US20050288605A1 - Bone marrow aspiration system - Google Patents

Abstract

Bone marrow aspiration devices and methods are disclosed for use in preparing a substrate. In general, the device includes an elongate penetrating element, a chamber adapted to retain a substrate, and a fluid extraction mechanism that is effective to pull fluid through the elongate penetrating element, into the chamber, and through the substrate. The device is particularly advantageous in that it will allow for the removal of fluids from a patient's body and the preparation of a substrate in a single process, thereby providing a more efficient method and device for preparing a substrate.

Description

CROSS REFERENCE TO RELATED APPLICATIONS
• This application is a continuation of U.S. patent application Ser. No. 10/298,371 filed on Nov. 18, 2002 and entitled “Bone Marrow Aspiration System,” which is hereby incorporated by reference in its entirety.
FIELD OF THE INVENTION
• The present invention relates to devices and methods for preparing a substrate, and in particular to bone marrow aspiration devices and methods for preparing implantable bone grafts.
BACKGROUND OF THE INVENTION
• Bone grafts are often used to treat fractures, gaps in bones caused by trauma or infection, revision joint surgery, and oral/maxillofacial surgery. Bone grafts provide a framework into which the host bone can regenerate and heal. Once implanted, the bone cells weave into and through the porous microstructure of the bone graft to support the new tissue, blood cells and soft tissue as they grow to connect fractured bone segments.
• Bone grafts can be prepared from a variety of materials, including bone harvested from a patient. Bone harvesting procedures, however, can result in significant cost and morbidity, including scars, blood loss, pain, prolonged operative and rehabilitation time and risk of infection. Furthermore, in some clinical settings, the volume of the graft site can exceed the volume of the available autograft. Accordingly, alternative graft materials have been developed in an attempt to reduce the morbidity and cost of bone grafting procedures. Such alternative materials include purified or synthetic materials, such as ceramics, biopolymers, processed allograft bone and collagen-based matrices. These materials are typically used as carriers for bone marrow cells, and thus need to be prepared prior to implantation.
• Current procedures typically involve a two-step process which includes the withdrawal of bone marrow from a patient into several syringes, and then the subsequent preparation of the bone graft. The bone graft can be prepared by flushing the aspirated bone marrow one or more times to collect and concentrate the stem cells contained in the marrow into the bone graft. While this procedure can be very effective, it can also be time consuming typically requiring around 20 minutes for the aspiration procedure, and an additional 20 minutes for the graft preparation procedure.
• Accordingly, there is a need for more efficient methods and devices for preparing substrates.
BRIEF SUMMARY OF THE INVENTION
• In general, the present invention provides a bone marrow aspiration device having a chamber adapted to retain a substrate, an elongate penetrating element extending from a distal end of the chamber and having a proximal end, a distal end, and an inner lumen extending therebetween, and a fluid extraction mechanism coupled to the proximal end of the chamber and effective to draw fluid into the elongate penetrating element, and through a substrate disposed in the chamber. The device can also include a fluid permeable tray or container removably disposed within the chamber for retaining a substrate.
• In one embodiment, the chamber is an elongate, cylindrical barrel, and the fluid extraction mechanism is a plunger disposed within the barrel and having a handle adapted to move the plunger proximally to extract fluid through the device. The chamber is preferably adapted to retain a substrate in a position proximal to an inlet port formed in the distal end of the chamber. In another embodiment, the device includes a control member mated to the fluid extraction mechanism and effective to control the amount of fluid being extracted by the fluid extraction mechanism. The control member is preferably effective to control the rate of fluid being extracted by the fluid extraction mechanism. The control member can be, for example, a trigger mechanism effective to actuate the fluid extraction mechanism to extract a predetermined amount of fluid.
• In another embodiment, the device includes a fluid receptacle in communication with the chamber. The fluid receptacle is adapted to receive fluid passed through the chamber and through a substrate disposed within the chamber. The substrate is preferably disposed at an inlet port of the fluid receptacle, and the fluid receptacle is preferably removably mated to the chamber. The device can optionally include a unidirectional valve disposed between the chamber and the fluid receptacle for allowing fluid to flow only in a direction from the chamber to the fluid receptacle. The unidirectional valve can be disposed at the proximal end of the chamber such that fluid can flow from the chamber through the unidirectional valve, then through a substrate, and into the fluid receptacle.
