US20080188768A1 - Biopsy marker delivery system - Google Patents

Biopsy marker delivery system Download PDF

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Publication number
US20080188768A1
US20080188768A1 US11/496,830 US49683006A US2008188768A1 US 20080188768 A1 US20080188768 A1 US 20080188768A1 US 49683006 A US49683006 A US 49683006A US 2008188768 A1 US2008188768 A1 US 2008188768A1
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United States
Prior art keywords
marker
rod
method
biopsy
body
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Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Abandoned
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US11/496,830
Inventor
Sascha Zarins
Steven Kim
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Devicor Medical Products Inc
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Ethicon Endo Surgery Inc
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Filing date
Publication date
Priority to US09/954,792 priority Critical patent/US6605047B2/en
Priority to US10/639,050 priority patent/US7083576B2/en
Application filed by Ethicon Endo Surgery Inc filed Critical Ethicon Endo Surgery Inc
Priority to US11/496,830 priority patent/US20080188768A1/en
Assigned to ETHICON ENDO-SURGERY, INC. reassignment ETHICON ENDO-SURGERY, INC. ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: VIVANT MEDICAL, INC.
Assigned to ETHICON ENDO-SURGERY, INC. reassignment ETHICON ENDO-SURGERY, INC. ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: VIVANT MEDICAL, INC.
Publication of US20080188768A1 publication Critical patent/US20080188768A1/en
Assigned to DEVICOR MEDICAL PRODUCTS, INC. reassignment DEVICOR MEDICAL PRODUCTS, INC. ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: ETHICON ENDO-SURGERY, INC.
Assigned to GENERAL ELECTRIC CAPITAL CORPORATION, AS AGENT reassignment GENERAL ELECTRIC CAPITAL CORPORATION, AS AGENT SECURITY AGREEMENT Assignors: DEVICOR MEDICAL PRODUCTS, INC.
Application status is Abandoned legal-status Critical

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
    • A61B10/02Instruments for taking cell samples or for biopsy
    • A61B10/0233Pointed or sharp biopsy instruments
    • A61B10/0266Pointed or sharp biopsy instruments means for severing sample
    • A61B10/0275Pointed or sharp biopsy instruments means for severing sample with sample notch, e.g. on the side of inner stylet
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/39Markers, e.g. radio-opaque or breast lesions markers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
    • A61B10/02Instruments for taking cell samples or for biopsy
    • A61B10/0233Pointed or sharp biopsy instruments
    • A61B10/0283Pointed or sharp biopsy instruments with vacuum aspiration, e.g. caused by retractable plunger or by connected syringe
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00535Surgical instruments, devices or methods, e.g. tourniquets pneumatically or hydraulically operated
    • A61B2017/00539Surgical instruments, devices or methods, e.g. tourniquets pneumatically or hydraulically operated hydraulically
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/03Automatic limiting or abutting means, e.g. for safety
    • A61B2090/033Abutting means, stops, e.g. abutting on tissue or skin
    • A61B2090/034Abutting means, stops, e.g. abutting on tissue or skin abutting on parts of the device itself
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/03Automatic limiting or abutting means, e.g. for safety
    • A61B2090/038Automatic limiting or abutting means, e.g. for safety during shipment
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/39Markers, e.g. radio-opaque or breast lesions markers
    • A61B2090/3987Applicators for implanting markers

Abstract

A method for marking a biopsy cavity using a delivery device is provided. The delivery device may include a tube having a lumen and a side exit port communicating with the lumen, a rod slideably located in the lumen of the tube, and a tissue marker removably located at the distal end of the tube. The tissue marker may include a bioabsorbable material and a radiopaque marker. The radiopaque marker may be a metal band, a metal wire, or identified with a number, letter, symbol, or combination thereof.

Description

    RELATED APPLICATIONS
  • This is a continuation of U.S. application Ser. No. 10/639,050, filed on Aug. 11, 2003, which is a continuation of U.S. application Ser. No. 09/954,792, filed on Sep. 10, 2001, which issued as U.S. Pat. No. 6,605,047, both of which are hereby expressly incorporated by reference in their entirety.
  • FIELD OF THE INVENTION
  • This invention is directed to delivery devices for delivering subcutaneous cavity marking devices. More particularly, the delivery device may be used with biopsy systems permitting efficient placement of a biopsy marker within a cavity. The device may include an intermediate member which assists in deployment of the marking device. The device may also include a deployment lock to prevent premature deployment of a biopsy marker. The invention may further include the capability to match an orientation of a biopsy probe that has been rotated upon procurement of a biopsy sample.
  • BACKGROUND OF THE INVENTION
  • Over 1.1 million breast biopsies are performed each year in the United States alone. Of these, about 80% of the lesions excised during biopsy are found to be benign while about 20% of these lesions are malignant.
  • In the field of breast cancer, stereotactically guided and percutaneous biopsy procedures have increased in frequency as well as in accuracy as modern imaging techniques allow the physician to locate lesions with ever-increasing precision. However, for any given biopsy procedure, a subsequent examination of the biopsy site is very often desirable. There is an important need to determine the location, most notably the center, as well as the orientation and periphery of the subcutaneous cavity from which the lesion is removed.
  • In those cases where the lesion is found to be benign, for example, a follow-up examination of the biopsy site is often performed to ensure the absence of any suspect tissue and the proper healing of the cavity from which the tissue was removed. This is also the case where the lesion is found to be malignant and the physician is confident that all suspect tissue was removed and the tissue in the region of the perimeter of the cavity is “clean”.
  • In some cases, however, the physician may be concerned that the initial biopsy failed to remove a sufficient amount of the lesion. Such a lesion is colloquially referred to as a “dirty lesion” or “having a dirty margin” and requires follow-up observation of any suspect tissue growth in the surrounding marginal area of the initial biopsy site. Thus, a re-excision of the original biopsy site must often be performed. In such a case, the perimeter of the cavity must be identified since the cavity may contain cancerous cells. Moreover, the site of the re-excised procedure itself requires follow-up examination, providing further impetus for accurate identification of the location of the re-excised site. Therefore, a new marker may be placed after re-excision.
  • While biopsy markers are well known, examples of improved biopsy markers are described in U.S. patent application Ser. No. 09/285,329 entitled “SUBCUTANEOUS CAVITY MARKING DEVICE AND METHOD” and 09/347,185 entitled “SUBCUTANEOUS CAVITY MARKING DEVICE AND METHOD” each of which is incorporated by reference herein. Placement of such biopsy markers may occur through either invasive surgical excision of the biopsy, or minimally invasive procedures such as fine needle aspiration or vacuum assisted biopsy.
  • In a fine needle aspiration biopsy, a small sample of cells is drawn by a thin needle from the lump or area of suspect tissue. If the suspect area or lump cannot be easily felt, non-invasive imaging may be used to help the doctor guide the needle into the right area. A core biopsy is similar to a fine needle aspiration biopsy, except that a larger needle is used. Under a local anesthetic, the doctor makes a very small incision in the patient's skin and removes several narrow sections of tissue from the suspect area of tissue through the same incision. The core biopsy provides a breast tissue sample rather than just individual cells. Thus making it easier for the pathologist to identify any abnormalities.
  • Vacuum-assisted biopsy is performed through the skin and may rely upon ultrasound or stereotactic guidance to determine the location of a suspect area of tissue. Two commonly used vacuum-assisted breast biopsy systems are Mammotome® supplied by Johnson & Johnson Ethicon Endo-surgery or MIBB® supplied by Tyco International. Examples of such devices may be found in U.S. Pat. No. 5,526,822 entitled “Methods and Apparatus for Automated Biopsy and Collection of Soft Tissue,” U.S. Pat. No. 5,649,547 entitled “Methods and Devices for Automated Biopsy and Collection,” U.S. Pat. No. 6,142,955 entitled “Biopsy Apparatus and Method” and U.S. Pat. No. 6,019,733 entitled “Biopsy Apparatus and Method” the entirety of each of which is incorporated by reference herein. Such breast biopsy systems include a probe that is inserted through the skin and is usually adapted to provide a vacuum to assist in obtaining the biopsy sample.
