Method to retract a body vessel wall with remodelable material

• US 8,216,299 B2
• Filed: 03/31/2005
• Issued: 07/10/2012
• Est. Priority Date: 04/01/2004
• Status: Active Grant

• Current Assignee: Cook Medical Incorporated (Cook Group Incorporated)
• Original Assignee: Cook Medical Incorporated (Cook Group Incorporated)
• Inventors: Paul, Ram H. Jr., Case, Brian C.
• Primary Examiner(s): Matthews, William H.
• Assistant Examiner(s): Ganesan, Suba
• Application Number:
  US11/095,209
• Publication Number:
  US 20050222661A1
• Time in Patent Office: 2,658 Days
• Field of Search: 623/23.71, 623/23.75, 623/23.69, 623/23.7, 623/1.15, 623/1.38, 623/1.22, 623/1.49, 623/1.44, 623/1.51, 623/1.53, 623/1.1, 623/1.24, 623/1.41, 623/2.36, 623/2.38, 623/23.72, 606/200, 606/191, 606/194, 606/198, 606/192
• US Class Current: 623/1.38
• CPC Class Codes: A61F 2/2475 Venous valves
• CPC Class Codes: A61F 2/82 Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents stent-grafts for tubular structures of the body other than blood vessels A61F2/04; stent-grafts for blood vessels A61F2/07; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95; for closing wounds, or holding wounds closed A61B17/04 - A61B17/115; dilators A61M29/00
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61F 2210/0004 bioabsorbable
• CPC Class Codes: A61L 27/227 Other specific proteins or polypeptides not covered by A61L27/222, A61L27/225 or A61L27/24
• CPC Class Codes: A61L 27/3633 Extracellular matrix [ECM]
• CPC Class Codes: A61L 27/3641 characterised by the site of application in the body materials for artificial blood vessels A61L27/507; materials for use in artificial skin A61L27/60
• CPC Class Codes: A61L 27/3645 Connective tissue
• CPC Class Codes: A61L 27/367 Muscle tissue, e.g. sphincter

Abstract

The present invention provides remodelable materials for retracting the interior walls of a body vessel via remodeling processes. Also provided are methods, kits and devices for the same.

Claims

1. A method for remodelably retracting the interior wall of a body vessel by inducing contraction of a remodelable extracellular matrix material during a remodeling process on the interior wall of the body vessel, the method comprising:

(a) inserting a delivery system including a remodelable extracellular matrix material without a support frame annularly disposed around a portion of a catheter into a vein, wherein the remodelable extracellular matrix material is isolated from a tissue source and has an implantable first size;

(b) advancing the delivery system to a point of treatment within the vein;

(c) implanting the remodelable extracellular matrix material in contact with an interior wall of a body vessel at the point of treatment within the vein to induce inward retraction of the body vessel wall with said inward retraction beginning only after said implanting of the remodelable extracellular matrix material and only upon remodeling of the remodelable extracellular matrix material, the point of treatment being in the superficial venous system or the deep venous system at a treatment-effective distance of up to about 50 mm from a base of a valve leaflet within the vein to remodelably retract the interior wall of the vein at the base of the valve leaflet radially toward the center of the lumen of the body vessel, and

(d) maintaining the remodelable extracellular matrix material in contact with the interior wall of the body vessel for a time sufficient for the remodelable extracellular matrix material to undergo contraction after said implanting and during remodeling by patient tissue such that the size of the remodelable extracellular matrix material is reduced relative to its implantable first size, wherein said contraction during remodeling is effective after said implanting to pull a portion of the body vessel radially inward within the lumen of the body vessel to reduce the volume of the body vessel lumen at the point of treatment.

2. The method of claim 1, where the remodelable material comprises an extracellular matrix material having a thickness of about 100 to 200 micrometers.

3. The method of claim 1, where the remodelable material comprises at least two extracellular matrix materials, including an autologous tissue.

4. The method of claim 1, where the remodelable material comprises two or more layers of extracellular matrix material, including at least one cross-linked layer.

5. The method of claim 1, where the remodelable material comprises an Elastin or an elastin-like peptide.

6. The method of claim 1, where the remodelable material is perforated and comprises SIS.

7. The method of claim 6, where implanting the remodelable material further comprises the steps of:

inserting the remodelable material without a support frame into the lumen of a vein of the superficial venous system or the deep venous system containing a venous valve;

advancing the remodelable material to a point of treatment within the vein that is a distance of up to about 50 mm from the venous valve, as measured along the interior wall of the vein;

positioning the remodelable material in contact with an interior wall of the vein at the point of treatment; and

removing the catheter from the body vessel while maintaining the remodelable material in contact with the interior wall of the vein at the point of treatment.

8. The method of claim 1, where the remodelable extracellular matrix material is a first remodelable extracellular matrix material that is implanted at a first distance upstream from the base of the venous valve;

the method further comprising the step of;

implanting a second remodelable extracellular matrix material within the lumen of the body vessel at a second distance downstream from the base of the venous valve, such that the first remodelable extracellular matrix material and the second remodelable extracellular matrix material are maintained in contact with the wall of a body vessel without a support frame.

