Embodiments of the present invention relate to the field of cell processing, and in one particular embodiment, related to repairing cardiac tissue with autologous mononuclear cells obtained from bone marrow.
Autologous transplantation of bone marrow cells into infarcted myocardium shortly after acute myocardial infarction (AMI) has been shown to be a therapy beneficial for improving long-term outcome in these patients. Studies have suggested approximately 40 ml of aspirated bone marrow is required from the patient hours before the transplantation procedure.
The bone marrow is the tissue that manufactures the blood cells and is in the hollow part of most bones. The bone marrow is located in the central region of the bone and has a liquid-like texture and consistency. The bone marrow is surrounded by spongy bone material and a hard bone material such as the cortex. For treatment of AMI patients, bone marrow is typically taken from the hip bone (i.e., iliac crest). Bone marrow aspiration/biopsy procedures are painful and often poorly tolerated in adults. The aspiration procedure typically involves introducing an aspiration needle through the various layers of bone material including the cortex and into the bone marrow of the iliac crest, as illustrated in
Embodiments of a device to aspirate or extract bone marrow tissue from a patient are described. The bone marrow aspiration devices described herein facilitate the therapy of autologous bone marrow transplantation in AMI patients by reducing pain associated with the aspiration procedure, improving the efficiency, and tailoring the procedure to the specific requirements of the therapy. In one particular embodiment, the bone marrow aspiration device includes a first outer shaft with a distal cutting tip or edge for penetrating the bone cortex, a proximal handle, and an inner curved, elastic needle with a proximal adaptor suitable for connecting to a syringe. The curved, elastic needle may be made of a shape memory metal such as nickel titanium (NiTi) or another type of super-elastic metal.
In another embodiment of the present invention, the bone marrow aspiration device includes an aspiration needle with a resilient or shape memory wire (e.g., super elastic NiTi wire) disposed within a lumen of the aspiration needle. When the distal end of the wire is advanced out of the aspiration needle, the curved portion may be used to agitate and disturb the surrounding bone marrow region. This facilitates the aspiration of liquid bone marrow through the aspiration needle.
In another embodiment of the present invention, the bone marrow aspiration device may include a tubular anchoring structure, an aspiration needle which may be disposed within a lumen of the anchoring structure, and a mechanism of engagement between the anchoring structure and the aspiration needle which controls the forward movement of the needle into the bone cortex.
Still, another embodiment of the present invention, a method for bone marrow aspiration comprises inserting into a bone cortex a device. This device includes at least: a central body having a proximal and a distal end, and an outer shaft portion coupled to the distal end of the central body portion, with the outer shaft portion having a distal opening. There is at least one of a bone penetration needle and an aspiration needle disposed within a first lumen. The aspiration needle having a substantially linear configuration when positioned within the first lumen, and a substantially curved configuration when extended from the distal opening. The aspiration needle adapts to aspirate liquid bone marrow from a first region of a bone cavity, penetrating the bone cortex using at least one of a bone penetration needle and a cutting tip or edge of a first outer shaft of an aspiration device; and aspirating bone marrow using at least one of a bone penetration needle and the aspiration needle. Further in this method, aspiration may be accomplished by suction via syringe attached near the proximal end of the flexible aspiration needle and/or the bone penetration needle. Aspiration may be performed at different regions of the bone cavity repeatedly by rotating the aspiration needle and moving the aspiration needle distally along a longitudinal axis of the aspiration device. Moreover, a resilient wire, which can be driven by a motorized driving mechanism, may be used to break down bone marrow tissue after initial aspiration of bone marrow from a region to assist in repeated aspirations.
Additional embodiments, features and advantages of the medical device will be apparent from the accompanying drawings, and from the detailed description that follows below.
The present disclosure is illustrated by way of example, and not limitation, in the figures of the accompanying drawings in which:
In the following description, numerous specific details are set forth such as examples of specific materials or components in order to provide a thorough understanding of embodiments of the present invention. It will be apparent, however, to one skilled in the art that these specific details need not be employed to practice embodiments of the present invention. In other instances, well known components or methods have not been described in detail in order to avoid unnecessarily obscuring embodiments of the present invention.
The terms “on,” “above,” “below,” “between,” “adjacent,” and “near” as used herein refer to a relative position of one layer or element with respect to other layers or elements. As such, a first element disposed on, above or below another element may be directly in contact with the first element or may have one or more intervening elements. Moreover, one element disposed next to or adjacent another element may be directly in contact with the first element or may have one or more intervening elements.
Any reference to a particular feature, structure, or characteristic described in connection with any one embodiment within this specification should be construed as being included in at least that one embodiment. However, they may also appear in other embodiments, as described in this specification of the claimed subject matter. The appearances of the phrase, “in one embodiment” in various places in the specification are not necessarily all referring to the same embodiment.
