Method and apparatus for delivery of genes, enzymes and biological agents to tissue cells

• US 6,461,296 B1
• Filed: 02/22/2000
• Issued: 10/08/2002
• Est. Priority Date: 06/26/1998
• Status: Expired due to Fees

• Current Assignee: 2000 Injectx, Inc.
• Original Assignee: 2000 Injectx, Inc.
• Inventors: Desai, Ashvin H.
• Primary Examiner(s): Brown, Michael A.
• Application Number:
  US09/510,537
• Time in Patent Office: 959 Days
• Field of Search: 604/8, 604/105, 604/110, 604/113, 600/210, 600/225
• US Class Current: 600/210
• CPC Class Codes: A61B 1/018 for receiving instruments
• CPC Class Codes: A61B 17/3403 Needle locating or guiding means guides for suture needles A61B17/0482; guiding or tracking by nuclear magnetic resonance G01R33/285
• CPC Class Codes: A61B 17/3478 Endoscopic needles, e.g. for infusion biopsy needles A61B10/0233; catheters with injection needles A61M25/0067
• CPC Class Codes: A61B 2017/00057 Light
• CPC Class Codes: A61B 2017/00274 Prostate operation, e.g. prostatectomy, turp, bhp treatment
• CPC Class Codes: A61B 2017/3411 with a plurality of holes, e.g. holes in matrix arrangement
• CPC Class Codes: A61B 2017/3445 used as instrument channel for multiple instruments catheters A61B2017/22072
• CPC Class Codes: A61B 2018/00547 Prostate
• CPC Class Codes: A61B 2090/378 using ultrasound
• CPC Class Codes: A61B 6/12 Arrangements for detecting or locating foreign bodies
• CPC Class Codes: A61B 8/0841 for locating instruments
• CPC Class Codes: A61N 5/0601 Apparatus for use inside the body
• CPC Class Codes: A61N 5/062 Photodynamic therapy, i.e. excitation of an agent

Abstract

A method and apparatus for delivery of genes, enzymes and biological agents to tissue cells, including a method and apparatus wherein treatment fluids, including genes, enzymes and biological agents, are injected into a target area of a body providing selective attachment to the specific target cells without affecting normal tissue cells. The method is used to treat prostate cancer, breast cancer, uterine cancer, bladder cancer, stomach, lung, colon, and brain cancer, etc. A hollow core needle is inserted into a body, the needle being visually guided by a selected imaging technique. A first embodiment utilizes an endoscopic instrument, wherein a probe is inserted into the body, guided by the endoscope to the vicinity of the target area. The hollow core needle is guided to the vicinity by a channel through the probe. A needle adjustment apparatus is used to extend or retract the needle and adjust needle tip orientation toward a target area. The endoscope provides a view to an operator for adjustment of the apparatus to extend the tip of the needle into and through tissue, interstitially, to a target area for deposit of the specific treatment fluid. A non-invasive imaging technique is used either alone, or in addition to the endoscope, to give an operator a view of the needle for guiding the needle tip to the precise target area. Typical non-invasive techniques include CT scan, MRI, ultrasound, etc.

Claims

1. A method for treating a localized portion of body tissue comprising:

(a) inserting a needle apparatus in a body, said apparatus including at least one hollow core needle for delivering treatment fluid into said body wherein said needle apparatus further includes a sheath having a lumen of greater diameter than an outer diameter of said needle for providing a gap between said needle and said sheath, and said needle extending through said lumen, and said sheath having an evacuation port through a wall of said heath and said evacuation port having fluid communication with a suction connector for connection to a vacuum to extract fluid from said body through said gap;

(b) guiding said needle apparatus to a target tissue in need of treatment, and said guiding including use of an imaging technique for viewing inside an area of tissue without physically invading said area; and

(c) applying said treatment fluid to said target tissue through said needle apparatus;

wherein said treatment fluid is selected from the group consisting of genes, viruses, proteins, inhibitors, tissue markers, bioabsorbable polymers and other biological agents and chemotherapeutic agents.

2. A method for treating a localized portion of body tissue comprising:

(a) inserting a needle apparatus in a body, said apparatus including at least one hollow core needle for delivering treatment fluid into said body;

(b) guiding said needle apparatus to a target tissue in need of treatment, and said guiding including use of an imaging technique for viewing inside an area of tissue without physically invading said area wherein said imaging technique is an ultrasound technique, laser imaging or digital imaging technique; and

(c) applying said treatment fluid to said target tissue through said needle apparatus;

wherein said treatment fluid is selected from the group consisting of genes, viruses, proteins, inhibitors, tissue markers, bioabsorbable polymers and other biological agents and chemotherapeutic agents.

