Pro-cell intra-cavity therapeutic agent delivery device

• US 5,693,029 A
• Filed: 07/10/1995
• Issued: 12/02/1997
• Est. Priority Date: 07/10/1995
• Status: Expired due to Term

• Current Assignee: World Medical Manufacturing Corp. (Medtronic Plc)
• Original Assignee: World Medical Manufacturing Corp. (Medtronic Plc)
• Inventors: Leonhardt, Howard J.
• Primary Examiner(s): McDermott, Corrine M.
• Assistant Examiner(s): BLYVEIS, DEBORAH
• Application Number:
  US08/500,419
• Time in Patent Office: 876 Days
• Field of Search: 606/192, 606/194, 604/93, 604/96, 604/97, 604/98, 604/99, 604/100, 604/101, 604/102, 604/103, 604/280, 604/264, 604/46
• US Class Current: 604/264
• CPC Class Codes: A61B 2017/00247 Making holes in the wall of the heart, e.g. laser Myocardial revascularization
• CPC Class Codes: A61B 2017/22061 for spreading elements apart
• CPC Class Codes: A61B 2017/22077 with a part piercing the tissue A61B2017/22044 takes precedence
• CPC Class Codes: A61B 2017/22082 after introduction of a substance
• CPC Class Codes: A61B 2018/00392 Transmyocardial revascularisation
• CPC Class Codes: A61M 2025/0057 Catheters delivering medicament other than through a conventional lumen, e.g. porous walls or hydrogel coatings
• CPC Class Codes: A61M 2025/0086 the needles having bent tips, i.e. the needle distal tips are angled in relation to the longitudinal axis of the catheter
• CPC Class Codes: A61M 2025/0087 Multiple injection needles protruding laterally from the distal tip
• CPC Class Codes: A61M 2025/0096 being laterally outward extensions or tools, e.g. hooks or fibres
• CPC Class Codes: A61M 2025/105 having a balloon suitable for drug delivery, e.g. by using holes for delivery, drug coating or membranes
• CPC Class Codes: A61M 25/0084 being one or more injection needles
• CPC Class Codes: A61M 29/02 Dilators made of swellable material balloon catheters for angioplasty A61M25/104

Abstract

A flexible and kink-proof intra-cavity delivery catheter for precise placement and injection of therapeutic agent(s) into and/or through the wall of a body cavity at a precise treatment site with even distribution throughout. One or more needle assemblies are disposed around a calibrated balloon which, when inflated, brings each needle assembly into contact with and enables the piercing of the cavity wall to a calibrated depth. Each needle assembly consists of a plurality of tissue insertion needles along the longitudinal axis of the needle assembly. Precise amounts of the therapeutic agent are then quickly delivered through the needle assembly directly into the diseased body tissue. When the calibrated balloon is deflated, retraction members pull the needle assemblies back into the catheter body for catheter repositioning or catheter withdrawal. The problems of overtreatment and undertreatment of the treatment site and the body with therapeutic agents, uneven distribution of therapeutic agents within the diseased treatment site, additional trauma to the treatment site, and long term blockage of body fluid distal to the treatment site via known drug delivery catheters are thereby eliminated.

Claims

1. A catheter device and a system useful in the treatment of internal body cavity walls such as blood vessels, said catheter comprising:

a catheter body having a first inner lumen, a second inner lumen, and one or more outer lumens, a proximal backend, and a distal end, said first inner lumen, said second inner lumen and said outer lumens extending from said proximal backend to said distal end;

said first inner lumen existing for the introduction of a guide wire, catheterization balloon, light source, or other device;

an expandable and flexible invention site located close to said distal end of said catheter body comprising one or more needle assemblies each located within one of said outer lumens, an internal inflation balloon in fluid communication with said second lumen and circumferentially surrounding and sealed to said first inner lumen and said second inner lumen such that an internal void is formed within said internal inflation balloon, one or more retraction members encircling said needle assemblies, and portals;

said outer lumens circumferentially surrounding said first inner lumen, said second inner lumen and said internal inflation balloon;

said second inner lumen having a fill hole and a stopper or seal, said fill hole located within said internal inflation balloon, said stopper sealing said second inner lumen distal to said fill hole;

said needle assemblies each comprising a hollow shaft having an open proximal end and a sealed distal end, further having a plurality of tissue insertion needles, said tissue insertion needles and said hollow shaft residing entirely within one of said outer lumens when said internal inflation balloon is deflated, said tissue insertion needles each having a tip with an opening, said tips aligned with said portals;

said hollow shaft, said tissue insertion needles and said tips are sealingly connected and in fluid communication such that therapeutic agents can be transferred from said proximal end of said hollow shaft and out of said open tips of said tissue insertion needles;

said portals extending through said catheter body and into said outer lumens, circumferentially surrounding said internal inflation balloon;

said retraction members are for drawing said tissue insertion needles back into said catheter body;

said inner inflation balloon having a known and calibrated inflation rate and said tissue insertion needles having a known and calibrated length such that inflation of said internal inflation balloon causes said tips of said tissue insertion needles to extend through said portals and pierce the body tissue at a desired treatment site to a known and calibrated depth for the delivery of desired therapeutic agents.