Embodiments of a device to aspirate or extract bone marrow tissue from a patient are described. The bone marrow aspiration device described herein facilitates the therapy of autologous bone marrow transplantation in AMI patients by reducing pain associated with the aspiration procedure, improving the efficiency, and tailoring the procedure to the specific requirements of the therapy. In one particular embodiment, the bone marrow aspiration device includes a first outer shaft with a distal cutting tip or edge for penetrating the bone cortex, a proximal handle, and an inner curved, elastic needle with a proximal adaptor suitable for connecting to a syringe. The curved, elastic needle may be made of a shape memory metal such as nickel titanium (NiTi) or another type of super-elastic metal.
In use, the outer shaft is advanced through the bone cortex, for example, of the iliac crest. The curved, elastic needle is introduced into the outer shaft and advanced until the distal end is positioned near the distal end of the outer shaft (i.e., near the distal cutting tip or edge). Suction is applied through a syringe attached near the proximal end of the needle to aspirate bone marrow cells immediately adjacent to the distal cutting tip or edge. After bone marrow cells are obtained from this region, the needle may be advanced further past the distal end of the outer shaft such that the curved end of the needle exits the outer shaft and naturally curves to one side. In one embodiment, the curvature of the needle may be limited to a particular degree (e.g., 90 degrees). The advancement and curvature of the needle allows for a new region of the bone marrow to be accessed for aspiration by device. Aspiration of this new region may be repeated several times by advancing the curved end of the needle in different angular directions and at different depths into the bone marrow containing spongy bone. Thus, the desired amount of bone marrow cells may be aspirated more efficiently and with less pain than with current aspiration systems, which require angular movements of the entire needle, and multiple punctures to obtain the desired amount of bone marrow cells.
In another embodiment of the present invention, the bone marrow aspiration device includes an aspiration needle with a resilient or shape memory wire (e.g., super elastic NiTi wire) disposed within a lumen of the aspiration needle. In use, the aspiration needle is advanced through the cortex and into the bone marrow. Suction is applied to a syringe coupled to the aspiration needle to remove a desired amount of liquid bone marrow. The resilient wire includes a curved portion near the distal end, so that when the distal end is contained within the lumen of the aspiration needle, the curved portion is substantially straight and constrained from curving. When the distal end of the wire is advanced out of the aspiration needle, the curved portion may be used to agitate and disturb the surrounding bone marrow region. This facilitates the aspiration of liquid bone marrow through the aspiration needle. The extent of the wire curvature may be varied and is selected to suit the bone selected for the procedure. In one embodiment, the resilient wire may be moved independent of the aspiration needle. Thus, when the liquid bone marrow is aspirated, the resilient wire may be moved periodically to prevent clogging.
The resilient wire may have various structural configurations. In one embodiment, the resilient wire may have a helical configuration shaped like a corkscrew or simply a single curve bent at an angle. When the resilient wire is rotated on its axis and/or moved in a longitudinal direction, the resilient wire can dislodge clumps of bone marrow tissue or other tissue within the lumen of the aspiration needle to prevent clogging. Alternatively, the resilient wire may be coupled to a mechanical, electrical, or pneumatic actuator to provide vibrational, axial, or rotational movement of the resilient wire. In one embodiment, the resilient wire may be formed by joining a super-elastic shape memory wire (e.g., NiTi) and a high tensile strength wire (e.g., stainless steel) with, for example, a lap joint, or other joints known in the art, to provide a smooth wire surface for the overall resilient wire. The distal portion of the wire may be made of NiTi and the proximal driving portion of the aspiration needle may be made of stainless steel. This configuration provides superior torque and pushability for the aspiration needle to penetrate through the cortex without hindering fluid or cell movement through the aspiration needle.
In another embodiment of the present invention, the bone marrow aspiration device may include a tubular anchoring structure, an aspiration needle which may be disposed within a lumen of the anchoring structure, and a mechanism of engagement between the anchoring structure and the aspiration needle which controls the forward movement of the needle into the bone cortex. Alternatively, the aspiration device may also include a sensor (e.g., torque, pressure, positional) which can monitor the progress of advancing the aspiration needle through the bone cortex.
In use, the anchoring structure is positioned over the outer surface of the bone cortex, allowing the distal end of the anchoring structure to penetrate into the surface of the bone. In one embodiment, the distal end may have external cutting threads, such that with a small amount of rotation and pressure, the distal end can anchor into the surface of the bone cortex. The aspiration needle may then be introduced into the proximal end of the anchoring structure and advanced until the distal tip contacts the cortical surface. The engagement mechanism near the proximal end of the aspiration device may be threads on the inside of the proximal anchoring structure and the outside of the proximal end of the aspiration needle. When the aspiration needle is rotated, a controlled forward movement results, allowing the distal tip of the aspiration needle to penetrate the bone cortex and into the bone marrow cavity. A sensor coupled to the aspiration device may be used to detect when the aspiration needle reaches the bone marrow cavity. Alternatively, the advancement of the aspiration needle may be done in a more controlled manner by a small power unit with a variable speed/torque drive attached near the proximal end of the aspiration device. The drive unit may be coupled to the sensor such that the needle advancement is automatically stopped when the bone cortex is penetrated.
