Guide block for biopsy or surgical devices

FIELD OF THE INVENTION

0001This invention relates generally to the field of medical devices and methods. In particular, the invention relates to devices and methods for placing a surgical device, such as a biopsy device, in a desired location in relation to a patient during a biopsy procedure.

BACKGROUND OF THE INVENTION

0002In diagnosing and treating certain medical conditions, it is often desirable to perform a biopsy, in which a specimen or sample of tissue is removed for pathological examination, tests and analysis. As is known, obtaining a tissue sample by biopsy and the subsequent examination are typically employed in the diagnosis of cancers and other malignant tumors, or to confirm that a suspected lesion or tumor is not malignant. Examination of tissue samples taken by biopsy is of particular significance in the diagnosis and treatment of breast cancer.

0003Magnetic resonance imaging (MRI) is often used to locate the site within a breast where a potentially cancerous lesion or tumor is located. Interventional MRI is the magnetic resonance imaging technique (often involving real time imaging) that allows a surgeon to perform MRI-guided tissue biopsy or surgery. One application of interventional MRI is to guide a surgeon during a biopsy or surgical operation on one or both of the breasts of a female patient.

0004Interventional MRI procedures typically require a magnetic resonance signal detection coil which has large openings so that the surgeon can have access to the surgical site through the coil with the biopsy device or other surgical devices. The MRI device may also include compression plates to compress the breast. Compression plates contain needle guide holes to allow for proper placement of a needle during a needle biopsy or larger windows configured to hold guide blocks. Guide blocks have block bodies with needle guide holes or with larger openings to allow access for larger biopsy devices. The guide blocks assist the physician with proper placement and stabilization of the biopsy device during a biopsy procedure.

0005The compression plates are secured to the housing of the signal detection coil. Markers, such as Vitamin E Capsules, which are highly visible under MRI device are placed on the compression plates and the position of the markers relative to the suspect tissue is measured using the magnetic resonance images. The proper window of the compression plate is then determined by finding the window in the compression plate which is closest to the desired entry point.

0006For larger biopsy devices the guide blocks are usually cube-shaped and contain about nine circular openings spaced in three rows of three. Due to the configuration of the openings in the guide block and the large size of some biopsy devices it is often difficult to precisely reach the desired tissue location. Present guide blocks for larger biopsy devices do not allow for access to every area of tissue directly behind the block. Thus, there is need in the art for improved guide blocks which allow access to all areas of tissue directly behind the block.

0007<patcit id="pcit0001" dnum="US20040167543A1"><text>US 2004/0167543 A1</text></patcit> describes an instrument trajectory guide in the form of a circular block clamped into an adjustable base. Lumens pass through the block displaced from one another and providing different trajectories for the passage of a surgical instrument therethrough.

0008Further, <patcit id="pcit0002" dnum="DE29519103U1"><text>DE 295 19 103 U1</text></patcit> teaches a device comprising a ground plate for supporting a holding and guidance device for a surgical instrument.

SUMMARY OF THE INVENTION

0009The present invention provides a use of a guide block by fitting within a four sided grid opening of a grid compression plate of an MRI device according to claim 1 and a combination of a guide block and a compression plate according to claim 4. Preferred aspects of the invention are provided according to the dependent claims.

0010This disclosure relates to placement of surgical devices during biopsy procedures and in particular to devices and methods for placement of a biopsy device during a breast biopsy. In one embodiment of the present disclosure a guide block has a body with a proximal face, a distal face and a longitudinal axis extending between the proximal and distal faces. The guide block has four passageways which are configured to slidably receive a surgical device, such as a biopsy device. The body of the guide block is configured to fit within a grid on the compression plate of a magnetic resonance imaging (MRI) device.

0011The four passageways extend longitudinally between the proximal and distal faces of the block and are parallel to the longitudinal axis. The first passageway is centrally disposed. The second passageway is located vertical or horizontal to the first passageway. The third passageway is located diagonal to the first and has a longitudinal opening along its length which is in fluid communication with the opening in the first passageway. The fourth passageway is located diagonal to the first passageway and on an opposite side of the body from the third passageway. The configuration of the passageways allows for all tissue directly behind the guide block to be accessed by rotating the guide block.

