111111
`
`1111111111111111111111111111111111111111111111111111111111111
`US008288745B2
`
`(12) United States Patent
`Corbitt et al.
`
`(10) Patent No.:
`(45) Date of Patent:
`
`US 8,288,745 B2
`Oct. 16, 2012
`
`(54) METHOD OF UTILIZlNG AN l:i\1PLANT FOR
`TARGETI:NG EXTERNAL BEAM RADLUION
`
`(75)
`
`Inventors: John Corbitt, Atlantis, FL (US); Lori
`Anthony, Atlantis, PL (US)
`
`(73) Assignee: Senorx, [nc .. lrvine, CA (US)
`
`( *) Notice:
`
`Subject to any disclaimer, the term of tills
`patent is extended or adjusted under 35
`U .S.C. 154(b) by II 06 days.
`
`(21) Appl. No.: 12/110,748
`
`(22) Filed:
`
`Apr. 28, 2008
`
`(65)
`
`Prior Publication l)ata
`
`US 2008/0281388 A1
`
`Nov. 13, 2008
`
`Related U.S. Application Data
`
`(60) Continuation-in-part of application No. 11/ 108,785,
`filed on Apr. 19, 2005, now Pat. No. 7,637,948, which
`application No.
`is a
`continuation-in-part of
`10/627,7 18, filed on Jul. 28, 2003, now Pat. No.
`6,881 ,226, wruch is a continuation of application No.
`09/828.806, filed on Apr. 10, 2001 , now Pat. No.
`6,638,308, wruch is a division of application No.
`09/ !69,351 , filed on Oct. 9, 1998, now Pat. No.
`6,214.045.
`
`(60) Provisional application No. 60/061 ,588, filed on Oct.
`10, 1997, provisional application No. 60/077,639,
`filed on Mar. 11 , 1998, provisional application No.
`60/091 ,306, filed on Jun. 30, 1998.
`
`(51)
`
`[nt.CI.
`(2006.01)
`A61F 7100
`(52) U.S. C1. .. ........ 250/515.1; 250/492. 1; 60011 ; 600/2;
`607/ 108; 62317; 623/8; 623/23.75; 606177;
`424/400
`
`(58) Field of Classification Search ............... 250/515.1 ,
`250/492.1; 600/l , 2; 607/108; 62317, 8,
`623/23.75; 606177; 424/400
`See application file for complete search history.
`
`(56)
`
`References Cited
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`
`(Continued)
`
`Primary Examiner - Michael Logie
`
`ABSTRACT
`(57)
`A novel method of partial breast radiation utilizing a breast
`implant wbicb can provide a stable and improved target for
`stereotactic radiation treatment.
`
`30 Claims, 8 nrawing Sheets
`
`Focal Exhibit 1001 Page 1
`
`

`
`US 8,288,745 B2
`Page2
`
`U.S. PATENT DOCUMENTS
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`Written Opinion of the International Searching authority of PCT/
`US2009/00255l mailed Jul. 10,2009.
`Eisclt. P. et al, "Development ofTecbnologies Aiding Large-Tissue
`Engineering". Biotecbnol. Prog., vol. 14. No. I, pp. 134-140,1998.
`* cited by examiner
`
`Focal Exhibit 1001 Page 2
`
`

`
`U.S. Patent
`
`Oct. 16, 2012
`
`Sheet 1 of 8
`
`US 8,288,745 B2
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`100
`'\0
`
`Fl6.1
`
`Focal Exhibit 1001 Page 3
`
`

`
`U.S. Patent
`
`Oct. 16, 2012
`
`Sheet 2 of 8
`
`US 8,288,745 B2
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`12.0
`100
`110
`
`Fl6.2.
`
`Focal Exhibit 1001 Page 4
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`

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`U.S. Patent
`
`Oct. 16, 2012
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`Sheet 3 of 8
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`US 8,288,745 B2
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`100
`170
`110
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`Fl6.3
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`Focal Exhibit 1001 Page 5
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`

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`U.S. Patent
`
`Oct. 16, 2012
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`Sheet 4 of 8
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`US 8,288,745 B2
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`170
`J20
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`f{oO
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`fl6.'t
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`Focal Exhibit 1001 Page 6
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`