• In other aspects, the device includes a conduit extending between the proximal end of the elongate penetrating element and the inlet port of the chamber such that fluid can flow from the elongate penetrating element, through the conduit, and into the chamber. The conduit can be removably attached to the proximal end of the elongate penetrating element and the inlet port in the chamber. The device can also include a second conduit extending from the outlet port of the chamber to an inlet port in the fluid receptacle for allowing fluid to flow from the chamber to the receptacle, and a third conduit extending from the outlet port of the fluid receptacle to the fluid extraction mechanism.
• The present invention also provides methods for preparing a substrate. The method generally includes the step of providing a bone marrow aspirator device having an elongate penetrating element having a proximal end, a distal end adapted to penetrate bone, and an inner lumen extending therebetween. A chamber is in fluid communication with the proximal end of the elongate penetrating element, and a substrate is disposed within the chamber. The penetrating element also includes a fluid extraction mechanism effective to pull fluid through the elongate penetrating element, into the chamber, and through the substrate. The method further includes the steps of penetrating the distal end of the elongate penetrating element into a patient, and actuating the fluid extraction mechanism to pull fluid from the patient through the elongate penetrating element, into the chamber, and through the substrate, thereby concentrating cells from a biological material within the substrate.
BRIEF DESCRIPTION OF THE DRAWINGS
• The invention will be more fully understood from the following detailed description taken in conjunction with the accompanying drawings, in which:
• FIG. 1 is a diagram illustrating one embodiment of a bone marrow aspiration device having an elongate penetrating element, a chamber, a fluid receptacle, and a fluid extraction mechanism;
• FIG. 2 is a diagram illustrating another embodiment of a bone marrow aspiration device according to the present invention in which the chamber, fluid extraction mechanism, and fluid receptacle are disposed within a housing;
• FIG. 3 is a diagram illustrating another embodiment of a bone marrow aspiration device having a chamber, an elongate penetrating element extending from a distal end of the chamber, and fluid extraction mechanism disposed within the chamber; and
• FIG. 4 is a diagram illustrating yet another embodiment of a bone marrow aspiration device having a substrate disposed within a handle of an elongate penetrating element.
DETAILED DESCRIPTION OF THE INVENTION
• The present invention provides bone marrow aspiration devices and methods for preparing a substrate by extracting fluids directly from a patient through a substrate. In general, the device includes an elongate penetrating element, a chamber adapted to retain a substrate, and a fluid extraction mechanism that is effective to pull fluid through the elongate penetrating element, into the chamber, and through the substrate. The device is particularly advantageous in that it will allow for the removal of fluids from a patient's body and the preparation of a substrate in a single process, thereby providing a more efficient method and device for preparing a substrate.
• A person having ordinary skill in the art will appreciate that a variety of substrates and fluids can be used with the system of the present invention, and that the term “substrate” as used herein is intended to encompass both implantable and non-implantable substrates, used alone or in combination with other substrates. By way of non-limiting example, suitable implantable substrates include bone grafts, fusion cages, ceramic bone substitutes, soft tissue grafts, such as skin tendons, and ligaments, and other suitable implantable material, and suitable non-implantable substrates include filters for filtering particular elements from a fluid. In an exemplary embodiment, the present invention is used to prepare an implantable substrate by flowing fluid therethrough, and one or more filters are optionally used in combination with the implantable substrate. The filter(s) can be positioned upstream and/or downstream from the implantable substrate, and can be adapted to filter particular elements from a fluid, such as, for example, red blood cells from plasma. Alternatively, or in addition, the filter can contain a biological agent or fluid for treating fluid passing therethrough. Suitable fluids for use with the present invention include, for example, fluids having regenerative properties, such as bone marrow, blood, platelet rich plasma, placenta, synovial fluid, and amniotic fluid, and suspensions containing stem cells, growth factors, and proteins.
