Device and method for aspirating bone marrow

Inventors

Schenden, Michael • Katakowski, Mark • Buller, Benjamin

Assignees

Forever Labs Inc

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Publication Number

US-10973500-B2

Patent

Publication Date

2021-04-13

Expiration Date


Abstract

A device and method for aspirating bone barrow. The device includes a double syringe assembly having a distal syringe and a proximal syringe coupled to the distal syringe. A plunger includes a distal end disposed within a barrel of the distal syringe and a proximal end disposed within a barrel of the proximal syringe. A needle assembly is coupled to the double syringe assembly and includes a needle having an outer tube and an inner tube disposed within the outer tube. Upon actuation of the plunger, the distal syringe aspirates bone marrow through the outer tube of the needle and into a chamber of the distal syringe. At the same time, the proximal syringe injects fluid through the inner tube of the needle at the same rate in which the bone marrow is aspirated.

Core Innovation

The invention describes a bone-marrow aspiration device that includes a double syringe assembly with a distal syringe and a proximal syringe coupled together, and a single plunger having a distal end disposed within the barrel of the distal syringe and a proximal end disposed within the barrel of the proximal syringe. The distal syringe extracts bone marrow from a target area through the outer tube of a needle assembly into a chamber of the distal syringe, while the proximal syringe injects fluid into the target area through an inner tube of the needle at the same time and at the same rate in which the bone marrow is extracted. The plunger controls the flow volume so that the fluid volume ejected by the chamber of the proximal syringe is equal to the bone marrow volume received by the chamber of the distal syringe.

The needle assembly includes a needle with an outer tube and an inner tube disposed within the outer tube, a housing surrounding a portion of the needle, and a connector extending from the housing and attached to the distal syringe. The inner tube of the needle is separate and sealed from the outer tube of the needle, preventing bone marrow extracted through the outer tube from mixing with any fluid ejected from the proximal syringe into the inner tube. The method aspect provides that the injection fluid is delivered through an inner tube separate from an aspiration path that includes an outer tube or an aspiration needle.

The invention further provides method claims that include extracting bone marrow from a target area through one of an aspiration needle or an outer tube of a needle assembly into a chamber of a distal syringe or an aspiration syringe, and injecting fluid from a chamber of a proximal syringe or an injection syringe through one of an injection needle separate from the first needle or an inner tube of the needle assembly into the target area before or simultaneous to extracting the bone marrow. The method prevents negative pressure during aspiration by using the inner tube separate from and disposed within the outer tube, and by controlling flow volume in the distal and proximal syringe chambers so that a volume of fluid injected is equal to a volume of bone marrow extracted.

Claims Coverage

The independent claims are clm-00001, clm-00010, and clm-00018, covering both a double-syringe device and methods of aspirating bone marrow. Across these independent claims, the document sets out a coordinated aspiration/injection arrangement with a separate inner tube and outer tube, and a flow-volume relationship that equates injected fluid volume with extracted bone-marrow volume, while preventing negative pressure during aspiration.

Double syringe assembly with single plunger for simultaneous aspiration and injection

A device comprising a double syringe assembly with a distal syringe and a proximal syringe coupled together and a single plunger with a distal end disposed within the distal syringe barrel and a proximal end disposed within the proximal syringe barrel, such that upon actuation the distal syringe extracts bone marrow through an outer tube into the distal chamber while the proximal syringe injects fluid through an inner tube into the target area at the same time and same rate, with the plunger controlling flow volume so the injected fluid volume equals the bone marrow volume received.

Separate and sealed inner tube disposed within outer tube to prevent mixing and negative pressure

A needle assembly having a needle with an outer tube and an inner tube disposed within the outer tube, where the inner tube is separate and sealed from the outer tube, preventing any bone marrow extracted through the outer tube from mixing with any fluid ejected through the inner tube, and where the inner tube disposed within the outer tube prevents negative pressure during aspiration in the method context.

Method of aspirating with injection before or simultaneous to extraction to prevent negative pressure

A method comprising extracting bone marrow from a target area through one of an aspiration needle or an outer tube of a needle assembly into a chamber of a distal syringe, and injecting fluid through one of an injection needle separate from the first needle or an inner tube of the needle assembly into the target area one of before or simultaneous to extracting the bone marrow, with the inner tube separate from and disposed within an outer tube of the aspiration needle through which the bone marrow is extracted to prevent negative pressure during aspiration.

Flow-volume control equating injected fluid volume and extracted bone marrow volume

A method further comprising controlling a flow volume in each chamber of the distal syringe and the proximal syringe such that a volume of fluid injected from the chamber of the proximal syringe is equal to a volume of bone marrow extracted by the distal syringe.

The independent claim set covers a coordinated system in which bone marrow is extracted through an outer tube into a distal syringe chamber while injection fluid is delivered through a separate, sealed inner tube into the target area before or simultaneous to extraction, with plunger or chamber flow-volume control so injected fluid volume equals extracted marrow volume, and with negative pressure during aspiration prevented by the inner tube separated from the outer tube.

Stated Advantages

Reduced/mitigated patient pain and anxiety.

Increased withdrawal rate.

Reduced risk of damaging bone marrow sample by avoiding excessive negative pressure (e.g., reduced hemolysis risk).

Documented Applications

Bone-marrow aspiration in a target area, including use where a target anatomy mapping includes posterior superior iliac spine with an aspiration hole and a separate injection hole, as described in the partial content.

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