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`U.S. Patent
`
`Oct. 16, 2012
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`Sheet 5 of 8
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`US 8,288,745 B2
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`FIG 5a
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`Focal Exhibit 1001 Page 7
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`

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`U.S. Patent
`
`Oct. 16, 2012
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`Sheet 6 of 8
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`US 8,288,745 B2
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`100
`110
`
`FIG.~b
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`Focal Exhibit 1001 Page 8
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`

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`U.S. Patent
`
`Oct. 16, 2012
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`Sheet 7 of 8
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`US 8,288,745 B2
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`fl6.lo
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`Focal Exhibit 1001 Page 9
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`

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`U.S. Patent
`
`Oct. 16, 2012
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`Sheet 8 of 8
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`US 8,288,745 B2
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`100
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`120
`110
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`Focal Exhibit 1001 Page 10
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`

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`us 8,288,745 82
`
`1
`METHOD OF UTILIZlNG AN IMPLANT FOR
`TARGETING EXTERNAL BEAM RADIATION
`
`STATEMENT OF PRIORITY
`
`TI1is application is a contin uation in part of U.S. patent
`application Ser. No. I 1/108.785 filed on Apr. 19, 2005 now
`U.S. Pat. No. 7 ,63 7. 948 which is a continuation in part ofU .S.
`patent application Ser. No. 10/627,7 I 8 tiled Jul. 28, 2003,
`now U.S. Pat. No. 6,881 ,226, which is a continuation of U.S.
`patent application Ser. No. 09/828,806 filed Apr. l 0, 200 I,
`now U.S. Pat. No. 6.638,308, wbjcb is a division of U.S.
`patent application Ser. No. 09/ 169.351. filed Oct. 9, 1998,
`now U.S. Pat. No. 6,214,045, which claims the benefitofU.S.
`Provisional Application Ser. No. 60/061.588, filed Oct. 10,
`1997, U .S. Provisional Application Ser. No. 60/077,639 filed
`Mar. I L 1998, and U.S. Provisional Application Ser. No.
`60/091.306, filed Jun. 30, 1998. the disclosures of which are
`incorporated herein by reference.
`
`BACKGROUND OF THE INVENTION
`
`Radiation for breast cancer currently mainly consists of
`full breast radiation, which imparts radiotherapy to the f11ll
`area of the breast. It necessarily involves surrounding struc(cid:173)
`t1Jres such as, but notlin1ited to the heart, lungs, esophagus,
`chest wall, ribs and other structure-'S t11at are in close proximity
`to the breast. A new concept of partial breast radiation target(cid:173)
`ing the area of the breast involved by cancer is currently
`gaining popularity. sn.dies thus far indicate that it is as effec(cid:173)
`tive as full breast radiation and eliminates damage to the
`surrounding organs. Partial breast radiation is currcnlly being
`delivered lhrougb temporarily implanted balloon catheters
`such as but not limited to the MAMMOSJTE or the CON(cid:173)
`TVRA. Ths process involves placing a radioactive seed or
`target down the catheter for a brief period of tin1e, over three
`to five days. Unforttmately, this method of utilizing a catheter
`and radioactive seed bas a number of drawbacks. Utilizing a
`concentrated dose of radiation over a short period of time in
`the form of a radioactive seed planted through means of the
`catheter or o1her surgical means creates a mul1itude of side
`effects such as fat necrosis, seromas, hematomas, infection
`and undesirable cosmetic outcomes. When a lumpectomy is
`performed. a temporary balloon catheter is put into place with
`the catheter extmding fromt11e breast. This allows an opening
`into the cavity which increase the chru1ce of infection. Fur(cid:173)
`t1Jennore, this method requires the physician to wait for the
`pathology report to indicate margins of the specimen to be
`free of cancer (as well as the absence of cancer from the
`lymph nodes) before the temporary balloon can be removed
`and a Manllllosite, Contura or other external catheters can be
`implru1ted in preparation for partial breast radiation t11erapy.
`This sequence of procedures is preferred as soon as possible
`following lumpectomy. An additional drawback to the cath(cid:173)
`eter methodology is the need to aspirate air from the Jumpec(cid:173)
`tomy cavity. Air in a lumpectomy cavity creates "hot spots" or
`high heat conditions within tlle cavity when subjected to
