Post-biopsy cavity treatmetn implants and methods
An embodiment of a post-biopsy cavity treatment implant includes a first portion including a first porous matrix defining a first controlled pore architecture or crosslinking density, and a second portion coupled to the first portion. The second portion includes a second porous matrix that defines a second controlled pore architecture or a second crosslinking density that is different from the first controlled pore architecture or the first crosslinking density, causing the second portion to swell in a different manner than the first portion when the implant is placed in an aqueous environment.
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1. Field of the Invention
The present invention relates to post-biopsy cavity treatment methods and implants. More particularly, the present inventions relates to post-biopsy cavity treatment implants inserted into cavities formed in soft tissue that may be created during a biopsy or therapeutic excisional procedure.
2. Description of the Related Art
Breast biopsies are routinely performed in the United States following a detection of abnormalities discovered through mammographic visualization, manual palpation or ultrasound examination. There are a number of traditional methods to obtain breast biopsy tissue samples, including surgical excisional biopsies and stereotactic and ultrasound guided needle breast biopsies. Recently, methodologies have emerged that are based upon percutaneous minimally invasive large intact tissue sample collection. The use of these devices results in a unique cavity connected to the skin by a narrow neck. However, it is becoming apparent, therefore, that the post-biopsy biopsy cavities left by these procedures may both offer and require different post procedural treatments, as compared to the cavities left by needle, core biopsy procedures or open surgical procedures, due to the different nature, size and shape of the cavity created by conventional biopsy devices, as well as the narrow connection to the skin characterized by percutaneous approaches.
In certain cases, locating a previously biopsied area is highly desirable. Therefore, to mark the biopsy site, a variety of biopsy site markers and identifiers have been developed, ranging from metal clips to pellets and sponges placed during or right after the biopsy procedure. Usually, these markers contain radiopaque and/or echogenic articles and include features such as metal clips and air or gas bubbles incorporated in a biodegradable matrix. From the foregoing, it is apparent that improved methods and devices are needed to treat the cavities left by biopsy devices that are configured to retrieve large intact specimens.
SUMMARYThe present invention, according to an embodiment thereof, is a post-biopsy cavity treatment implant. The post-biopsy cavity treatment implant may include a first portion including a first porous matrix defining a first controlled pore architecture, and a second portion coupled to the first portion, the second portion including a second porous matrix defining a second controlled pore architecture that may be different from the first controlled pore architecture to cause the second portion to swell in a different manner than the first portion when the post-biopsy cavity treatment implant may be implanted in an aqueous environment.
According to further embodiments, the second portion may swell faster than the first portion when the implant is implanted in the aqueous environment. The second portion may swell to a greater extent than the first portion when the implant is implanted in the aqueous environment. The first controlled pore architecture may differ from the second controlled pore architecture with respect to one or more of: pore density, pore shape, pore orientation and pore dimensions, for example. The first and/or second portions may include a radiopaque material disposed therein. The first and/or second portions may include a radioactive material disposed therein. The first and/or second portions may include a paramagnetic material disposed therein. The first and second portions may include a dye, a pigment, a contrast media and/or a therapeutic agent disposed therein, for example. The first and/or second portions may be biodegradable. The first and/or second portions may include collagen. The first and second portions include one or more of a polylactide (PLA), a polyglycolide (PGA), a poly(lactide-co-glycolide) (PLGA), a polyglyconate, a polyanhydride, PEG, cellulose, a gelatin, a lipids, a polysaccharide, a starches and a polyorthoesters, for example. The first and second portions may be configured so as to form a laminar structure. The first portion may define a first surface and the second portion may define a second surface that faces the first surface to define an interface between the first and second portions. The interface may be visualizable under ultrasound when the post-biopsy cavity treatment implant is implanted. At least the first portion may include a plurality of fibers and/or fibrils. The first portion may form an inner core and the second portion may form an outer shell disposed at least partially around the first portion. The first and/or second portions may include an internal reservoir configured to contain one or more of a dye, a pigment and a therapeutic agent, for example. The internal reservoir may be configured to deliver the dye, pigment and/or therapeutic agent through elution when the implant is implanted in the aqueous environment. The internal reservoir may be configured to deliver the dye, pigment and/or therapeutic agent (for example) at a first rate when the reservoir is breached and at a second rate that is lower than the first rate when the reservoir is not breached. The implant may include a third portion, the third portion being radiopaque. The third portion may include a metal. The third portion may include a third porous matrix defining a third controlled pore architecture, the first, second and third portions collectively defining a predetermined pore density gradient. The second portion may be configured to have a second crosslinking density and the first portion may be configured to have a first crosslinking density that is greater than the second crosslinking density. The second portion may be configured to swell to a greater degree than the first portion when the implant is implanted in the aqueous environment. The first and second portions may include collagen and a crosslinking density of the first and/or second portions may be controlled through adding a selected amount of a bifunctional reagent to the collagen. The bifunctional reagent may include a aldehyde and/or a cyanamide. The aldehyde may include a glutaraldehyde, for example. The first and second portions may include collagen and a crosslinking density of the first and second portions may be controlled by an application of energy to the collagen. The application of energy may include dehydrothermal processing and/or exposure to UV light or radiation, for example. The first and second portions may include collagen and a crosslinking density of the first and/or second portions may be controlled by a combination of dehydrothermal processing and exposure to cyanamide, for example.