2. A Catheter according to claim 1, wherein said plurality of tissue insertion needles are all of the same calibrated and known length.

3. A Catheter according to claim 1, wherein said plurality of tissue insertion needles are of calibrated and known different lengths.

4. A Catheter according to claim 1, wherein said needle assemblies are flexible and kink resistant.

5. A Catheter according to claim 1, wherein said invention site has a distal end;

said needle assemblies extend from said proximal backend of said catheter body to said distal end of said invention site.

6. A Catheter according to claim 1, wherein said needle assemblies have a proximal end and said invention site has a distal end;

said proximal end of each of said needle assemblies extend from a point within said catheter body located distal to said proximal backend and proximal to said invention site, to said distal end of said invention site;

said proximal end of each of one or more of said needle assemblies forming a leak-proof joint with one of said outer lumens;

said outer lumen being in fluid communication with said needle assembly through said leak-proof joint.

7. A catheter device and a system useful in the treatment of internal body cavity walls such as blood vessels, said catheter comprising:

a catheter body having a first inner lumen, and one or more outer lumens, a proximal backend, and a distal end, said first inner lumen and said outer lumens extending from said proximal backend to said distal end;

an internal inflation balloon and an expandable and flexible invention site, said internal inflation balloon positioned within said inner lumen along said expandable and flexible invention site during a delivery cycle, said first inner lumen also existing for the introduction of a guide wire, catheterization balloon, light source, or other device;

said expandable and flexible invention site located close to said distal end of said catheter body comprising one or more needle assemblies each located within one of said outer lumens, one or more retraction members encircling said needle assemblies, and portals;

said first inner lumen surrounded circumferentially by said outer lumens;

said needle assemblies each comprising a hollow shaft having an open proximal end and a sealed distal end, further having a plurality of tissue insertion needles, said tissue insertion needles and said hollow shaft residing entirely within one of said outer lumens when said internal inflation balloon is deflated, said tissue insertion needles each having a tip with an opening, said tips aligned with said portals;

said hollow shaft, said tissue insertion needles and said tips are sealingly connected and in fluid communication such that therapeutic agents can be transferred from said proximal end of said hollow shaft and out of said tips of said tissue insertion needles;

said retraction members are for drawing said tissue insertion needles back into said catheter body;

said portals extending through said catheter body and into said outer lumens, circumferentially positioned around said expandable and flexible invention site;

said inner inflation balloon having a known and calibrated inflation rate and said tissue insertion needles having a known and calibrated length such that inflation of said internal inflation balloon causes said tips of said tissue insertion needles to extend through said portals and pierce the body tissue at a desired treatment site to a known and calibrated depth for the delivery of desired therapeutic agents.

8. A Catheter according to claim 7, wherein said plurality of tissue insertion needles are all of the same calibrated and known length.

9. A Catheter according to claim 7, wherein said plurality of tissue insertion needles are of calibrated and known different lengths.

10. A Catheter according to claim 7, wherein said needle assemblies are flexible and kink resistant.

11. A Catheter according to claim 7, wherein said invention site has a distal end;

said needle assemblies extend from said proximal backend of said catheter body to said distal end of said invention site.

12. A Catheter according to claim 7, wherein said needle assemblies have a proximal end and said invention site has a distal end;

said proximal end of each of said needle assemblies extend from a point within said catheter body located distal to said proximal backend and proximal to said invention site, to said distal end of said invention site;

said proximal end of each of one or more of said needle assemblies forming a leak-proof joint with one of said outer lumens;

said outer lumen being in fluid communication with said needle assembly through said leak-proof joint.

13. A catheter device useful in the treatment of internal body cavity walls such as blood vessels, said catheter comprising:

a catheter body having one or more lumens each with a proximal opening and portals for providing passage from the outside of a patient to a treatment site within said patient;

an internal lumen adjacent to and surrounded by said one or more lumens;

one or more needle assemblies residing within said one or more lumens for providing fluid communication from outside said patient to said treatment site;

an expander for engaging said one or more needle assemblies with said treatment site through said portals.

14. The catheter device of claim 13, further comprising:

a retractor for retracting said needle assemblies within said one or more lumens.

15. The catheter device of claim 13, wherein:

said one or more needle assemblies have one or more needles for piercing said treatment site.

16. The catheter device of claim 15, wherein:

said one or more needles are of calibrated and known lengths.

17. The catheter device of claim 13, wherein:

said one or more needle assemblies are flexible and kink resistant.