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08/23/07 - USPTO Class 433 |  23 views | #20070196791 | Prev - Next | About this Page  433 rss/xml feed  monitor keywords

Stem cell and dental pulp harvesting method and apparatus

USPTO Application #: 20070196791
Title: Stem cell and dental pulp harvesting method and apparatus
Abstract: Methods and apparatus for recovering dental pulp from dentition of a donor are disclosed, wherein the pulp from within extracted teeth utilizing such methods and apparatus is harvested, while preserving a sterile environment and avoiding trauma and infection, and stem cells, dendritic cells, and other cells isolating from the pulp, and the various cells propagated and expanded for subsequent use in repair or regeneration of tissues of the body, for therapeutic treatments, and other medical purposes. (end of abstract)



Agent: Thomas W. Cook Thomas Cook Law Office - Sausalito, CA, US
Inventors: Roger Anton Sramek, Bahram Javid
USPTO Applicaton #: 20070196791 - Class: 433217100 (USPTO)

Related Patent Categories: Dentistry, Method Or Material For Testing, Treating, Restoring, Or Removing Natural Teeth, By Lining Or Coating

Stem cell and dental pulp harvesting method and apparatus description/claims


The Patent Description & Claims data below is from USPTO Patent Application 20070196791, Stem cell and dental pulp harvesting method and apparatus.

Brief Patent Description - Full Patent Description - Patent Application Claims
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CROSS REFERENCE TO RELATED APPLICATIONS

[0001] This application is a continuation of application Ser. No. 09/975,041, which has issued as U.S. Pat. No. 6,767,740, application Ser. No. 10/857,643, and application Ser. No. 11/484,795, from which applicant claims priority.

TECHNICAL FIELD OF THE INVENTION

[0002] The present invention relates generally to methods and apparatus for recovering dental pulp from dentition of a patient or other donor, in order to use the pulp so secured, and the stem cells and other cells contained in the pulp, for beneficial medical purposes. More specifically, the present invention relates to a method of obtaining dental pulp from teeth at times and under conditions most suitable, such as during normal tooth loss of "deciduous" teeth. At such times teeth may be taken, and the pulp from within the teeth extracted or "harvested," while preserving a sterile environment to avoid contamination of the pulp and, at the same time, avoiding trauma and infection of the donor. The pulp so secured may be utilized by isolating from it "stem cells," which may exhibit an ability to differentiate into cells of the same or other types, or propagated and manipulated to exhibit such "plasticity," for subsequent use in repair or regeneration of the same or other tissues of the body. The pulp may also be utilized by isolating from it other kinds of cells, such as dendritic cells which may exhibit an ability to detect hostile proteins foreign to a patient's body, for subsequent use in therapeutic treatments.

BACKGROUND ART OF THE INVENTION

[0003] In recent years, scientific interest has increased in cell biology in the areas of the derivation of cells, and the ability of certain cells to differentiate into cells of specific tissues. A broad interest in these areas dates back to the first report of animals produced by in vitro fertilization ("IVF") in 1959, through the first report of the first fertilization of a human egg by IVF in 1968, and the report of the first IVF baby born in England in 1978. However, as a result of interest in developing innovative cell replacement strategies to rebuild tissues and restore critical functions of the diseased or damaged human body, some studies in these areas have more recently focused on the derivation and culturing of "stem cells," and more particularly on human stem cells.

[0004] A stem cell is a cell that has the ability to divide (self replicate) for indefinite periods, often throughout the life of the organism. Under the right micro-environmental conditions, or given the right signals, stem cells can give rise ("differentiate") to the many different cell types that make up the organism. That is, stem cells have the potential to develop into mature cells that have characteristic shapes and specialized functions, such as heart muscle, skin cells, hepatic tissues, or nerve cells.