`radiation therapy, thereby causing burns and other undesir(cid:173)
`able side effects. Accordingly, it is desirable to aspirate or
`remove the ai.r, most commonly with a syringe and needle.
`Unfo111mately. the current method catheter may be ptmcn•red
`by the needle during aspiration, creating problems for its
`subsequent use and effectiveness in treatment. These prob(cid:173)
`lems are resolved by use of the proposed method. We propose
`the use of external beam radiation delivered through a multi(cid:173)
`directional stereotactic radiation source such as but not lim(cid:173)
`ited to the CYBERKNIFE, the BRAIN LAB, and otl1er exter-
`
`2
`nal beam sources. However, external beam radiation requires
`a sufficiently identifiable target. Currently, external beam
`radiation is used on solid organs such as the liver that contains
`a tumor or the bead of the pancreas that contains a nunor
`5 whereby a gold seed is implanted in these structures and acts
`as a guide for focusing the extemal stereotactic beam. The
`solid tissue of these organs provides a stable, non-shifting
`environment for placement of the seed which acts as a target
`tor d1e external beam source. The use of the catheter in breast
`10 tissue has been previously necessary due to the presence of
`primarily fatty tissue in the breast, precluding a stable envi(cid:173)
`rotmJent for placement of a small setJd ortarget.ln fatty tissue,
`a small seed or target would move from the intended target
`site. rendering the tllerapy ineffective. The breast is an exter-
`15 nal structure, constmcted primarily offatty tissue. unlike the
`other mentioned organs. Consequently, what is necessary
`then, is a means of stabil izing a seed or od1er target source
`within the fany tissue of the breast, which seed or other target
`source may then be utilized as a target in a new method of
`20 partial breast radiation. The proposed invention addresses this
`problem. Being an external structure also, tlle breast is also
`capable of being more rigidly fixed for targeting in stereotac(cid:173)
`tic radiation machines than the intemal organs and is tllere(cid:173)
`fore a good candidate for utilizing partial irradiation through
`25 careful targeting of the intemal .implant and/or marker.
`U.S. Pat. No. 6,214,045, issued to the applicant, discloses
`a breast implant of resorbable material sized to replace
`excised tissue and allowing for in-growth of fibrous tissue to
`replace tlle implant. The implant may be elastic. compress-
`30 ible, and expandable and may further contain diagnostic sub(cid:173)
`stances. TI1e specification ofU .S. Pat. No. 6,2 14,045 is incor(cid:173)
`porated by reference herein. Certain diagnoslie substances
`are identified in the '045 patent as "x-ray opaque or metallic
`material for identification of the area." Many embodiments of
`35 the implants described in the '045 patent may act as appro(cid:173)
`priate targets for stereotactic radiation sources as radiopaque
`targets. Biodegradable materials such as, but not limited to.
`collagen and otl1er suitably dense biocompatible materials,
`may be configured suitably radiopaque. The implants may
`40 alternatively be constructed of two or more differelllmateri(cid:173)
`als or contain large amounts of air, which will a lso aid in
`acquisition and targeting by a suitable stereotactic radiation
`source. The implant may be shaped spherical to keep the
`lumpectomy cavity open in a more uniform manner however
`45 this is not always necessary as the lumpectomy cavity created
`by a biopsy procedure can be allowed to partially collapse and
`conform to the size or shape of the implant. Consequently. the
`implant shape may guide the external beam source in order to
`allow a more specific area of the cavity to be radiated on one
`so side or the other, or uniformly circumferentially in the event
`of utilizing a spherical implant. Particularly when compared
`with the previously disclosed catheter methodology, the abil(cid:173)
`ity to utilize variously shaped implants is superior to the
`catheter, which is spherically shaped. in the event it is neces-
`55 sary to constmct a non-sphericallumpectomy cavity to obtain
`the desired margins upon removal of the cancer. The implant
`itself may act as the radio-opaq11e target or may have added to,
`more or less, the central portion of the implant, a tiny metallic
`marker such as but not limited to a gold seed or a tit-anium seed
`60 to further aid as a gt1ide for ilie external beam. To confonu
`with desired diagnostic needs and procedures. more than one
`marker may be utilized in a single implant or more than one
`implant, placed within the lumpectomy cavity. Different
`marker materials may be contained within a single inlplant or
`65 within more than one implant placed within the ltunpectomy
`cavity. Any metallic material, suitably steri lized. or other
`relatively dense biocompatible material, may be utilized as a
`
`Focal Exhibit 1001 Page 11
`
`