According to another embodiment thereof, the present invention is a method for mapping a lymphatic system following a cavity generating procedure. The method may include steps of providing a post-biopsy cavity treatment implant, the implant including a collagenous matrix having a non-uniform cross-linking density that is configured to cause the implant to swell non-uniformly when placed within an aqueous environment, the implant including a dye or a pigment contained therein; implanting the provided post-biopsy cavity treatment implant into the cavity; closing the cavity with the post-biopsy cavity treatment implant implanted therein; causing the dye/pigment to be released from the implant and to propagate through the lymphatic system, and visualizing the propagated dye/pigment in the lymphatic system using a selected visualization mode.
The implant in the providing step may include a reservoir disposed within the collagenous matrix, the reservoir containing a volume of the dye/pigment and the causing step may include a step of breaching the reservoir to release the dye/pigment. The breaching step may include a step of squeezing the implanted post-biopsy cavity treatment implant. The causing step may include a step of waiting for a predetermined period of time during which the implant degrades within the cavity and releases the dye/pigment. The dye and/or pigment may be loaded within the collagenous matrix of the implant. The visualizing mode in the visualizing step may include ultrasound, X-ray, MRI, elastography, microwave and/or the unaided eye, for example.
According to still another embodiment, a post-biopsy cavity treatment implant according to the present invention may include a first portion may include a first collagenous matrix, the first collagenous matrix being controlled to have a first crosslinking density, and a second portion in contact with the first portion, the second portion may include a second collagenous matrix, the second collagenous matrix being controlled to have a second crosslinking density, the first crosslinking density being controlled to be different than the second cross-linking density.
Another embodiment of the present invention is a post-biopsy cavity treatment implant that includes a first portion including a first collagenous matrix defining a first controlled pore architecture, and a second portion coupled to the first portion, the second portion may include a second collagenous matrix, the second collagenous matrix being controlled to have a first controlled crosslinking density to cause the second portion to swell in a different manner than the first portion when the post-biopsy cavity treatment implant is implanted in an aqueous environment.
Yet another embodiment of the present invention includes a method of filling a cavity created by an excisional procedure. The cavity may have a predetermined shape and the method may include the steps of providing an implant, the implant including at least a first portion and a second portion, the first portion may include a first collagenous matrix that defines a first selected crosslinking density, the second portion may include a second collagenous matrix that defines a second selected crosslinking density that may be different than the second cross-linking density, the first and second cross-linking densities being selected so as to cause the first and second portions to swell into a size and a shape that may be similar to the predetermined shape of the cavity when the implant is implanted; implanting the implant within the cavity through an incision; adding an aqueous solution to the cavity if the cavity may be not sufficiently aqueous to cause the implant to swell, and closing the incision with the implant implanted in the cavity.
The first portion may include a plurality of first collagenous fibers (or fibrils), each of the plurality of first collagenous fibers having the first selected crosslinking density. The second portion may include a plurality of second collagenous fibers (or fibrils), each of the plurality of second collagenous fibers having the second selected crosslinking density.
