Debulking catheters and methods

• US 7,699,790 B2
• Filed: 07/21/2004
• Issued: 04/20/2010
• Est. Priority Date: 12/20/2000
• Status: Expired due to Fees

• Current Assignee: Covidien LP (Medtronic Plc)
• Original Assignee: ev3, Inc. (Medtronic Plc)
• Inventors: Simpson, John B.
• Primary Examiner(s): Hindenburg; Max
• Assistant Examiner(s): Hoekstra; Jeffrey G
• Application Number:
  US10/896,741
• Publication Number:
  US 20050177068A1
• Time in Patent Office: 2,099 Days
• Field of Search: 600/564, 600/562, 600/567, 600/570, 606/167, 606/170, 606/180
• US Class Current: 600/564
• 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 2017/00685 Archimedes screw
• CPC Class Codes: A61B 2017/2927 the angular position of the head being adjustable with respect to the shaft
• CPC Class Codes: A61B 2017/320032 Details of the rotating or oscillating shaft, e.g. using a flexible shaft

Abstract

A debulking catheter comprising a tissue debulking assembly for removing a contiguous strand of material from a body lumen. Catheters of the present invention generally include a catheter body having proximal and distal portions and a tissue debulking assembly disposed at least partially within the distal portion. The tissue debulking assembly is radially movable to expose at least a portion of the assembly through a window on the catheter body. The catheter is advanced transluminally through the body lumen to contact material in the body lumen and remove a plane of contiguous material that has a length that is typically longer than a length of the window on the catheter. The contiguous material may be directed into a collection chamber. Thereafter, the material may be removed from the collection chamber and preserved or tested.

Claims

1. A method of excising and testing material from a body lumen, the method comprising:

providing a catheter having a rotating cutter, a tissue collection chamber, and a cutting window, the rotating cutter being movable between a stored position and an exposed position, at least part of the rotating cutter becoming exposed through the cutting window when moving to the exposed position;

exposing the cutter by moving the cutter to the exposed position;

advancing the catheter to move the rotating cutter through material in a first site in the body lumen, the rotating cutter remaining in the exposed position so that the cutter and the window maintain their orientation with respect to one another when advancing the catheter through the material, the material cut by the rotating cutter comprising a contiguous strand longer than the cutting window and retaining a structure of the tissue prior to removal and being directed through the cutting window and into the tissue collection chamber as the catheter is advanced through the material;

removing the material from the collection chamber; and

performing one or more tests on at least a portion of the material removed from the collection chamber.

2. The method of claim 1 comprising placing the material in a preserving agent, tissue fixative, or a preparation agent prior to testing.

3. The method of claim 2, wherein the preserving agent, tissue fixative, or preparing agent comprises saline, heparinized saline, liquid nitrogen, formalin, a membrane lysis agent, a RNA preparation agent, or a DNA preparation agent.

4. The method of claim 1, wherein the tests comprise genomic screening, DNA hybridization, RNA hybridization, gene expression analysis, PCR amplification, proteomic testing, drug efficacy screening, determining the presence of one or more DNA markers, determining the presence of one or more RNA markers, determining the presence of one or more protein markers, histological testing, histopathology, cytopathology, cell type analysis, tissue type analysis, or biopsy.

5. The method of claim 1, wherein performing one or more tests comprises analyzing the material for the presence of DNA RNA, or a protein marker comprising a smooth muscle proliferative promoter, a smooth muscle proliferative inhibitor, a cellular marker, an apoptotic marker, a cell cycle protein, a transcriptional factor, a proliferative marker, an endothelial growth factor, an adhesion molecule, a cytokine, a chemokine, a chemokine receptor, an inflammation marker, an extracellular matrix molecule, an interleukin, a growth factor, a glycoprotein, a proteoglycan, a cell-surface marker, a serum marker, or an immune factor.

6. The method of claim 1, wherein prior to removing the material form the collection chamber the method further comprises:

moving the cutter to the stored position;

repositioning the catheter at a second site;

exposing the cutter by moving the cutter to the exposed position;

advancing the catheter to move the rotating cutter through material in the second site, the rotating cutter remaining in the exposed position so that the cutter and the window maintain their orientation with respect to one another when advancing the catheter through the material, the material cut by the rotating cutter being directed through the cutting window and into the collection chamber as the catheter is advanced through the material.

7. The method of claim 6, wherein the first site and the second site are in the same body lumen.

8. The method of claim 6, wherein the first site and the second site are in different body lumens.

9. The method of claim 1, wherein advancing the catheter to move the rotating cutter through the material excises at least one contiguous strand of material from the inner surface of the body lumen, wherein the at least one contiguous strand comprises from about 1 mg to about 2000 mg of material.

10. The method of claim 9, wherein the at least one contiguous strand comprises from about 1 mg to about 100 mg of material, from about 100 to about 200 mg of material, from about 200 mg to about 300 mg of material, from about 300 to about 400 mg of material, from about 400 to about 500 mg of material, from about 500 to about 600 mg of material, from about 600 to about 700 mg of material, from about 700 to about 800 mg of material, or from about 800 mg to about 2000 mg of material.