  • FIGS. 1A-1D illustrate an exemplary biopsy probe 10. As illustrated, the distal ends of probes 10 of these biopsy systems are adapted to both penetrate tissue and to contain a cutting member 12 which facilitates the removal of the biopsy sample. The cutting member 12 will contain an aperture 14 (often referred to as a “probe window.”) The aperture 14 may be located on a side of a probe 10.
  • Once inserted through the skin, the cutting member 12 of the probe 10 aligns with suspect tissue 1 via stereotactic, ultrasound, or other means. After proper positioning of the probe 10, a vacuum draws the breast tissue 1 through the probe aperture 14 into the probe 10. As illustrated in FIG. 1B, once the tissue 1 is in the probe 10, the cutting member 12 actuates to capture a tissue sample 3. The tissue sample 3 may then be retrieved through the probe 10 to a tissue collection area (e.g., a standard pathology tissue cassette). FIG. 1C illustrates the probe 10 after the tissue sample is cleared from the aperture 14. Note that the illustration depicts a portion of the cutting member 12 as being retracted, leaving aperture 14 open; the cutting member 12 may alternatively be placed in a closed position during retrieval of the tissue sample.
  • The biopsy system is often adapted such that the cutting member 12 and aperture 14 rotate (e.g., via manipulation of a thumbwheel on the probe or biopsy system) with respect to the biopsy system. After excision of a tissue sample from the area of suspect tissue, the radiologist or surgeon may rotate the probe 10 and the aperture 14 to a new position relative to the biopsy system. FIG. 1D illustrates the probe 10 and aperture 14 after being rotated but without being removed from the body. The rotation of the probe 10 and aperture 14 permits excision of multiple subsequent biopsy samples from a target area of suspect tissue with only a single insertion of the biopsy probe 10. It should be noted that FIG. 1D is provided merely to illustrate the rotation of the probe 10 within the body. As such, the placement of biopsy markers is not illustrated in the figure. Moreover, the cutting member 12 is depicted in a closed position. This may ease rotation of the probe 10 within the tissue.
  • The entire cycle may be repeated until sampling of all desired areas occurs (typically, 8 to 30 samples of breast tissue are taken up to 360 degrees around the suspect area). Accordingly, it is important that the operator of the biopsy system is able to identify the orientation of the probe aperture 14 relative to the biopsy system at any given time while the probe aperture 14 remains within the tissue. Often, demarcations on the thumbwheel permit the identification of the probe orientation.
  • The above described removal of tissue samples creates tissue cavities. Hence, for reasons that are apparent to those familiar with such biopsy procedures, placement of a biopsy marker through the probe is most desirable. For example, repeated removal of the probe and insertion of a biopsy marking device may cause unneeded additional discomfort to the patient undergoing the procedure; removal of the probe may introduce error in placement of the biopsy marker into the desired location; repeated removal and insertion of each of the devices may prolong the duration of the procedure or spread cancer cells; after the probe removes a tissue sample, it is in the optimal location to deposit a marker; etc.
  • Biopsies may be performed with other tissue sampling devices as described in U.S. Pat. Nos. 4,699,154; 4,944,308, and 4,953,558 the entirety of each of which is incorporated by reference herein. Such devices obtain a biopsy sample through a hollow biopsy needle having an aperture located in a distal end of the biopsy needle. As with the biopsy devices previously described, once the tissue sampling devices removes tissue and creates a biopsy cavity, it may be desirable to place a marker in the area of the biopsy cavity.
  • In view of the above, there remains a need for an improved biopsy marker delivery system that may facilitate placement of a biopsy marker and also may be used with commercially available biopsy systems.
  • SUMMARY OF THE INVENTION
  • This invention relates to delivery systems for delivery of biopsy cavity marking devices. A basic variation of the invention includes a tissue marker delivery device comprising a tube having a lumen extending there through, a tissue marker removably seated in a distal end of the tube, a rod slideably located within the tube lumen and having a first end extending through a proximal end of tube and a second end in the tube lumen; and an intermediate member separating the rod from the biopsy marker, where advancement of the rod in a distal direction displaces the intermediate member to displace the tissue marker from said marker seat. In a variation of this invention, the intermediate member is discrete from both the rod and the tissue marker. The intermediate member may comprise a flexible covering as described herein.
  • Another variation of the invention includes a delivery device for use with a biopsy probe having an aperture, the delivery device comprising a body having proximal and distal ends and a passageway extending therethrough, an elongate sheath having a lumen extending therethrough, the sheath extending distally from the distal end of the body, the sheath lumen in fluid communication with the body passageway, an access tube having a proximal and a distal end and a lumen extending from at least a portion of the access tube through the proximal end, the access tube slideably located within the body passageway and the sheath lumen, a marker seat located towards the distal end of the access tube, a rod slideably located within the access tube lumen and having a first end extending through the proximal end of the body and a second end in communication with the marker seat, wherein advancement of the rod in a distal direction advances the marker seat distally until the marker seat is adjacent to the probe aperture such that a marker in the marker seat may be deployed from the aperture. For example, when using a biopsy probe having an aperture in a side wall of the probe, the marker seat may be advanced within the aperture and subsequently deploys a marker. When the inventive device is used with biopsy probes having an aperture in a distal end of the probe, the marker seat may be advanced just proximal to the aperture in preparation for subsequent deployment of the marker.
  • The rod may advance the marker seat through a number of configurations. For example, the rod may be sized to have an interference fit with a portion of the access tube lumen. Another example includes a device configured such that the rod engages a marker which is situated in the marker seat. In such a case, a sheath may restrain the marker in the marker seat. Thus, until the marker is no longer constrained by the sheath, the rod will advance the marker within the sheath. In another variation, the rod may be in communication with a fluid that is itself in communication with the marker seat. In such a case, the rod may apply a force on the fluid to advance the marker seat and/or displace a marker from the marker seat. In some variations, the fluid may serve to displace a flexible covering out of the marker seat. It is contemplated that the rod of the present invention may advance the marker seat through a combination of configurations either described herein or known to those familiar with similar delivery devices.
  • A variation of the invention also includes a delivery device as described above, wherein the body father comprises a keyway along the passageway, and the body has an orientation being defined relative to the keyway, the delivery device further comprising an access tube key located on the access tube and adapted to be slideably located within the body keyway, the access tube key adapted to maintain an orientation of the access tube with the body orientation.
  • Variations of the invention may also include a deployment lock having a first end and a second end, the first end moveably located in the body and the second end located outside of the body, the first end adapted to engage a portion of the rod to prevent at least distal movement of the rod, whereupon disengagement of the first end of the deployment lock from the portion of the rod permits distal movement of the rod. The deployment lock may be removable from the device or may be moveable within the device so as to permit disengagement of the lock from the rod while still being attached to the body of the device.
  • The invention also may include a rod stop fixedly located on the rod, wherein after the rod is advanced into the marker seat, the rod stop engages the access tube stop preventing further distal movement of the rod. The rod stop may also include a rod key that is adapted to maintain an orientation of the rod with the body orientation.
  • A variation of the device includes an access tube stop fixedly located on a portion of the access tube being located within the body, wherein advancement of the rod in a distal direction advances the marker seat distally until the access tube stop engages the distal end of the body preventing further distal movement of the access tube whereupon further distal advancement of the rod advances into the marker seat. In one variation of the invention, engagement of the access tube stop against the distal end of the body places the marker seat adjacent to the biopsy probe aperture.
