Biopsy localization method and device

Information

  • Patent Grant
  • 10010380
  • Patent Number
    10,010,380
  • Date Filed
    Thursday, September 16, 2004
    20 years ago
  • Date Issued
    Tuesday, July 3, 2018
    6 years ago
Abstract
Methods for localizing a biopsy site are disclosed. The method includes taking a tissue sample from a biopsy site and positioning a detectable, bioabsorbable element at the biopsy site at the time that the tissue sample was taken. The tissue sample is then tested. The biopsy site is then relocated by finding the bioabsorbable element. The bioabsorbable element may be made of collagen, gelatin, cellulose, polylactic acid, and/or polyglycolic acid. The detectable bioabsorbable element may be relocated using ultrasound or mammography. The bioabsorbable element may also swell upon contact with body fluid.
Description
BACKGROUND OF THE INVENTION

In the U.S. alone approximately one million women will have breast biopsies because of irregular mammograms and palpable abnormalities. See FIG. 1 which diagrams the current treatment algorithm for non-palpable breast lesions. Biopsies can be done in a number of different ways for non-palpable lesions, including surgical excisional biopsies and stereotactic and ultrasound guided needle breast biopsies. In the case of image directed biopsy, the radiologist or other physician takes a small sample of the irregular tissue for laboratory analysis. If the biopsy proves to be malignant, additional surgery (typically a lumpectomy or a mastectomy) is required. The patient then returns to the radiologist a day or two later where the biopsy site (the site of the lesion) is relocated by method called needle localization, a preoperative localization in preparation for the surgery.


Locating the previously biopsied area after surgical excision type of biopsy is usually not a problem because of the deformity caused by the surgery. However, if the biopsy had been done with an image directed needle technique, as is common, help in relocating the biopsy site is usually needed. One procedure to permit the biopsy site to be relocated by the radiologist during preoperative localization is to leave some of the suspicious calcifications; this has its drawbacks.


Another way to help the radiologist relocate the biopsy site involves the use of a small metallic surgical clip, such as those made by Biopsys. The metallic clip can be deployed through the biopsy needle, and is left at the biopsy site at the time of the original biopsy. With the metallic clip as a guide, the radiologist typically inserts a barbed or hooked wire, such as the Hawkins, Kopans, Homer, Sadowski, and other needles, back into the patient's breast and positions the tip of the wire at the biopsy site using mammography to document the placement. The patient is then taken to the operating room with the needle apparatus sticking out of the patient's breast. While the clip provides a good indication of the biopsy site to the radiologist during preoperative localization, the clip remains permanently within the 80% of patients with benign diagnoses. Also, because the clip is necessarily attached to a single position at the periphery of the biopsy site, rather than the center of the biopsy site, its location may provide a misleading indication of the location of diseased tissue during any subsequent medical intervention. In addition, the soft nature of breast tissue permits the tip of the barbed or hooked needle to be relatively easily dislodged from the biopsy site. The clip is also relatively expensive.


Another localization method involves the use of laser light from the tip of a optical fiber connected to a laser. A pair of hooks at the tip of the optical fiber secures the tip at the biopsy site; the glow indicates the position of the tip through several centimeters of breast tissue. This procedure suffers from some of the same problems associated with the use of barbed or hooked wires. Another preoperative localization procedure injects medical-grade powdered carbon suspension from the lesion to the skin surface. This procedure also has certain problems, including the creation of discontinuities along the carbon trail.


SUMMARY OF THE INVENTION

The present invention is directed to a biopsy localization method and device which uses a locatable bioabsorbable element left at the biopsy site so that if testing of the biopsy sample indicates a need to do so, the biopsy site can be relocated by finding the bioabsorbable element. This eliminates the need to use of metallic clips during biopsies and often eliminates the need for a return to the radiologist for preoperative needle localization. In addition, the bioabsorbable element can be used as a therapeutic tool for treatment of the diseased lesion and for hemostasis.


A biopsy localization device made according to the invention includes a bioabsorbable element delivered in a pre-delivery state to a soft tissue biopsy site of a patient by an element delivery device. The bioabsorbable element may be palpably harder than the surrounding soft tissue at the biopsy site when in the post-delivery state.