11. The method of claim 1, wherein advancing the catheter moves the cutter through the material excises at least one contiguous strand of material from the body lumen, wherein the length of the at least one contiguous strand is longer than a largest dimension of the cutting window.

12. The method of claim 1, wherein the material comprises plaque tissue.

13. The method of claim 1, wherein prior to removing the material form the collection chamber the method further comprises:

moving the cutter to the stored position;

repositioning the catheter at a second site;

exposing the cutter by moving the cutter to the exposed position;

advancing the catheter to move the rotating cutter through material in the second site, the rotating cutter remaining in the exposed position so that the cutter and the window maintain their orientation with respect to one another when advancing the catheter through the material, the material cut by the rotating cutter being directed through the cutting window and into the collection chamber as the catheter is advanced through the material.

14. The method of claim 13, wherein the first site and the second site are in the same body lumen.

15. The method of claim 13, wherein the first site and the second site are in different body lumens.

25. A method of diagnosing a condition of a patient comprising performing one or more diagnostic test on the material excised according to the method of claim 1;

and proposing a therapeutic protocol based on information derived from one or more of the diagnostic tests.

26. A method of excising and testing material removed from a body lumen according to the method of claim 1, the method comprising harvesting the material from the collection chamber of the catheter while maintaining the heterogeneous structure of the material as it was removed from the inner surface of the lumen of the patient, and performing one or more tests on at least a portion of the material removed from the catheter.

27. The method as in claim 26, wherein the tests comprise monitoring the progress of a treatment regimen.

28. The method as in claim 26, wherein the tests comprise designing a treatment directive for the patient.

29. The method of claim 26, wherein the tests comprise designing a treatment protocol for the patient.

30. The method of claim 26, wherein the tests comprise drug efficacy screening.

31. The method of claim 26, wherein the material is collected from a single site.

32. The method of claim 26, wherein the material is collected from at least one additional site in the same or a different body lumen.

33. The method of claim 26, wherein the material comprises arterial plaque and associated tissue.

16. A method for excising and testing material from a vascular location, comprising the steps of:

providing a catheter having a body, an opening leading to a tissue collection chamber, and a rotatable cutter, the cutter being movable between a stored position and an exposed position, the cutter becoming at least partially exposed when moving from the stored position to the exposed position;

introducing the catheter into a patient'"'"'s vascular system with the cutter in the stored position, the catheter being introduced to the vascular location where material is to be excised;

exposing the cutter by moving the cutter to the exposed position;

rotating the cutter;

advancing the catheter after the exposing step and the rotating step, wherein the rotating cutter and the opening advance together so that material cut by the rotating cutter comprises a contiguous strand longer than the cutting window that retains a structure of the tissue prior to removal and is directed through the opening and into the tissue collection chamber as the catheter is advanced;

removing the catheter from the vascular location;

harvesting the material from the collection chamber after the catheter has been removed from the vascular location and the vascular system of the patient; and

performing one or more tests on at least a portion of the material removed from the collection chamber.

17. The method of claim 16 comprising placing the material in a preserving agent, tissue fixative, or a preparation agent prior to testing.

18. The method of claim 17, wherein the preserving agent, tissue fixative, or preparing agent comprises saline, heparinized saline, liquid nitrogen, formalin, a membrane lysis agent, a RNA preparation agent, or a DNA preparation agent.

19. The method of claim 16, wherein the tests comprise genomic screening, DNA hybridization, RNA hybridization, gene expression analysis, PCR amplification, proteomic testing, drug efficacy screening, determining the presence of one or more DNA markers, determining the presence of one or more RNA markers, determining the presence of one or more protein markers, histological testing, histopathology, cytopathology, cell type analysis, tissue type analysis, or biopsy.

20. The method of claim 16, wherein performing one or more tests comprises analyzing the material for the presence of DNA RNA, or a protein marker comprising a smooth muscle proliferative promoter, a smooth muscle proliferative inhibitor, a cellular marker, an apoptotic marker, a cell cycle protein, a transcriptional factor, a proliferative marker, an endothelial growth factor, an adhesion molecule, a cytokine, a chemokine, a chemokine receptor, an inflammation marker, an extracellular matrix molecule, an interleukin, a growth factor, a glycoprotein, a proteoglycan, a cell-surface marker, a serum marker, or an immune factor.

21. The method of claim 16, wherein advancing the catheter to move the rotating cutter through the material excises at least one contiguous strand of material from the inner surface of the body lumen, wherein the at least one contiguous strand comprises from about 1 mg to about 2000 mg of material.

22. The method of claim 21, wherein the at least one contiguous strand comprises from about 1 mg to about 100 mg of material, from about 100 to about 200 mg of material, from about 200 mg to about 300 mg of material, from about 300 to about 400 mg of material, from about 400 to about 500 mg of material, from about 500 to about 600 mg of material, from about 600 to about 700 mg of material, from about 700 to about 800 mg of material, or from about 800 mg to about 2000 mg of material.

23. The method of claim 16, wherein advancing the catheter moves the cutter through the material excises at least one contiguous strand of material from the body lumen, wherein the length of the at least one contiguous strand is longer than a largest dimension of the cutting window.

24. The method of claim 16, wherein the material comprises plaque tissue.