BONE MARROW ASPIRATION SYSTEM
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.
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 INVENTIONThe 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 INVENTIONBone 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 INVENTIONIn 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 DRAWINGSThe invention will be more fully understood from the following detailed description taken in conjunction with the accompanying drawings, in which:
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.
The chamber 82 can have a variety of shapes and sizes, but should be adapted to retain a substrate 84, and to allow fluid to flow therethrough. As shown in
The chamber 82 can optionally include a basket (not shown) or similar structure disposed therein for holding the substrate 84. The basket, or a portion of the basket, can be permanently or removably disposed within the chamber 82, or can be integrally formed with the chamber 82. 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 a substrate 84 therebetween. In another embodiment, the chamber 82 can include a side-opening, slot, or door formed therein for slidably receiving the substrate 84 or basket containing a substrate. Examples of suitable chambers 82 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.
The inlet 90 in the chamber 82 is coupled to the penetrating element 110, preferably via a first conduit 100, and is effective to allow fluid to flow from the penetrating element 110 into the chamber 82. The penetrating element 110 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 in
The outlet 92 in the chamber 82 is coupled to a fluid extraction mechanism 114, preferably via a fluid receptacle 88. A second conduit 108 can extend from the outlet 92 in the chamber 82 to an inlet 94 formed in the fluid receptacle 88, and a third conduit 104 can extend from an outlet 96 in the fluid receptacle 88 to the fluid extraction mechanism 114. The fluid receptacle 88 can have virtually any shape and size, but should be effective to hold a predetermined amount of fluid extracted from a patient. The receptacle 88 should also be airtight to allow fluid to be drawn into the penetrating element 110 from an outside fluid source, through the chamber 82, and into the fluid receptacle 88. As shown in
The fluid extraction mechanism 114, which is coupled to the fluid receptacle 88, or optionally directly to the outlet 92 in the chamber 82, can also have a variety of configurations. The extraction mechanism 114 should, however, be effective to create a vacuum force in the device 80 to draw fluid into the penetrating element 110, through the chamber 82 and the substrate 84 disposed within the chamber 82, and into the fluid receptacle 88. As shown in
In use, the penetrating element 110 is positioned at a fluid site in a patient's body, or the inlet 90 in the chamber 82 is mated to an external fluid source. The fluid extraction mechanism 114 is then activated to pull fluid from the patient through the device 80, whereby fluid travels from the penetrating element 110 to the chamber 82 via conduit 100, through the substrate 84 disposed within the chamber 82, and to the fluid receptacle 88 via conduit 108. The process of extracting fluid through the device 80 can be repeated several times, as desired.
The device 80 can also optionally include fluid flow control mechanisms for controlling the rate of fluid flow through the device 80. By way of non-limiting example, the fluid extraction mechanism 114 can be adapted to pull fluid through the device 80 at a predetermined rate. Alternatively, or in addition, the conduits 100, 108, and 104 can have a size effective to control the rate of fluid flow therethrough. The inlets and outlets 90, 92, 94, 96 in the chamber 82 and/or fluid receptacle 88 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 the device 80.
The chamber 42 can have virtually any shape and size, but is preferably formed within a distal portion of the housing 51 and includes a proximal end 58, a distal end 56, and an inner lumen 60 extending therebetween. The proximal end 58 of the chamber 42 is adapted to slidably receive the fluid extraction mechanism, e.g., plunger 50, and the distal end 56 of the chamber 42 is adapted to mate with an external fluid source, or to a penetrating element 110. An inlet 62 is formed in the distal end 56 of the chamber 42 and is adapted to mate to the external fluid source, and an outlet 70 is formed adjacent the proximal end 58 of the chamber 42 and is coupled to the fluid receptacle 48. The inlet 62 and outlet 70 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, the inlet 62 is effective to allow fluid to flow only in a direction into the inner lumen 60 of the chamber 42, and the outlet 70 is effective to allow fluid to flow only in a direction from the inner lumen 60 of the chamber 42 into the fluid receptacle 48.