BRIEF DESCRIPTION OF THE DRAWINGSFor a further understanding of the objects and advantages of the present invention, reference should be made to the following detailed description, taken in conjunction with the accompanying figures, in which:
6B is a cross sectional view of the post treatment cavity of
As shown in
As shown in
Treating the post-biopsy cavity 126 is desirable for a variety of reasons. One such reason is to accommodate the unique size and shape of the cavity 126 created by the device 100. It is desirable to influence and/or promote the healing process of the cavity, and to do so in a predictable manner. One aspect of influencing the healing process of the cavity 126 is promoting the growth of new connective tissue within the cavity 126 in a predictable manner. Indeed, it is desirable to influence and promote both tissue ingrowth within the cavity and to influence the formation of hematomas and seromas. Another reason for treating the post-biopsy cavity 126 is to modify it in such a manner as to render it recognizable immediately and preferably long after the procedure that created the cavity 126. The cavity 126, left untreated, may be visible under ultrasound. However, that may not be the case and it is believed to be desirable to at least partially fill the cavity 126 with a cavity treatment implant that will render the cavity 126 clearly visible under various imaging modalities, including modalities such as ultrasound, X-ray, MRI, elastography, microwave and the unaided eye, for example. Such visibility may be due to the structure of a cavity treatment implant or devices implanted within the cavity and/or a recognizable pattern of tissue ingrowth caused or influenced by the continuing or past presence of post-biopsy cavity treatment implants disclosed herein. Other desirable attributes of embodiments of the implantable post-biopsy cavity treatment implant of the present invention include hemostasis, and the ability to deliver one or more therapeutic agents to the patient at the post-biopsy cavity treatment implant site such as, for example, lido/epi, Non-Steroidal Anti-Inflammatory Drugs (NSAIDS), tissue growth factors, anti-neoplastic medications (to name a few) or combinations of the above and/or others. Filling the cavity 126 may have other benefits, including cosmetic. Indeed, filling the cavity and promoting a smooth, gradual, recognizable and orderly tissue ingrowth pattern may prevent dimpling, skin depressions and the like sometimes associated with the removal of a large intact specimen during the biopsy procedure. Embodiments of the present invention may also find utility in augmentation or reconstructive procedures for the breast or other soft tissue.
According to an embodiment of the present invention, the post-biopsy cavity treatment implant may have a size and a shape that at least partially fills the cavity. Advantageously, the present post-biopsy cavity treatment implant, after insertion, may have a characteristic shape that is readily perceptible and recognizable through various modalities, including, for example, ultrasound, X-ray or MRI. The shape of the present post-biopsy cavity treatment implant may also influence the manner in which tissue growths therein. Preferably, embodiments of the present post-biopsy cavity treatment implant should be shaped and dimensioned so as to uniquely accommodate the size and shape of the cavity 126 created by the device 100 of
According to an embodiment thereof, the present invention may include an implantable post-biopsy cavity treatment implant having one or more of the structures, characteristic and properties described herein. As shown in
Whereas
The post-biopsy cavity treatment implant 802 may alternatively be structured such that its distal 808 portion swells faster than its proximal portion 806 such as shown in
According to embodiments of the present invention, the present post-biopsy cavity treatment implant may include or be formed of biocompatible and water swellable material, such as collagen, for example. The collagen molecule is rod-shaped triple helix and consists of a three polypeptide chains coiled about each other. Besides the central triple helical region of the collagen molecule, there are terminal peptides regions known as telopeptides. These telopeptides are non-helical and are subdivided into two groups; namely, amino terminals and carboxyl terminals. Intermolecular crosslinking between triple helical molecules of collagen occurs in the telopeptides regions. Crosslinking may also occur within the central triple helical region of the collagen molecule, and is known as intramolecular crosslinking. It is the control of the formation and density of such crosslinks that is responsible for some of the mechanical, physicochemical and biological properties of the embodiments of the present post-biopsy cavity treatment implant disclosed herein.
The embodiments of the present post-biopsy cavity treatment implant may be selectively biodegradable and/or bio-absorbable such that it degrades and/or is absorbed after its predetermined useful lifetime is over. An effective way of controlling rate of biodegradation of embodiments of the present post-biopsy cavity treatment implant is to control and selectively vary the number and nature (e.g., intermolecular and/or intramolecular) of crosslinks in the implant material. Control of the number and nature of such collagen crosslinks may be achieved by chemical and/or physical means. Chemical means include the use of such bifunctional reagents such as aldehyde or cyanamide, for example. Physical means include the application of energy through dehydrothermal processing, exposure to UV light and/or limited radiation, for example. Also, a combination of both the chemical and the physical means of controlling and manipulating crosslinks may be carried out. Aldehydes such as glutaraldehydes, for example, are effective reagents of collagenous biomaterials. The control and manipulation of crosslinks within the collagenous matrix of the present post-surgery cavity treatment implant may also be achieved, for example, through a combination of dehydrothermal crosslinking and exposure to cyanamide. For example, the present post-surgery cavity treatment implant may, through proper control of the crosslinking density within the collagen matrix thereof, be designed and implemented to remain long term in situ at the implant site within the cavity 126. Crosslinking density may be indirectly measured, for example, via measurement of the swelling ratio where identical dry and wetted samples are weighted and weight is compared.