[0005] It is widely recognized that a fertilized egg may generate all the cells and tissues that make up an embryo and that support its development in utero. The fertilized egg divides and differentiates until it produces a mature organism which, in mammals, requires the division of cells and their differentiation into more than 200 kinds of cells in the mature organism. These kinds of cells include nerve cells (neurons), blood cells (such as erythrocytes, monocytes, lymphocytes), and bone cells (osteocytes). "Pluripotent" stem cells can give rise to cells derived from all three embryonic germ layers (mesoderm, endoderm, and ectoderm) of an embryo, and much attention has therefore been focused recently on pluripotent stems cells from organisms at early stages of embryonic development. However, ethical concerns have been raised about the use of embryonic cells. As a result, adult (i.e., not embryonic) stem cells have taken on more importance as a source for stem cells for developing innovative therapeutic strategies.

[0006] An adult stem ("AS") cell is an undifferentiated (unspecialized) cell that is found in a differentiated (specialized) tissue; it can renew itself and become specialized to yield all of the specialized cell types of the tissue from which it originated, and possibly other specialized cells. AS cells are capable of self-renewal for the lifetime of the organism. Cells capable of differentiating along only one lineage (i.e, "unipotent" cells, which allow a steady state of self-renewal), have been assumed for most tissues of adults until recently. Adult bone marrow cells, for example, have been known and used for decades in transplant therapies. However, even tissues containing only unipotent cells may be repaired if the tissue becomes damaged. When replacement of multiple cell types is required, pluripotent stem cells may become activated to repair the damage. Thus, for several decades stem cells harvested from skeletal bone marrow have been used in therapy in cases of cancer, aplastic anemia, lymphomas, and other life-threatening diseases. Sometimes marrow is transplanted directly from a donor to a patient requiring rescue therapy, and sometimes it is first preserved for a time in liquid nitrogen prior to transplantation.

[0007] It was not until recently that researchers have considered the possibility that stem cells in adult tissues could generate the specialized cell types of another type of tissue from that in which they normally reside. However, recent studies have demonstrated that blood stem cells (derived from bone marrow) may be able to generate both skeletal muscle and neurons. This facility of AS cells to generate specialized cell types of another type of tissue has been variously referred to as "plasticity," "unorthodox differentiation," or "transdifferentiation." Presently, there is evidence that AS cells can generate mature, fully functional cells, or that the cells have restored lost function in vivo. Collectively, studies on plasticity suggest that stem cell populations in adult mammals are not fixed entities, and that after exposure to a new environment, they may be able to populate other tissues and possibly differentiate into other cell types.

[0008] Most studies on plasticity show plasticity in adult stem cells involving cells derived from bone marrow or brain tissue. Bone marrow appears to contain three stem cell populations, hematopoietic stem cells, bone marrow stromal cells, and (possibly) endothelial progenitor cells. Bone marrow stromal cells are a mixed cell population of cells that generate bone, cartilage, fat, fibrous connective tissue, and the reticular network that supports blood cell formation (mesenchymal stem cells of the bone marrow also give rise to these tissues, and may constitute the same population of cells as the bone marrow stromal cells). Studies of hematopoietic stem cells from bone marrow demonstrate an ability to regenerate an entire tissue system, i.e., all cell types found in blood. Thus, bone marrow shows promise as a source for AS cells exhibiting plasticity, and further development of materials and techniques may allow the utilization of all three stem cell populations found in bone marrow.

[0009] Efforts are now underway to take advantage of the newly found capability of adult stem cells, with the goal of devising new treatments for disease and disability. Medical science is now providing voluminous evidence of many potential uses for stem cells, such as organogenesis, gene therapy, anti-aging therapies, angiogenesis, organ and tissue repair (particularly in cases of nerve damage), and the treatment of brain tumors, liver disease, and other diseases. AS cells from marrow may now be treated with certain chemicals such as dimethyl sulfoxide (DMSO) and hetastard with PBS, cryopreserved in liquid nitrogen, and later removed, thawed and used for transplantation and other therapies. Today there is new evidence that AS cells may be found in more tissues and organs than previously thought, and that these cells are capable of developing into more kinds of cells than previously imagined. Efforts to devise new treatments for disease and disability utilizing AS cells hold great promise for the future if AS cells may be (i) secured from tissues of the body in a safe, painless, and convenient way, (ii) secured in acceptable quantity, (iii) isolated, (iv) propagated and aggregated ("expanded" via cellular division) to numbers useable for tissue regeneration, (v) and adapted to generate cell types of another type of tissue from that in which they normally reside.