  • In another variation of the invention a portion of the distal end of the access tube is removed to define the marker seat. The invention may also include a covering located over at least the marker seat, where at least a portion of the covering is adapted to displace into and out of the marker seat. Movement of the rod into the marker seat displaces the covering out of the marker seat. In variations of the invention using such a covering, there is no direct contact between the actuator (e.g., rod, etc.) and a marker placed within the marker seat.
  • In another variation of the invention, the inventive device includes a delivery device key adapted to seat in the biopsy probe and maintain an orientation of the access tube with an orientation of the biopsy probe. The delivery device key may be located on the elongated sheath or on the body of the device. In some variations of the invention, seating the delivery device key in the biopsy probe will cause a distal end of the outer sheath to be placed immediately proximal to the biopsy probe aperture.
  • Variations of the invention also may include a biopsy marker that is seated in the marker seat.
  • Although the delivery device and method described herein for delivering a marking device to a subcutaneous cavity is suited for use with a biopsy probe, the invention is not necessarily limited as such. Variations of the inventive device may be used with any type of biopsy procedure.
  • The invention also contains a kit containing a biopsy marker delivery device as described herein and an introducer cannula. The introducer cannula may be used to facilitate insertion of the delivery device into the patient to assist in delivery of a biopsy marker. The kit may also include a biopsy probe. The biopsy probe may be a spring-loaded biopsy probe.
  • The invention also includes a method for marking a biopsy cavity. In one variation, the inventive method includes using a delivery device having a marker, a tube removably seating the marker, a rod within the tube, and an intermediate member separating the rod and the marker, the method comprising, advancing the marker and delivery device to the biopsy cavity, actuating the rod to displace the intermediate member on the delivery device; and depositing the marker in the cavity upon displacing the intermediate member.
  • BRIEF DESCRIPTION OF THE DRAWINGS
  • FIG. 1A illustrates biopsy probe for use with variations of the present invention.
  • FIG. 1B illustrates the biopsy probe of FIG. 1A in which tissue is drawn through an aperture of the probe for excision of a biopsy sample.
  • FIG. 1C illustrates the biopsy probe of FIG. 1A where the biopsy sample is cleared from the aperture.
  • FIG. 1D illustrates the biopsy probe of FIG. 1A rotated within the body.
  • FIG. 2 provides a perspective view of a variation of a delivery device of the present invention.
  • FIGS. 3A-3K illustrate various components that may be used in delivery devices of the present invention;
  • FIGS. 4A-4C provide cross sectional views of a portion of a delivery device of the present invention during actuation of the device.
  • FIGS. 5A-5D illustrate cross sectional views of a delivery device of the present invention deploying a marker.
  • FIGS. 6A-6K illustrate various configurations of the device.
  • FIG. 6A illustrates a tissue cavity marking device with a spherical body and a single centrally-located marker.
  • FIG. 6B shows a tissue cavity marking device with a cylindrical body and two ring-shaped markers aligned near the cylinder's longitudinal axis.
  • FIG. 6C shows another tissue cavity marking device with a multi-faced or irregular body and a single centrally-located marker.
  • FIG. 6D illustrates a tissue cavity marking device with a body having pores.
  • FIG. 6E is a cross-sectional view of a radial extension of FIG. 6D.
  • FIG. 6F illustrates a tissue cavity marking device with a body having an outer shell of a bioabsorbable material.
  • FIGS. 6G-6J illustrate various configurations of the device having a body comprising suture-type material.
  • FIG. 6G illustrates a tissue cavity marking device with a number of loops.
  • FIG. 6H illustrates a tissue cavity marking device with a pair of opposing loops.
  • FIG. 6I illustrates a tissue cavity marking device with two pairs of opposing loops.
  • FIG. 6J illustrates a tissue cavity marking device having a pair of opposing loops where the loops are longitudinally folded forming opposing members.
  • FIG. 6K illustrates a tissue cavity marking device with two pairs of opposing loops where each loop is longitudinally folded forming opposing members.
  • FIGS. 7A-7F illustrate various configurations of the marker.
  • FIG. 8A illustrates a cavity marking device having multiple body components traversed by a single wire or suture marker.
  • FIG. 8B illustrates a cavity marking device having a helically wound wire or suture marker.
  • FIG. 8C illustrates a cavity marking device having wire or suture markers on the perimeter of the body.
  • FIG. 7D illustrates a cavity marking device having wire or markers on the ends of the body.
  • DETAILED DESCRIPTION OF THE INVENTION
  • The following discussion of the variations of the invention and the reference to the attached drawings are for explanatory purposes and do not exhaustively represent the possible combinations and variations of the invention. Those skilled in the art will readily appreciate that many variations may be derived using the following description. The following examples are intended to convey certain principles of the invention. These examples are not intended to limit the scope of the claims to any particular example. It is understood that the claims are to be given their broadest reasonable interpretation in view of the description herein, any prior art, and the knowledge of those of ordinary skill in the field. Furthermore, it is understood that the invention is not limited to the markers described herein. Instead, the invention may be used with any type of biopsy marker or tissue marker.
  • FIG. 2 illustrates a perspective view of a variation of a biopsy marker delivery device 20 of the present invention. In this variation, the delivery device 20 includes a body 22 having an elongate sheath 28 extending from a distal end 24 of the body 22 and a rod 30 extending from a proximal end 26 of the body 22. This variation of the device 20 also includes a deployment lock 32 having a first end 34 moveably located in the body 22 of the device 20 and second end 36 located outside of the body 22. As discussed below, the first end 34 of the deployment lock 32 engages a portion (not shown) of the rod 30 preventing distal movement of the rod. Disengagement of the first end 34 of the deployment lock 32 from the rod 30 permits movement of the rod 30 within the device 20.
  • As will be apparent, the device 20 may incorporate features to permit ease in handling the device 20. For example, the proximal ends of the body 22 and the rod 30 each may have portions 40, 42 of increased surface area that assist in the ability to actuate the device. Also, the second end 36 of the deployment lock may have raised surface areas 44 that permit an operator to grip the deployment lock 32 when an operator disengages the first end 34 of the deployment lock 32 from the rod 30. Such features, which permit ease in handling the device, are well known to those skilled in the art and are not meant to limit the scope of the invention.
  • FIG. 3A illustrates a cross sectional view of a body 22 and elongate sheath 28 of a variation of the inventive device. In this variation, the body 22 has a proximal end 26, a distal end 24, and a passageway 46 extending through the body 22. The variation of the body 22 depicted in FIG. 3A also contains a keyway 48 extending through at least a portion of the body passageway 46. As described below, the keyway 48 permits alignment and/or maintaining orientation of components of the inventive device with an orientation of the body 22. The ability to identify an orientation of the device relative to, for example, a biopsy probe is desirable for proper deployment of a biopsy marker. The keyway 48 may be a male or female keyway which permits mating of a corresponding key such that a component having such a key will maintain orientation while moved through the device.
  • In the variation depicted in FIG. 3A, the distal end 24 of body 22 includes an end component 50 that reduces a diameter of the passageway 46 therethrough. It should be noted that the body 22 may be optionally designed without such an end component 50. For example, the body 22 could be designed as a unitary piece. In variations where the body 22 is constructed as a unitary piece, the body passageway 46 may optionally have an area of reduced diameter at the distal end 24. This area of reduced diameter made from a uniform reduction of the diameter of the passageway 46 or may have one or more protrusions which effectively reduce the diameter of the passageway 46. The body 22 may also include an opening 52 through which a deployment lock may be inserted through the body 22. As discussed above, the body 22 may also include a portion 40 of increased surface area that permits handling of the device. The body may be formed out of materials such as ABS, polycarbonate, acetyl, or acrylic.