One preferred material used as the bioabsorbable element is a dehydrated collagen plug. This type of plug may swell and is palpable for subsequent location by the surgeon. The collagen plug may not swell at all. In some situations, such as with small breasted women or where the biopsy site is close to the surface, a non-swellable bioabsorbable material, such as a round pellet of PGA, can be used instead of a swellable bioabsorbable material. The bioabsorbable material can also be made so that it is absorbed quickly to produce a local tissue inflammation; such a localized inflammation can be used to locate the biopsy site instead of location by palpation. Instead of leaving, for example, a collagen plug, a PGA pellet or a bioabsorbable suture material at the biopsy site for location by palpation or inflammation, a length of bioabsorbable suture material, a collagen filament, or other bioabsorbable material extending from the biopsy site out through the skin can be used. In this case the surgeon can follow the bioabsorbable suture material to the biopsy site in a manner similar to that used with Hawkins needles. In other cases, such as in the case of a deeply located lesion or large breast, the bioabsorbable material may need to be located by the radiologist, by for example, ultrasound or mammography. In any event the bioabsorbable material will typically be absorbed within about a month of placement. The invention thus eliminates the use of metal clips during biopsies and usually eliminates the need for return to the radiologist for preoperative localization.


While the primary use of the device is intended to localize the site of needle biopsies for possible future surgical excision, the device may also be useful in marking the site of surgical excisional biopsies. For example, during a wide surgical excision for cancer diagnosed by a recent surgical excisional biopsy, surgeons frequently have difficulty in determining the precise relationship of the previously excised tissue to the surgical wound. Therefore, more tissue is removed than might have been removed had the exact location of the previous lesion been more definite. With the present invention, a bioabsorbable element may be inserted into the biopsy site during a surgical excisional biopsy before the wound is closed to mark the site for potential wide excision should the biopsy reveal cancer. Alternatively, a bioabsorbable element may be placed at the biopsy site using a delivery device by partially or completely closing the wound and then depositing the bioabsorbable element through the delivery device and removing the delivery device through the closed incision. The presence of the palpable marker within the previous excisional biopsy site would allow the surgeon to more easily and confidently remove tissue around this site, and preserve more normal breast tissue.


Another use of the device is to primarily localize a non-palpable lesion prior to surgical excisional biopsy. Instead of using the needle/wire apparatus which has a tendency to migrate and become dislodged with traction, the palpable marker may be inserted into the suspicious area of the breast under mammographic or ultrasonic guidance immediately prior to the surgical excisional biopsy. This would provide a palpable locator for the surgeon as described above. In this instance, the marker would only need to be palpable, and not necessarily bioresorbable, since the intent would be to remove it in all cases.


In addition to permitting the biopsy site to be located by subsequent palpation or other means, the invention also can provide hemostasis and therapeutic benefits. The bioabsorbable element may comprise a therapeutic agent; the therapeutic agent may comprise at least a chosen one of a chemotherapeutic agent, a radiation agent and a gene therapy agent. Since the bioabsorbability can be varied from a day or two to a year or more, the material may be used to treat the diseased tissue and not just locate it. Some current therapies include radiation, chemotherapy, gene therapy as well as other technologies and therapies. Because the bioabsorbability can be easily varied, a medium can be place into the bioabsorbable element and be externally excited or triggered in those cases where the biopsy results are malignant. Further, the bioabsorbability concept can be used for future implantation of a therapeutic agent. For example, if the bioabsorbable element is a dehydrated collagen, this material could be used as a reservoir for, for example, delivery of materials that effect chemotherapy, brachytherapy, etc. Once the laboratory results are received and show the biopsy is malignant and therapy is required, by surgical excision or otherwise, the physician may inject, for example, a radiation pellet, a chemotherapeutic agent or a gene therapeutic agent into or adjacent to the bioabsorbable element for direct treatment of the diseased tissue.


The change in the bioabsorbable element can be via one of several ways, such as hydration or desiccation, change in temperature, electrical stimulation, magnetic stimulation, chemical or physical reaction with another material, additives, enzymatic reactions, ionization, electrical charges, absorption, as well as other means. The invention may employ one or more of these techniques or measures or others, to change the consistency, hardness and or size of the bioabsorbable element between its deployed and non-deployed states. The visual detectability of the bioabsorbable element may be aided by the use of a coloring agent, such as methylene blue or some other dye. The radiographic detectability of the element may be enhanced by a radiopaque marker. As well, ultrasonic detectability may be enhance by special treatment of the bioresorbable element.


The bioresorbable element may have margins which are roughened so as to prevent migration within the tissues. Filaments extending from the margins of the bioresorbable element may be utilized also to stabilize the position of the device within the cavity. The filaments may or may not be composed of the same material as the bioresorbable element.


The provision of hemostasis helps to lessen the bleeding and swelling within and about the biopsy site. This can be accomplished by physical or chemical means. That is, the device may swell so that it essential fills the biopsy cavity or the device may have a chemical reaction with blood or blood products to cause effective blood clotting, or both. Other methods for causing local hemostasis are also possible with the invention.


