Radiation based method locating and differentiating sentinel nodes

• US 5,732,704 A
• Filed: 10/13/1995
• Issued: 03/31/1998
• Est. Priority Date: 10/13/1995
• Status: Expired due to Term

• Current Assignee: Devicor Medical Products Incorporated (Danaher Corporation)
• Original Assignee: Neoprobe Corporation
• Inventors: Orahood, Richard C., Magill, Michael D., Thurston, Marlin O., Olson, Karl W.
• Primary Examiner(s): Lateef, Marvin M.
• Assistant Examiner(s): SHAW, SHAWNA JEANNINE
• Application Number:
  US08/542,955
• Time in Patent Office: 900 Days
• Field of Search: 128/659, 128/653.1, 128/654, 128/898, 250/336.1, 250/370.07, 607/901
• US Class Current: 600/431
• CPC Class Codes: A61B 6/4258 for detecting non x-ray radiation, e.g. gamma radiation A61B6/037 takes precedence
• CPC Class Codes: A61B 6/4423 related to hygiene or sterilisation
• CPC Class Codes: G01T 1/161 Applications in the field of nuclear medicine, e.g. in vivo counting apparatus for radiation diagnosis A61B6/00
• CPC Class Codes: Y10S 977/906 Drug delivery

Abstract

The method for identifying a sentinel lymph node located within a grouping of regional nodes at a lymph draininage basin associated with neoplastic tissue wherein a radiopharmaceutical is injected at the situs of the neoplastic tissue. This radiopharmaceutical migrates along a lymph duct toward the drainage basin containing the sentinel node. A hand-held probe with a forwardly disposed radiation detector crystal is maneuvered along the duct while the clinician observes a graphical readout of count rate amplitudes to determine when the probe is aligned with the duct. The region containing the sentinel node is identified when the count rate at the probe substantially increases. Following incision, the probe is maneuvered utilizing a sound output in connection with actuation of the probe to establish increasing count rate thresholds followed by incremental movements until the threshold is not reached and no sound cue is given the surgeon. At this point of the maneuvering of the probe its detector will be in adjacency with the sentinel node which then may be removed.

Claims

1. The method for identifying a sentinel lymph node located within a grouping of regional nodes at a lymph drainage basin associated with neoplastic tissue, comprising the steps of:

(a) identifying the situs of said neoplastic tissue;

(b) injecting at the situs of said neoplastic tissue a radiopharmaceutical effective for movement with lymph along a lymph duct;

(c) providing a hand manipulable radiation probe with a detector having a forward surface which is perpendicular to a detector axis, said probe being responsive to photon emissions impinging at said forward surface of said detector to provide probe output signals;

(d) providing a control system for receiving said probe output signals, said control system providing an energy level validation of said probe output signals and a perceptible output representing a photon count rate of value above a threshold count rate value, said threshold count rate and value being derived in conjunction with a base count rate established by said probe output signals in response to photon emissions from said radiopharmaceutical subsequent to said injection thereof and being actuable to increase said threshold count rate value;

(e) permitting said radiopharmaceutical to migrate along a lymphatic duct to the situs of a sentinel lymph node following said injection;

(f) positioning said probe detector forward surface at an initial position at the anticipated region of said situs of said sentinel lymph node and actuating said control system;

(g) then moving said probe a distance to a next position, and in the presence of a generation of said perceptible output, actuating said control system so as to elevate said threshold count rate value; and

(h) reiterating step (g) until said movement deriving said perceptible output is of a distance of short extent effective to identify a position of said probe corresponding with a peak rate of said photon emissions impinging at said forward surface of said detector and representing an alignment of said detector axis with said sentinel lymph node.

2. The method of claim 1 in which said step (g) for moving said probe is carried out within a locus of movement wherein said detector axis is substantially retained in parallel relationship with its orientation at said initial position.

3. The method of claim 1 in which said step (g) for moving said probe is carried out within the locus of movement parallel with said detector axis.