• FIG. 1 illustrates one embodiment of a bonemarrow aspiration device80 according to the present invention. As shown, thedevice80 includes achamber82 that is adapted to retain at least onesubstrate84, apenetrating element110 coupled to aninlet90 formed in thechamber82, and afluid extraction mechanism114 coupled to anoutlet92 formed in thechamber82. Thedevice80 can also optionally include afluid receptacle88 disposed between theoutlet92 of thechamber82 and thefluid extraction mechanism114. In use, thefluid extraction mechanism114 is effective to draw fluid into the penetratingelement110 from an outside fluid source, such as a patient's body, through thechamber82 and thesubstrate84 disposed within thechamber82. The fluid can then be collected in thefluid receptacle88.
• Thechamber82 can have a variety of shapes and sizes, but should be adapted to retain asubstrate84, and to allow fluid to flow therethrough. As shown inFIG. 1, thechamber82 has a generally cylindrical shape and includes afirst end106 having aninlet90, a second end108 having anoutlet92, and a hollow interior91 extending therebetween and adapted to receive and hold asubstrate84. The inlet andoutlet90,92 in thechamber82 can each have any shape and size and, by way of non-limiting example, can be in the form of a port or a valve. Preferably, the inlet andoutlet90,92 are each in the form of a one-way valve that is effective to control the direction of fluid flow therethrough. More preferably, theinlet90 allows fluid to flow into thechamber82, and theoutlet92 allows fluid to flow out of thechamber82.
• Thechamber82 can optionally include a basket (not shown) or similar structure disposed therein for holding thesubstrate84. The basket, or a portion of the basket, can be permanently or removably disposed within thechamber82, or can be integrally formed with thechamber82. The basket, or at least a portion of the basket, is fluid permeable to allow fluid to flow through a substrate disposed therein. By way of non-limiting example, the basket can include first and second porous members, e.g., screens, positioned at a distance apart from one another and effective to hold asubstrate84 therebetween. In another embodiment, thechamber82 can include a side-opening, slot, or door formed therein for slidably receiving thesubstrate84 or basket containing a substrate. Examples ofsuitable chambers82 and baskets for use with the device of the present invention are disclosed in U.S. patent application Ser. No. 10/223,674, filed on Aug. 19, 2002 and entitled “Device For Controlling Fluid Flow Through a Medium,” the teachings of which are hereby incorporated by reference.
• Theinlet90 in thechamber82 is coupled to the penetratingelement110, preferably via afirst conduit100, and is effective to allow fluid to flow from the penetratingelement110 into thechamber82. The penetratingelement110 can have a variety of configurations, and is adapted to penetrate into tissue and/or bone to allow fluid to be extracted therefrom. As shown inFIG. 1, the penetratingelement110 includes ahandle112 and an elongatetissue piercing member86, e.g., a needle. Suitable examples of an elongate penetratingelement110 are disclosed in U.S. patent application Ser. No. 10/194,752, filed on Jul. 12, 2002, and entitled “Bone Marrow Aspirator,” which is hereby incorporated by reference in its entirety.
• Theoutlet92 in thechamber82 is coupled to afluid extraction mechanism114, preferably via afluid receptacle88. A second conduit108 can extend from theoutlet92 in thechamber82 to aninlet94 formed in thefluid receptacle88, and athird conduit104 can extend from anoutlet96 in thefluid receptacle88 to thefluid extraction mechanism114. Thefluid receptacle88 can have virtually any shape and size, but should be effective to hold a predetermined amount of fluid extracted from a patient. Thereceptacle88 should also be airtight to allow fluid to be drawn into the penetratingelement110 from an outside fluid source, through thechamber82, and into thefluid receptacle88. As shown inFIG. 1, thereceptacle88 includes aninlet94 coupled to thechamber82 via conduit108, and anoutlet96 coupled to afluid extraction mechanism114 viaconduit104. The inlet andoutlets94,96 can have any configuration, and can be formed anywhere in thereceptacle88. Preferably, however, theinlet94 is positioned to allow fluid to drain into thereceptacle88 from thechamber82, and theoutlet96 is positioned at a location that will prevent fluid from being pulled therethrough intoconduit104. This will allow thefluid extraction mechanism114 to create a vacuum force within thedevice80 without drawing fluid into thefluid extraction mechanism114.
• Thefluid extraction mechanism114, which is coupled to thefluid receptacle88, or optionally directly to theoutlet92 in thechamber82, can also have a variety of configurations. Theextraction mechanism114 should, however, be effective to create a vacuum force in thedevice80 to draw fluid into the penetratingelement110, through thechamber82 and thesubstrate84 disposed within thechamber82, and into thefluid receptacle88. As shown inFIG. 1, thefluid extraction mechanism114 is in the form of a vacuum pump. A person having ordinary skill in the art will appreciate that a variety of devices can be used to extract fluid through thesystem80, including both mechanical and/or electrical devices.