  • The inventive device also includes an elongate sheath 28 extending distally from a distal end 24 of the body 22. The elongate sheath 28 contains a lumen (not shown) that extends through the sheath 28. The sheath lumen is in fluid communication with the body passageway 46. By fluid communication, it is meant that the passageways merely intersect or join one another. The elongate sheath 28 may be flexible such that the sheath 28 may be advanced to a biopsy site, either through a device, such as a biopsy probe, cannula, etc., or through a biopsy tract created by the biopsy procedure. In any case, variations of the invention may include sheaths 28 that may have sufficient rigidity to access the biopsy cavity (in some cases the sheath 28 may even contain a reinforcing member, e.g., a braid, stiffening member.) The sheath may comprise materials such as polyethylene (PE), especially high density PE (HDPE), nylon, urethane, or a fluoropolymer.
  • A variation of the inventive device, as illustrated in FIG. 3A, may also contain a delivery device key 38. The delivery device key 38 may be located on the elongated sheath 28 (as illustrated) or may be located on the body 22. As discussed above, it may be necessary to rotate a biopsy probe to retrieve multiple tissue samples. The delivery device key 38 is adapted to be seated into a biopsy probe (not shown) such that when the biopsy probe is rotated, an orientation of the device may match the orientation of the aperture of the biopsy probe. The delivery device key 38 may include a raised protrusion or other surface which may mate with a portion of the biopsy probe. In some variations of the inventive device, the length of the elongate sheath 28 is selected such that when the delivery device key 38 is engaged in a biopsy probe, the distal end of the elongate sheath 28 is located adjacent to an aperture of the biopsy probe.
  • FIG. 3B illustrates a cross sectional view of a variation of a deployment lock 32 of the inventive device. The deployment lock 32 includes a first end 34 and a second end 36. The first end 34 of the deployment lock 32 is adapted to be inserted into the device body and to engage a portion of a rod (as illustrated below) to at least prevent the rod from distal movement through the device. Thus, “locking” the device. The second end 36 of the deployment lock 32 may be located outside of the device body and is adapted to permit disengagement of the deployment lock 32 from the rod. For example, the variation of the deployment lock 32 depicted in FIG. 3B is adapted to be removed from the device via pulling the second end 36 of the deployment lock 32. While this variation of the deployment lock 32 is designed to be removed from the device, variations of deployment locks of the present invention may remain within the device while simultaneously disengaging from a rod to permit movement of the rod. Additionally, variations of the deployment lock 32 may also contain one or more securing arms 51, which assist in retention of the deployment lock 32 in a “locked” position.
  • FIG. 3C illustrates a side view of a rod 30 of the present invention. The rod 30 may be a tubular or other member. The rod 30 may have a lumen extending therethrough. The rod 30 may be flexible as required to navigate through a sheath which may itself be located in a biopsy probe. Some materials from which the rod may be constructed include nylon, urethane, PE, and fluoropolymers. As discussed above, the rod 30 may have a portion 42 of increased surface area or increased diameter at a proximal end or along any length of the rod 30. The rod 30 also includes a rod stop 54 located along a length of the rod 30. FIG. 3D illustrates a cross sectional view of the rod stop 54 taken along the line 3D-3D of FIG. 3C. As shown in FIG. 3D, variations of the rod stop 54 may include a rod key 56. The rod key 56 is adapted to mate with the body keyway to maintain the orientation of the rod with respect to the device. Although the rod key 56 depicted in FIG. 3D is a male key, the rod key 56 is intended to mate with the corresponding keyway. Accordingly, the rod key 56 may be a female rather than male fitting. Furthermore, the rod key 56 of the present invention is not limited to placement on the rod stop 54. For example, variations of the inventive device may include a rod key which may be located on a rod 30 as opposed to the rod stop 54.
  • FIG. 3E illustrates a side view of a variation of an access tube 58 of the present invention. The access tube 58 comprises proximal 68 and distal ends 70 with a lumen 72 extending at least from a portion of the tube 58 through the proximal end 68. In some variations of the invention, the lumen may extend throughout the tube. However, the lumen may also be closed at a distal end 70 such that when a biopsy marker (not shown) is placed in a marker seat 62, the biopsy marker is prevented from advancing distally within the access tube. This is especially useful when side ejection of a marker is desired. In such a case, the closed distal end 70 prevents a marker from remaining within a portion of the lumen 72 of the tube 58 at the distal end 70. The distal end 70 may be either closed or have an occluding member placed therein. The access tube 58 may be flexible as required by the procedure being used to access a biopsy cavity. The access tube 58 may be constructed from materials such as nylon, urethane, PE, or a fluoropolymer.
  • As illustrated in FIG. 3E, the access tube may also include an access tube stop 60. In this variation, the access tube stop 60 is located at the proximal end 68 of the access tube 58. However, the invention is not limited as such as the access tube stop 60 may be located over any portion of the access tube 58. FIG. 3F illustrates a cross-sectional view of the access tube stop 60 of FIG. 3E as taken along lines 3F-3F. In this variation the access tube stop 60 also contains an access tube key 66. As discussed above, the access tube key 66 mates with a body keyway such that the access tube 58 and marker seat 62 are able to maintain a desired orientation within the device. The access tube key 66 may be male or female depending upon the body keyway.
  • The access tube 58 will contain a marker seat 62 located towards a distal end 70 of the tube 58. The marker seat 62 will be adapted depending upon the biopsy marker used with the device. For example, a marker seat 62 may be formed by removing a portion of the access tube 58. In some variations of the invention, the invention may have an intermediate member that separates the biopsy marker from the actuating member of the device (e.g., the rod, etc.) and ejects/deploys the marker from the device. The intermediate covering may be discrete from the tube and tissue marker, e.g., a flexible covering 64 as described below. However, it is also contemplated that a portion of the tube itself could be configured to serve as the intermediate member (e.g., a weakened section of a tube that is adapted to fold into the tube lumen to seat the marker and unfold from the lumen to deploy the marker.)
  • As described above, a variation of the invention includes an intermediate member that is a flexible covering 64. The flexible covering 64 may be located over a portion of the tube 58 which includes the marker seat 62. FIG. 3G illustrates a cross-sectional view of the marker seat 62 taken along the line 3G-3G of FIG. 3E. FIG. 3G illustrates the marker seat 62 covered by the flexible covering 64. As shown, at least a portion of the flexible covering 64 is placed or folded into the marker seat 62. In such variations, the flexible covering 64 assists in deployment of the marker as the flexible covering 64 may be displaced and/or unfolded out of the marker seat 62. In any case, when a flexible covering is used, there may be no contact between any actuator (e.g., rod, etc.) and marker. The flexible covering may be made from any commercially available medical grade flexible material such as polyethylene terephthalate (PET), polytetrafluoroethylene (PTFE), or PEP.
  • FIG. 3E also illustrates a rod 30 slideably located within the access tube 58 where a distal end of the rod 30 maybe located adjacent to the marker seat 62. Distal advancement of the rod 30 advances the access tube 58 within the device. In one variation, the distal end of the rod 30 may be urged against a marker (not shown) seated in the marker seat 62. Since the marker will be constrained within the marker seat, which is located within an elongate sheath (not shown), the marker will be unable to deploy from the marker seat 62. Accordingly, as a result of the rod 30 pushing against the marker (constrained within the marker seat 62) the access tube 58 and marker seat 62 advance with the rod 30. Once the marker is no longer constrained by a sheath, e.g., the marker and marker seat are either placed within or advanced out of an aperture of the biopsy probe, then the force of the rod 30 applied against the marker will eject the marker from the marker seat 62.