Other features and advantages of the invention will appear from the following description in which the preferred embodiments and methods have been set forth in detail in conjunction with the accompany drawings.





BRIEF DESCRIPTION OF THE DRAWINGS


FIG. 1 is a flow diagram of a conventional treatment algorithm for nonpalpable breast lesions;



FIG. 2 is a flow diagram of a treatment algorithm according to the present invention;



FIG. 3 is a simplified view illustrating a biopsy needle assembly obtaining a tissue sample of an abnormality at a target site;



FIG. 4 illustrates the main housing and sheath of the needle biopsy assembly left in place after the tissue sample has been removed leaving a biopsied open region at the target site;



FIG. 5 illustrates the barrel of the delivery device of FIG. 4 inserted into the main housing of the biopsy needle assembly and the plunger depressed injecting the bioabsorbable element into the biopsied open region, thus effectively filling the biopsied open region at the target site;



FIG. 6 illustrates the location of the bioabsorbable element of FIG. 5 with the surgeon using his or her fingers; and



FIG. 7 illustrates a bioabsorbable thread extending from the bioabsorbable element of FIG. 5 up through the patient's skin, the thread being delivered to the bioabsorbable element using the delivery device of FIGS. 4 and 5.





DESCRIPTION OF THE SPECIFIC EMBODIMENTS


FIG. 2 illustrates a treatment algorithm 2 according to the present invention. As a result of a routine mammography 4, a tumor or other abnormality may be detected as at 6. The typical response will often include additional magnification mammograms or a follow-up mammogram scheduled for some time in the future, such as six months. This is indicated at 8. If the tumor is not palpable, see 9, an image guided needle biopsy by a breast radiologist is typically conducted as at 10. Image guided needle biopsies can be done in a number of ways. Presently, stereotactic (x-ray) and ultrasound guided needle biopsies are commonly used, primarily because of their accuracy, speed and minimal trauma to the patient. Stereotactic needle biopsies typically use a stereotactic table, such as made by Fisher or Lorad, which provides mammography (x-ray) guidance to a biopsy needle assembly. Ultrasound guided biopsies can be conducted with any one of a number of commercially available instruments. An exemplary biopsy needle assembly 14, illustrated in FIG. 3, includes a biopsy needle 13 passing through a sheath 20 extending from a hollow main housing 22. The tip 12 of biopsy needle 13 of biopsy needle assembly 14 is automatically inserted to the abnormality 16 at the target site 18. Biopsy needle 13 has a laterally directed side opening 24 adjacent to tip 12 used to capture a tissue sample of abnormality 16. Once the tissue samples have been obtained, the removed tissue creates a biopsied open region 26 at target site 18. See FIG. 4. Following the removal of biopsy needle 13 from sheath 20 and main housing 22, the barrel 30 of a bioabsorbable element delivery device 32 is inserted through main housing 22 and into sheath 20. Barrel 30 contains a bioabsorbable element 34, see FIG. 5 Bioabsorbable element 34 is, in this preferred embodiment, a plug of dehydrated collagen, such as that sold by several companies such as Davol, Datascope, Integra Life Sciences, Collagen Matrix, Vascular Solutions, et al. Bioabsorbable element 34 may swell on contact with an aqueous liquid within biopsied open region 26 and substantially fills the biopsied open region as suggested in FIG. 5. In this preferred embodiment, bioabsorbable element 34 is transformed from its pre-delivery state within barrel 30 to its post-delivery state at region 26 and in the process swells and becomes somewhat softer in its post-delivery state than in its pre-delivery state. However, in its post-delivery state, bioabsorbable element 34 is palpably harder, preferably at least about 1.5 times harder, than the surrounding soft tissue, typically breast tissue 36. This permits bioabsorbable element 34 at the target site 18 to be relocated by palpation of the patient by the physician, see FIG. 6, to find the bioabsorbable element 6 and as discussed in more detail below.


A bioabsorbable element could be made of materials other than collagen and could be in a form other than a solid, relatively hard plug in its pre-delivery state. For example, bioabsorbable element 34 in its pre-delivery state within barrel 30 could be in a liquid or otherwise flowable form; after being deposited at open region 26 at target site 18, the bioabsorbable element could change to become palpably harder than the surrounding tissue 36 to permit subsequent relocation of target site 18 by palpation. In some situations, it may be desired that bioabsorbable element 34 not change its size or hardness between its pre-delivery state and its post-delivery state, such as being palpably harder than the surrounding tissue 36 in both states. In a preferred embodiment, transformation of bioabsorbable element 34 is by contact with an aqueous liquid.


However, transformation of the bioabsorbable element, which can be in terms of, for example, hardness, texture, shape, size, or a combination thereof, can be due to other factors, such as application of thermal energy, radiation, magnetic energy, etc.