`
`us 8,288,745 82
`
`10
`
`3
`markerwitb.in the implant. Where the external beam radiation
`is uti lized, it accomplishes local brachytherapy with its ben(cid:173)
`efits and the beam can be configured over varying time peri(cid:173)
`ods so as to eliminate many of the complications associated
`with the current method of partial breast radiation, the balloon 5
`ManunoSite or Contura. Use of the implants described in the
`'045 patent, addresses a multitude of the current problems
`known to the medical industry such as but not limited to
`cosmetic deformities, seromas, hematomas, infection and the
`like wlule simultaneously providing the stable target neces-
`sary for successful targeted radiation therapy. The 045
`implants are config11red to keep the cavity open and support
`the surrounding tissue. This is particularly important in radia(cid:173)
`tion therapy as new tissue growth will be iuhibited by the 15
`presence of radiation therapy. Accordingly, tb.is method and
`use of the implant will enable the IU111pectomy site to retain its
`configuration throughout radiation therapy and thereafter
`provide time for regeneration and in-growth of new tissue
`upon tem1ination of radiation therapy. Once the external 20
`beam radiation is accomplished, the implant may biodegrade
`over a period of rime allowing ingrowth of the patient's own
`natural tissues and, therefore reduce the risk of undesirable
`cosmetic changes to the overlying skin or the breast. 1t may
`also have added to d1e implant hemostatic agents to minimize 25
`bleeding, other metallic markers, oncologic ageuts, antibiot-
`ics and the like.
`A11other advantage in the use of t11e implant for targeted
`partial breast radiation therapy is that the biodegradable
`implant can be inserted into the breast at the time of the 30
`lumpectomy but radiatiou therapy my be delayed without
`presenting complications in the maintenance ofd1e targeting
`means, treatment or to the patient. With the use of the catheter
`methodology, the externally extruding catheter and its prior
`discussed issues necessitates immediate radiation therapy
`treatment to minimize, to the extent possible, poteutial com(cid:173)
`plications such as infection and discomfort to the patient.
`Immediate radiation therapy is not always preferred because
`the surgical wound is fresh and has not healed. The use of 40
`radiatiouli.trt:ber retards healing and promotes seroma fomla(cid:173)
`tion, infection, and cosmetic defects because of poor healiltg.
`The proposed meiliodology, utilizing dle implant, allows the
`implant to be placed in dle lumpectomy cavity and the wound
`surgically sealed. The patient may maintain a normal lifestyle 45
`and radiation tl1erapy may be scheduled as appropriate in the
`particular case. The patient may undergo chemoilierapy and
`can delay radiation therapy up to about 120 days without
`decreasing the therapeutic effects of the radiation. l11e
`implant may degrade somewhat over a period of time while 50
`the breast is heal ing to allow the IUlllpectomy cavity to com(cid:173)
`press down upon the implant or scar down arotmd the implant
`shrinking the cavity and stabilizing the target for future radia(cid:173)
`tion. Future radiation therapy may be initiated many days or
`weeks after tbe lumpectomy. Radiation therapy may be dis- 55
`continued, if necessary, and re-instituted as necessary, witJ1in
`the life of the biodegradable implant or. in the case of a
`marker, at any time thereafter. This accomplishes the preven(cid:173)
`tion of hematomas or seromas, resulting in a better cosmetic
`outcome while maintaining a stable target for future therapy 60
`or diagnosis.
`
`35
`
`DESCRIPTION OF THE DR.J.\.WINGS
`
`FIG. 1 depicts one embodiment of au implant placed within 65
`a breast lumpectomy cavity to act as a target for radiation
`therapy emissions.
