Bone Marrow Aspiration Device And Method

Patent No. US11576659 (titled "Bone Marrow Aspiration Device And Method") was filed by Cervos Medical Llc on Mar 13, 2020.

What is this patent about?

’659 is related to the field of medical devices, specifically devices and methods for bone marrow aspiration. Bone marrow aspiration is a procedure to collect bone marrow samples for diagnostic or therapeutic purposes. Traditional methods involve a stiff needle that can be difficult to maneuver and may require multiple punctures, leading to patient trauma and potentially diluting the sample with blood.

The underlying idea behind ’659 is to provide a bone marrow aspiration device with improved control and precision during the aspiration process. This is achieved by incorporating a screw mechanism that allows the user to move the aspiration cannula within the bone with leverage against the patient's body. This mechanism enables controlled advancement or retraction of the cannula, facilitating aspiration from different depths within the bone marrow space.

The claims of ’659 focus on methods of aspirating bone marrow using an introducer cannula and a mechanism to move the cannula within the bone with leverage on the patient. Claim 1 covers aspirating bone marrow at a first depth, moving the introducer cannula to a second depth using the mechanism, and then aspirating again. Claim 14 adds an aspiration cannula that extends beyond the introducer cannula, with the mechanism moving both cannulas in tandem to different depths for aspiration.

In practice, the device works by first inserting an introducer cannula into the bone, often with a sharp stylet to penetrate the cortical bone. The stylet is then removed, and an aspiration cannula may be inserted through the introducer cannula. The screw mechanism , consisting of a threaded jacket and a lead screw, allows the user to precisely adjust the depth of the cannula(s) within the bone. By rotating the lead screw, the cannula(s) can be advanced or retracted, and the threaded jacket provides a surface to contact the patient, providing leverage for controlled movement.

This design differentiates itself from prior approaches by providing a mechanical advantage for both inserting and retrieving the cannula, especially when it becomes lodged in the bone. The screw mechanism also acts as a depth guide , allowing for precise repositioning of the aspiration cannula to optimize stem cell counts in the extracted bone marrow. Furthermore, the airtight connection between the introducer and aspiration cannulas prevents air leakage during aspiration, which can contaminate the sample.

How does this patent fit in bigger picture?

Technical landscape at the time

In the mid-2010s when ’659 was filed, bone marrow aspiration was typically implemented using stiff needles, at a time when clinicians commonly relied on multiple punctures to obtain sufficient sample volumes. Hardware or software constraints made it non-trivial to precisely control the depth and angle of needle insertion, increasing the risk of trauma and sample contamination.

Novelty and Inventive Step

The examiner approved the application because the prior art failed to disclose or make obvious a method of aspirating bone marrow that includes positioning an introducer cannula at a first depth, aspirating marrow, moving the cannula with leverage to a second depth using a mechanism on the introducer assembly, and aspirating marrow at the second depth. No combination of prior art taught or suggested each element of claim 1. The examiner made similar findings with respect to claim 13.

Claims

This patent contains 19 claims, with claims 1 and 14 being independent. The independent claims are directed to methods of aspirating bone marrow using an introducer assembly to reach different depths within the bone. The dependent claims generally elaborate on specific features, components, or steps related to the bone marrow aspiration methods described in the independent claims.

Key Claim Terms New

Definitions of key terms used in the patent claims.

Term (Source)Support for SpecificationInterpretation
Aspiration cannula
(Claim 14)
“The aspiration assembly includes an aspiration cannula that is receivable in the lumen of the introducer cannula and that extends beyond the distal end of the introducer cannula. The aspiration cannula includes a port to aspirate bone marrow, the port being distal to the distal end of the introducer cannula.”A cannula that is inserted through the introducer cannula and extends beyond its distal end, having a port for aspirating bone marrow.
Introducer assembly
(Claim 1, Claim 14)
“A bone marrow aspiration device includes an introducer assembly and an aspiration assembly to couple to the introducer assembly. The introducer assembly includes an introducer cannula having a proximal end and a distal end. The aspiration device further includes a mechanism at the introducer assembly to move the introducer cannula and the aspiration cannula in tandem relative to a distal end of the mechanism when the aspiration cannula is positioned within bone.”A part of the bone marrow aspiration device that includes the introducer cannula and a mechanism for moving the introducer cannula within the bone.
Introducer cannula
(Claim 1, Claim 14)
“A bone marrow aspiration device includes an introducer assembly and an aspiration assembly to couple to the introducer assembly. The introducer assembly includes an introducer cannula having a proximal end and a distal end. The introducer cannula defines a lumen between the distal and proximal ends, and the distal end is configured to penetrate bone of a patient.”A cannula that is part of an introducer assembly and is positioned in bone to allow aspiration of bone marrow through its lumen or to allow insertion of an aspiration cannula.
Moving the introducer cannula
(Claim 1, Claim 14)
“The aspiration device further includes a mechanism at the introducer assembly to move the introducer cannula and the aspiration cannula in tandem relative to a distal end of the mechanism when the aspiration cannula is positioned within bone. The mechanism can be configured to move the introducer cannula and aspiration cannula proximally with leverage on the patient. The threaded jacket of the mechanism can define a surface to contact the patient to provide the leverage.”Using a mechanism at the introducer assembly to move the introducer cannula within the bone, with leverage on the patient, to different depths.
Moving the introducer cannula and the aspiration cannula in tandem
(Claim 14)
“The aspiration device further includes a mechanism at the introducer assembly to move the introducer cannula and the aspiration cannula in tandem relative to a distal end of the mechanism when the aspiration cannula is positioned within bone. When moved by the mechanism, the introducer cannula and the aspiration cannula can move without relative rotation to each other.”The introducer cannula and the aspiration cannula are moved together, without relative rotation to each other, by the mechanism at the introducer assembly.

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US11576659

CERVOS MEDICAL LLC
Application Number
US16817777
Filing Date
Mar 13, 2020
Status
Granted
Expiry Date
Oct 5, 2036
External Links
Slate, USPTO, Google Patents