According to further embodiments of the present invention, the post-biopsy cavity treatment implant may be formed of or include other biomaterials such as, for example, bioresorbable poly(ester)s such as polylactide (PLA), polyglycolide (PGA), poly(lactide-co-glycolides) (PLGA), polyglyconate, polyanhydrides and their co-polymers, PEG, cellulose, gelatins, lipids, polysaccharides, starches and/or polyorthoesters and the like. According to an embodiment of the present invention, the present post-biopsy cavity treatment implant may be formed of or include collagen having a predetermined structure. Such predetermined structure refers not only to the overall shape of the implant, but also to the structure of its internal collagen matrix. Indeed, embodiments of the present invention include a macroporous cross-linked polymer matrix having a predetermined pore architecture. A “pore”, as the term is used herein, includes a localized volume of the present post-biopsy cavity treatment implant that is free of the material from which the post-biopsy cavity treatment implant is formed. Pores may define a closed and bounded volume free of the material from which the post-biopsy cavity treatment implant is formed. Alternatively, pores may not be bounded and many pores may communicate with one another throughout the internal matrix of the present post-biopsy cavity treatment implant. The pore architecture, therefore, may include closed and bounded voids as well as unbounded and interconnecting pores and channels. The internal structure of the post-biopsy cavity treatment implant according to embodiment of the present invention defines pores whose dimensions, shape, orientation and density (and ranges and distributions thereof), among other possible characteristics are tailored so as to maximize the visibility of the resultant post-biopsy cavity treatment implant 802 under various modalities, notably ultrasound and X-ray, for example. Unlike polymeric matrices that contain bubbles of gas through a process in which gas is forced through a dispersion in a hydrated state, embodiments of the present post-biopsy cavity treatment implant have an internal structure that defines internal voids without requiring such gas to be forced therethrough. There are numerous methods and technologies available for the formation collagenous matrices of different pore architectures and porosities. By tailoring the dimensions, shape, orientation and density of the pores of the present implant, a recognizable pattern of post-biopsy cavity treatment implant material may be formed that may be readily visualized under, for example, ultrasound, X-ray, elastography or microwave radiation. This recognizable pattern may then influence the pattern of tissue ingrowth within the cavity 126, forming a porous scaffold on and within which tissue may infiltrate and grow. In turn, this pattern of tissue ingrowth may be readily recognizable under ultrasound and/or other imaging modalities discussed above long after the post-biopsy cavity treatment implant has been absorbed by the body or has degraded.
According to an embodiment of the present invention, the post-biopsy cavity treatment implant may be formed of or include a collagen matrix having a predetermined pore architecture. For example, the post-biopsy cavity treatment implant may include one or more sponges of lyophilized collagen having a predetermined pore architecture. Suitable collagen material for the post-biopsy cavity treatment implant may be available from, for example, DEVRO, Integra Life Sciences, Collagen Matrix and Kensey Nash, among others. The present post-biopsy cavity treatment implant, after implantation in the cavity 126, swells on contact with various body fluids therein and substantially fills a predetermined portion or the entire biopsied cavity, and does so in predictable manner.
Such a post-biopsy cavity treatment implant may be configured to have a hemostatic functionality to stop bleeding within the cavity 126 through a biochemical interaction with blood (such as coagulation) and/or other bodily fluids. The post-biopsy cavity treatment implant may, according to further embodiments, also be used to medically treat the patient. That is, the porous matrix of the present post-biopsy cavity treatment implant may be imbibed or loaded with a therapeutic agent to deliver the agent through elution at the cavity 126. Such a therapeutic agent may include, for example, an antibiotic agent, an analgesic agent, a chemotherapy agent, an anti-angiogenesis agent or a steroidal agent, to name but a few of the possibilities.
The post-biopsy cavity treatment implant 802 shown in
Moreover, the cross-sectional characteristics of the post-biopsy cavity treatment implant 1100 may be changed. For example, the first portion 1102 may form a cylindrical inner core of collagenous material having a first predetermined pore architecture and the second portion 1104 may form a cylindrical outer shell around the inner core and may define a second pore architecture. In this manner, the outer surface of the post-biopsy cavity treatment implant 1100 may swell at a different rate (e.g., faster) than the rate at which the inner core swells. Moreover, the pore architectures may be chosen to maximize not only water absorption, but also to promote tissue ingrowth, to facilitate imaging and/or may be tailored to contain and release a pharmaceutical agent at a controllable rate and/or under predetermined conditions. Alternatively, the inner core may be formed of or include a non-collagenous material (such as a polylactic or polyglycolic material, for example) and the outer shell may include a collagenous material, for example. The outer shell may include a solid matrix of collagenous material having a predetermined pore architecture and/or may include wound fibers of collagenous material having a predetermined pore architecture, for example.