The fluid receptacle 48 can also have virtually any shape and size, and can be permanently or removably mated to the chamber 42. The fluid receptacle 48 should be adapted to hold a predetermined amount of fluid. Preferably, the fluid receptacle 48 has a generally cylindrical shape having an inner lumen 49 formed therein, and is removably attached to the housing 51 such that the inner lumen 49 of the fluid receptacle 48 is in fluid communication with the inner lumen 60 of the chamber 42 via outlet 70. The fluid receptacle 48 can be attached to the housing 51 using a variety of mating techniques, but is preferably attached to the housing 51 using a threaded engagement (not shown).
The device 40 further includes a substrate 46 disposed within the inner lumen 60 of the chamber 42, within the fluid receptacle 48, or between the chamber 42 and fluid receptacle 48. Preferably, the substrate 46 is disposed within the fluid receptacle 48 just downstream of the outlet 70, as shown in
In another embodiment (not shown), the substrate 46 can be disposed within the chamber 42, adjacent the inlet 62, thereby eliminating the need for a fluid receptacle 48 and reducing the volume of the system 40. The reduced volume will allow fluid to be drawn into the system 40 without requiring significant vacuum forces. In an exemplary embodiment, the chamber 42 and fluid receptacle 48 are adapted to retain a volume of fluid in the range of about 20 cc to 60 cc.
The fluid extraction mechanism 50, which is coupled to the proximal end 58 of the chamber 42, can also have a variety of configurations. Preferably, as shown in
In use, the inlet 62 formed in the distal end 57 of the housing 51 is coupled to an external fluid source, such as an elongate penetrating element 110 via a conduit 66. A substrate 46 is positioned within the fluid receptacle 48, which is mated to the housing 51 and in fluid communication with the chamber 42 via outlet 70. The trigger mechanism 54 is then grasped and actuated to create a vacuum within the chamber 42, thereby drawing fluid through the elongate penetrating element 44 and into the inner lumen 60 of the chamber 42. The one-way valve 70 prevents fluid from being drawn into the chamber 42 from the receptacle 48. The fluid can then optionally flow freely into the fluid receptacle 48 via port 70, or the handle 59 can be grasped to move the plunger 50 distally, thereby forcing fluid into the receptacle 48 and through the substrate 46. The one-way valve 62 prevents fluid from flowing back out of the chamber 42 and into conduit 66. The process can be repeated several times as desired.
The chamber 12 can have a variety of shapes and sizes, but is preferably an elongate cylindrical member having a proximal end 22, a distal end 18, and an inner lumen 24 extending therebetween. As shown in
The chamber 12 is adapted to retain a substrate 14, which can be positioned anywhere within the chamber 12, but is preferably positioned in the distal portion of the chamber 12. In one embodiment, the chamber 12 can include a basket or tray (not shown) formed therein for receiving the substrate 14. 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 a substrate 14 therebetween. The porous members can be mated to one another, and can be removably or permanently disposed within the chamber. Alternatively, or in addition, the chamber 12 can include a side opening or door (not shown) formed therein for allowing the substrate 14, or a container holding a substrate 14, to be inserted and withdrawn from the chamber 12. As previously stated, examples of suitable containers 28 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 the chamber 12.
The elongate penetrating element 16 can also have a variety of shapes and sizes, but is preferably an elongate, cylindrical member having a proximal end 32, a distal end 34, and an inner lumen (not shown) extending therebetween. The distal end 34 should be adapted to penetrate into tissue and/or bone, and thus preferably includes a distal-most piercing tip 34′ in fluid communication with the inner lumen. In an exemplary embodiment, the elongate penetrating element 16 is a needle that is removably mated to the distal end 18 of the chamber 12. The elongate penetrating element 16 can be mated to the distal end 18 of the chamber 12 using a variety of mating techniques.