`
`4
`FIG. 2 depicts an alternative embodiment of an implant
`placed within a breast ltm1pectomy cavity and containing an
`internal marker to act as a target for radiation therapy emis(cid:173)
`sions.
`FIG. 3 depicts one example of an implant placed within a
`breast lumpectomy cavity an d subjected to radiation therapy
`emissions.
`FIG. 4 depicts an alternative embodiment of an implant
`containing an internal marker to act as a target for radiation
`therapy emissions.
`FIGS. SA and SB depict implants of various shapes and
`configurations placed witJ1in breast lumpectomy cavities.
`FJG. 6 depicts a partially re-absorbed implant within a
`shrinking breast huupectomy cavity.
`FIG. 7 depicts a partially re-absorbed implant containing a
`metallic marker witb.in a shrinking breast lumpectomy cavity.
`
`DETAILED DESCRIPTION OF THE DRAWINGS
`
`ln FIG. l , a substantially spherical implant (100) is com(cid:173)
`posed of biodegradable material and is placed within a breast
`lumpectomy cavity (11 0) following a biopsy or other surgical
`procedure.l11e implant may be constructed of materials such
`as biodegradable foams, sponges, gels, liquids. or other bio(cid:173)
`compatible substances. The material is formed in such a way
`tbat it can support surrounding breast tissue, assisting in
`breast cosmesis by keeping the breast lumpectomy cavity
`from collapsing. The implant further ftmctions as a radio(cid:173)
`opaque target for external beam stereotactic partial breast
`radiotherapy. The implant can be constntcted with varying
`pore sizes thus allowing for example, more air to be incorpo(cid:173)
`rated into the implant, rendering the implant more radio(cid:173)
`opaque wl1ile preventing t11e collection of air pockets within
`the breast cavity which create unsuitable conditions for radia(cid:173)
`tion therapy. The implant does not need to be the exact size of
`the lumpectomy cavity, however. Breast tissue will collapse
`arotmd ilie implant, keeping the cavity open and relative ly
`equal distance from t11e center o f t11e implant. The implant is
`of a sufficient size and solid consistency to allow a stereotac(cid:173)
`tic radiation source to be directed to the implant as a target for
`delivery of radiation therapy to the surrounding margins of
`the lumpectomy cavity in a precise configuration as deter(cid:173)
`mined by the radiotherapist.
`In FIG. 2. the implant (100) of FIG. 1 further contains a
`gold seed, metallic seed, titanium clip or other suitably dense
`in1plru11 material (120) to aid in successful targeting of the
`implant area for a stereotactic radiation source. Since margins
`can vary ·from patient to patient, the use of an implant material
`can serve as a g11ide for programming the stereotactic radia(cid:173)
`tion unit. The target material may be centrally located within
`the implant or located about the periphery of the implant. One
`or more implant materials may be concurrently used as nec(cid:173)
`essary to conform the intended radiation therapy to the
`patient's breast cancer treatment. As t11e target material may
`or may not be biodegradable, the implant material may
`remain available for extended radiation therapy as necessary.
`Biodegradable material may have variable absorption rates.
`In FIG. 3, an example of multi-directional (stereotactic)
`radiation therapy (160) targets a breast implant (100) in the
`breast lumpectomy cavity (110), partially irradiating the
`breast within targeted margins (170) around the lumpectomy
`cavity (110).
`In FIG. 4, an example of multi-directional (stereotactic)
`radiation therapy (160) targets a breast implant (1 00) contain(cid:173)
`ing an internal marker (120), in the breast lumpectomy cavity
`(110). partially irradiating the breast within targeted margins
`(170) around t11e lumpectomy cavity (110).
`
`Focal Exhibit 1001 Page 12
`
`

