US5997509A — Minimally invasive gene therapy delivery device a…

Claim 1

Independent Claim 165 words

A device for injecting a therapeutic substance into bodily tissue wherein a portion of the device is inserted into a cavity within a body of a patient prior to injection, said device comprising: an elongate tubular member having a proximal end for operation outside of the patient's body, and a distal end for operation inside the patient's body; an elongate flexible tube located within said tubular member, said flexible tube having a proximal end and a distal end, said distal end having a needle mounted theron; and a marking ring mounted on the distal end of said flexible tube for leaving a discernable indication on the bodily tissue at the location where the therapeutic substance is injected, said flexible tube being moveable axially relative to said tubular member for remotely extending and retracting said needle mounted on the distal end of said flexible tube, whereby, when extended, said needle can penetrate the bodily tissue of the patient for injecting the therapeutic substance into the tissue.

Claim 2

Independent Claim 165 words

A device for injecting a therapeutic substance into bodily tissue wherein a portion of the device is inserted into a cavity within a body of a patient prior to injection, said device comprising: an elongate tubular member having a proximal end for operation outside of the patient's body, and a distal end for operation inside the patient's body; an elongate flexible tube located within said tubular member, said flexible tube having a proximal end and a distal end, said distal end having a needle mounted theron; and a marking ring mounted on the distal end of said flexible tube for leaving a discernable indication on the bodily tissue at the location where the therapeutic substance is injected, said flexible tube being moveable axially relative to said tubular member for remotely extending and retracting said needle mounted on the distal end of said flexible tube, whereby, when extended, said needle can penetrate the bodily tissue of the patient for injecting the therapeutic substance into the tissue.

Claim 3

Dependent Claim 79 words

The device of claim 1 further including a cup mounted on said distal end of said tubular member, said needle and said platen being maintainable in a retracted position in said cup during positioning of said needle within the patient's body relative to the bodily tissue, said needle and said marking means being subsequently extendable from said cup when said needle is intended to penetrate the bodily tissue by moving said flexible tube axially relative to said tubular member.

Claim 4

Dependent Claim 41 words

The device of claim 2 further including a control means located on the proximal end of said tubular member and operable to remotely control the attitude of said cup relative to the bodily tissue of the patient within the patient's body.

Claim 5

Dependent Claim 49 words

The device of claim 2 further including a syringe for containing the therapeutic substance, said syringe being in fluid communication with said needle through said flexible tube, said syringe also being axially movable relative to said tubular member for extending said needle and said marking ring from said cup.

Claim 6

Dependent Claim 70 words

The device of claim 1 further including a platen, said needle projecting from said platen, said platen including said marking ring thereon, said platen being remotely movable with said flexible tube and said needle, whereby, when said needle penetrates the bodily tissue, said marking ring contacts the surface of the bodily tissue for creating a discernable mark thereon, while said platen also limits the depth of penetration by said needle.

Claim 7

Dependent Claim 17 words

The device of claim 5 wherein said marking ring includes an absorbent material saturated with a dye.

Claim 8

Dependent Claim 54 words

The device of claim 1 further including a control means mounted near said proximal end of said tubular member, said control means being operable outside the body of the patient for remotely causing the distal portion of said tubular member to flex transversely for controllably positioning said needle inside the body of the patient.

Claim 9

Independent Claim 102 words

A device for delivering a therapeutic substance to a bodily tissue, said device comprising: an elongate tubular member, said tubular member having a proximal end and a distal end; a flexible tube located within said tubular member, said flexible tube having a proximal end and a distal end; a hollow needle disposed at said distal end of said flexible tube for delivering the therapeutic substance into the bodily tissue; and a remotely extensible and retractable marking means located on the distal end of said flexible tube, said marking means being capable of indicating when an injection has been made in the tissue.

Claim 10

Independent Claim 102 words

A device for delivering a therapeutic substance to a bodily tissue, said device comprising: an elongate tubular member, said tubular member having a proximal end and a distal end; a flexible tube located within said tubular member, said flexible tube having a proximal end and a distal end; a hollow needle disposed at said distal end of said flexible tube for delivering the therapeutic substance into the bodily tissue; and a remotely extensible and retractable marking means located on the distal end of said flexible tube, said marking means being capable of indicating when an injection has been made in the tissue.

