Libraries and data structures of materials removed by debulking catheters

• US 7,794,413 B2
• Filed: 09/21/2005
• Issued: 09/14/2010
• Est. Priority Date: 04/19/2005
• Status: Expired due to Fees

• Current Assignee: Covidien LP (Medtronic Plc)
• Original Assignee: ev3, Inc. (Medtronic Plc)
• Inventors: Simpson, John B., Soito, Angela
• Primary Examiner(s): Hindenburg; Max
• Assistant Examiner(s): HOEKSTRA, JEFFREY GERBEN
• Application Number:
  US11/230,924
• Publication Number:
  US 20060236019A1
• Time in Patent Office: 1,819 Days
• Field of Search: 600/300, 600/301, 600/308, 600/562, 600/587, 128/920, 128/923, 128/925, 707/100, 707/104.1, 703/11
• US Class Current: 600/587
• CPC Class Codes: A61B 10/0096 Casings for storing test samples A61B10/0038 and A61B10/0045 take precedence; preservation of living parts of the human or animal body A01N1/02; containers for retaining a material to be analysed B01L3/50; containers for enzymology or microbiology C12M1/16; swab-sampler being part of enzymology or microbiology container C12M1/30
• CPC Class Codes: A61B 10/02 Instruments for taking cell samples or for biopsy A61B10/0038 and A61B10/0045 take precedence; needle locating or guiding means A61B17/3403; samplers for enzymology or microbiology C12M1/26; sampling or preparing biological specimens G01N33/48
• CPC Class Codes: A61B 10/0266 means for severing sample
• CPC Class Codes: A61B 10/04 Endoscopic instruments
• CPC Class Codes: A61B 17/320725 with radially expandable cutting or abrading elements A61B17/32075 takes precedence
• CPC Class Codes: A61B 17/320758 with a rotating cutting instrument, e.g. motor driven A61B17/320725, A61B17/32075 and A61B17/320783 take precedence; for removing intra-ocular material A61F9/00763; endoscopic rotatable cutting instruments A61B17/32002
• CPC Class Codes: A61B 17/320783 through side-hole, e.g. sliding or rotating cutter inside catheter
• CPC Class Codes: A61B 2017/00778 Operations on blood vessels A61B2017/22097, A61B2017/320741 take precedence
• CPC Class Codes: A61B 2017/320791 with cutter extending outside the cutting window
• CPC Class Codes: A61B 90/90 Identification means for patients or instruments, e.g. tags
• CPC Class Codes: G16H 10/40 for data related to laboratory analysis, e.g. patient specimen analysis
• CPC Class Codes: G16H 10/60 for patient-specific data, e.g. for electronic patient records
• CPC Class Codes: G16H 50/20 for computer-aided diagnosis, e.g. based on medical expert systems
• CPC Class Codes: Y02A 90/10 Information and communication technologies [ICT] supporting adaptation to climate change, e.g. for weather forecasting or climate simulation

Abstract

Material removed by a debulking catheter from a body lumen can be preserved. Materials can be collected from many different patients and/or from multiple procedures on individual patients. Data which describe the properties or qualities of the removed material and/or the patient and/or the patient'"'"'s family or environment can be stored on computer readable media. The stored data can be used to draw correlations, to stratify groups of patients, to provide risk assessments, to provide diagnoses and/or prognoses. Further tests can be done on the stored materials at later times after the procedures have been completed.

Claims

1. An article of manufacture, said article comprising:

a computer readable media having computer executable instructions stored thereon, which when executed by a computer causes the computer to perform an operation comprising;

receiving a plurality of sets of data fields derived from patient samples, wherein each set of data fields comprise;

a first value corresponding to a property of a first excised tissue sample comprising one or more continuous strips of material from the inner surface of a vascular lumen, and

a second value corresponding to data identifying a patient;

a third data field corresponding to the patient'"'"'s health;

storing the plurality of sets of data fields;

correlating the data fields; and

stratifying the patient for a treatment regime.

2. The article of manufacture of claim 1 wherein the third data field comprises a value corresponding to cardiac health of the patient.

3. The article of manufacture of claim 1 wherein the property is selected from the group consisting of:

a level of a marker in the tissue, a composition of the tissue sample, histologic characterization of the tissue, an immunochemical characterization of the tissue, a genomic characteristic, level of a mRNA, a location of the vascular lumen from which the tissue was excised, a volume or a mass of the excised tissue.

4. The article of manufacture of claim 1 further comprising:

a fourth data field comprising a value corresponding to a characteristic of the patient'"'"'s blood.

5. The article of manufacture of claim 4 wherein the patient'"'"'s blood was withdrawn at the time of or before tissue excision.

6. The article of manufacture of claim 1 further comprising:

a fifth data field comprising a value corresponding to family history of the patient.

7. The article of manufacture of claim 1 further comprising:

a sixth data field comprising a value corresponding to the patient'"'"'s medical history.

8. The article of manufacture of claim 1 further comprising:

a seventh data field comprising a value corresponding to a property of a second tissue sample excised from the vascular lumen of the patient at a distinct time.

9. The article of manufacture of claim 8 wherein the second tissue sample is excised from the same vascular lumen as the first tissue sample.

10. The article of manufacture of claim 1 further comprising:

an eighth data field comprising a value corresponding to a property of a second tissue sample excised from distinct vascular lumen of the patient on a same day as the first tissue sample.

11. The article of manufacture media of claim 1 wherein said media are associated with one or more excised tissue samples in labeled storage containers, wherein the computer readable media comprise a ninth data field which comprises a value which links the labeled storage containers with a value in the second data field.

12. The article of manufacture of claim 1 wherein said media are associated with one or more excised tissue samples in labeled storage containers, wherein the storage containers are labeled with a value in the second data field.

13. The article of manufacture of claim 1 wherein said media are associated with one or more samples in labeled storage containers, wherein the one or more samples comprise a component extracted or processed from an excised vascular tissue from a vascular lumen of the patient, wherein the component is selected from the group consisting of DNA, RNA, cDNA, and protein, and wherein the computer readable media comprise a tenth data field which comprises a value which links the labeled storage containers with a value in the second data field.

14. The article of manufacture of claim 1 wherein said media are associated with one or more samples in labeled storage containers, wherein the storage containers are labeled with a value in the second data field, wherein the samples comprise a component extracted or processed from an excised vascular tissue from a vascular lumen of the patient, wherein the component is selected from the group consisting of DNA, RNA, cDNA, and protein.

15. The article of manufacture of claim 1 wherein said vascular lumen comprises an artery and said tissue sample comprises a member selected from the group consisting of a plaque, an occlusive material, a stenotic material, and a hyperplastic material.

16. The article of manufacture of claim 15 wherein said value comprises a result of a characterization, a test, or a diagnosis performed on said first excised tissue sample, which result is stored within said first data structure.

17. The article of manufacture of claim 16 wherein said result comprises therapeutic efficacy information.

18. The article of manufacture of claim 17 wherein said therapeutic efficacy information comprises an efficacy of a treatment or a drug.

19. The article of manufacture of claim 16 wherein said test comprises a member selected from the group consisting of:

a genomic screening, a DNA hybridization, a RNA hybridization, a gene expression analysis, a PCR amplification, a proteomic test, a drug efficacy screening, a determination of the presence of one or more protein markers, a determination of the presence of one or more DNA markers, a determination of the presence of one or more RNA markers, a histological test, a histopathology, a cytopathology, a cell type analysis, a tissue type analysis, a test to determine sensitivity to drugs, a test to determine sensitivity to toxins, and a biopsy.