• In use, the penetratingelement110 is positioned at a fluid site in a patient's body, or theinlet90 in thechamber82 is mated to an external fluid source. Thefluid extraction mechanism114 is then activated to pull fluid from the patient through thedevice80, whereby fluid travels from the penetratingelement110 to thechamber82 viaconduit100, through thesubstrate84 disposed within thechamber82, and to thefluid receptacle88 via conduit108. The process of extracting fluid through thedevice80 can be repeated several times, as desired.
• Thedevice80 can also optionally include fluid flow control mechanisms for controlling the rate of fluid flow through thedevice80. By way of non-limiting example, thefluid extraction mechanism114 can be adapted to pull fluid through thedevice80 at a predetermined rate. Alternatively, or in addition, theconduits100,108, and104 can have a size effective to control the rate of fluid flow therethrough. The inlets andoutlets90,92,94,96 in thechamber82 and/orfluid receptacle88 can also be adapted to regulate the rate of fluid flow. A person having ordinary skill in the art will appreciate that a variety of techniques can be used to control the rate of fluid flow through thedevice80.
• FIG. 2 illustrates another embodiment of a bonemarrow aspiration device40 according to the present invention. Thedevice40 is similar todevice80 described with respect toFIG. 1, except that the fluid extraction mechanism50,chamber42, andfluid receptacle48 are disposed within ahousing51 and combined into asingle device40 that is adapted to mate to an external fluid source, such as an elongate penetratingelement110 described about with respect toFIG. 1. As shown inFIG. 2, thedevice40 generally includes ahousing51 having proximal and distal ends55,57, achamber42 formed within thedistal end57 of thehousing51, and a fluid extraction mechanism50 disposed within theproximal end55 of thehousing51. Thedevice40 can also include afluid receptacle48 or reservoir which forms part of thechamber42 and is preferably integrally formed with, fixedly attached to, or removably attached to thehousing51. One of thefluid receptacle48 and thechamber42 is adapted to retain asubstrate46. In use, fluid is drawn into thechamber42 from an external fluid source, such as a patient's body via the penetratingelement110, and is pushed or pulled through thesubstrate46 and collected in thefluid receptacle48.
• Thechamber42 can have virtually any shape and size, but is preferably formed within a distal portion of thehousing51 and includes aproximal end58, a distal end56, and aninner lumen60 extending therebetween. Theproximal end58 of thechamber42 is adapted to slidably receive the fluid extraction mechanism, e.g., plunger50, and the distal end56 of thechamber42 is adapted to mate with an external fluid source, or to apenetrating element110. Aninlet62 is formed in the distal end56 of thechamber42 and is adapted to mate to the external fluid source, and anoutlet70 is formed adjacent theproximal end58 of thechamber42 and is coupled to thefluid receptacle48. Theinlet62 andoutlet70 can each have a variety of configurations, but are preferably one-way valves effective to control the direction of fluid flow. In an exemplary embodiment, theinlet62 is effective to allow fluid to flow only in a direction into theinner lumen60 of thechamber42, and theoutlet70 is effective to allow fluid to flow only in a direction from theinner lumen60 of thechamber42 into thefluid receptacle48.
• Thefluid receptacle48 can also have virtually any shape and size, and can be permanently or removably mated to thechamber42. Thefluid receptacle48 should be adapted to hold a predetermined amount of fluid. Preferably, thefluid receptacle48 has a generally cylindrical shape having aninner lumen49 formed therein, and is removably attached to thehousing51 such that theinner lumen49 of thefluid receptacle48 is in fluid communication with theinner lumen60 of thechamber42 viaoutlet70. Thefluid receptacle48 can be attached to thehousing51 using a variety of mating techniques, but is preferably attached to thehousing51 using a threaded engagement (not shown).
• Thedevice40 further includes asubstrate46 disposed within theinner lumen60 of thechamber42, within thefluid receptacle48, or between thechamber42 andfluid receptacle48. Preferably, thesubstrate46 is disposed within thefluid receptacle48 just downstream of theoutlet70, as shown inFIG. 2. Thesubstrate46 can be disposed within a fluid permeable basket or container, as discussed above with reference toFIG. 1, or alternatively, thefluid receptacle48 itself can be modified to retain thesubstrate46. By way of non-limiting example, thefluid receptacle48 can include first and second porous members (not shown) positioned a distance apart from one another and effective to retain a substrate therebetween. A person having ordinary skill in the art will appreciate that a variety of techniques can be used to position a substrate within thefluid receptacle48, or alternatively within thechamber42.
• In another embodiment (not shown), thesubstrate46 can be disposed within thechamber42, adjacent theinlet62, thereby eliminating the need for afluid receptacle48 and reducing the volume of thesystem40. The reduced volume will allow fluid to be drawn into thesystem40 without requiring significant vacuum forces. In an exemplary embodiment, thechamber42 andfluid receptacle48 are adapted to retain a volume of fluid in the range of about 20 cc to 60 cc.