Post-biopsy cavity treatment implants according to embodiments of the present invention need not be formed as a solid mass of collagen (
Most any of the portions or layers of the embodiments disclosed herein may be configured to contain one or more dyes/pigments and/or pharmaceutical agents. The post-biopsy cavity treatment implants discussed herein may be rendered selectively radiopaque by the selective mechanical, chemical or physical incorporation of a radiopaque articles or particles into the collagenous matrix of embodiments of the present post-biopsy cavity treatment implant. For example, the post-biopsy cavity treatment implant may define pores having a predetermined and recognizable architecture and may incorporate some radiopaque compound or particles such as, for example barium sulfate or other commonly used radiopaque or radioactive materials.
Embodiments of the present invention may also include recognizable articles or substances within the collagenous matrix such as, for example, dyes and/or pigments (i.e., including both synthetic dyes and natural pigments). The dyes/pigments may be incorporated within the collagenous dispersion that forms the constituent layers or portions of the embodiments of the post-biopsy cavity treatment implants disclosed herein. Such dyes/pigments may form mapping compounds that may be gradually released into the body upon implantation of the present post-surgery cavity treatment implant and may form the basis of lymphatic mapping in the future. In this manner, lymphatic mapping may be carried out immediately after a biopsy procedure via elution of the mapping compound (e.g., dyes/pigments and/or radioactive agent) deposited into the collagenous matrix of the implant. In the case wherein a cancer is detected or suspected in the tissue specimen retrieved by the biopsy procedure, this elution of mapping compound from the post-biopsy cavity treatment implant may enable the physician to skip the conventional step of injecting dyes/pigments into the patient, which dye/pigment injection step is conventionally carried out prior to a (sentinel) lymph node status evaluation procedure. Embodiments of the post-biopsy cavity treatment implant according to present invention may include metal-less dyes/pigments as well radiopaque, radioactive or paramagnetic metal-containing dyes/pigments such as, for example, porphyrins and/or porphyrin derivatives (such as chlorophyll and/or chlorophyll derivatives, for example) that are bound to the collagenous matrix. The porphyrins and/or porphyrin derivatives may be tailored, for example, to enhance crosslinking and enhance wound healing and/or to control biodegradation, among other reasons. A metal with paramagnetic properties (such as Mn, for example) may be placed within the porphyrins or porphyrin derivatives so that another mode of recognition may be achieved. Impregnation of the present post-biopsy cavity treatment implant with porphyrins or porphyrin derivatives (for example, copper chlorophyllin) gives the post-biopsy cavity treatment implant a lymphatic mapping functionality due to the elution of the porphyrins or porphyrin derivatives into the surrounding tissue lymphatic drainage system.
According to other embodiments of the present invention, the present post-biopsy cavity treatment implants may define or include an internal reservoir configured to contain a volume of a mapping compound and/or a beneficial therapeutic agent. Following the biopsy procedure and the subsequent implantation of the present post-biopsy cavity treatment implant having a predetermined pore architecture into the biopsy cavity and following a histopathology report on the excised biopsy specimen, the physician or RN may pinch or squeeze the post-biopsy cavity treatment implant to express the mapping compound(s) and/or agent(s) into the surrounding tissue via lymphatic system to the sentinel node and other lymphatics. In the absence of such squeezing or pinching, the mapping compound and/or therapeutic agent may much more gradually find its way into the surrounding tissue through elution following a gradual biodegradation of the reservoir.
Use of the post-biopsy cavity treatment implants disclosed herein is not limited to filling post biopsy cavities. Indeed, the present post-biopsy cavity treatment implants also find utility in the correction of defects caused by poorly healed cavities, whatever their origin or cause. The present post-biopsy cavity treatment implants may be placed in cavities in which it is desired that the collagen matrices be replaced, over time, with (human or animal) autogenous tissue. Hence, the embodiments of the present invention may be used for the repair of tissue that has been damaged due to tissue removal, thereby providing a favorable tissue scaffold in which autogenous tissue may infiltrate and grow. In addition, embodiments of the post-biopsy cavity treatment implants according to the present invention may serve to absorb exudates within the cavity, thereby further facilitating the healing process.
While the foregoing detailed description has described preferred embodiments of the present invention, it is to be understood that the above description is illustrative only and not limiting of the disclosed invention. For example, the post-biopsy cavity treatment implants disclosed herein may be configured to have a unique “signaturing” capability, in which a specific code appears under a given imaging modality. The specific code may be formed within or molded into the structure of the collagen matrix or matrices. For example, a combination of the elements with different crosslinking patterns (e.g., bundles of cylindrical fibers or layers of collagen sponges) may be used for both pattern recognition and predictable filling of the post biopsy procedure cavity. Alternatively, the code may be embodied as a discrete echogenic or radiopaque constituent element of the implant. The codes may confer information to the radiologist or treating physician when viewed under X-ray or ultrasound. Alternatively still, the post-biopsy cavity treatment implants having predetermined pore architectures and/or controlled crosslinking densities according to the disclosed embodiments may include a biocompatibly-sealed integrated circuit that may be interrogated electronically to convey information to the physician. Those of skill in this art may recognize other alternative embodiments and all such alternative embodiments are deemed to fall within the scope of the present invention.
