Bone Marrow Aspiration Device And Method

Patent No. US11564669 (titled "Bone Marrow Aspiration Device And Method") was filed by Cervos Medical Llc on Jun 18, 2021.

What is this patent about?

’669 is related to the field of medical devices, specifically those used for bone marrow aspiration . Bone marrow aspiration is a procedure to collect a sample of bone marrow for diagnostic testing. Traditional aspiration needles can be difficult to maneuver within the bone, potentially causing trauma and requiring multiple punctures to obtain sufficient sample volume. This can dilute the sample with blood and reduce its quality.

The underlying idea behind ’669 is to provide a bone marrow aspiration device with improved control and maneuverability within the bone. The key inventive insight is the integration of a screw mechanism that allows for precise adjustment of the cannula's depth and controlled retraction, enabling aspiration from multiple locations within the bone marrow space with a single insertion. This mechanism also provides leverage to remove the cannula if it becomes lodged.

The claims of ’669 focus on a bone marrow aspiration device featuring a cannula with a closed distal end and side apertures for aspiration. The cannula extends through a lead screw and threaded jacket mechanism , which allows adjustment of the exposed cannula length. The lead screw's length is at least 50% of the cannula's maximum exposed length, enabling the mechanism to reposition the cannula to different depths within the bone with rotation of the handle.

In practice, the device is inserted into the bone with the cannula extending a desired distance. The screw mechanism's jacket is then secured against the patient's skin, providing leverage. By rotating the handle, the cannula can be advanced or retracted in a controlled manner, allowing aspiration from different locations within the bone marrow. The closed distal end of the cannula with side apertures helps to minimize blood contamination of the sample.

This design differentiates itself from prior approaches by providing a mechanical advantage for both insertion and retraction of the cannula, as well as precise depth control. Traditional needles often require forceful insertion and can be difficult to remove if lodged. The screw mechanism provides a controlled and less traumatic method for accessing and sampling bone marrow from multiple locations, potentially improving sample quality and reducing patient discomfort.

How does this patent fit in bigger picture?

Technical landscape at the time

In the mid-2010s when ’669 was filed, bone marrow aspiration was typically performed using stiff needles, at a time when systems commonly relied on direct puncture to access marrow. Hardware or software constraints made precise control over needle depth and aspiration location non-trivial.

Novelty and Inventive Step

The examiner approved the application because the prior art did not disclose or make obvious a bone marrow aspiration device that combines a cannula, a handle, a removable solid stylet, and a screw mechanism. The screw mechanism includes a threaded jacket with a non-threaded portion to receive a lead screw, and the lead screw's length is at least 50% of the cannula's exposed length, enabling the screw mechanism to reposition the cannula to different depths within the bone by rotating the handle.

Claims

This patent contains 8 claims, with claim 1 being independent. Independent claim 1 is directed to a bone marrow aspiration device that includes a cannula, a handle, and a screw mechanism for adjusting the cannula's depth. The dependent claims elaborate on specific features of the bone marrow aspiration device described in claim 1, such as the shape of the threaded jacket, the inclusion of a stylet, and the handle's connector.

Key Claim Terms New

Definitions of key terms used in the patent claims.

Term (Source)Support for SpecificationInterpretation
Central lumen
(Claim 1)
“The mechanism can include a screw assembly that includes a threaded jacket and a lead screw receivable in the threaded jacket. At least a portion of the introducer cannula can extend through the lead screw, e.g., through a central lumen defined by the lead screw.”The opening defined by the lead screw through which the cannula extends.
Exposed length
(Claim 1)
“An exposed length (also referred to as maximum exposed length) can include the length of the introducer cannula that extends from the distal end of the threaded jacket when the screw mechanism is fully retracted. The exposed length can include the length of the aspiration cannula that extends beyond the distal end of the introducer cannula. The exposed length can be between about 0.75 inches and about 8.5 inches.”The length of the cannula that extends from the distal end of the threaded jacket. This length is adjustable by the screw mechanism.
Lead screw
(Claim 1)
“The mechanism can include a screw assembly that includes a threaded jacket and a lead screw receivable in the threaded jacket. At least a portion of the introducer cannula can extend through the lead screw, e.g., through a central lumen defined by the lead screw. A length of the introducer cannula that extends from a distal end of the threaded jacket and, for example, into bone can be adjusted by advancing the lead screw into the threaded jacket, e.g., by rotating the lead screw in a first direction, or reversing the lead screw out of the threaded jacket, e.g., by rotating the lead screw in a second direction, opposite to the first direction.”A component of the screw mechanism that is receivable in the threaded jacket and through which the cannula extends. Advancing or reversing the lead screw adjusts the exposed length of the cannula.
Side aperture
(Claim 1)
“In some embodiments, aspiration is done through a relatively big hole (port) at the distal end of a cannula that is positioned in the bone space. Aspiration may be through one or more holes that are smaller, e.g., side holes (ports) in the cannula. For example, the diameter of a side hole can be smaller than the inner diameter of the introducer cannula.”An opening in the cannula, spaced proximally from the closed distal end, through which bone marrow can be aspirated.
Threaded jacket
(Claim 1)
“The screw mechanism can include a jacket that is threaded and through which the screw travels. The threaded jacket can be large enough, i.e., be of sufficient axial length, to be easily grasped by one hand while the operator uses the other hand to turn the screw. The jacket can also provide leverage when the cannula is withdrawn from the bone space using the screw mechanism. Once the cannula is position in the bone to a certain depth, the jacket can be screwed down against the skin of the patient.”A component of the screw mechanism that includes both a non-threaded portion to receive a lead screw and a threaded portion to engage the lead screw. It is used to adjust the exposed length of the cannula.

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US11564669

CERVOS MEDICAL LLC
Application Number
US17351709
Filing Date
Jun 18, 2021
Status
Granted
Expiry Date
Dec 19, 2035
External Links
Slate, USPTO, Google Patents