4. The method of claim 1 in which an initial said base count rate is derived in response to photon emissions from said radiopharmaceutical at about said initial position.

5. The method of claim 1 in which said threshold count rate initially is derived as said base count rate increased by a select range value, and thereafter as the next previous threshold count rate increased by a select range value.

6. The method of claim 5 in which said select range value is a statistically significant value above said base count rate.

7. The method of claim 5 in which:

said perceptible output is an audible output; and

said step (g) actuation of said control system is carried out by manually deriving a said range value selected to adjust said threshold count rate value to a level adequate to terminate said audible output when generated.

8. The method of claim 1 in which said detector forward surface is provided having an area of about 38 square millimeters.

9. The method for identifying a sentinel lymph node located within a grouping of regional nodes at a lymph drainage basin of a patient associated with neoplastic tissue, comprising the steps of:

(a) identifying the situs of neoplastic tissue;

(b) injecting through the epidermis of said patient, at the situs of said neoplastic tissue, a radiopharmaceutical effective for movement with lymph along a lymph duct;

(c) providing a hand manipulable radiation probe with a detector having a forward surface which is perpendicular to a detector axis, said probe being responsive to photon emissions impinging at said forward surface of said detector to provide probe output signals;

(d) providing a control system for receiving said probe output signals, said control system generating a first visually perceptible graphics output representing a photon count rate corresponding with said probe output signals;

(e) permitting said radiopharmaceutical to migrate along a lymphatic duct toward the situs of a sentinel lymph node following said injection;

(f) orienting said probe detector forward surface in a manner defining a scanning surface at a location adjacent said epidermis and within a region adjacent said situs of neoplastic tissue;

(g) surveying the region of said lymphatic duct with respect to said epidermis by;

(1) moving said probe outwardly and transversely with respect to said situs of said neoplastic tissue while maintaining said detector forward surface in parallel relationship with said scanning surface;

(2) simultaneously determining peak said photon count rates from said control system first perceptible output;

(3) designating the position of said probe detector axis at said epidermis as extending into adjacency with a portion of said lymphatic duct for each said determined peak photon count;

(4) reiterating steps (1), (2), and (3) until said first perceptible output represents an enhanced photon count rate corresponding with a lymph node contained concentration of said radiopharmaceutical; and

(h) locating and isolating said lymph node within the region from which said enhanced photon count rate emanates.

10. The method of claim 9 in which said step (f) includes the steps of:

moving said probe in a locus surrounding and spaced from said situs of neoplastic tissue; and

simultaneously determining peak said photon count rates from said control system first perceptible output;

designating the position of said probe detector axis at said epidermis in correspondence with said determined peak outputs as extending into adjacency with a commencing portion of said lymphatic duct.

11. The method of claim 10 in which:

said control system is actuable to provide a second perceptible output representing a photon count rate value above a threshold count rate value derived in conjunction with a base count rate established by said probe output signals generated in response to photon emissions from said radiopharmaceutical;

said step (h) for locating said lymph node includes the steps of;

(1) positioning said probe detector forward surface at the anticipated region of said situs of said sentinel lymph node as determined at step (g)(4) and actuating said control system;

(2) then moving said probe a distance to a next position effective to cause generation of said second perceptible output and actuating said control system so as elevate said threshold count rate value; and

(3) reiterating step (2) until said movement deriving said second perceptible output is a distance of short extent effective to derive a position of said probe corresponding with a peak rate of said photon emissions impinging at said forward surface of said detector and representing an alignment of said detector axis with said sentinel lymph node.