BRIEF DESCRIPTION OF THE DRAWINGS

0012<ul id="ul0001" list-style="none"><li><figref idref="f0001">FIG. 1</figref> is a front elevational view of a device embodying features of the disclosure.</li><li><figref idref="f0001">FIG. 2</figref> is a rear elevational view of a device embodying features of the disclosure.</li><li><figref idref="f0001">FIG. 3</figref> is a side elevational view of a device embodying features of the disclosure.</li><li><figref idref="f0002">FIG. 4</figref> is a side elevational view of a device embodying features of the disclosure.</li><li><figref idref="f0002">FIG. 5</figref> is a longitudinal cross sectional view of the device taken along lines D-D in <figref idref="f0001">FIG. 2</figref>.</li><li><figref idref="f0002">FIG. 6</figref> is a longitudinal cross sectional view of the device taken along lines B-B in <figref idref="f0001">FIG. 2</figref>.</li><li><figref idref="f0003">FIG. 7</figref> is a elevational view of a magnetic resonance imaging device having compression plates with grids configured to receive devices embodying features of the disclosure.</li><li><figref idref="f0003">FIG. 8</figref> is a front elevational view of a device embodying features of the disclosure.</li><li><figref idref="f0003">FIG. 9</figref> is a rear elevational view of a device embodying features of the disclosure.</li><li><figref idref="f0004">FIG. 10</figref> is a longitudinal cross sectional view of a device shown in <figref idref="f0003">FIGS. 8 and 9</figref>.</li><li><figref idref="f0004">FIG. 11</figref> is a side view of a device embodying features of the disclosure within the grid of a compression plate.</li></ul>

DETAILED DESCRIPTION OF THE INVENTION

0013<figref idref="f0001 f0002">FIGS. 1-6</figref> are perspective views of devices embodying features of the disclosure. A device embodying features of the disclosure includes a guide block 10 having a body 12 with a proximal face 14, a distal face 16 and a longitudinal axis 18 extending between the proximal 14 and distal 16 faces. The guide block 10 has four passageways 20 which extend longitudinally between the proximal 14 and distal 16 faces of the guide block 10 and which are parallel to the longitudinal axis 18. Each passageway 20 of the guide block 10 is configured to slidably receive a surgical device, such as the biopsy device in <patcit id="pcit0003" dnum="US6454727B"><text>U.S. Pat. No. 6,454,727</text></patcit> assigned to the assignee of the present invention. Preferably the passageways 20 are cylindrically shaped.

0014The first passageway 22 is centrally disposed. The second passageway 24 is located vertical or horizontal to the first passageway 22 and parallel to the longitudinal axis. The third passageway 26 is located diagonal to the first passageway 22, and is parallel to the longitudinal axis. The third passageway also has a longitudinal opening along its length which is in fluid communication with the opening in the first passageway 22. The fourth passageway 28, is parallel to the longitudinal axis, and is located diagonal to the first passageway 22 and in an opposite side of the body 12 from the diagonal location of the third passageway 26. Two suitable configurations of the passageways 20 within the guide block 10, shown in <figref idref="f0001">FIGS. 1 and 2</figref>, are mirror images of one another.

0015The guide block 10 is configured to be used in conjunction with a locating or imaging devices such as a magnetic resonance imaging (MRI) device. An example of an MRI breast coil and grid device is the Invivo 7 channel breast biopsy array 800239 in <figref idref="f0003">FIG. 7</figref> (photo obtained from www.mridevices.com/products/CoilProduct Detail.aspx?ID=43). A MRI device 30 used to detect suspect tissue in breasts has a detection coil 32 with large openings 34. The MRI device 30 also includes compression plates 36 to compress the breast. The compression plates 36 are secured to the housing of the detection coil 32 and include grid 38 with grid openings 40 so that the surgeon can have access to the surgical site through the coil 32 with the biopsy device or other surgical devices. The grid openings 40 have four sides 42 and are configured to receive the guide blocks 10 and hold them in place. Preferably the guide block 10 has a proximal face 14 with four equal sides 44. When the guide block 10 is placed into the grid opening 40 any one of the four sides 44 of the proximal face 14 of the guide block may align with any one of the four sides 42 of a grid opening 40 to secure the block within the grid 38.

0016The location of the passageways 20 within the block 10 allows a biopsy device to gain access to all areas of tissue behind the block 10. By rotating the block before placing it within the grid opening 40, each area of tissue behind the block 10 will, at some point, be accessible through one of the four passageways 20.

0017In some embodiments the proximal face 14 has a larger surface area than the surface area of the distal face 16 and forms a radially projecting shoulder 46 which prevents the block from advancing too far past the grid opening 40. The shoulder 46 extends about 0.508 mm (0.02 inches) to about 1.524 mm (0.06 inches) from the outside wall of the body.