In one embodiment, the proximal portion 206 and the distal portion 207 of aspiration needle 203 may be curved. When extended out from the outer shaft portion 202, the distal portion 207 of aspiration needle 203 curves toward a particular direction as illustrated in
In one embodiment, aspiration needle 203 may be made of a super-elastic material or metal. In an alternative embodiment, aspiration needle 203 may be made of a shape memory metal such as NiTi. The super-elastic material or shape memory metal of aspiration needle 203 allows for the curvature of distal portion 207 when advanced past the distal opening of outer shaft 202. Aspiration needle 203 may also be made of a combination of super-elastic or NiTi and high tensile strength materials. For example, the distal portion 207 of aspiration needle 203 may be made of NiTi while the rest of aspiration needle 203 is made of stainless steel.
In use, the needle portion 303 is advanced through the cortex and into the bone marrow cavity. Suction may be applied device 300 by drawing back plunger 302 so that liquid bone marrow may be collected in lumen 305 formed by elongated syringe body 301. In an alternative embodiment, a separate syringe may be coupled to device 300 to collect the desired amount of liquid bone marrow. Resilient wire 304 includes a curved portion 311 near the distal end, so that when the curved portion 311 is contained within lumen 305 of the needle portion 303, the curved portion 311 is substantially straight and constrained from curving. When the distal end of resilient wire 304 (i.e., curved portion 311) is advanced out of needle portion 303, the curved portion 311 may be used to agitate and disturb the surrounding bone marrow tissue. This facilitates the aspiration of liquid bone marrow through device 300. The extent of the curvature for curved portion 311 may be varied and is selected to suit the bone selected for the procedure. In one embodiment, the resilient wire 304 may be moved independently of the needle portion 303. Thus, when the liquid bone marrow is aspirated, the resilient wire 304 may be moved periodically to prevent clogging.
In one alternative embodiment, resilient wire 304 may be coupled to a mechanical, electrical, or pneumatic actuator (generally represented by actuator 306) to provide vibrational, axial, or rotational movement of resilient wire 304. In one embodiment, the resilient wire 304 may be formed by joining a super-elastic shape memory wire (e.g., NiTi) and a high tensile strength wire (e.g., stainless steel) with a lap joint to provide a smooth wire surface for the overall resilient wire. The curved portion 311 of resilient wire 304 may be made of NiTi and the proximal driving portion of needle portion 303 may be made of stainless steel. This configuration provides superior torque and pushability for needle portion 303 to penetrate through the cortex without hindering fluid or cell movement through device 300.
The resilient wire, and in particular the curved portion, may have various structural configurations.
As illustrated in
In an alternative embodiment, a sensor 430 may be coupled to device 400 to detect a penetration depth for distal end 403 and/or attachment of anchoring members 408, 409 to the surface of bone cortex 405. In another embodiment, sensor 430 may be coupled to the power unit that drives the bone penetration needle 402, such that needle advancement is automatically stopped when bone cortex 405 is penetrated.
Bone marrow tissue may be aspirated from the opening of distal end 403 and through a second lumen 412 of bone penetrating needle 402. For example, a syringe (not shown) may be in fluid communication with second lumen 412 of bone penetrating needle 402 to apply pressure and receive the aspirated liquid bone marrow. In an alternative embodiment, an aspiration needle 407 may be advanced through second lumen 412 of bone penetrating needle 402 and extended distally past the opening of distal end 403. In one embodiment, aspiration needle 407 may be substantially similar to aspiration needle 203 described above with respect to
In one embodiment, aspiration needle 407 may be made of a super-elastic material or metal. In an alternative embodiment, aspiration needle 407 may be made of a shape memory metal such as NiTi. The super-elastic material or shape memory metal of aspiration needle 407 allows for the curvature of the distal portion when advanced past the distal opening of bone penetration needle 402. Aspiration needle 407 may also be made of a combination of super-elastic or NiTi and high tensile strength materials. For example, the distal portion of aspiration needle 407 may be made of NiTi while the rest of aspiration needle 407 is made of stainless steel.
A sensor (e.g., sensor 430) may be coupled to device 400 to detect a penetration depth for distal end 403 and/or attachment of the anchoring members (e.g., 420, 421, 422, 423) to the surface of bone cortex 405. In another embodiment, the sensor may be coupled to a power unit that drives the bone penetration needle 402, such that needle advancement is automatically stopped when the bone cortex is penetrated.
In the foregoing specification, a medical device has been described with reference to specific exemplary embodiments thereof. It will, however, be evident that various modifications and changes may be made thereto without departing from the broader scope of the medical device as set forth in the appended claims. The specification and figures are, accordingly, to be regarded in an illustrative rather than a restrictive sense. Moreover, it is understood that