Returning again to FIG. 2, it is seen that after insertion of bioabsorbable element 34, the biopsy sample is sent to pathology for evaluation at 36. If the pathology report, which is available a day or two after the biopsy, is benign, the patient is so informed and the bioabsorbable element simply is absorbed by the patient within, for example, a month as at 38. If the pathology report is positive, so that cancer is found, the biopsied open region 26 at the target site 18 is located by the surgeon by palpation as suggested by FIG. 6. After finding the target site by palpation, which eliminates the need for preoperative localization by the radiologist, appropriate medical treatment, such as excisional surgery, can be performed.


If the tumor is palpable, the surgeon may choose to make a direct incisional biopsy as at 48. According to the present invention, bioabsorbable delivery device 32 could be used to place bioabsorbable element 34 at the site of the incisional biopsy. After removal of delivery device 32, the incision would be closed, the biopsy sample would be sent to pathology and the patient would go home with the procedure preceding as discussed above, starting with item 36.


It may be preferred that bioabsorbable element 34 also act as a hemostatic agent to stop bleeding at site 18 by virtue of physical means, by filling or substantially filling open region 26, as well as chemical means through the chemical interaction, such as coagulation, with blood components. In addition, bioabsorbable element 34 could be covered by a non-hemostatic degradable outer layer so that hemostasis or other action is delayed until the outer layer has been eroded. In some situations, it may be necessary or at least desirable to shield the bioabsorbable element from the blood or other body fluids until after the bioabsorbable element is in place at target site 18. This could be accomplished by, for example, physically isolating the bioabsorbable element from body fluids by using a removable physical barrier during delivery of the bioabsorbable element. Alternatively, a bioabsorbable coating or layer, as described above, may be used. The bioabsorbable element may be changed from its pre-delivery state to its post-delivery state in a variety of manners including hydration, changing the temperature, electrical stimulation, magnetic stimulation, chemical reaction with a stimulating agent, physically interaction with an activating member (such as a knife blade which could be used to slice open a capsule containing the bioabsorbable element), by ionizing the bioabsorbable element, or by absorption or adsorption of a fluid by the bioabsorbable element.


The invention may also be used to medically treat the patient. That is, the bioabsorbable element-could include a therapeutic element which would be activated only if the pathology report indicated the need for the medical treatment. Various ways of activating an agent in a bioabsorbable element could be used, such as injecting a radiation-emitting element at the vicinity of the target site, externally irradiating the target site, providing a triggering substance to the target site, manual pressure, photodynamic therapy, sclerosing chemistry, vibrational therapy, ultrasound, and the like. Alternatively, the bioabsorbable element could be made so that it includes no such activating agent; rather, medical treatment could be provided by, for example, delivery of a chemotherapy agent, a radiation emitting element, thermal energy, electrical energy, vibrational energy, gene therapy, vector therapy, anti-angiogenesis therapy. To facilitate the delivery, the bioabsorbable element may contain a radiopaque marker or may have properties to aid in detecting it by ultrasound, in addition to being palpable.


An important use for the invention is in the treatment of breast cancer. In one embodiment, it is desirable that bioabsorbable element 34 in its post-delivery state have a hardness of at least about one and a half times that of breast tissue so that it is palpably harder than the surrounding tissue. Also, it is desired that bioabsorbable element 34, in one embodiment, swells from its pre-delivery state to its post-delivery state so to fill or at least substantially fills open region 26. To achieve this it is preferred that bioabsorbable element 34 swells about 50 to 1500%, and more preferably about 100 to 300%, from the pre-delivery state to the post delivery state, typically when placed in contact with an aqueous liquid. It is preferred that the bioabsorbable element has a longest dimension of at least about 0.5 cm in its post-delivery state to aid its location by palpation.


While the bioabsorbable element is preferably made of collagen in one embodiment, the bioabsorbable element can include, for example, one or more of the following materials; polyactic and polyglycolic acids, polyorthoesters, resorbable silicones and urethanes, lipids, polysaccharides, starches, ceramics, polyamino acids, proteins, hydrogels and other gels, gelatins, polymers, cellulose, elastin, and the like.


In some situations it may be desired to use a bioabsorbable filament 44 extending from bioabsorbable element 34 through the patient's skin 46 as shown in FIG. 7. This can be accomplished by delivering bioabsorbable filament 44 through sheath 20 as bioabsorbable element 34 is injected into region 26 at target site 18. In some situations it may not be possible or desirable to use bioabsorbable element 34; in those situations it may be useful to provide for only bioabsorbable filament 44 extending from target site 18 to above the patient's skin 46.