  • In another variation, the distal end of the rod 30 and the lumen 72 of the access tube 58 may be sized such to provide a friction fit between the lumen 72 and the rod 30. Thus, the friction fit permits the rod 30 to advance the access tube 58 until the access tube 58 meets with sufficient resistance to permit the rod 30 to advance independently of the access tube 58. In any case, advancement of the rod 30 in a distal direction advances the marker seat 62 distally until the marker seat 62 is adjacent to the probe aperture such that a marker located in the marker seat 62 may be ejected from the probe aperture.
  • The invention includes variations where the rod advances the marker seat through a combination of configurations either described herein or known to those familiar with similar delivery devices.
  • FIG. 3H illustrates a side view of a portion of the access tube 58 of FIG. 3E. In this illustration, the rod 30 is able to advance independently of the access tube 58 and advances into the marker seat 62. As a result, the rod 30 displaces and/or unfolds the flexible covering 64 out of the marker seat 62. Although not illustrated, this action permits the deployment of the marker (not shown) seated within the marker seat 62. In those variations of the invention not having a flexible covering 64, the rod 30 may deploy the marker via direct contact. In such cases, the distal end of the rod 30 is adapted to assist in deploying the marker (e.g., the distal end of the rod may be tapered, rounded, hinged to eject the marker, etc.) Variations of the invention also include a marker seat that permits deployment of a marker through a distal opening in the lumen of the elongate sheath.
  • FIG. 3I illustrates another variation of the present invention. In this variation, a rod 30 is slideably located within the access tube 58 where a distal end 76 of the rod 30 is adjacent to a fluid 74. In this variation, distal advancement of the rod 30 also advances the access tube 58 within the device when a marker (not shown) is constrained in the marker seat 62 by an outer sheath (not shown.) Such a result occurs as advancement of the rod 30 displaces the fluid 74. Because the marker is constrained in the marker seat 62, the fluid 74 cannot displace the flexible covering 64 from the marker seat 62. Instead, the force on the fluid 74 applied by the distal end 76 of the rod 30 acts to distally advance the marker seat 62 and marker out of the sheath. Once the marker is advanced out of the sheath and is no longer constrained, the force applied by the distal end 76 of the rod 30 displaces the fluid 74 which displaces the flexible covering 64 thereby ejecting the marker from the marker seat 62.
  • FIG. 3J illustrates a state of the device after the marker is freed from constraint by the sheath. As illustrated, the displacement of the fluid 74 by the distal end of the rod 76 displaces the flexible covering 64 from the marker seat 62 to eject the marker. As illustrated in FIGS. 3I and 3J, the distal end 76 of the rod 30 may be adapted such that it forms a seal (e.g., through sizing, use of a sealing gasket, etc.) with the lumen 72 of the access tube 58.
  • In some variations of the invention the rod 30 may be entirely replaced with fluid. In such a case, a syringe or similar apparatus would provide an actuator/pressure source to displace the fluid and deploy the marker. Moreover, the flexible covering 64 may also be fluid-tight such that the fluid cannot escape from the device. For example, FIGS. 3I and 3J show the flexible covering 64 as having fluid tight seals 78. It is noted that the position of the seals 78, as illustrated, is merely for exemplary purposes as the seals may be placed in any position such that fluid does not escape. As is apparent, in most cases, the distal end 70 of the access tube 58 will be sealed to prevent leakage of the fluid 74. In some cases, the distal end 70 may be adapted to deliver or leak the fluid in a controlled manner. The fluid 74 may be any biocompatible liquid or gas, e.g., saline fluid, air, etc. In some cases, as the rod 30 exerts a force on the fluid 74, the fluid may compress 74. In such cases, it may become necessary to add additional fluid 74 to the device.
  • FIG. 3K illustrates a variation of an access tube 58 for use with the present invention. As illustrated, the distal end 70 of the access tube 58 may be tapered to permit the access tube 58 to enter a cavity where tissue has collapsed or narrowed the tract entering the cavity.
  • It should be noted that the rod 30 and access tube 58 of the present invention may be sufficiently flexible to navigate through a biopsy probe, cannula, etc., to access a biopsy site. However, some applications may require variations of the invention having a rigid access tube and rod.
  • FIG. 4A illustrates a cross sectional view of a portion of a variation of inventive delivery device 20. As illustrated, the device 20 is in a “locked” position as the deployment lock 32 engages a portion of the rod 30 to prevent at least distal movement of the rod 30. In this variation, a first end 34 of the deployment lock 32 engages a rod stop 54 on a rod 30. Although the deployment lock 32 may be removed from the body 22, variations of the invention contemplate that the deployment lock 32 may disengage from the rod 30 while remaining attached to the body 22. As mentioned above, in variations of the device 20 for use with a biopsy probe (not shown), the device may have a delivery device key (not shown) as well. The delivery device key permits the orientation of the device to match the orientation of the probe aperture as it is rotated within thee body of a patient. Moreover, the delivery device key may be placed such that the distal end of the elongate sheath 28 is placed adjacent to the probe aperture when the delivery device key is engaged to the biopsy probe.
  • FIG. 4B illustrates a cross sectional view of a portion of the variation of the inventive delivery device 20 where the deployment lock (not shown) is removed from the body 22 via an opening 52 in the body 22. As a result, the rod 30 is able to be advanced in a distal direction within the device 20. As described above, advancement of the rod 30 permits advancement of an access tube 58 within the device 20. As illustrated in FIG. 4B, once an access tube stop 60 engages a distal end 24 of the body 22, the access tube 58 is prevented from further distal movement. Therefore, once the access tube 58 advances out of a distal end of the elongated sheath 28, the access tube stop 60 engages the distal end 24 of the body 22 preventing further distal movement. However, the access tube 58 advances sufficiently to permit advancement of the marker seat out of the distal end of the sheath 28. In some variations of the inventive device 20, the body 22 may also contain a keyway (not shown) as discussed above. Accordingly, the access tube 58 will contain a corresponding key which permits the orientation of the access tube to match the orientation of the device. Maintaining this orientation may also permit the marker seat to be oriented within the device 20 such that it is aligned with an aperture of a probe to permit deployment of the marker through the probe aperture.
  • In variations of the invention not having an access tube stop 60, distal movement of the rod 30 advances the marker seat distally due to the distal end of the rod pushing against a marker within the marker seat. Since the marker is constrained by the sheath and/or biopsy probe, it remains within the marker seat. Once the marker is advanced out of the sheath 28 and is placed adjacent to the probe aperture, it is no longer constrained by the sheath 28 or the biopsy probe. At this point, further distal movement of the rod 30 ejects the now unconstrained marker from the marker seat through the probe aperture and into a biopsy cavity.
  • FIG. 4C illustrates a cross sectional view of the device 20 of FIG. 4B where the rod 30 is further distally advanced to deploy a marker. In this variation, the rod contains a rod stop 54 which limits the distal advancement of the rod 30. Accordingly, the device 20 will be configured such that the rod 30 is able to deploy the marker prior to being prevented from further distal advancement.
  • FIGS. 5A-5B illustrate a partial cross sectional view of a variation of a delivery device of the present invention for use with a biopsy probe 10. FIG. 5A illustrates the inventive delivery device after the access tube 58 is advanced out of the elongate sheath 28. As discussed above, the elongate sheath 28 may be placed immediately adjacent to an aperture 14 of the probe 10 and the access tube 58 is advanced within the aperture 14. Also as discussed above, the device may permit orientation of the components of the device with the aperture 14 of the probe 10.
  • FIG. 5B illustrates the invention where the rod 30 may move independently of the access tube 58: In variations of the device having a marker 100 seated in the marker seat 62 upon a flexible covering 64, distal movement of the rod 30 may force the flexible covering 64 out of the marker seat 62 thereby deploying the marker 100.
