Methods for controlled depth injections into interior body cavities
First Claim
1. A method for injecting a therapeutic fluid a controlled distance into the surface of an interior body cavity in a subject in need thereof, said method comprising:
- (a) introducing a catheter into the interior of a body cavity by advancing the catheter through the vascular system of the subject, said catheter comprising;
i) an elongate hollow catheter body having a proximal end and a distal end with a flexible portion at the distal tip thereof, said catheter body being sized and constructed to be advanced intravascularly into an interior body cavity of a subject;
ii) a hollow needle housed throughout the catheter body, said needle having a distal portion with a sharp tip and a proximal portion in fluid communication with a fluid source, said needle further having a retracted needle position wherein the sharp tip of the needle is disposed within the catheter body, and an advanced needle position wherein the sharp tip of the needle extends a fixed distance beyond a distal end face of the catheter body, iii) a needle stop attached to the needle that tethers the distal portion of needle during flexure while the proximal portion of the needle remains freely slideable within the catheter body, and iv) an advancement mechanism attached to the needle for advancing the needle distally a fixed distance to the advanced needle position;
wherein the needle stop prevents withdrawal of the distal portion of the needle into the catheter body upon flexure of the catheter prior to actuation of the advancement mechanism to advance the needle to the advanced needle position, thereby exposing a fixed length of the sharp tip of the needle;
(b) contacting the surface of the body cavity with the distal portion of the catheter, (c) advancing the sharp distal portion of the injector needle the controlled distance into the surface of the body cavity; and
(d) introducing a therapeutic amount of a therapeutic fluid into the surface of the body cavity through the sharp tip of the injector needle.
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Accused Products
Abstract
A flexible tissue injection catheter is used to accomplish injections at a precisely controlled depth of precisely controlled volumes of a therapeutic or diagnostic agent into an interior body cavity, such as the epicardium or myocardium of the heart. In one embodiment, the invention method includes repeated injections at spaced intervals along the myocardium or epicardium of sterile fluid containing autologous bone marrow aspirate to promote angiogenesis. For myocardial injection, depth penetration is controlled by using a catheter that allows the operator to control depth penetration by means of an adjustable needle stop attached to the catheter handle. In another embodiment depth penetration during epicardial injections is controlled by use of an injection catheter having an operator-controlled adjustable needle stop that produces a sensible signal, such as a visible or audible signal, marking each increment of needle tip exposed by operation of the adjustable needle stop.
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Citations
38 Claims
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1. A method for injecting a therapeutic fluid a controlled distance into the surface of an interior body cavity in a subject in need thereof, said method comprising:
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(a) introducing a catheter into the interior of a body cavity by advancing the catheter through the vascular system of the subject, said catheter comprising;
i) an elongate hollow catheter body having a proximal end and a distal end with a flexible portion at the distal tip thereof, said catheter body being sized and constructed to be advanced intravascularly into an interior body cavity of a subject;
ii) a hollow needle housed throughout the catheter body, said needle having a distal portion with a sharp tip and a proximal portion in fluid communication with a fluid source, said needle further having a retracted needle position wherein the sharp tip of the needle is disposed within the catheter body, and an advanced needle position wherein the sharp tip of the needle extends a fixed distance beyond a distal end face of the catheter body, iii) a needle stop attached to the needle that tethers the distal portion of needle during flexure while the proximal portion of the needle remains freely slideable within the catheter body, and iv) an advancement mechanism attached to the needle for advancing the needle distally a fixed distance to the advanced needle position;
wherein the needle stop prevents withdrawal of the distal portion of the needle into the catheter body upon flexure of the catheter prior to actuation of the advancement mechanism to advance the needle to the advanced needle position, thereby exposing a fixed length of the sharp tip of the needle;
(b) contacting the surface of the body cavity with the distal portion of the catheter, (c) advancing the sharp distal portion of the injector needle the controlled distance into the surface of the body cavity; and
(d) introducing a therapeutic amount of a therapeutic fluid into the surface of the body cavity through the sharp tip of the injector needle. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24)
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25. A method for promoting angiogenesis of an area of a heart, said method comprising:
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(a) introducing a catheter into the interior of the heart by advancing the catheter through the vascular system of the subject, said catheter comprising;
i) an elongate hollow catheter body having a proximal end and a distal end with a flexible portion at the distal tip thereof, said catheter body being sized and constructed to be advanced intravascularly into an interior body cavity of a subject;
ii) a hollow needle housed throughout the catheter body, said needle having a distal portion with a sharp tip and a proximal portion in fluid communication with a fluid source, said needle further having a retracted needle position wherein the sharp tip of the needle is disposed within the catheter body, and an advanced needle position wherein the sharp tip of the needle extends a fixed distance beyond a distal end face of the catheter body, iii) a needle stop attached to the needle that tethers the distal portion of needle during flexure while the proximal portion of the needle remains freely slideable within the catheter body, and iv) an advancement mechanism attached to the needle for advancing the needle distally a fixed distance to the advanced needle position;
wherein the needle stop prevents withdrawal of the distal portion of the needle into the catheter body upon flexure of the catheter prior to actuation of the advancement mechanism to advance the needle to the advanced needle position, thereby exposing a fixed length of the sharp tip of the needle;
(b) contacting the myocardium of the heart with the distal portion of the catheter;
(c) advancing the sharp distal portion of the injector needle the controlled distance into the myocardium; and
(d) introducing a therapeutic amount of an angiogenesis-promoting fluid a precisely controlled depth into the myocardium at multiple spaced locations through the sharp tip of the injector needle. - View Dependent Claims (26, 27, 28, 29)
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30. A method for promoting angiogenesis of an area of a heart, said method comprising:
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(a) introducing a hollow needle a precisely controlled distance into the epicardium of the heart of the subject during a surgical procedure, and (b) injecting an angiogenesis promoting fluid comprising autologous bone marrow aspirate of the subject in a substantially sterile condition into the epicardium via the hollow needle at a plurality of spaced locations;
wherein therapeutic fluid is introduced at a controlled depth in the range from about 0.1 cm to about 2 cm and wherein the volume of the fluid introduced at each of the locations is controlled to be in the range from about 0.1 ml to about 2.0 ml. - View Dependent Claims (31, 32, 33, 34, 35, 36, 37, 38)
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Specification