While it is presently preferred that bioabsorbable element delivery device 32 be guided through a portion of needle assembly 14, that is sheath 20 and main housing 22, in some situations it may be useful to cover sheath 20 with an outer sheath which would be left in place after the biopsy sample has been removed and the entire biopsy needle assembly 14 has been removed. The sheath left in place would then be used to guide barrel 30 of delivery device 32 to target site 18. Of course, delivery device 32 could take a number of different forms such as a syringe containing fluid or paste that is injected through a needle or through the housing 22 and sheath 20 or through an outer sheath. Alternatively, other delivery devices could be employed for delivery of bioresorbable element 34.


The invention has applicability toward the correction of a defect that is caused by breast tissue removal for biopsy or diseased tissue removal. Collagen is often placed in the body where it is eventually replaced by human autogenous tissue. Hence, the invention could be used for the repair of tissue that has been damaged due to tissue removal. The delivery device described heretofore could be used for installing a material (synthetic or mammalian) into the cavity for such a cosmetic or reconstructive repair. The material would typically be an effectively non-bioabsorbable material, such as a silicon gel-filled capsule or bag.


Modification and variation can be made to the disclosed embodiments without departing from the subject of the invention as defined in the following claims.


Any and all patents, patent applications, and printed publications referred to above are incorporated by reference.

Claims
  • 1. A biopsy method comprising: positioning a sheath and a biopsy needle with respect to a target site in tissue to be biopsied;extending the biopsy needle at least partially through the sheath;removing at least one tissue biopsy sample from the target site through the biopsy needle;removing the biopsy needle from the sheath while leaving the sheath positioned in the tissue at the target site;after the step of removing the biopsy needle, inserting a delivery device into the sheath, wherein the delivery device comprises at least one dehydrated bioabsorbable element including starch; anddelivering the bioabsorbable element from the delivery device to the target site from which the tissue biopsy sample was removed.
  • 2. The method of claim 1, further comprising relocating a biopsy site from which the tissue biopsy sample was removed by imaging the bioabsorbable element.
  • 3. The method of claim 2, further comprising testing the tissue biopsy sample removed prior to the step of relocating the site.
  • 4. The method of claim 1, wherein the bioabsorbable element has a pre-delivery state different from a post-delivery state.
  • 5. The method of claim 1, wherein the bioabsorbable element has one consistency in the delivery device, and wherein the bioabsorbable element has a different consistency at a time after being delivered into the site from which tissue was removed.
  • 6. A breast biopsy localization method comprising: positioning a sheath having a distal end with respect to a target site in breast tissue to be biopsied;taking a tissue sample from the target site within a patient by a needle biopsy device passing through and extending from the distal end of the sheath so as to create a biopsy site;removing the biopsy needle from the sheath while leaving the sheath in the breast tissue;without removing the sheath from the breast tissue, and after removing the biopsy needle from the sheath, inserting a bioabsorbable element delivery device into the sheath, wherein the bioabsorbable element delivery device contains at least one detectable bioabsorbable element;deploying the at least one detectable bioabsorbable element through the bioabsorbable element delivery device to mark the biopsy site from which the tissue sample was taken.
  • 7. The method of claim 6, further including the step of relocating the biopsy site by imaging to find the detectable bioabsorbable element.
  • 8. The method of claim 7, wherein the step of relocating the biopsy site by imaging comprises detecting the bioabsorbable element with ultrasound.
  • 9. The method of claim 6, wherein the biopsy needle comprises a laterally directed side opening, and wherein the step of inserting the biopsy needle through and extending from the distal end of the sheath comprises positioning the laterally directed side opening beyond the distal end of the sheath.
  • 10. The method of claim 6, wherein the detectable bioabsorbable element comprises a material selected from the group consisting of collagen, proteins, gelatins, starches, polysaccharides, ceramics, polyamino acids and hydrogels.
  • 11. The method of claim 7, wherein the detectable bioabsorbable element has a pre-delivery state prior to its delivery to the target site, and a post-delivery state after being deployed to the target site, and wherein the post-delivery state is physically different from the pre-delivery state.
  • 12. The method of claim 7, wherein the step of relocating the biopsy site comprises locating the detectable bioabsorbable element after the detectable bioabsorbable element swells from its pre-delivery state to its post-delivery state.
Parent Case Info