  • FIG. 5C illustrates the use of the inventive device used with a probe 10 that contains a distal aperture 14 (e.g., a biopsy needle, etc.) In this case, the device is advanced out of the aperture 14 so that the marker 100 may be deployed in a biopsy cavity. FIG. 5D illustrates another variation of the inventive device where a distal end 70 of the rod 30 permits advancement of the device through a tissue tract (the channel leading from the biopsy cavity to the outside of the patient's body which is created during the biopsy procedure) that may constrict in diameter. It is noted that the sheath 28 may also be adapted to facilitate advancement through a narrowed tissue tract. For instance, if a biopsy probe is removed from the site, the device illustrated in FIG. 5D may be solely advanced into the tissue tract to deposit the biopsy marker 100. Furthermore, the device illustrated in FIG. 5D may be used with a biopsy probe as shown in FIG. 5C.
  • FIGS. 6A-6K show various configurations of a preferred subcutaneous cavity marking device of the present invention. Here the marking device (101) is displayed as having either a generally spherical body (102) (FIG. 6A), a generally cylindrical body (104) (FIG. 6B), or a multi-faced or irregular body (106) (FIG. 6C). In general, it is within the scope of this invention for the body to assume a variety of shapes. For example, the body may be constructed to have substantially curved surfaces, such as the preferred spherical (102) and cylindrical (104) bodies of FIGS. 1A and 1B, respectively. The body may have conical or ellipsoidal, etc. shapes as well. It is further within the scope of this invention for the body to have substantially planar surfaces, such as polyhedric (i.e. cubic, tetrahedral, etc.) or prismatic, etc. forms. Finally, the body may also have an irregular or random shape, in the case of a gel, combining features of various curved and planar surfaces. Body (106) of FIG. 6C is an example of such an irregular body shape. The particular body shape will be chosen to best match to the biopsy cavity in which the device is placed. However, it is also contemplated that the body shape can be chosen to be considerably larger than the cavity. Therefore, expansion of the device will provide a significant resistance against the walls of the cavity. Moreover, the aspect ratio of the device is not limited to what is displayed in the figures. For example, the cylindrical body (104) may have a shorter or longer length as required.
  • In the bodies of FIGS. 6A and 6C, the generally spherical marker (150) is located at or near the geometric center of the body. Such a configuration will aid the physician in determining the exact location of the biopsy cavity, even after the body degrades and is absorbed into the human or mammalian body.
  • In the case of the ring-shaped markers (154) of FIG. 6B, they are generally aligned along the longitudinal axis (114) of body (104). Note that although the ring-shaped markers (154) are spatially oriented so that the longitudinal axis (114) of the body (104) lies along the longitudinal axes (not shown) of each marker (154), each marker may individually or together assume a wide variety of random or predetermined spatial orientations other than the aligned orientation as seen in FIG. 6C. It can be appreciated that any asymmetric marker such as marker (154) is useful in aiding a physician to determine the spatial orientation of the deployed inventive device.
  • Obviously, marker (150), (154) may reside in locations other than those demonstrated in FIGS. 6A-6C. It is, however, preferred that markers (150), (154) dwell in a predetermined, preferably central, location and orientation in the device body so to aid the physician in determining the location and orientation of the biopsy cavity. The markers herein described may be affixed to the interior or on the surface of the body by any number of suitable methods. For instance, the marker may be merely suspended in the interior of the body (especially in the case where the body is a gel), it may be woven into the body (especially in the case where the marker is a wire or suture), it may be press fit onto the body (especially in the case where the marker is a ring or band), or it may affixed to the body by a biocompatible adhesive. Any suitable means to affix or suspend the marker into the body in the preferred location is within the scope of the present invention.
  • Tissue regrowth in a particular orientation can also be promoted by a body design shown in FIG. 6D. Here, body (110) contains a number of pores (138) through which tissue may grow. The pores may also be aligned in a substantially parallel fashion, traversing the thickness of the body so that tissue may regrow from one side of the body through to the other side. This is demonstrated in inset FIG. 6E, which shows an arm (130) of FIG. 6D in longitudinal cross section, complete with pores (138) traversing through the thickness of arm (130). Such pores (138) can be parallel to each other as shown in FIG. 1E, or they may be perpendicularly, radially, or even randomly oriented in the device body.
  • A trio of markers is also shown in FIG. 6D evenly aligned along the body longitudinal axis (140). Barb marker (156), spherical marker (150), and ring-shaped marker (154) demonstrate the use of different multiple markers in a single body (110). As previously described, such a design helps a physician to determine the spatial orientation of the inventive device when it is deployed in a biopsy cavity. Although the barb marker (156) is illustrated in a ‘V’ configuration, it is an important aspect of the barb marker (156) to have a shape that is clearly not spherical. This allows the barb marker (156) to be easily distinguished from calcifications that may be observed during any non-invasive imaging techniques.
  • FIG. 6F depicts a further embodiment of the present invention in which body (112) is enveloped in an outer shell (142) consisting of a layer of bioabsorbable material such those mentioned above. This configuration allows the perimeter of the biopsy cavity to be marked to avoid exposing the cavity, in the case of a “dirty” margin where re-excision may be necessary, to remaining cancerous cells as the tissue begins to re-grow into the cavity. Such a shell (142) can be radiopaque and/or echogenic in situ, or it may be augmented with an additional coating of an echogenic and/or radiopaque material. The shell (142) can also be made to be palpable so that the physician or patient can be further aided in determining the location and integrity of the implanted inventive device.
  • Shell (142) may be designed to have a varying bioabsorption rate depending upon the thickness and type of material making up the shell (142). In general, the shell can be designed to degrade over a period ranging from as long as a year or more to as little as several months, weeks, or even days. It is preferred that such a bioabsorbable shell be designed to degrade between two and six months; especially preferred is three months. In the design of FIG. 6F, interior (144) of body (112) may be a cross-linked, collagenous material that is readily absorbed by the human or mammalian body once the shell (142) degrades. Interior (144) may be filled with a solid or gelatinous material that can be optionally made radiopaque by any number of techniques herein described.
  • As will be described in additional detail with respect to FIGS. 7A-7F, marker (150) in the device shown in FIG. 6F may be permanently radiopaque or echogenic, or it also may be bioabsorbable and optionally coated with a radiopaque and/or echogenic coating that similarly degrades over a predetermined period of time. It is more important from a clinical standpoint that the marker remain detectable either permanently or, if the patient is uncomfortable with such a scenario, for at least a period of about one to five years so that the physician may follow up with the patient to ensure the health of the tissue in the vicinity of the biopsy cavity. Especially preferable is a marker whose radiopacity or echogenicity lasts from between about one and three years.
  • Each of the bodies depicted in FIGS. 6A-6F may be made from a wide variety of solid, liquid, aerosol-spray, spongy, or expanding gelatinous bioabsorbable materials such as collagen, cross-linked collagen, regenerated cellulose, synthetic polymers, synthetic proteins, and combinations thereof. Also contemplated is a body made from a fibrin-collagen matrix, which further prevent unnecessary bleeding, and minimizes the possibility of hematoma formation.