3. An apparatus for injecting treatment fluid into a body comprising:

an assembly including

(a) needle apparatus including a hollow core needle for delivering treatment fluid to a target tissue in a body; and

(b) guiding apparatus for guiding a tip of said hollow core needle to said target tissue and said guiding apparatus including non-invasive imaging apparatus for viewing inside an area of tissue without physically invading said area with said guiding apparatus, wherein said non-invasive imaging apparatus includes ultrasound apparatus, and digital imaging devices;

wherein said treatment fluid is selected from the group consisting of genes, viruses, proteins, inhibitors, vaccines, tissue markers, bioabsorbable polymers, chemotherapeutic agents and other biological agents.

4. A treatment apparatus for injecting treatment fluid into a body comprising:

an assembly including

(a) needle apparatus including a hollow core needle for delivering treatment fluid to a target tissue in a body wherein said needle apparatus further includes a sheath having a lumen, and said needle extending through said lumen, wherein said lumen is of greater diameter than an outer diameter of said needle providing a space between said needle and said sheath, and said sheath having an evacuation port through a wall of said sheath and said evacuation port having fluid communication with a suction connector; and

(b) guiding apparatus for guiding a tip of said hollow core needle to said target tissue and said guiding apparatus including non-invasive imagine apparatus for viewing inside an area of tissue without physically invading said area with said guiding apparatus;

wherein said treatment fluid is selected from the group consisting of genes, viruses, proteins, inhibitors, vaccines, tissue markers, bioabsorbable polymers, chemotherapeutic agents and other biological agents.

5. A treatment apparatus as recited in claim 4 wherein said hollow core needle has a tubular wall with a closed distal end and at least one hole in said wall for discharging said fluid.

6. A method for treating a localized portion of body tissue comprising:

(a) inserting a needle apparatus in a body, said apparatus including at least one hollow core needle for delivering treatment fluid into said body;

(b) guiding said needle apparatus to a target tissue in need of treatment, and said guiding including use of an imaging technique for viewing inside an area of tissue without physically invading said area;

(c) applying said treatment fluid to said target tissue through said needle apparatus; and

(d) heating said target tissue for selective tissue destruction;

wherein said treatment fluid is selected from the group consisting of genes, viruses, proteins, inhibitors, tissue markers, bioabsorbable polymers and other biological agents and chemotherapeutic agents.

7. A method as recited in claim 6 wherein said heating is accomplished by subjecting said target tissue to energy supplied by a media selected from the group consisting of laser beams, electromagnetic waves, ultrasound, and electrical current.

8. A method for treating a localized portion of body tissue comprising:

(a) inserting a needle apparatus in a body, said apparatus including at least one hollow core needle for delivering treatment fluid into said body wherein said inserting is further performed using a hand piece attached to said needle apparatus, and said hand piece includes fluid delivery apparatus for delivering said treatment fluid through said needle wherein said handpiece is constructed to allow use of an imaging device;

(b) guiding said needle apparatus to a target tissue in need of treatment, and said guiding including use of an imaging technique for viewing inside an area of tissue without physically invading said area;

(c) applying said treatment fluid to said target tissue through said needle apparatus; and

(d) illuminating tissue with a selected light frequency for enhancing the detection of diseased tissue;

wherein said treatment fluid is selected from the group consisting of genes, viruses, proteins, inhibitors, tissue markers, bioabsorbable polymers and other biological agents and chemotherapeutic agents.

9. A method for treating a localized portion of body tissue comprising:

(a) inserting a needle apparatus in a body, said apparatus including at least one hollow core needle for delivering treatment fluid into said body wherein said inserting is further performed using a hand piece attached to said needle apparatus, and said hand piece includes fluid delivery apparatus for delivering said treatment fluid through said needle wherein said handpiece is constructed to allow use of an imaging device;

(b) guiding said needle apparatus to a target tissue in need of treatment, and said guiding including use of an imaging technique for viewing inside an area of tissue without physically invading said area;

(c) applying said treatment fluid to said target tissue through said needle apparatus;

(d) injecting tissue with a light discriminating material; and

(e) observing light from said tissue to discern diseased tissue from healthy tissue;

wherein said treatment fluid is selected from the group consisting of genes, viruses, proteins, inhibitors, tissue markers, bioabsorbable polymers and other biological agents and chemotherapeutic agents.

10. A method as recited in claim 9 wherein said material is a dye.

11. A method is recited in claim 9 wherein said material is a phosphorescent material.

12. A method for treating a localized portion of body tissue comprising:

(a) inserting a needle apparatus in a body, said apparatus including at least one hollow core needle for delivering treatment fluid into said body;

(b) guiding said needle apparatus to a target tissue in need of treatment, and said guiding including use of an imaging technique for viewing inside an area of tissue without physically invading said area;

(c) applying said treatment fluid to said target tissue through said needle apparatus;

(d) applying a fluid to an area including said target tissue wherein said fluid is selectively absorbable by said target issue; and

(e) applying energy to said area to cause selective heating of said target tissue;

wherein said treatment fluid is selected from the group consisting of genes, viruses, proteins, inhibitors, tissue markers, bioabsorbable polymers and other biological agents and chemotherapeutic agents.