This application is a continuation of U.S. application Ser. No. 10/839,112, filed May 4, 2004, which is a continuation of U.S. application Ser. No. 10/027,157, filed Dec. 20, 2001, now issued as U.S. Pat. No. 6,730,042, which is a continuation of U.S. application Ser. No. 09/900,801, filed Jul. 6, 2001, now issued as U.S. Pat. No. 6,699,205, which is a continuation of U.S. application Ser. No. 09/336,360, filed Jun. 18, 1999, now issued as U.S. Pat. No. 6,270,464, which application claims the benefit of the following Provisional patent applications: Biopsy Localization Device, Application No. 60/090,243, filed Jun. 22, 1998; Biopsy Localization and Hemostasis Device, Application No. 60/092,734, filed Jul. 14, 1998; Device and Method of Biopsy Localization and Hemostasis, Application No. 60/114,863, filed Jan. 6, 1999; and Device and Method of Biopsy Localization, Hemostasis & Cancer Therapy, Application No. 60/117,421, filed Jan. 27, 1999, all of the which are herein expressly incorporated by reference in the their entirety.

US Referenced Citations (206)
Number Name Date Kind
2899362 Sieger, Jr. et al. Aug 1959 A
3001522 Silverman Sep 1961 A
3194239 Sullivan Jul 1965 A
3818894 Wichterle Jun 1974 A
3823212 Chvapil Jul 1974 A
3976071 Sadek Aug 1976 A
3996938 Clark, III Dec 1976 A
4007732 Kvavle Feb 1977 A
4034759 Haerr Jul 1977 A
4197846 Bucalo Apr 1980 A
4230123 Hawkins Oct 1980 A
4248214 Hannah Feb 1981 A
4298998 Naficy Nov 1981 A
4320201 Berg Mar 1982 A
4331577 Hanna May 1982 A
4356572 Guillemin Nov 1982 A
4425908 Simon Jan 1984 A
4438253 Casey et al. Mar 1984 A
4541438 Parker Sep 1985 A
4545367 Tucci Oct 1985 A
4592356 Gutierrez Jun 1986 A
4608965 Anspach, Jr. Sep 1986 A
4611594 Grayhack Sep 1986 A
4638802 Okada Jan 1987 A
4647480 Ahmed Mar 1987 A
4650466 Luther Mar 1987 A
4655211 Sakamoto et al. Apr 1987 A
4682606 Decaprio Jul 1987 A
4693237 Hoffmon Sep 1987 A
4744364 Kensey May 1988 A
4763642 Horowitz Aug 1988 A
4774948 Markham Oct 1988 A
4787391 Elefteriades Nov 1988 A
4789401 Ebinger Dec 1988 A
4799495 Hawkins Jan 1989 A
4813422 Fisher Mar 1989 A
4817622 Pennypacker Apr 1989 A
4832686 Anderson May 1989 A
4838280 Haaga Jun 1989 A
4847049 Yamamoto Jul 1989 A
4852568 Kensey Aug 1989 A
4907589 Cosman Mar 1990 A
4909250 Smith Mar 1990 A
4966583 Debbas Oct 1990 A
4970298 Silver Nov 1990 A
4986279 O'Neill Jan 1991 A
5002548 Campbell Mar 1991 A
5014713 Roper May 1991 A
5018530 Rank May 1991 A
5030201 Palestrant Jul 1991 A
5074840 Yoon Dec 1991 A
5080655 Haaga Jan 1992 A
5083570 Mosby Jan 1992 A
5085629 Goldberg Feb 1992 A
5100423 Fearnot Mar 1992 A
5102415 Guenther Apr 1992 A
5108421 Fowler Apr 1992 A
5120802 Mares Jun 1992 A
5127916 Spencer Jul 1992 A
RE34056 Lindgren et al. Sep 1992 E
5148813 Bucalo Sep 1992 A
5158084 Ghiatas Oct 1992 A
5183463 Debbas Feb 1993 A
5183464 Dubrul Feb 1993 A
5186922 Shell et al. Feb 1993 A
5192300 Fowler Mar 1993 A
5195540 Shiber Mar 1993 A
5195988 Haaga Mar 1993 A
5197482 Rank Mar 1993 A
5204382 Wallace Apr 1993 A
5207705 Trudell May 1993 A
5221269 Miller Jun 1993 A
5236410 Granov Aug 1993 A
5281408 Unger Jan 1994 A
5282781 Liprie Feb 1994 A
5282827 Kensey et al. Feb 1994 A
5325857 Nabai Jul 1994 A
5326350 Li Jul 1994 A
5330483 Heaven Jul 1994 A