Claims
1. A post-biopsy cavity treatment implant, comprising:
- a first portion including a first porous matrix defining a first controlled pore architecture, and
- a second portion coupled to the first portion, the second portion including a second porous matrix defining a second controlled pore architecture that is different from the first controlled pore architecture to cause the second portion to swell in a different manner than the first portion when the post-biopsy cavity treatment implant is implanted in an aqueous environment.
2. The post-biopsy cavity treatment implant of claim 1, wherein the second portion swells faster than the first portion when the implant is implanted in the aqueous environment.
3. The post-biopsy cavity treatment implant of claim 1, wherein the second portion swells to a greater extent than the first portion when the implant is implanted in the aqueous environment.
4. The post-biopsy cavity treatment implant of claim 1, wherein the first controlled pore architecture differs from the second controlled pore architecture with respect to at least one of: pore density, pore shape, pore orientation and pore dimensions.
5. The post-biopsy cavity treatment implant of claim 1, wherein at least one of the first and second portions includes a radiopaque material disposed therein.
6. The post-biopsy cavity treatment implant of claim 1, wherein at least one of the first and second portions includes a radioactive material disposed therein.
7. The post-biopsy cavity treatment device of claim 1, wherein at least one of the first and second portions includes a paramagnetic material disposed therein.
8. The post-biopsy cavity treatment implant of claim 1, wherein at least one of the first and second portions includes a dye disposed therein.
9. The post-biopsy cavity treatment implant of claim 1, wherein at least one of the first and second portions includes a pigment disposed therein.
10. The post-biopsy cavity treatment implant of claim 1, wherein at least one of the first and second portions includes a contrast media disposed therein.
11. The post-biopsy cavity treatment implant of claim 1, wherein at least one of the first and second portions includes a therapeutic agent disposed therein.
12. The post-biopsy cavity treatment implant of claim 1, wherein at least one of the first and second portions is biodegradable.
13. The post-biopsy cavity treatment implant of claim 1, wherein at least one of the first and second portions includes collagen.
14. The post-biopsy cavity treatment implant of claim 1, wherein the first and second portions include at least one of a polylactide (PLA), a polyglycolide (PGA), a poly(lactide-co-glycolide) (PLGA), a polyglyconate, a polyanhydride, PEG, cellulose, a gelatin, a lipids, a polysaccharide, a starches and a polyorthoesters.
15. The post-biopsy cavity treatment implant of claim 1, wherein the first and second portions are configured so as to form a laminar structure.
16. The post-biopsy cavity treatment implant of claim 1, wherein the first portion defines a first surface and wherein the second portion defines a second surface that faces the first surface to define an interface between the first and second portions.
17. The post-biopsy cavity treatment implant of claim 4, wherein the interface is visualizable under ultrasound when the post-biopsy cavity treatment implant is implanted.
18. The post-biopsy cavity treatment implant of claim 1, wherein at least the first portion includes a plurality of fibers.
19. The post-biopsy cavity treatment implant of claim 1, wherein the first portion forms an inner core and wherein the second portion forms an outer shell disposed at least partially around the first portion.
20. The post-biopsy cavity treatment implant of claim 1, wherein at least one of the first and second portions includes an internal reservoir configured to contain at least one of a dye, a pigment and a therapeutic agent.
21. The post-biopsy cavity treatment implant of claim 20, wherein the internal reservoir is configured to deliver the at least one of dye, pigment and therapeutic agent through elution when the implant is implanted in the aqueous environment.
22. The post-biopsy cavity treatment implant of claim 20, wherein the internal reservoir is configured to deliver the at least one of dye, pigment and therapeutic agent at a first rate when the reservoir is breached and at a second rate that is lower than the first rate when the reservoir is not breached.
23. The post-biopsy cavity treatment implant of claim 1, further including a third portion, the third portion being radiopaque.
24. The post-biopsy cavity treatment implant of claim 23, wherein the third portion includes a metal.
25. The post-biopsy cavity treatment implant of claim 1, further including a third portion including a third porous matrix defining a third controlled pore architecture, the first, second and third portions collectively defining a predetermined pore density gradient.
26. The post-biopsy cavity treatment implant of claim 1, wherein the second portion is configured to have a second crosslinking density and wherein the first portion is configured to have a first crosslinking density that is greater than the second crosslinking density.