9. The method of claim 8, wherein the first remodelable material is implanted upstream from a native venous valve and the second remodelable material is implanted downstream from a native venous valve.

10. The method of claim 1, where the remodelable material has a thickness of about 100 to 200 micrometers and is implanted at a treatment-effective distance of between about 1 mm-about 50 mm from the base of a leaflet of the venous valve, as measured along the interior wall of the body vessel.

11. The method of claim 1, where the remodelable material is perforated.

12. The method of claim 1, where the body vessel is a vein and the remodelable material is implanted about 1-10 mm from the base of a leaflet of a venous valve within the vein, as measured along the interior wall of the vein.

13. The method of claim 1, further comprising the step of contacting the remodelable material with a crosslinking agent before implanting the remodelable material within the body vessel.

14. The method of claim 1, where the remodelable material is characterized by at least one of the following:

(a) the remodelable material is a multilaminate construct including a xenogenic biomaterial and an autologous material;

(b) the remodelable material comprises an Elastin or an elastin-like peptide; and

(c) the remodelable material comprises small intestine submucosa.

15. The method of claim 1, where the remodelable material is a multilaminate construct including a xenogenic biomaterial and an autologous material.

16. A method for treating venous valve insufficiency by remodelably retracting the bases of two venous valve leaflets closer together to promote increased coaptation of the venous valve leaflets of a native incompetent venous valve within a vein by inducing contraction of a remodelable material in contact with an interior wall of the vein, the method comprising:

(a) inserting a first remodelable material and a second remodelable material each annularly disposed without a support frame around an inflatable portion of a balloon catheter into a vein, where the first remodelable material and the second remodelable material are independently selected from the group consisting of;

submucosa, renal capsule membrane, dura mater, pericardium, serosa, peritoneum membrane and basement membrane, and wherein the first remodelable material and the second remodelable material are isolated from a tissue source and each have an implantable first size;

(b) advancing the first remodelable material and the inflatable portion of the balloon catheter to a first point of treatment within the vein;

(c) first securing the first remodelable material to an interior wall of the vein at the first point of treatment by inflating the inflatable portion of the balloon catheter;

(d) deflating the inflatable portion of the balloon catheter and advancing the second remodelable material to a second point of treatment within the vein;

(e) second securing the second remodelable material to the interior wall of the vein at the second point of treatment, the first point of treatment and the second point of treatment each being in a body vessel of the superficial venous system or the deep venous system containing a venous valve including a leaflet having a base attached to the body vessel, the first point of treatment and the second point of treatment both being at a distance of up to about 50 mm from the base of the leaflet of the venous valve within the body vessel to induce remodelable retraction of the base of the leaflet radially inward toward the interior of the body vessel; and

(f) maintaining the first and second remodelable materials in contact with the interior wall of the body vessel for a time sufficient for the first and second remodelable materials to undergo contraction only upon remodeling by patient tissue such that the size of the first and second remodelable materials is reduced relative to their implantable first size only after said first and second securing steps, wherein said contraction during remodeling is effective to pull a portion of the body vessel radially inward within the lumen of the body vessel to reduce the volume of the body vessel lumen at the point of treatment.

17. The method of claim 16, where the first remodelable material and the second remodelable material are both maintained in contact with an interior wall of the body vessel for at least about 2 days.

18. The method of claim 16, where the first remodelable material comprises a crosslinked extra-cellular matrix material and has a thickness of about 100 to 200 micrometers.

19. The method of claim 16, where the first remodelable material and the second remodelable material comprises one or more materials independently selected from the group consisting of:

an autologous tissue, elastin, an elastin-like peptide and SIS.

20. A method for retracting the interior wall of a vein, the method comprising:

(a) inserting a delivery system including a remodelable extracellular matrix material without a support frame into a vein, wherein the remodelable extracellular matrix material is isolated from a tissue source and has an implantable first size;

(b) advancing the remodelable extracellular matrix material to a point of treatment within the vein;

(c) implanting the remodelable extracellular matrix material in contact with an interior wall of a body vessel at the point of treatment within the vein, the point of treatment being in the superficial venous system or the deep venous system at a treatment-effective distance of up to about 50 mm from a base of a valve leaflet within the vein to retract the interior wall of the vein at the base of the valve leaflet radially toward the center of the lumen of the body vessel only after said implanting and only upon remodeling of the remodelable extracellular matrix material by patient tissue, and

(d) maintaining the remodelable extracellular matrix material in contact with the interior wall of the body vessel for a time sufficient for the remodelable extracellular matrix material to undergo contraction after said implanting and during remodeling by patient tissue such that the size of the remodelable extracellular matrix material is reduced relative to its implantable first size after said implanting and during remodeling by patient tissue, wherein said contraction during remodeling is effective after said implanting to pull a portion of the body vessel radially inward within the lumen of the body vessel to reduce the volume of the body vessel lumen at the point of treatment.