[0010] The present invention is directed to the identification of a source of AS cells and other cells within a tissue and organ of the body, and a method for removal of such cells safely and conveniently, by a means which maintains a sterile field, so that the cells may be set aside for isolation, and in such quantity as to be use for propagation to numbers and forms usable for tissue regeneration. Such removal of cells from the body using the present invention takes place under circumstances which offer the minimum of discomfort, is maximally safe, and may in most cases be undertaken in the normal course of body growth and tissue replacement. The present invention is also directed to an apparatus useful for accomplishing the method of the invention. More specifically, the present invention is directed to the identification of teeth as a source of a variety of cells useful for therapeutic purposes (AS cells and other cells useful for medical purposes, such as dendritic cells and precursor cells, collectively "Useful Cells"), the removal of teeth under controlled conditions to preserve sterility, and the further removal of the pulp within such teeth (these processes collectively, "Harvesting"), so that Useful Cells within such teeth may be subsequently isolated and utilized for tissue repair or regeneration.

[0011] A number of schemes have been devised to extract human bone marrow. Such schemes employ methods and apparatus applied at various locations of the human skeleton or soft tissue. Published scientific papers, including the recent paper from the National Institute of Health entitled Stem Cells: Scientific Progress and Future Research Directions (June 2001), indicate that sources of AS cells include bone marrow, peripheral blood, blood vessels, the cornea and the retina of the eye, brain, skeletal muscle, dental pulp, liver, skin, the lining of the gastrointestinal tract, and pancreas. Methods and apparatus have been developed to remove stem cells from some of these areas of the human body. As to removal of stem cells from bone material specifically, such methods and apparatus include:

[0012] U.S. Pat. No. 5,913,859 to Shapira, which discloses an apparatus for extracting bone marrow from the jawbone of a patient before, during, or after dental procedures.

[0013] U.S. Pat. No. 6,110,176 to Shapira, which discloses a method for extracting bone marrow from the jawbone of a patient before, during, or after dental procedures.

[0014] In addition, bone marrow collection for transplantation purposes is often accomplished by inserting a needle into a donor's hip or pelvic bone. A needle is inserted into the bone approximately 25 to 30 times through several small incisions made in the pelvic area. Each insertion of the needle takes a "core," which may be aspirated through the needle. The extraction process typically lasts at least one hour or more, or until approximately 1,000 to 1,500 milliliters of the donor's marrow and blood is withdrawn. The donor of the donated marrow requires hospitalization, but may recover fully in a few weeks after the procedure. However, the extraction process is painful, and the patient may feel fatigued for a period of time after the procedure is performed. Further, the procedure requires general anesthesia in an operating theater. This type of device is also frequently used at bedside as a means of taking small biopsy samples using a single coring of the ilial crest. Bone marrow may also be obtained by similar methods from the sternum, or from long bones such as the tibia or femur in adolescents, or other methods having similar drawbacks.