0018In one embodiment of the device each side 44 of the proximal face 14 of the device is about 10.2 mm (0.4 inches) to about 33.0 mm (1.3 inches) long, typically about 22.9 mm (0.9 inches) long. In this embodiment the center of the first passageway 22 is about 5.08 mm (0.2 inches) to about 15.2 mm (0.6 inches) from each side 44 of the proximal face, typically about 10.2 mm (0.4 inches) from each side 44. The center of the second passageway 24 is about to 2.5 mm (0.1 inches) about 8.89 mm (0.35 inches) from the center of the first passageway 22, typically about 5.08 mm (0.2 inches) away from the center of the first passageway 22. The center of the third passageway 26 is about 2.54 mm (0.1 inches) to about 6.35 mm (0.25 inches), typically about 3.81 mm (0.15 inches) away from the center of the first passageway 22. The center of the fourth passageway 28 is about 381 mm (15 inches) to about 12.7 mm (0.5 inches) away from the center of the first guide passageway 22, typically about 7.62 mm (0.3 inches). The length of block 10 is about 12.7 mm (0.5) to about 22.9 mm (0.9), typically about 20.3 mm (0.8 inches).

0019In one embodiment the guide block 10 includes at least one tab 48 on the perimeter of the body which extends between the proximal and distal faces and which has a distal portion near the distal face of the block with a raised area 50. The tabs 48 are configured to allow the raised area 50 to bend inward toward the body when placing the block within a. grid opening 40. Once in the opening the raised area 50 extends radially outward and presses against the sides 42 of the grid opening 40 as a means to maintain its position.

0020In some embodiments the tab is about 1.27 mm (0.05 inches) to about 3.81 mm (0.15 inches) wide, preferably about 2.54 mm (0.10 inches) wide. The tabs range in length from about 6.35 mm (0.25) to about 20.3 mm (0.8 inches) long. In some embodiments of the invention at least one tab 48 is about 1.27 mm (0.05) to about 5.1 mm (0.2 inches) wide, preferably about 3.81 mm (0.15 inches) wide.

0021The guide block 10 may be formed from a plastic such as MAKROLON(R), a polycarbonate from Bayer Material Sciences a division of Bayer AG.

0022A method embodying features of the disclosure includes providing a guide block 10 having a body 12 with four passageways 20 which are configured within the body. The first passageway 22 is centrally disposed. The second passageway 24 is located vertical or horizontal to the first passageway 22 and parallel to the longitudinal axis. The third passageway 26 is located diagonal to the first passageway 22, and is parallel to the longitudinal axis. The third passageway also has a longitudinal opening along its length which is in fluid communication with the opening in the first passageway 22. The fourth passageway 28, is parallel to the longitudinal axis, and is located diagonal to the first passageway 22 and in on opposite side of the body 12 from the diagonal location of the third passageway 26. The method further includes inserting the guide block into a grid opening 40 of an MRI device 30 nearest to the suspect tissue and selecting the orientation of the block 10 to provide access to the desired location in patient.

0023In some methods embodying features of the disclosure an imaging device configured to locate suspect tissue is provided to locate the suspect tissue. Preferably the imaging device is magnetic resonance imaging 30.

0024An alternative embodiment of the disclosure illustrated in <figref idref="f0003 f0004">FIGS. 8-11</figref> include a guide block 52 having a body 54 with a proximal face 56, a distal face 58, and a longitudinal axis 60 extending between the proximal face 56 and distal face 58. The guide block 52 has at least one passageway 62 disposed within the body which extends between the proximal and distal faces and are not parallel to the longitudinal axis. This embodiment provides access to tissue located outside of the exterior border of the grid 64 of the compression plate 66.

0025A method embodying features of the disclosure includes providing a guide block 52 having a body 54 with a proximal face 56 a distal face 58, and a longitudinal axis 60 extending between the proximal and distal faces. The guide block 52 has at least one passageway 62 disposed within the body 54 which extends between the proximal 56 and distal faces 58 and which is not parallel to the longitudinal axis 60. The method further includes inserting the guide block 52 into a grid opening 68 of a compression plate 66 nearest to the suspect tissue and selecting the orientation of the block 52 to provide access to the desired location in the patient.

0026While particular forms of the invention have been illustrated and described herein, it will be apparent that various modifications and improvements can be made to the invention.

0027Moreover, individual features of embodiments of the invention may be shown in some drawings and not in others, but those skilled in the art will recognize that individual features of one embodiment of the invention can be combined with any or all the features of another embodiment. Accordingly, it is not intended that the invention be limited to the specific embodiments illustrated. It is therefore intended that this invention be defined by the scope of the appended claims as broadly as the prior art will permit.