27. The post-biopsy cavity treatment implant of claim 26, wherein the second portion is configured to swell to a greater degree than the first portion when the implant is implanted in the aqueous environment.
28. The post-biopsy cavity treatment implant of claim 1, wherein the first and second portions include collagen and wherein a crosslinking density of at least one of the first and second portions is controlled through adding a selected amount of a bifunctional reagent to the collagen.
29. The post-biopsy cavity treatment implant of claim 28, wherein the bifunctional reagent includes at least one of a aldehyde and a cyanamide.
30. The post-biopsy cavity treatment implant of claim 29, wherein the aldehyde includes a glutaraldehyde.
31. The post-biopsy cavity treatment implant of claim 1, wherein the first and second portions include collagen and wherein a crosslinking density of the first and second portions is controlled by an application of energy to the collagen.
32. The post-biopsy cavity treatment implant of claim 31, wherein the application of energy includes at least one of dehydrothermal processing, exposure to UV light and radiation.
33. The post-biopsy cavity treatment implant of claim 1, wherein the first and second portions include collagen and wherein a crosslinking density of at least one of the first and second portions is controlled by a combination of dehydrothermal processing and exposure to cyanamide.
34. A method for mapping a lymphatic system following a cavity generating procedure, comprising:
- providing a post-biopsy cavity treatment implant, the implant including a collagenous matrix having a non-uniform cross-linking density that is configured to cause the implant to swell non-uniformly when placed within an aqueous environment, the implant including a dye or a pigment contained therein;
- implanting the provided post-biopsy cavity treatment implant into the cavity;
- closing the cavity with the post-biopsy cavity treatment implant implanted therein;
- causing the dye/pigment to be released from the implant and to propagate through the lymphatic system, and
- visualizing the propagated dye/pigment in the lymphatic system using a selected visualization mode.
35. The method of claim 34, wherein the implant in the providing step includes a reservoir disposed within the collagenous matrix, the reservoir containing a volume of the dye/pigment and wherein the causing step includes a step of breaching the reservoir to release the dye/pigment.
36. The method of claim 35, wherein the breaching step includes a step of squeezing the implanted post-biopsy cavity treatment implant.
37. The method of claim 34, wherein the causing step includes a step of waiting for a predetermined period of time during which the implant degrades within the cavity and releases the dye/pigment.
38. The method of claim 34, wherein the at least one of dye and pigment is loaded within the collagenous matrix of the implant.
39. The method of claim 34, wherein visualizing mode in the visualizing step includes at least one of ultrasound, X-ray, MRI, elastography, microwave and the unaided eye.
40. A post-biopsy cavity treatment implant, comprising:
- a first portion comprising a first collagenous matrix, the first collagenous matrix being controlled to have a first crosslinking density, and
- a second portion in contact with the first portion, the second portion comprising a second collagenous matrix, the second collagenous matrix being controlled to have a second crosslinking density, the first crosslinking density being controlled to be different than the second cross-linking density.
41. The post-biopsy cavity treatment implant of claim 40, wherein the second portion swells faster than the first portion when the implant is implanted in the aqueous environment.
42. The post-biopsy cavity treatment implant of claim 40, wherein the second portion swells to a greater extent than the first portion when the implant is implanted in the aqueous environment.
43. The post-biopsy cavity treatment implant of claim 40, wherein at least one of the first and second collagenous matrices includes a radiopaque material disposed therein.
44. The post-biopsy cavity treatment implant of claim 40, wherein at least one of the first and second collagenous matrices includes a radioactive material disposed therein.
45. The post-biopsy cavity treatment device of claim 40, wherein at least one of the first and second collagenous matrices includes a paramagnetic material disposed therein.
46. The post-biopsy cavity treatment implant of claim 40, wherein at least one of the first and second collagenous matrices includes a dye disposed therein.
47. The post-biopsy cavity treatment implant of claim 40, wherein at least one of the first and second collagenous matrices includes a pigment disposed therein.
48. The post-biopsy cavity treatment implant of claim 40, wherein at least one of the first and second collagenous matrices includes a contrast media disposed therein.
49. The post-biopsy cavity treatment implant of claim 40, wherein at least one of the first and second collagenous matrices includes a therapeutic agent disposed therein.
50. The post-biopsy cavity treatment implant of claim 40, wherein at least one of the first and second portions is biodegradable.
51. The post-biopsy cavity treatment implant of claim 40, wherein at least one of the first and second portions includes collagen.
52. The post-biopsy cavity treatment implant of claim 40, wherein the first and second portions include at least one of a polylactide (PLA), a polyglycolide (PGA), a poly(lactide-co-glycolide) (PLGA), a polyglyconate, a polyanhydride, PEG, cellulose, a gelatin, a lipids, a polysaccharide, a starches and a polyorthoesters.