`
`us 8,288,745 8 2
`
`5
`In FIG. SA and FIG. SB, an implant (100) in the breast
`lumpectomy cavity (110) may be configured to confonn to
`the ltUnpectomy cavity excised to create sufficient margins
`for excision of cancer or in accordance with good medical
`practice for the surgical procedure. The ability to coufom1 the 5
`implant to the cavity allows appropriate margins to be main(cid:173)
`tained for following radiation treatment and supports the
`surrounding breast tissue without deformation.
`ln FIG. 6. the implant (100) has partially reabsorbed as a
`consequence of the passage of time. Unlike the prior art
`catheter, the implant can act as a target to the biopsy site for
`weeks or months after implantation, to allow for healing,
`chemotl1erapy or otl1er issues necessitating a delay in radia(cid:173)
`tion treatment. The surrounding breast tissue comprising the
`lumpectomy cavity collapses or generates growth as the
`implant resorbs, holding tl1e implant in place and the geom(cid:173)
`etry of the breast tissue in static relation.
`In FIG. 7, the resorbing implant (100) also contains one or
`more markers (120) to aid intargeting.Again, the implant and
`marker allow the treating physician to delay radiatiou treat(cid:173)
`ment pending healing, chemotherapy or other favorable rea(cid:173)
`sons for delay.
`
`6
`10. The method of claim 1, wherein the radiation therapy is
`delivery of a therapeutically effective dosage of radiation to
`said breast tissue surrounding tl1e implant via 3-D coufom1al
`radiation therapy.
`11. TI1e method of claim 10 further comprising the step of
`i11itiating targeting of a radiation beam for delivery of radia(cid:173)
`tion therapy occurs about 1-90 days subsequent placement of
`the implant.
`12. The method of claim 1, wherein tl1e radiation tl1erapy is
`1 o del ivcry of a therapeutically effective dosage of radiation to
`said breast tissue surrotU1ding the implant via intensity modu(cid:173)
`lated radiatiou therapy.
`13. 11Je method of claim l , wherein the breast cavity is a
`lumpectomy cavity, and further comprising the step of aspi(cid:173)
`t5 rating air from the lumpectomy cavity at any time after place(cid:173)
`ment of ilie implant.
`14. The method of claim 1 further comprising the step of
`initiating targeting of a radiation beam for delivery of radia(cid:173)
`tion therapy occurs about 1-90 days subsequent placement of
`20 the implant.
`15. The method of claim 1 f·urther comprising the steps of
`initiating chemotherapy and thereafter. initiating targeting of
`a radiation beam for delivery of radiation therapy occurs up to
`120 days subsequent placement of the implant.
`16. TI1e method of claim 1, wherein said substantially
`radio-opaque implant has a shape selected to guide the deliv(cid:173)
`ery of radiation therapy to the margins around said breast
`cavity.
`17. The method of claim 1, wherein said substantially
`radio-opaque implrulf is constmcted of a porous material.
`18. A method of partial breast radiation comprising the
`steps of:
`placi11g witl1in a breast lumpectomy cavity an implant cou(cid:173)
`stmcted of biocompatible and biodegradable material
`with a substantially radio-opaque marker contained
`within the implant, and said implant supporting the tis-
`sue surrounding the breast lumpectomy cavity; and
`directing a radiation beam to said implant, said substan(cid:173)
`tially radio-opaqtie marker within said implant serving
`as a target for delivery of radiation therapy to margins
`around the breast cavity, such that the radiation beam
`does not materially irradiate the whole of the breast.
`19. The method of claim 18, wherein the radiation therapy
`is delivery of a therapeutically effective dosage of radiation to
`said breast tissue sttrrotmding the implru1t or marker via a
`stereotactic radiation machine.
`20.111e method of claim 18, wherein the radiation therapy
`is delivery of multiple therapeutically effective dosages of
`radiation to said breast tissue surrounding the implant or
`marker in a single treatment via a stereotactic radiation
`machine.
`21.1l1e method ofclaim 18, wherein the radiation therapy
`is delivery of a therapeutically effective dosage of radiation to
`said breast tissue surrounding the implant or marker via mul(cid:173)
`tidirectional radiation therapy.
`22. The method of claim 18, wherein the radiation therapy