  • Examples of synthetic bioabsorbable polymers that may be used for the body of the device are polyglycolide, polyglycolic acid (PGA), polylactide, polylactic acid (PLA), poly .epsilon.-caprolactone, polydioxanone, polylactide-coglycolide, e.g., block or random copolymers of PGA and PLA, and other commercial bioabsorbable medical polymers. Preferred is spongy collagen or cellulose. As mentioned above, materials such as hemostatic and pain-killing substances may be incorporated into the body and marker of the cavity marking device. The use of hemostasis-promoting agents provides an obvious benefit as the device not only marks the site of the biopsy cavity but it aids in healing the cavity as well. Furthermore, such agents help to avoid hemotomas. These hemostatic agents may include AVITENE Microfibrillar Collagen Hemostat, ACTIFOAM collagen sponge, sold by C. R. Bard Inc., GELFOAM, manufactured by Upjohn Company, SURGICEL Fibrillar from Ethicon Endosurgeries, Inc., and TISSEEL VH, a surgical fibrin sealant sold by Baxter Healthcare Corp. The device may also be made to emit therapeutic radiation to preferentially treat any suspect tissue remaining in or around the margin of the biopsy cavity. It is envisioned that the marker would be the best vehicle for dispensing such local radiation treatment or similar therapy. Also, the body itself may be adapted to have radiopaque, echogenic, or other characteristics that allow the body to be located by non-invasive technique without the use of a marker. Such characteristics permit the possibility of locating and substantially identifying the cavity periphery after deployment but prior to absorption of the device. Furthermore, an echogenic coating may be placed over the radiopaque marker to increase the accuracy of locating the marker during ultrasound imaging.
  • Further, as illustrated in FIGS. 6G-6K, the device can be deployed as a loosely wound ball or looped arrangement of bio-absorbable surgical material with a marker placed at the geometric center of the device. The material may be, for example, resilient suture material, that upon deployment into a tissue cavity provides resistance against the cavity wall and allows the marker to be located at substantially the center of the cavity. In this variation, suture material may be looped through the band/ring (154); in such a configuration, the suture material acts as the body of the inventive device. As described elsewhere, the suture may be comprised of a bio-absorbable material. The suture material may also have radiopaque, echogenic or other characteristics described herein that aid in the non-invasive location of the device. Desirably, the suture material (158) is flexible to facilitate the expansion of the body while in the cavity. The device may be in the form of multiple passes of suture material (158) looped through a marker (154) (FIG. 6G). The suture material may also configured in the form a pair of opposing loops (160) with a marker (154) between the loops (160) (FIG. 6H), or two pairs of opposing loops (160) with the marker (154) in the center of the device (FIG. 6I). The opposing loops (160) may be bent longitudinally to form opposing members (162) (FIGS. 6J, 6K). The longitudinally bent opposing member (162) may be, but is not necessarily, formed by applying heat to the suture to set the ‘bend.’ An aspect of this variation is that the opposing members (162) provide resistance against the walls of a delivery device, thereby, minimizing the possibility of the marking device being prematurely released from the delivery device. Upon the desired deployment, the resiliency of the suture will expand the device and provide significant resistance against the walls of the cavity with the opposing members (162) providing additional resistance.
  • FIGS. 7A-7G illustrate various forms of the marker (110). The marker (110) may be in the form of a sphere (150) (FIG. 7A), a hollow sphere (152) (FIG. 7B), a ring or band (154) (FIG. 7C), a barb (156) (FIG. 7D), or a flexible suture or flexible wire (158) (FIG. 7E), or a crimped tube or a folded strip of material 172 (FIG. 7G). Also, the marker may have a distinguishing mark (170) (FIG. 7F). As mentioned above, the barb (156) is illustrated in FIG. 7D as having a “V” shape. The barb (156) is intended to distinguish the marker from calcifications when viewed under non-invasive imaging techniques. As such, the barb (156) is not limited to the “V” shape, rather it has a shape that is easily distinguishable from a spherical or oval calcification.
  • The hollow sphere (152) marker design of FIG. 7B is more susceptible to detection by ultrasound than the solid sphere (150) of FIG. 7A. Such sphere markers (150, 152) can be a silicon bead, for instance. In the case of a ring or band marker (154) seen in FIG. 7C, the body of the cavity marking device may be woven or placed through the band/ring (154). The marker may also be a wire or suture (158) as shown in FIG. 7E and as discussed in greater detail below. In such a case, the marker (158) may be affixed to the exterior perimeter of the body by an adhesive or woven through the body. Another improvement may arise from the marker wire or suture (158) being configured in a particular pattern within the body of the device, e.g., wrapping around the body in a helical manner. In the case of the marker (150) shown in FIG. 7F, distinguishing or identifying mark (170) can be in the form of simple marks as shown, or it may be one or more numbers, letters, symbols, or combinations thereof. These marks (170) are preferably located in more than one location on the marker (150) so that the marker may be readily and simply identified from multiple orientations under a variety of viewing conditions. Such a mark (170) can be used to identify the patient and her condition, provide information about the marker and body of the tissue cavity marking device, provide information about the circumstances and date of the implantation, who performed the procedure, where the procedure was performed, etc. In the case of multiple biopsy sites, this distinguishing mark (170) permits one to differentiate and identify each different site. The mark (170) may be applied via any number of techniques such as physical inscription, physical or plasma deposition, casting, adhesives, etc. The mark (170) may also be an electronic chip providing any necessary information in electronic form that can be remotely detected by appropriate means.
  • An important aspect of the invention is that the marker may be radiopaque, echogenic, mammographic, etc., so that it can be located by non-invasive techniques. Such a feature can be an inherent property of the material used for the marker. Alternatively, a coating or the like can be added to the marker to render the marker detectable or to enhance its detectability. For radiopacity, the marker may be made of a non-bioabsorbable radiopaque material such as platinum, platinum-iridium, platinum-nickel, platinum-tungsten, gold, silver, rhodium, tungsten, tantalum, titanium, nickel, nickel-titanium, their alloys, and stainless steel or any combination of these metals. By mammographic we mean that the component described is visible under radiography or any other traditional or advanced mammography technique in which breast tissue is imaged.
  • As previously discussed, the marker can alternatively be made of or coated with a bioabsorbable material. In this case, the marker can, for instance, be made from an additive-loaded polymer. The additive is a radiopaque, echogenic, or other type of substance that allows for the non-invasive detection of the marker. In the case of radiopaque additives, elements such as barium- and bismuth-containing compounds, as well as particulate radio-opaque fillers, e.g., powdered tantalum or tungsten, barium carbonate, bismuth oxide, barium sulfate, etc. are preferred. To aid in detection by ultrasound or similar imaging techniques, any component of the device may be combined with an echogenic coating. One such coating is ECHO-COAT from STS Biopolymers. Such coatings contain echogenic features which provide the coated item with an acoustically reflective interface and a large acoustical impedance differential. As stated above, an echogenic coating may be placed over a radiopaque marker to increase the accuracy of locating the marker during ultrasound imaging.
  • Note that the radiopacity and echogenicity described herein for the marker and the body are not mutually exclusive. It is within the scope of the present invention for the marker or the body to be radiopaque but not necessarily echogenic, and for the marker or the body to be echogenic but not necessarily radiopaque. It is also within the scope of the invention that the marker and the body are both capable of being simultaneously radiopaque and echogenic. For example, if a platinum ring marker were coated with an echogenic coating, such a marker would be readily visible under x-ray and ultrasonic energy. A similar configuration can be envisioned for the body or for a body coating.
  • The marker is preferably large enough to be readily visible to the physician under x-ray or ultrasonic viewing, for example, yet be small enough to be able to be percutaneously deployed into the biopsy cavity and to not cause any difficulties with the patient. More specifically, the marker will not be large enough to be palpable or felt by the patient.
  • Another useful version of the invention is shown in FIG. 8A. In this device, there are several cylindrical body members (302); however, there is no limit to the number of body members that can make up the device. The body members (302) can individually or together take on a variety of sizes and shapes as discussed above depending on the characteristics of the biopsy cavity to be filled. The body members (302) may uniformly or in combination be made of one or more materials suitable for use in a biopsy cavity as previously described.