53. The post-biopsy cavity treatment implant of claim 40, wherein the first and second portions are configured so as to form a laminar structure.
54. The post-biopsy cavity treatment implant of claim 40, wherein the first portion defines a first surface and wherein the second portion defines a second surface that faces the first surface to define an interface between the first and second portions.
55. The post-biopsy cavity treatment implant of claim 54, wherein the interface is visualizable under ultrasound when the post-biopsy cavity treatment implant is implanted in the aqueous environment.
56. The post-biopsy cavity treatment implant of claim 40, wherein at least the first portion includes a plurality of fibers.
57. The post-biopsy cavity treatment implant of claim 40, wherein the first portion forms an inner core and wherein the second portion forms an outer shell disposed at least partially around the first portion.
58. The post-biopsy cavity treatment implant of claim 40, wherein at least one of the first and second portions includes an internal reservoir configured to contain at least one of a dye, a pigment and a therapeutic agent.
59. The post-biopsy cavity treatment implant of claim 58, wherein the internal reservoir is configured to deliver the at least one of dye, pigment and therapeutic agent through elution when the implant is implanted in the aqueous environment.
60. The post-biopsy cavity treatment implant of claim 58, wherein the internal reservoir is configured to deliver the at least one of dye, pigment and therapeutic agent at a first rate when the reservoir is breached and at a second rate that is lower than the first rate when the reservoir is not breached.
61. The post-biopsy cavity treatment implant of claim 40, further including a third portion disposed between the first and second portions, the third portion being radiopaque.
62. The post-biopsy cavity treatment implant of claim 61, wherein the third portion includes a metal.
63. The post-biopsy cavity treatment implant of claim 40, further including a third portion including a third porous matrix defining a third controlled pore architecture, the first, second and third portions collectively defining a predetermined pore density gradient.
64. The post-biopsy cavity treatment implant of claim 1, wherein the first and second portions include collagen and wherein the crosslinking density of the at least one of the first and second portions is controlled through adding a selected amount of a bifunctional reagent to the collagen.
65. The post-biopsy cavity treatment implant of claim 64, wherein the bifunctional reagent includes at least one of a aldehyde and a cyanamide.
66. The post-biopsy cavity treatment implant of claim 65, wherein the aldehyde includes a glutaraldehyde.
67. The post-biopsy cavity treatment implant of claim 40, wherein the first and second portions include collagen and wherein a crosslinking density of the first and second portions is controlled by an application of energy to the collagen.
68. The post-biopsy cavity treatment implant of claim 67, wherein the application of energy includes at least one of dehydrothermal processing, exposure to UV light and radiation.
69. The post-biopsy cavity treatment implant of claim 40, wherein the first and second portions include collagen and wherein the crosslinking density of at least one of the first and second portions is controlled by a combination of dehydrothermal processing and exposure to cyanamide.
70. A post-biopsy cavity treatment implant, comprising:
- a first portion including a first collagenous matrix defining a first controlled pore architecture, and
- a second portion coupled to the first portion, the second portion comprising a second collagenous matrix, the second collagenous matrix being controlled to have a first controlled crosslinking density to cause the second portion to swell in a different manner than the first portion when the post-biopsy cavity treatment implant is implanted in an aqueous environment.
71. Method of filling a cavity created by an excisional procedure, the cavity having a predetermined shape, the method comprising the steps of:
- providing an implant, the implant including at least a first portion and a second portion, the first portion comprising a first collagenous matrix that defines a first selected crosslinking density, the second portion comprising a second collagenous matrix that defines a second selected crosslinking density that is different than the second cross-linking density, the first and second cross-linking densities being selected so as to cause the first and second portions to swell into a size and a shape that is similar to the predetermined shape of the cavity when the implant is implanted;
- implanting the implant within the cavity through an incision;
- adding an aqueous solution to the cavity if the cavity is not sufficiently aqueous to cause the implant to swell, and
- closing the incision with the implant implanted in the cavity.
72. The method of claim 71, wherein the first portion comprises a plurality of first collagenous fibers, each of the plurality of first collagenous fibers having the first selected crosslinking density.
73. The method of claim 71, wherein the second portion comprises a plurality of second collagenous fibers, each of the plurality of second collagenous fibers having the second selected crosslinking density.
Type: Application
Filed: Jul 25, 2003
Publication Date: Jan 27, 2005
Applicant: RUBICOR MEDICAL, INC. (Redwood City, CA)
Inventors: Ary Chernomorsky (Walnut Creek, CA), James Vetter (Portola Valley, CA), Simon Chernomorsky (Brighton, MA)
Application Number: 10/627,960