• The fluid extraction mechanism50, which is coupled to theproximal end58 of thechamber42, can also have a variety of configurations. Preferably, as shown inFIG. 2, the fluid extraction mechanism50 is a plunger slidably disposed within thehousing51. The plunger50 includes anelongate portion52 having a distal, sealingmember72, such as a gasket or grommet, formed on a distal end thereof for creating a fluid-tight seal between thechamber42 and the proximal portion of thehousing51. The plunger50 can also include a proximal,handle member59 extending proximally from thehousing51. Thehandle59 can be used to grasp and move the plunger50 within the housing to create a vacuum force to direct fluid through thedevice40. Theelongate portion52 of the plunger50 can optionally be mated to atrigger mechanism54 which is effective to engage and move the plunger50 in one of a proximal direction or a distal direction. Preferably, thetrigger mechanism54 is used to move the plunger50 in a proximal direction to create a vacuum force to draw fluid into thechamber42, and thehandle59 is used to move the plunger50 in a distal direction to push fluid throughoutlet70 and into thereceptacle48, wherein the fluid passes through thesubstrate46. Thetrigger mechanism54 can also be adapted to move the plunger50 in predetermined increments. In an exemplary embodiment, thetrigger mechanism54 is adapted to draw about 2 cc of fluid into thechamber42. This is particularly effective to allow 2 cc samples of fluid to be drawn from several fluid sites within a patient's body. By way of non-limiting example, thetrigger mechanism54 can be a ratchet-type mechanism. A person having ordinary skill in the art will appreciate that a variety of techniques can be used for moving the plunger50 within thehousing51.
• In use, theinlet62 formed in thedistal end57 of thehousing51 is coupled to an external fluid source, such as an elongate penetratingelement110 via aconduit66. Asubstrate46 is positioned within thefluid receptacle48, which is mated to thehousing51 and in fluid communication with thechamber42 viaoutlet70. Thetrigger mechanism54 is then grasped and actuated to create a vacuum within thechamber42, thereby drawing fluid through the elongate penetrating element44 and into theinner lumen60 of thechamber42. The one-way valve70 prevents fluid from being drawn into thechamber42 from thereceptacle48. The fluid can then optionally flow freely into thefluid receptacle48 viaport70, or thehandle59 can be grasped to move the plunger50 distally, thereby forcing fluid into thereceptacle48 and through thesubstrate46. The one-way valve62 prevents fluid from flowing back out of thechamber42 and intoconduit66. The process can be repeated several times as desired.
• FIG. 3 illustrates yet another embodiment of a bonemarrow aspiration device10 according to the present invention. In this embodiment, thechamber12,fluid extraction mechanism20, and elongate penetratingelement16 are combined to form an all-in-onedevice10. As shown, thedevice10 generally includes achamber12 adapted to retain asubstrate14, an elongate penetratingelement16 coupled to adistal end18 of thechamber12, and afluid extraction mechanism20 slidably disposed within aproximal end22 of thechamber12. Thefluid extraction mechanism20 is effective to draw fluid from a patient or other outside fluid source, through the penetratingelement16, into thechamber12, and through thesubstrate14.
• Thechamber12 can have a variety of shapes and sizes, but is preferably an elongate cylindrical member having aproximal end22, adistal end18, and aninner lumen24 extending therebetween. As shown inFIG. 3, thechamber12 is in the form of a syringe barrel and includes a tapereddistal end18 adapted to mate to a penetratingelement16, and an openproximal end22 adapted to slidably receive thefluid extraction mechanism20. Theproximal end22 of thechamber12 can optionally include a flange (not shown) or similar feature formed around an outer surface of theproximal end22 to facilitate ease of handling. Theinner lumen24 of thechamber12 should have a size sufficient to allow slidable movement of thefluid extraction mechanism20 therein, and to retain a predetermined amount of fluid. Preferably, theinner lumen24 has a length L that is sufficient to allow thefluid extraction mechanism20 to be moved between the proximal and distal ends22,18 to draw a predetermined amount of fluid into thechamber12. Moreover, the length L should be sufficient to enable thefluid extraction mechanism20 to be moved without coming into contact with thesubstrate14.