While an elongate penetrating element 16 is shown, the distal end 18 of the chamber 12 can be adapted to mate to any device or external fluid source. For example, the elongate penetrating element 16 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 to
In use, the extraction mechanism 20 is movable between a first position (shown in
Movement of the fluid extraction mechanism 20 can be effected manually and/or mechanically. By way of non-limiting example, the fluid extraction mechanism 20 can be mated to a ratchet-style handle or similar mechanism for moving the plunger 20. 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 a plunger 20 is shown for creating a vacuum force within the chamber 12, a variety of other fluid extraction mechanisms can be used. For example, the chamber 12 can be coupled to a vacuum pump, as discussed with respect to
The device 10 can also optionally include a mechanism for controlling the rate of fluid flow through the chamber 12 and the substrate 14. By way of non-limiting example, the penetrating element 16 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 penetrating element 16 and the chamber 12, for example, within the luer 26. 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, the luer 26 is one-way valve that allows fluid to flow only in a direction from the elongate penetrating element 16 into the chamber 12.
Preferably, as shown, the handle 202 includes proximal and distal surfaces 212, 214, and first and second side surfaces 226, 228 extending between the proximal and distal surfaces 212, 214. The shape of the handle 202 is preferably adapted to facilitate single-handed use and manipulation thereof. For example, the distal surface 214 of the handle 202 can include one or more finger-receiving recesses 230. The elongate penetrating element 204 includes a proximal portion 210 coupled to the handle 202 and having a proximal end with an inlet port 212 formed therein, and a distal portion 216 having a smooth outer surface and a solid, distal piercing tip 218. A substantially cylindrical sidewall 220 defines an inner lumen 222 in the elongate penetrating element 204 which extends from the inlet port 224 to a position proximal to the distal piercing tip 218. The elongate penetrating element 204 also includes at least one opening 232 formed in the sidewall and in communication with the inner lumen. The opening 232 is preferably positioned proximal to the distal piercing tip 218.
The device 200 further includes a chamber 206 disposed within the handle 202 and adapted to retain a substrate 208. The chamber 206 is in fluid communication with the elongate penetrating element 204, and is preferably position between the proximal and distal portions 210, 216 of the penetrating element 204. The handle 202 can include a side opening or door (not shown) formed therein for providing access to the chamber 206, and the substrate 208, or container holding the substrate 208, disposed within the chamber 206.
The proximal surface 212 of the handle 202 is preferably adapted to allow access to the inlet port 224 of the elongate penetrating element 204. By way of non-limiting example, the handle 202 can include a receiving well 238 formed in or mated to the proximal surface 212 of the handle 202 and adapted to seat the base of a medical device, such as a surgical syringe, to enable mating between the medical device and the inlet port 224 on the elongate penetrating element 202. In an exemplary embodiment, as shown, the receiving well 238 has a cylindrical shape which conforms to the shape of the base of a surgical syringe. The receiving well 238 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 well 238 can extend outward from the proximal surface 212 of the handle 202. The receiving well 238 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 well 238 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, the handle 202 is grasped and manipulated to position the elongate penetrating element 204 at a fluid site in a patient's body. A syringe or other fluid extraction mechanism is then coupled to the inlet port 224 in the elongate penetrating element 204, and activated to draw fluid up through the distal portion 216 of the penetrating element 204, through the substrate 208 disposed within the chamber 206, and through the proximal portion 210 of the penetrating element 204 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
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 of claim 1, wherein the distal surface of the handle includes at least one finger-receiving recess formed thereon.
3. The device of claim 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 of claim 3, wherein the receiving well includes a mating element formed thereon for removably mating to a surgical syringe.
5. The device of claim 1, further comprising a substrate removably disposed within the chamber.
6. The device of claim 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 of claim 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 of claim 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 of claim 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 of claim 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 of claim 7, wherein the implantable substrate comprises a fusion cage.
13. The device of claim 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 of claim 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 of claim 1 5, 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 of claim 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 of claim 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 of claim 18, wherein the fluid passes through a filter prior to passing through the fusion cage.
22. The method of claim 18, wherein the fluid passes through a filter after passing through the fusion cage.
Type: Application
Filed: Aug 31, 2005
Publication Date: Dec 29, 2005
Inventors: Richard Pellegrino (Mendon, MA), John Voellmicke (Cumberland, RI)
Application Number: 11/162,180