  • Here one or more markers may traverse two or more body member segments through the interior of the body members (302) as shown in FIG. 8A. Here, markers (318) are located substantially parallel to the longitudinal axis (320) of each right cylindrical body member (302) in their interior, connecting each body member (302) while marking their geometric center as between the markers. Such a marker (318) may be used in conjunction with the other markers as described above and may also be accompanied by one or more additional markers arranged randomly or in a predetermined pattern to variously mark particular sections of the device. Alternately, such a marker may, singly or in combination with other markers, be affixed on or near the surface of the sponge so as to mark the perimeter of the body member (302).
  • Of course, when used in conjunction with other connecting markers, marker (318) need not necessarily connect each body member; it may be used solely to indicate the orientation or location of each individual sponge or the entire device, depending on the material, geometry, size, orientation, etc. of marker (318). When not used in this connecting function, therefore, marker (318) need not traverse two body members (302) as shown in FIG. 8A.
  • A variety of patterns can be envisioned in which all or part of the perimeter of the sponge body is marked. For example, a marker (322) can wrap around the body (302) in a helical pattern (FIG. 8B), or it can be used in conjunction with other markers (324) in a pattern parallel to the longitudinal axis (320) of the body (302) (FIG. 8). Another useful perimeter marking pattern is shown in FIG. 8D, where marker segments (326) are affixed at or near the surface of the circular bases of the cylindrical body (302) in a cross pattern, indicating the ends of the sponge and their center. Any marker pattern, internal or external to the body, is within the scope of the present invention. For the applications depicted in FIGS. 8A-8D, it is preferred that the marker be a radiopaque or echogenic wire or suture.
  • Another possible configuration is obtained by combining the suture or wire markers (158) in a body with any other type marker (150, 152, 154, or 156) or vice versa. For example, in FIG. 8B, a spherical marker (150) may be placed in the center of the cylindrical body (302). Therefore, the cylindrical body (302) would contain the suture or wire marker (322) wrapped helically adjacent to the outer perimeter, and a marker (150) would be placed in the center of the cylindrical body (302). Such a combination may be obtained with any of the body and marker configurations as defined above.
  • Also, turning back to the marking device (101) in FIG. 6A or the marking device (101) of FIG. 6B, the markers (150 or 154) may be substituted with one or more suture or wire markers (158) preferably, but not exclusively, extending through the center and pointing radially away from the center. This configuration allows marking of the cavity perimeter and establishing of the directionality of the cavity itself.
  • Any of the previously-described additional features of the inventive device, such as presence of pain-killing or hemostatic drugs, the capacity for the marker to emit therapeutic radiation for the treatment of various cancers, the various materials that may make up the marker and body, as well as their size, shape, orientation, geometry, etc. may be incorporated into the device described above in conjunction with FIGS. 8A-8D
  • From the foregoing, it is understood that the invention provides an improved biopsy marker delivery system. While the above descriptions have described the invention for use in the marking of biopsy cavities made through a vacuum-assisted breast biopsy procedure, the invention is not limited to such. The invention disclosed herein may be used with any biopsy procedure discussed herein or otherwise known.
  • The invention herein has been described by examples and a particularly desired way of practicing the invention has been described. However, the invention as claimed herein is not limited to that specific description in any manner. Equivalence to the description as hereinafter claimed is considered to be within the scope of protection of this patent.

Claims (28)

1. A method for marking a biopsy cavity comprising the steps of:
providing a delivery device comprising:
a tube having a lumen extending therethrough and a side exit port communicating with the lumen;
a rod slideably located in the lumen of the tube; and
a tissue marker removably located at the distal end of the tube, wherein the marker comprises a bioabsorbable material and a metal band;
advancing the delivery device to the biopsy cavity;
actuating the rod to displace the tissue marker through the side exit port; and
depositing the tissue marker in the biopsy cavity.
2. The method of claim 1, wherein the bioabsorbable material is disposed through the metal band.
3. The method of claim 1, wherein the metal band is disposed within the bioabsorbable material.
4. The method of claim 1, wherein the delivery device further comprises an intermediate member separating the rod from the tissue marker.
5. The method of claim 4, wherein the delivery device further comprises a fluid between the rod and the intermediate member, where advancement of the rod in a distal direction displaces the fluid to displace the intermediate member.
6. The method of claim 4, wherein the intermediate member comprises a flexible covering.
7. The method of claim 6, wherein the flexible covering is made from a material selected from the group consisting of polyethylene terephthalate, polytetrafluoroethylene, and FEP.
8. A method for marking a biopsy cavity comprising the steps of:
providing a delivery device comprising:
a tube having a lumen extending therethrough and a side exit port communicating with the lumen;
a rod slideably located in the lumen of the tube; and
a tissue marker removably located at the distal end of the tube, wherein the marker comprises a bioabsorbable material and a metal wire;
advancing the delivery device to the biopsy cavity;
actuating the rod to displace the tissue marker through the side exit port; and
depositing the tissue marker in the biopsy cavity.
9. The method of claim 8, wherein the wire is disposed about the bioabsorbable material.
10. The method of claim 8, wherein the wire is disposed within the bioabsorbable material.
11. The method of claim 8, wherein the wire is in the shape of a letter.
12. The method of claim 11, wherein the wire is in the shape of the letter “V”.
13. The method of claim 8, wherein the wire is configured in a particular pattern within the bioabsorbable material.
14. The method of claim 8, wherein the delivery device further comprises an intermediate member separating the rod from the tissue marker.
15. The method of claim 14, wherein the delivery device further comprises a fluid between the rod and the intermediate member, where advancement of the rod in a distal direction displaces the fluid to displace the intermediate member.
16. The method of claim 14, wherein the intermediate member comprises a flexible covering.
17. The method of claim 16, wherein the flexible covering is made from a material selected from the group consisting of polyethylene terephthalate, polytetrafluoroethylene, and FEP.
18. A method for marking a biopsy cavity comprising the steps of:
providing a delivery device comprising:
a tube having a lumen extending therethrough and a side exit port communicating with the lumen;
a rod slideably located in the lumen of the tube; and
a tissue marker removably located at the distal end of the tube, wherein the marker comprises a bioabsorbable material and a radiopaque marker identified with a number, letter, symbol, or combinations thereof;
advancing the delivery device to the biopsy cavity;
actuating the rod to displace the tissue marker through the side exit port; and
depositing the tissue marker in the biopsy cavity.
19. The method of claim 18, wherein the radiopaque marker is suspended in the interior of the bioabsorbable material.
20. The method of claim 18, wherein the radiopaque marker is affixed to the surface of the bioabsorbable material.
21. The method of claim 18, wherein the radiopaque marker is affixed to the interior of the bioabsorbable material.
22. The method of claim 18, wherein the radiopaque marker is a wire.
23. The method of claim 22, wherein the wire is in the shape of a letter.
24. The method of claim 23, wherein the letter is a “V.”
25. The method of claim 18, wherein the delivery device further comprises an intermediate member separating the rod from the tissue marker.
26. The method of claim 25, wherein the delivery device further comprises a fluid between the rod and the intermediate member, where advancement of the rod in a distal direction displaces the fluid to displace the intermediate member.
27. The method of claim 25, wherein the intermediate member comprises a flexible covering.
28. The method of claim 27, wherein the flexible covering is made from a material selected from the group consisting of polyethylene terephthalate, polytetrafluoroethylene, and FEP.
US11/496,830 2001-09-10 2006-07-31 Biopsy marker delivery system Abandoned US20080188768A1 (en)

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US20030050571A1 (en) 2003-03-13
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EP1424930A4 (en) 2007-03-07
EP1424930B8 (en) 2011-06-15
EP1424930B1 (en) 2011-04-06
WO2003022133A3 (en) 2003-11-06
WO2003022133A2 (en) 2003-03-20
US6605047B2 (en) 2003-08-12
US7083576B2 (en) 2006-08-01
EP1424930A2 (en) 2004-06-09

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