with the catch 42 on the hub 24. Other mechanisms for latching the cannula assembly and push rod assembly together may alternatively be used.
A wire piece 22 extending proximally from the hub 24 may be put on a wire driver to drive the cannula into the bone. Under fluoroscopic imaging, the physician targets towards the area to be treated with biologic material, such as bone cement. The cannula is pushed through hard bone into soft, cancellous bone, where lesions are present, under power.
Once the tip is in place, the toggle 40 is released from the catch 42 to disengage the push rod assembly 10 from the cannula assembly 20 and remove the push rod assembly 10. This leaves the cannula 34 in the bone. A syringe is engaged with the connector of the cannula assembly 20. This may be done, for example, via threading of a luer lock. With the syringe engaged, the physician pushes biologic material, for example up to about 3 ccs of bone cement or calcium phosphate, into the cannula, which then exits the device. This can be done through openings 37 and/or through open distal end of the cannula. The physician can adjust the delivery device to align the openings 37 with the area of bone to be treated by using the alignment ridge 35 of cannula assembly 20. The alignment ridge gives the physician a tactile and visual indication of position of the openings 37.
The push rod assembly 10 may be reengaged with the cannula assembly 20 and the push rod pushed to expel any excess material into the bone. The delivery device may then be kept in place for approximately 5 minutes to allow the material to set. After the material is set, the driver can be put in reverse and the delivery device pulled out.
As used herein, the terms “substantially” or “generally” refer to the complete or nearly complete extent or degree of an action, characteristic, property, state, structure, item, or result. For example, an object that is “substantially” or “generally” enclosed would mean that the object is either completely enclosed or nearly completely enclosed. The exact allowable degree of deviation from absolute completeness may in some cases depend on the specific context. However, generally speaking, the nearness of completion will be so as to have generally the same overall result as if absolute and total completion were obtained. The use of “substantially” or “generally” is equally applicable when used in a negative connotation to refer to the complete or near complete lack of an action, characteristic, property, state, structure, item, or result. For example, an element, combination, embodiment, or composition that is “substantially free of” or “generally free of” an element may still actually contain such element as long as there is generally no significant effect thereof.
To aid the Patent Office and any readers of any patent issued on this application in interpreting the claims appended hereto, applicants wish to note that they do not intend any of the appended claims or claim elements to invoke 35 U.S.C. § 112(f) unless the words “means for” or “step for” are explicitly used in the particular claim.
Additionally, as used herein, the phrase “at least one of [X] and [Y],” where X and Y are different components that may be included in an embodiment of the present disclosure, means that the embodiment could include component X without component Y, the embodiment could include the component Y without component X, or the embodiment could include both components X and Y. Similarly, when used with respect to three or more components, such as “at least one of [X], [Y], and [Z],” the phrase means that the embodiment could include any one of the three or more components, any combination or sub-combination of any of the components, or all of the components.
In the foregoing description various embodiments of the present disclosure have been presented for the purpose of illustration and description. They are not intended to be exhaustive or to limit the invention to the precise form disclosed. Obvious modifications or variations are possible in light of the above teachings. The various embodiments were chosen and described to provide the best illustration of the principals of the disclosure and their practical application, and to enable one of ordinary skill in the art to utilize the various embodiments with various modifications as are suited to the particular use contemplated. All such modifications and variations are within the scope of the present disclosure as determined by the appended claims when interpreted in accordance with the breadth they are fairly, legally, and equitably entitled.
The present application claims the benefit of U.S. Provisional patent Application No. 62/968,872, filed on 31 Jan. 2020, the entire contents of which are incorporated herein by references.
| Number | Date | Country | |
|---|---|---|---|
| 62968872 | Jan 2020 | US |