• Thechamber12 is adapted to retain asubstrate14, which can be positioned anywhere within thechamber12, but is preferably positioned in the distal portion of thechamber12. In one embodiment, thechamber12 can include a basket or tray (not shown) formed therein for receiving thesubstrate14. The basket or tray can be formed from first and second porous members, e.g., screens, positioned a distance apart from one another and effective to retain asubstrate14 therebetween. The porous members can be mated to one another, and can be removably or permanently disposed within the chamber. Alternatively, or in addition, thechamber12 can include a side opening or door (not shown) formed therein for allowing thesubstrate14, or a container holding asubstrate14, to be inserted and withdrawn from thechamber12. As previously stated, examples of suitable containers28 for use with the device of the present invention are disclosed in U.S. patent application Ser. No. 10/223,674, filed on Aug. 19, 2002 and entitled “Devices For Controlling Fluid Flow Through A Medium,” the teachings of which are hereby incorporated by reference. A person having ordinary skill in the art will appreciate that a variety of techniques can be used to retain a substrate within thechamber12.
• The elongate penetratingelement16 can also have a variety of shapes and sizes, but is preferably an elongate, cylindrical member having aproximal end32, adistal end34, and an inner lumen (not shown) extending therebetween. Thedistal end34 should be adapted to penetrate into tissue and/or bone, and thus preferably includes a distal-most piercingtip34′ in fluid communication with the inner lumen. In an exemplary embodiment, the elongate penetratingelement16 is a needle that is removably mated to thedistal end18 of thechamber12. The elongate penetratingelement16 can be mated to thedistal end18 of thechamber12 using a variety of mating techniques.FIG. 3 illustrates one embodiment of a mating element in the form of astandard luer26. Theluer26 includes an inner lumen having threads formed therein for mating to corresponding threads formed on each of thedistal end18 of thechamber12 and theproximal end32 of the penetratingelement16. Theluer26 can alternatively be permanently mates to the penetratingelement16 to allow removal of both theluer26 and the penetratingelement16 from thechamber12. A person having ordinary skill in the art will appreciate that a variety of engagement techniques can be used to mate the penetratingelement16 to thechamber12, including, for example, a snap fit engagement, an interference fit, and a magnetic engagement. Those skilled in the art will appreciate that various techniques can be used for permanently or releasably mating the penetratingelement16 to thechamber12.
• While an elongate penetratingelement16 is shown, thedistal end18 of thechamber12 can be adapted to mate to any device or external fluid source. For example, the elongate penetratingelement16 can be replaced with a flexible tube that can mate to a separate penetrating device, such as a needle, or to a fluid source.
• Still referring toFIG. 3, thefluid extraction mechanism20, which is slidably disposed within theproximal end22 of thechamber12, is effective to withdraw fluid from a patient or other reservoir into thechamber12 and through thesubstrate14 disposed within the chamber. Thefluid extraction mechanism20 can have virtually any configuration, but is preferably a plunger having aproximal end32 and adistal end30. Theproximal end32, e.g., handle, preferably has a shape adapted to facilitating grasping thereof to allow a user to move thefluid extraction mechanism20 with respect to thechamber12. Thedistal end30 of thefluid extraction mechanism20 is slidably disposed within theinner lumen24 of thechamber12, and has a size and shape adapted to form a seal within thechamber12 to create a vacuum force. Thedistal end30 can optionally include a sealing member, such as a gasket or grommet, to assist in maintaining a fluid-tight seal within thechamber12. The sealing member should, however, allow slidable movement of thefluid extraction mechanism20 with respect to thechamber12.
• In use, theextraction mechanism20 is movable between a first position (shown inFIG. 3), in which thefluid extraction mechanism20 is substantially disposed within thechamber12, and a second position (not shown), in which thefluid extraction mechanism20 is substantially extended from thechamber12. Movement of thefluid extraction mechanism20 from the first position to the second position creates a vacuum force within thechamber12 that is effective to draw fluid from the external fluid source, e.g., the patient, via the penetratingelement16 into thechamber12. Conversely, movement from the second position to the first position will create a pressure in thechamber12, thereby causing fluid disposed within thechamber12 to be pushed out of the chamber through the penetratingelement16, or more preferably, through an outlet port formed in thechamber12.
• Movement of thefluid extraction mechanism20 can be effected manually and/or mechanically. By way of non-limiting example, thefluid extraction mechanism20 can be mated to a ratchet-style handle or similar mechanism for moving theplunger20. A person having ordinary skill in the art will appreciate that virtually any actuation mechanism can be employed with the devices according to the present invention. Moreover, while aplunger20 is shown for creating a vacuum force within thechamber12, a variety of other fluid extraction mechanisms can be used. For example, thechamber12 can be coupled to a vacuum pump, as discussed with respect toFIG. 2.