Claim 11

Dependent Claim 50 words

The device of claim 8 wherein said marking means includes a platen, said needle being mounted on said platen, said platen including a marking ring thereon, whereby when said needle penetrates the bodily tissue, said marking ring will contact the surface of the tissue for creating a discernable mark thereon.

Claim 12

Dependent Claim 17 words

The device of claim 9 wherein said marking ring includes an absorbent material saturated with a dye.

Claim 13

Dependent Claim 65 words

The device of claim 8 further including a cup mounted on said distal end of said tubular member, said needle and said marking means being maintainable in a retracted position in said cup during positioning of said needle relative to the bodily tissue, said needle and said marking means being subsequently extendable from said cup when said needle is intended to penetrate the bodily tissue.

Claim 14

Dependent Claim 44 words

The device of claim 11 further including a syringe for containing the therapeutic substance, said syringe being in fluid communication with said needle through said flexible tube, said syringe being movable relative to said tubular member for extending said needle and said marking means.

Claim 15

Dependent Claim 41 words

The device of claim 8 further including a control means for enabling said distal end of said tubular member to be controllably flexed in a transverse manner for positioning said distal end of said tubular member proximate to the bodily tissue.

Claim 16

Independent Claim 129 words

A method of delivering a therapeutic substance to an area of bodily tissue within the body of a patient, said method comprising: providing an elongate tubular member having a proximal end and a distal end, said tubular member having a needle and a marking means extensible from said distal end; inserting the distal end of said tubular member into the patient's body; positioning said distal end of said tubular member proximate to the bodily tissue to be treated; retaining said needle and said marking means in a retracted position during positioning of said distal end relative to the bodily tissue; extending said needle and said marking means to penetrate the tissue with said needle; injecting said therapeutic substance; and marking said tissue to indicate the location of the injection.

Claim 17

Independent Claim 129 words

A method of delivering a therapeutic substance to an area of bodily tissue within the body of a patient, said method comprising: providing an elongate tubular member having a proximal end and a distal end, said tubular member having a needle and a marking means extensible from said distal end; inserting the distal end of said tubular member into the patient's body; positioning said distal end of said tubular member proximate to the bodily tissue to be treated; retaining said needle and said marking means in a retracted position during positioning of said distal end relative to the bodily tissue; extending said needle and said marking means to penetrate the tissue with said needle; injecting said therapeutic substance; and marking said tissue to indicate the location of the injection.

Claim 18

Dependent Claim 35 words

The method of claim 14 further including the step of repositioning said distal end and said needle proximate to the bodily tissue in a location adjacent to the first injection site for making successive injections.

Claim 19

Dependent Claim 28 words

The method of claim 15 wherein the locations for the subsequent injections are determined at least in part based upon marks left at the location of previous injections.

Claim 20

Dependent Claim 26 words

The method of claim 14 in which said tubular member is inserted into the patient through a port located within an incision in the patient's body.

Claim 21

Dependent Claim 47 words

The method of claim 14 in which a plurality of successive injections are made in a grid-like pattern over an area of tissue, with a mark being left at the site of each successive injection to ensure coverage of the entire desired area of tissue being treated.

Claim 22

Dependent Claim 62 words

The method of claim 14 in which the therapeutic substance is retained within a syringe in fluid communication with said needle by a flexible tube, said syringe and said flexible tube being movable axially relative to said tubular member so that said needle is extended by the step of moving said syringe and said flexible tube axially relative to said tubular member.

Claim 23

Dependent Claim 68 words

The method of claim 14 wherein a platen is included for contacting the tissue during injection, said platen and said needle being fixed relative to each other, and said marking means comprising a raised ring located on the surface of said platen, whereby, when said needle penetrates the tissue, said marking means and said platen contact the tissue surface for controlling the depth of penetration by said needle.

Annuity Stage	Window Opens	Payment Deadline	Surcharge Period Until	Estimated Fee	Status
3.5 Years (Year 4)	2002-12-06	2003-06-07	2003-12-07	$2000.00	Window Closed / Lapsed
7.5 Years (Year 8)	2006-12-06	2007-06-07	2007-12-07	$3760.00	Window Closed / Lapsed
11.5 Years (Year 12)	2010-12-06	2011-06-07	2011-12-07	$7700.00	Window Closed / Lapsed

Minimally invasive gene therapy delivery device and method

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