[0015] Thus, there is a need for extraction methods that avoid the considerable inconvenience and discomfort of current methods, and apparatus to accomplish such methods, so that AS cells may be secured for use, and for isolation and propagation of AS cells for the medical benefits to be derived for donors and other patients. While the inventions disclosed in these prior patents, methods, and articles fulfill their respective objectives, these prior patents do not describe or suggest a method or apparatus designed to utilize AS cells, and other cells, found in teeth. These prior methods and apparatus of the prior art are directed to securing bone marrow from skeletal tissues, including areas of the skeleton closely associated with dentition, but not from the dentition itself. That is, nothing in the prior art refers to any method for obtaining tissue from teeth in order to produce AS cells for tissue repair or replacement, or other purposes (such as research). No apparatus of the prior art is constructed to achieve this result. Further, the prior art, to the extent it is used to secure marrow from bone, is directed to main skeletal components only, that is iliac (pelvic) bones, long bones, the skull, and connective tissues, all of which tissues the body must replace or repair after marrow is removed. Accordingly, no prior method of marrow removal may be employed without some trauma and increased risk to the donor or patient, or both. Using the method of the present invention, on the other hand, a user may conveniently secure tooth pulp from a patient at the time of normal tooth loss during growth, or during dental work in which teeth are removed, or routinely maintained (such as drilling for a "root canal"), which patient may then receive the benefits derived from that pulp, including any benefits derived from his or her own AS and other cells. Significantly, a user may, using the method of the present invention, take tooth pulp, from which AS cells may be secured, and apply those cells which may exhibit plasticity to the benefit of other individuals, and to the repair or regeneration of a variety of tissue types within the donor or such other individuals.

[0016] Moreover, the pulp secured from the donor's teeth may be utilized by isolating from it dendritic and other cells, which may then be utilized in therapeutic treatment for their ability to detect hostile or foreign proteins. Further, AS cells may be a particularly good source of genetic material for gene therapy (in, e.g., the production of "genomic pharmaceuticals"), and in genotyping for donor registration and donor matching. Finally, teeth are not affected by the soft tissue or hard tissue tumors of other parts of the body, including tumors of the jaw, even after metastasis of such tumors. Accordingly, it may be possible to take teeth from a patient prior to administering chemotherapy or radiotherapy in the treatment of cancer in other parts of the body. It may then be possible to autograft the expanded AS and other cells harvested from those teeth back into the patient. By such a procedure, it may be possible to thereby reintroduce into the patient his or her own "fresh," non-cancerous regenerative cells. Such cells, as with bone marrow "rescue" therapy, have not have been exposed to the damaging effects of chemotherapy and radiotherapy, and so are unaffected by such therapies. However, such cells are less likely to have tumorous or metastasized tissues which could then repopulate the patient. All such benefits are derived from the present invention, which provides for securing AS and other cells without trauma, usually at a time convenient to the donor, and generally in a sterile field without significant possibility of contaminating the cells so secured.

[0017] In this respect, the method of the present invention substantially departs from pre-existing methods of the prior art, and all apparatus associated with methods of the prior art, and in so doing provides the user with a means for harvesting stem cells (and other cells which may be found in teeth and applied for medical purposes) from the pulp of teeth. By using the invention disclosed herein, users gain the highly desirable ability to secure AS cells for present or future use for tissue regeneration or replacement, while avoiding trauma and long recovery, contamination of the pulp, risk of infection of and by the donor, and other problems associated with extracting marrow from other parts of the body.

DISCLOSURE OF INVENTION

Summary of the Invention

[0018] The present invention overcomes the problems and disadvantages of the prior art by utilizing pulp from teeth, a location from which AS cells (and other cells) have not before now been obtained for medical purposes.

[0019] A normal tooth contains living tissue known as "dental pulp." This tissue occupies a canal extending from the apex of the tooth root (or roots), where it communicates with the bone in which the tooth is anchored (the mandible on the lower part of the mouth, and the facial maxillae on the upper part of the mouth), to the area immediately under the crown of the tooth. The canal in each tooth is relatively narrow in and near the root apex, but widens out near the crown into a pulp chamber, which is an enlarged area accommodating a larger volume of dental pulp than is present in the root. The pulp chamber is therefore the location of the great majority of the dental pulp of the tooth. The volume of dental pulp within the pulp chamber contains sufficient dental pulp to be useful in the process of extracting pulp to obtain the AS cells residing there (or "Harvest" or "Harvesting" such cells) for medical use (and other cells). Locating and Harvesting dental pulp from teeth, and particularly the pulp chamber of teeth, for isolation and use of AS cells and other useful cells, is the purpose and object of both the method and apparatus of the present invention.

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