• Thedevice10 can also optionally include a mechanism for controlling the rate of fluid flow through thechamber12 and thesubstrate14. By way of non-limiting example, the penetratingelement16 can include an inner lumen having a diameter that is adapted to restrict the flow of fluid therethrough. In another embodiment, the device can include micro-bore tubing disposed within the fluid flow path and having an internal lumen sized to restrict the rate of fluid flow. The micro-bore tubing is preferably disposed between the penetratingelement16 and thechamber12, for example, within theluer26. One skilled in the art will appreciate that a variety of fluid flow control devices can be used with the present invention.
• The direction of fluid flow through the device can also be controlled. By way of non-limiting example, one or more one-way or dual-check valves can be provided for controlling the direction of fluid flow. Preferably, theluer26 is one-way valve that allows fluid to flow only in a direction from the elongate penetratingelement16 into thechamber12.
• FIG. 4 illustrates yet another embodiment of anaspiration device200 having ahandle202 and an elongate penetratingelement204 coupled to thehandle202. A person having ordinary skill in the art will appreciate that thedevice200 can have a variety of configurations, as generally described in U.S. patent application Ser. No. 10/194,752, entitled “Bone Marrow Aspirator,” filed on Jul. 12, 2002, which is hereby incorporated by reference in its entirety.
• Preferably, as shown, thehandle202 includes proximal anddistal surfaces212,214, and first and second side surfaces226,228 extending between the proximal anddistal surfaces212,214. The shape of thehandle202 is preferably adapted to facilitate single-handed use and manipulation thereof. For example, thedistal surface214 of thehandle202 can include one or more finger-receivingrecesses230. The elongate penetratingelement204 includes aproximal portion210 coupled to thehandle202 and having a proximal end with aninlet port212 formed therein, and adistal portion216 having a smooth outer surface and a solid, distal piercingtip218. A substantiallycylindrical sidewall220 defines aninner lumen222 in the elongate penetratingelement204 which extends from theinlet port224 to a position proximal to thedistal piercing tip218. The elongate penetratingelement204 also includes at least oneopening232 formed in the sidewall and in communication with the inner lumen. Theopening232 is preferably positioned proximal to thedistal piercing tip218.
• Thedevice200 further includes achamber206 disposed within thehandle202 and adapted to retain asubstrate208. Thechamber206 is in fluid communication with the elongate penetratingelement204, and is preferably position between the proximal anddistal portions210,216 of the penetratingelement204. Thehandle202 can include a side opening or door (not shown) formed therein for providing access to thechamber206, and thesubstrate208, or container holding thesubstrate208, disposed within thechamber206.
• Theproximal surface212 of thehandle202 is preferably adapted to allow access to theinlet port224 of the elongate penetratingelement204. By way of non-limiting example, thehandle202 can include a receiving well238 formed in or mated to theproximal surface212 of thehandle202 and adapted to seat the base of a medical device, such as a surgical syringe, to enable mating between the medical device and theinlet port224 on the elongate penetratingelement202. In an exemplary embodiment, as shown, the receiving well238 has a cylindrical shape which conforms to the shape of the base of a surgical syringe. The receiving well238 is preferably tapered along the inner surface toward the distal end to provide an interference fit with the base of a surgical syringe, and at least a portion of the receiving well238 can extend outward from theproximal surface212 of thehandle202. The receiving well238 can optionally include a mating element (not shown) for mating with the surgical syringe, or other medical device. While a variety of mating techniques can be used, the receiving well238 preferably includes threads (not shown) formed on the inner surface thereof. Other suitable mating techniques include, for example, an interference fit and a positive interlock engagement.
• In use, thehandle202 is grasped and manipulated to position the elongate penetratingelement204 at a fluid site in a patient's body. A syringe or other fluid extraction mechanism is then coupled to theinlet port224 in the elongate penetratingelement204, and activated to draw fluid up through thedistal portion216 of the penetratingelement204, through thesubstrate208 disposed within thechamber206, and through theproximal portion210 of the penetratingelement204 where the fluid is drawn into the syringe or other fluid extraction mechanism.
• It will be understood that the foregoing is only illustrative of the principles of the invention, and that various modifications can be made by those skilled in the art without departing from the scope and spirit of the invention. These three embodiments are but of few of those possible, all of which provide a bone aspiration device capable of infusing a fluid through a substrate.