12. The method for identifying within a patient, a sentinel lymph node being located within a grouping of regional nodes at a lymph drainage basin associated with neoplastic tissue, comprising the steps of:

(a) identifying the situs of neoplastic tissue;

(b) injecting at the situs of said neoplastic tissue a radiopharmaceutical effective for movement with lymph along a lymph duct;

(c) providing a hand manipulable radiation probe with a detector adjacent a window, said detector having a forward surface which is perpendicular to a detector axis, said probe being responsive to photon emissions impinging at said forward surface of said detector to provide probe output signals;

(d) providing a control system for receiving said probe output signals, said control system providing an energy level validation of said probe output signals and a perceptible output representing a photon count rate of value above a threshold count rate value, said threshold count rate value being derived in conjunction with a base count rate established by said probe output signals in response to photon emissions from said radiopharmaceutical subsequent to said injection thereof and being actuable to increase said threshold count rate value;

(e) permitting said radiopharmaceutical to migrate along a lymphatic duct to the situs of a sentinel lymph node following said injection;

(f) positioning said probe detector forward surface at an initial position at the anticipated region of said situs of said sentinel lymph node and actuating said control system;

(g) then moving said probe transversely along the epidermis of said patient a distance to a next position, and in the presence of a generation of said perceptible output, actuating said control system so as to elevate said threshold count rate value;

(h) reiterating step (g) until said movement deriving said perceptible output is a distance of short extent effective to identify a first position of said probe corresponding with a peak rate of said photon emissions impinging at said forward surface of said detector and representing an alignment of said detector axis with said sentinel lymph node;

(i) forming a surgical opening in said patient at said first position;

(j) then moving said probe window inwardly within said opening to a next position and in the presence of a generation of said next perceptible output, actuating said control system so as to effect a termination of said perceptible output; and

(k) reiterating step (j) until said movement deriving said perceptible output is of a limited extent effective to establish a second position of said probe corresponding with a peak rate of said photon emissions impinging at said forward surface of said detector and representing an adjacency of said probe window with said sentinel node.

13. The method of claim 12 in which said perceptible output is an audible output.

14. The method of claim 13 in which said steps (g) and (j) actuations of said control system are carried out by adding count rate values to the next previous threshold count rate at least until said perceptible output terminates.

15. The method of claim 12 in which an initial said base count rate is derived in response to photon emissions from said radiopharmaceutical at about said initial position.

16. The method of claim 12 in which said threshold count rate initially is derived as said base count rate increased by a select range value, and thereafter as the next previous threshold count rate increased by a select range value.

17. The method for identifying a sentinel lymph node located within a grouping of regional nodes at a lymph drainage basin of a patient associated with neoplastic tissue, comprising the steps of:

(a) identifying the situs of a neoplastic tissue;

(b) injecting through the epidermis of said patient, at the situs of said neoplastic tissue, a radiopharmaceutical effective for movement with lymph along a lymph duct;

(c) providing a hand manipulable radiation probe with a detector having a forward surface which is perpendicular to a detector axis, said probe being responsive to photon emissions impinging at said forward surface of said detector to provide probe output signals;

(d) providing a control system for receiving said probe output signals, said control system generating a first visually perceptible graphics output representing a photon count rate corresponding with said probe output signals, said output being a graphic depiction of photon count rate with respect to time provided at a readout;

(e) permitting said radiopharmaceutical to migrate along a lymphatic duct toward the situs of a sentinel lymph node following said injection;

(f) orienting said probe detector forward surface in a manner defining a scanning surface at a location adjacent said epidermis and within a region adjacent said situs of neoplastic tissue, said output being a graphic depiction of photon count rate with respect to time produced at a readout;

(g) surveying the region of said lymphatic duct with respect to said epidermis by;

(1) moving said probe outwardly and transversely with respect to said situs of said neoplastic tissue while maintaining said detector forward surface in parallel relationship with said scanning surface;

(2) simultaneously determining peak said photon count rates from said control system first perceptible output;

(3) designating the position of said probe detector axis at said epidermis as extending into adjacency with a portion of said lymphatic duct for each said determined peak photon count;

(4) reiterating steps (1), (2), and (3) until said first perceptible output represents an enhanced photon count rate corresponding with a lymph node contained concentration of said radiopharmaceutical; and

(h) locating and isolating said lymph node within the region from which said enhanced photon count rate emanates.

18. The method of claim 17 in which said graphic time depiction is horizontally scrolled at said readout.