5334216 Vidal Aug 1994 A
5334381 Unger Aug 1994 A
5342283 Good Aug 1994 A
5353804 Kornberg Oct 1994 A
5388588 Nabai Feb 1995 A
5394886 Nabai Mar 1995 A
5409004 Sloan Apr 1995 A
RE34936 Campbell May 1995 E
5411520 Nash et al. May 1995 A
5415656 Tihon May 1995 A
5417697 Wilk et al. May 1995 A
5422730 Barlow Jun 1995 A
5423321 Fontenot Jun 1995 A
5431676 Dubrul Jul 1995 A
5433751 Inoteb Jul 1995 A
5441517 Kensey et al. Aug 1995 A
5454790 Dubrul Oct 1995 A
5467780 Nabai Nov 1995 A
5469854 Unger Nov 1995 A
5479936 Nabai Jan 1996 A
5483972 Nabai Jan 1996 A
5487392 Haaga Jan 1996 A
5494030 Swartz Feb 1996 A
5507813 Dowd Apr 1996 A
5514379 Weissleder May 1996 A
5517997 Fontenot May 1996 A
5518730 Fuisz May 1996 A
5526822 Burbank Jun 1996 A
5549560 Von de Wijdeven Aug 1996 A
5556410 Mittermeir Sep 1996 A
5571181 Li Nov 1996 A
5571182 Ersek Nov 1996 A
5576016 Amselem Nov 1996 A
5591204 Janzen et al. Jan 1997 A
5626611 Liu May 1997 A
5634883 Chin Jun 1997 A
5636255 Ellis Jun 1997 A
5643246 Leeb Jul 1997 A
5643282 Kieturakis Jul 1997 A
5645566 Brenneman Jul 1997 A
5646146 Faarup Jul 1997 A
5647374 Crtrer Jul 1997 A
5656297 Bernstein Aug 1997 A
5660185 Shmulewitz Aug 1997 A
5670161 Healy Sep 1997 A
5676146 Scarborough Oct 1997 A
5676925 Klaveness Oct 1997 A
5688490 Tournier Nov 1997 A
5716375 Fowler Feb 1998 A
5716404 Vicante Feb 1998 A
5716407 Knapp Feb 1998 A
5735289 Pfeffer Apr 1998 A
5752974 Rhee May 1998 A
5792157 Mische Aug 1998 A
5794626 Kieturakis Aug 1998 A
5795308 Russin Aug 1998 A
5803901 Chin Sep 1998 A
5807276 Russin Sep 1998 A
5827324 Cassell Oct 1998 A
5868708 Hart Feb 1999 A
5869080 McGregor Feb 1999 A
5873904 Ragheb Feb 1999 A
5899935 Ding May 1999 A
5902310 Foerster May 1999 A
5922024 Janzen Jul 1999 A
5928260 Chin Jul 1999 A
5941910 Schindler Aug 1999 A
5980564 Stinson Nov 1999 A
6007563 Nash et al. Dec 1999 A
6015541 Greff Jan 2000 A
6027520 Tsugita Feb 2000 A
6053876 Fisher Apr 2000 A
6056700 Burney May 2000 A
6066325 Wallace May 2000 A
6071301 Cragg Jun 2000 A
6083522 Chu Jul 2000 A
6096070 Ragheb et al. Aug 2000 A
6113629 Ken Sep 2000 A
6136014 Sirimanne Oct 2000 A
6161034 Burbank Dec 2000 A
6162192 Cragg Dec 2000 A
6174330 Stinson Jan 2001 B1
6183497 Sing Feb 2001 B1
6214045 Corbitt Apr 2001 B1
6228055 Foerster May 2001 B1
6231834 Unger May 2001 B1
6248057 Mavity Jun 2001 B1
6261241 Burbank Jul 2001 B1
6270464 Fulton Aug 2001 B1
6271278 Park Aug 2001 B1
6277083 Eggers Aug 2001 B1
6309420 Preissman Oct 2001 B1
6312429 Burbank Nov 2001 B1
6331166 Burbank Dec 2001 B1
6335028 Vogel Jan 2002 B1
6340367 Stinson et al. Jan 2002 B1
6347241 Burbank Feb 2002 B2
6352682 Leavitt Mar 2002 B2
6356782 Sirimanne et al. Mar 2002 B1
6371904 Sirimanne Apr 2002 B1
6376742 Zdrahala et al. Apr 2002 B1
6427081 Burbank Jul 2002 B1
6589502 Coniglione Jul 2003 B1
6605047 Zarins Aug 2003 B2
6638308 Corbitt Oct 2003 B2
6656200 Li et al. Dec 2003 B2
6699205 Fulton Mar 2004 B2
6730042 Fulton May 2004 B2
6749554 Snow et al. Jun 2004 B1
6774278 Ragheb et al. Aug 2004 B1
7049346 Van Bladel et al. May 2006 B1
7713552 Bleyer et al. May 2010 B2
20010034528 Foerster Oct 2001 A1
20020007130 Burbank Jan 2002 A1
20020016555 Ritchard Feb 2002 A1
20020019640 McGuckin, Jr. Feb 2002 A1
20020026201 Foerster Feb 2002 A1