Claims (22)

1. A bone marrow aspiration device, comprising:

an elongate handle having proximal and distal surfaces adapted to facilitate grasping thereof, a pathway formed through the handle between the proximal and distal surfaces, and an inlet formed in the proximal surface of the elongate handle and in communication with a proximal end of the pathway, the inlet being configured to allow a surgical syringe to communicate with the pathway;

an elongate hollow tissue-penetrating element in communication with a distal end of the pathway and extending from the distal surface of the handle; and

a chamber formed in the elongate handle between the proximal and distal ends of the pathway, the chamber being adapted to hold a substrate therein such that fluid is adapted to flow through the elongate hollow tissue-penetrating element and through a substrate disposed in the pathway.

2. The device ofclaim 1, wherein the distal surface of the handle includes at least one finger-receiving recess formed thereon.

3. The device ofclaim 1, wherein the inlet comprises a receiving well formed in the proximal surface of the handle, the receiving well being adapted to seat a base of a surgical syringe.

4. The device ofclaim 3, wherein the receiving well includes a mating element formed thereon for removably mating to a surgical syringe.

5. The device ofclaim 1, further comprising a substrate removably disposed within the chamber.

6. The device ofclaim 1, further comprising a surgical syringe coupled to the inlet and adapted to draw fluid through the pathway.

7. A bone marrow aspiration device, comprising:

a housing defining a fluid chamber;

an implantable substrate disposed within the fluid chamber;

at least one filter disposed adjacent to the implantable substrate;

a tissue-penetrating element extending from the housing and in communication with the fluid chamber; and

a fluid extraction mechanism coupled to the housing and adapted to draw fluid through the tissue-penetrating element, into the fluid chamber, and through the implantable substrate.

8. The device ofclaim 7, wherein the housing comprises a syringe barrel, and the fluid extraction mechanism comprises a plunger slidably disposed within the syringe barrel.

9. The device ofclaim 7, wherein a filter is disposed upstream of the implantable substrate such that fluid travels from the elongate penetrating element, through the filter, then through the implantable substrate.

10. The device ofclaim 7, wherein a filter is disposed downstream of the implantable substrate such that fluid travels from the elongate penetrating element, through the implantable substrate, then through the filter.

11. The device ofclaim 7, wherein a first filter is disposed upstream of the implantable substrate, and a second filter is disposed downstream of the implantable substrate.

12. The device ofclaim 7, wherein the implantable substrate comprises a fusion cage.

13. The device ofclaim 7, further comprising a control mechanism coupled to the fluid extraction mechanism and adapted to control a rate of fluid being drawn through the device by the fluid extraction mechanism.

14. The device ofclaim 7, further comprising a one-way valve disposed between the tissue-penetrating element and the fluid chamber.

15. A bone marrow aspiration device, comprising:

a housing defining a fluid chamber adapted to retain an implantable substrate;

a tissue-penetrating element extending from the housing and in communication with the fluid chamber;

a fluid extraction mechanism coupled to the housing and adapted to draw fluid through the tissue-penetrating element and the fluid chamber to infiltrate an implantable substance disposed within the chamber with cells from the fluid; and

a fluid receptacle coupled to the housing and adapted to collect fluid that has passed through the chamber.

16. The device ofclaim 15, wherein the chamber includes a first outlet coupled to the fluid extraction mechanism, and a second outlet coupled to the fluid receptacle.

17. A method for preparing a substrate, comprising:

penetrating a distal end of an elongate penetrating element into a patient;

actuating a fluid extraction mechanism to pull bone marrow from the patient through the elongate penetrating element and through a substrate disposed within a chamber formed in a housing coupled to the elongate penetrating element such that the substrate is concentrated with cells from the bone marrow; and

collecting the bone marrow in a receptacle that is separate from the chamber.

18. A method for preparing a fusion cage, comprising:

penetrating a distal end of an elongate penetrating element into a patient; and

actuating a fluid extraction mechanism to pull bone marrow from the patient through the elongate penetrating element and through a fusion cage disposed within a housing coupled to the elongate penetrating element such that the fusion cage is concentrated with cells from the bone marrow.

19. The method ofclaim 18, wherein the fusion cage is formed from a material selected from the group consisting of allograft bone, autograft bone, synthetic materials, purified materials, and combinations thereof.

20. The method ofclaim 18, wherein the housing comprises a barrel, and actuating the fluid extraction mechanism comprises pulling a plunger disposed within the barrel to draw fluid through the elongate penetrating element and the fusion cage.

21. The method ofclaim 18, wherein the fluid passes through a filter prior to passing through the fusion cage.

22. The method ofclaim 18, wherein the fluid passes through a filter after passing through the fusion cage.

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