`is delivery of a therapeutically effective dosage of radiation to
`said breast tissue surrounding the implant or marker via
`image guided radiation therapy.
`23. ·nle method of claim 18, wherein t11e radiation therapy
`is delivery of a therapeutically effective dosage of radiation to
`said breast tissue surrounding the implant or marker via 3-D
`conformal radiation therapy.
`24. The method of claim 18, wherein the radiation therapy
`is delivery of a therapeutically effective dosage of radiation to
`said breast tissue surrounding tl1e implant or marker via inten(cid:173)
`sity modulated radiation therapy.
`
`35
`
`What is claimed is:
`l. A method of partial breast radiation therapy comprising 25
`the steps of:
`placing within a breast cavity a subst~mt ially radio-opaque
`implant constntcted of biocompatible and biodegrad(cid:173)
`able material, said substantially radio-opaque in1plant
`supporting tl1e tissue surrounding tl1e breast cavity; and 30
`directing a radiation beam to said substantially radio(cid:173)
`opaque implant serving as a target for del ivery of radia(cid:173)
`tion therapy to margins around the breast cavity. sucb
`that the radiation beam does not materially irradiate the
`whole of the breast.
`2. Tbe method of claim 1, wherein the radiation therapy is
`delivery of a therapeutically effective dosage of radiation to
`said breast tissue surrotmding the implant via a stereotactic
`radiation machine.
`3. The method of claim 2, wherein the radiation therapy is 40
`delivery of multiple therapeutically effective dosages of
`radiation to said breast tissue surrOtmding the implant in a
`single treatment via a stereotactic radiation machine.
`4. The method of claim 2, wherein the radiation therapy is
`del ivery of therapeutically eftective dosages of radiation to 45
`said breast tissue surrounding the implant multiple times in a
`single treatment via a stereotactic radiation machine.
`5. The method of claim 2 further comprising the step of
`initiating targeting of a radiation beam for delivery of radia(cid:173)
`tion therapy occurs about 1-90 days subsequent placement of 50
`the implant.
`6. The method ofclaim l , wherein the radiation ilierapy is
`delivery of a therapeutically effective dosage of radiation to
`said breast tissue surrounding tl1e implant via multidirec-
`tional radiation therapy.
`7. The method of claim 6 fur ther comprising the step of
`initiating targeting of a radiation beam for delivery of radia(cid:173)
`tion therapy occurs about 1 -90 days subsequent placement of
`the implant.
`8. The metl10d of claim 1, wherein the radiation therapy .is 60
`delivery of a therapeutically effective dosage of radiation to
`said breast tissue surrounding the implant via image guided
`radiation therapy.
`9. The method of claim 8 further comprising the step of
`initiating targeting of a radiation beam for delivery of radia- 65
`tion therapy occurs about 1-90 days subsequent placement of
`ilie implant.
`
`55
`
`Focal Exhibit 1001 Page 13
`
`

`
`us 8,288,745 8 2
`
`7
`25. The method of claim 18 further comprising the step of
`aspirating air from the breast lumpcctomy cavity at any time
`after placement of the implant.
`26. The method of claim 18 further comprising the step of
`initiating targeting of a radiation beam for delivery of radia(cid:173)
`tion therapy occurs about 1-90 days subsequent placement of
`the implant.
`27. 'llte method of claim 18 further comprising the step o f
`initiating targeting of a radiation beam for delivery of radia(cid:173)
`tion therapy occurs about 1-90 days subsequent placement of
`the implant.
`28. "llte method o f claim 18 further comprising the steps of
`initiating chemotherapy and thereafter, initiating targeting of
`
`8
`a radiation beam for delivery ofradiation tberapyoccurs up to
`120 days subsequent placement of the implant.
`29. lbe method of claim 18. wherein said implant has a
`shape selected to guide the delivery of radiation therapy to the
`s margins around said breast lumpectomy cavity.
`30. The method of claim 18. wherein the subslantially
`radio-opaque marker is a radio-opaque element centrally
`located within said implant, said radio-opaque element being
`constructed from a material different from the material from
`10 which said implant is constructed.
`
`* * • • *
`
`Focal Exhibit 1001 Page 14