20020026234 Li Feb 2002 A1
20020035324 Sirimanne Mar 2002 A1
20020107437 Sirimanne Aug 2002 A1
20020193815 Foerster Dec 2002 A1
20040049126 Zarins Mar 2004 A1
20040049269 Corbitt Mar 2004 A1
20040204660 Fulton Oct 2004 A1
20040210160 Fulton Oct 2004 A1
20040267155 Fulton Dec 2004 A1
20050020916 MacFarlane Jan 2005 A1
Foreign Referenced Citations (32)
Number Date Country
935625 Nov 1955 DE
3913935 Apr 1989 DE
4330958 Mar 1995 DE
4403789 Aug 1995 DE
146699 Sep 1987 EP
0255123 Feb 1988 EP
0350043 Apr 1990 EP
0481685 Oct 1991 EP
0534696 Mar 1993 EP
0769281 Apr 1997 EP
0293605 Dec 1998 EP
0894503 Mar 1999 EP
0966920 Dec 1999 EP
0983749 Mar 2000 EP
2714284 Jun 1995 FR
2020557 Nov 1979 GB
2132091 Jul 1984 GB
2001-510700 May 2001 JP
WO 9015576 Dec 1990 WO
WO 9314712 May 1993 WO
WO 9319803 Oct 1993 WO
WO 9520370 Jan 1995 WO
WO 9608208 Mar 1996 WO
WO 9806346 Feb 1998 WO
WO 9810712 Mar 1998 WO
WO 9847430 Oct 1998 WO
WO 9904704 Feb 1999 WO
WO 0012009 Mar 2000 WO
WO 0012010 Mar 2000 WO
WO 0038579 Jul 2000 WO
WO 0205717 Jan 2002 WO
WO 02205717 Jan 2002 WO
Non-Patent Literature Citations (11)
Entry
Clarkson, P.: “Sponge Implants for Flat Breasts,” Proceedings of the Royal Society of Medicine, vol. 53 at 880-881 (1960).
Dufrane, P. et al., “Prebiopsy Localization of Non-Palpable Breast Cancer,” Journal Beige de Radiologies, vol. 73, No. 5, pp. 401-404 (Oct. 1, 1990).
Fournier et al: “Experimental Studies and Preliminary Clinical Trial of Vinorelbine-loaded Polymeric Bioresorbable Implants for the Local Treatment of Solid Tumors”, Cancer Research 51, pp. 5384-5391, Oct. 1, 1991.
Ginde, Rajiv M., and Gupta, Rakesh K., “In Vitro Chemical Degradation of Poly (Glycolic Acid) Pellets and Fibers,” Journal of Applied Polymer Science, vol. 33, pp. 2411-2429 (1987).
Hoffmann et al: “Biodegradable Implants in Orthopaedic Surgery—A Review on the State-of-the-Art,”; Clinical Materials; vol. 10, 1992; pp. 75-80.
Hoffmann: “Biodegradable Implants in Traumatology: Review on the State-of-the-Art,”; Arch Orthop Trauma Surg (1995) 114:123-132 .
Pangman, W.J. and Wallace, R.M.: “The Use of Plastic Prosthesis in Breast Plastic and Other Soft Tissue Surgery,” The Western Journal of Surgery, Obstetrics and Gynecology at 508 (Aug. 1955).
Hussman et al., “Optical Breast Lesion Localization Fiber: Preclinical Testing of a New Device,” Radiology, 200:865-866 (Sep. 1996).
Hussman et al., “MR Mammographic Localization Work in Progress,” Radiology, 189:915-917 (1993).
“Surgical Treatment of Breast Disease, Making the Diagnosis of Breast Cancer: Non-Palpable Breast Masses,” BreastDoctor.com, http:/www.breastdoctor.com/breast/surgery/biopsy.htm.
“Surgical Treatment of Breast Disease: What's New? Diagnosing Breast Cancer: The ABBI Breast Biopsy System,” BreastDoctor.com, http://breastdoctor.com/breast/surgery/abbi.htm.
Related Publications (1)
Number Date Country
20050033195 A1 Feb 2005 US
Provisional Applications (4)
Number Date Country
60117421 Jan 1999 US
60114863 Jan 1999 US
60092734 Jul 1998 US
60090243 Jun 1998 US
Continuations (4)
Number Date Country
Parent 10839112 May 2004 US
Child 10943433 US
Parent 10027157 Dec 2001 US
Child 10839112 US
Parent 09900801 Jul 2001 US
Child 10027157 US
Parent 09336360 Jun 1999 US
Child 09900801 US