Patent Application
20100047210
The present invention relates generally to methods and apparatus for medical treatment and more particularly to systems and methods for controlling the position of a needle or other device within the wall of an organ or other body tissue mass.
In modern medicine there are numerous situations in which it is desirable to control the depth of penetration or positioning of a needle or other therapy delivering or diagnostic device that has been advanced into the wall of an organ, tumor or other body tissue mass. In some cases, the needle or other therapy delivering or diagnostic device is advanced into the desired anatomical structure by hand. In other cases, the needle or other therapy delivering or diagnostic device is advanced from a catheter that has been inserted into the patient's vasculature. Examples of catheters that have needles or other treatment devices that may be advanced from the catheter into adjacent tissue are described in U.S. Pat. No. 5,830,222 (Makower); U.S. Pat. No. 6,068,638 (Makower), U.S. Pat. No. 6,159,225 (Makower), U.S. Pat. No. 6,190,353 (Makower, et al.), U.S. Pat. No. 6,283,951 (Flaherty, et al.), U.S. Pat. No. 6,375,615 (Flaherty, et al.), U.S. Pat. No. 6,508,824 (Flaherty, et al.), U.S. Pat. No. 6,544,230 (Flaherty, et al.), U.S. Pat. No. 6,655,386 (Makower et al.), U.S. Pat. No. 6,579,311 (Makower), U.S. Pat. No. 6,602,241 (Makower, et al.), U.S. Pat. No. 6,655,386 (Makower, et al.), U.S. Pat. No. 6,660,024 (Flaherty, et al.), U.S. Pat. No. 6,685,648 (Flaherty, et al.), U.S. Pat. No. 6,709,444 (Makower), U.S. Pat. No. 6,726,677 (Flaherty, et al.) and U.S. Pat. No. 6,746,464 (Makower) and co-pending U.S. patent applications having Ser. Nos. 11/279,993; 11/279,265; 11/279,771; 11/610,092; 11/534,895; 11/613,764; 11/837,718; 12/054,533 and 12/045,120, the entire disclosures of which are expressly incorporated herein by reference.
In particular, it is sometimes desirable to control the depth at which a therapeutic substance is injected into an organ, tumor or other anatomical structure. For example, various therapeutic substances may be injected into ischemic, infracted or damaged areas of a patient's heart in order to stimulate neoangiogenesis in ischemic myocardium, establish new functional cardiac muscle cells, deter ventricular remodeling, deter scar formation at an infarct site or otherwise improve/maintain myocardial function. In some instances, these therapeutic substances may be combined with other ancillary agents (e.g., potentiators or radiographic markers) when injected into the myocardium.
The types of angiogenic substances that have been proposed for injection into the myocardium to stimulate neoangiogenesis in ischemic myocardial tissue include peptide growth factors, small molecule drugs and other active compounds, biologically active carbohydrates, recombinant biopharmaceuticals, agents that are active in the regulation of vascular physiology and cellular and gene therapy agents. Examples of specific angiogenic substances that fall within these general categories include but are not limited to: nitric oxide, agents that affect transcription or turnover of cellular mRNA or the efficiency with which specific mRNA translates into its protein product, antisense agents, hormones, soluble receptors, receptor ligands, synthetic and naturally occurring peptides, peptidomimetic compounds, specific and non-specific protease inhibitors, postaglandins, inhibitors of prostaglandin synthase and/or other enzymes involved in the regulation of prostaglandin synthesis, fibroblast growth factors (FGF's), acidic (aFGF, FGF-II) and basic (bFGF, FGF-I) fibroblast growth factors, vascular endothelial growth factors (VEGF), agents that stimulate endogenous production of VEGF such as platelet-derived growth factor (PDGF), purified monocyte-derived angiogenic substance (angiotropin), angiogenin, transforming growth factor alpha (TGF-α), transforming growth factor beta (TGF-β) and angiogenic cell precursors (e.g., stem cells).
Examples cell preparations that are purported to be injectable into the myocardium for the purpose of establishing new functional heart muscle include myocyte preparations, embryonic, adult and mesenchymal stem cell preparations, myoblast (including skeletal myoblast) preparations, bone marrow mononuclear cell preparations and possibly others.
Also, a substance that has been found to deter deleterious remodeling of the ventricle wall or otherwise improve myocardial function when injected to an area of infracted myocardium is platelet gel (PG). In some instances, platelet gel components (e.g., platelet concentrate and a thrombin containing solution) may be injected through separate lumens so that they become combined to form platelet gel immediately before or after entering the myocardium, as described in United States Patent Application Publication Nos. 2006/0041243 (Ser. No. 11/159,752) entitled Devices And Methods For Interstitial Injection Of Biologic Agents Into Tissue; 2007/0014784; 11/426219 (Ser. No. 11/426,219) entitled Methods and Systems for Treating Injured Cardiac Tissue; 2007/0042016 (Ser. No. 11/426,211) entitled Methods and Systems for Treating Injured Cardiac Tissue; 2007/0093748 (Ser. No. 11/643,359) entitled Methods and Systems for Treating Injured Cardiac Tissue; 2007/0172472 (Ser. No. 11/619,576) entitled Methods and Systems for Treating Injured Cardiac Tissue; 2008/0161757 (Ser. No. 11/969,085) entitled Devices and Methods for Injection of Multiple-Component Therapies 2008/0161772 (Ser. No. 11/969,094) entitled and Devices and Methods for Injection of Multiple-Component Therapies as well as copending U.S. patent application Ser. No. 12/106,839 entitled Dual Syringe Injector System, the entire disclosure of each such patent application being expressly incorporated herein by reference.
Also, it is sometimes desirable to deliver various other diagnostic, cosmetic or therapeutic substances (drugs, chemotherapeutic agents, other anti-cancer agents, radiographic contrast materials, biologics, cell preparations, gene therapy preparations, bulking agents, fillers, etc.) or to deliver implantable devices (e.g., drug delivery implants, electrodes, radiographic markers or tags, nanotechnology devices, etc.) through needles, cannulae or other elongate devices that have been inserted or advanced to specific locations within organs or tissue masses (normal or aberrant) within the bodies of human or animal subject. In many such cases, controlling the depth at which the substance or device is delivered into tissue is desirable.
The prior art has included a number of devices for limiting or controlling the depth to which a needle, injector or other device penetrates into a tissue mass when inserted by hand or from a catheter or other device. For example, U.S. Pat. No. 3,538,916 describes an injection pistol for intramuscular implantation of encapsulated liquid or solid chemical material. The depth of injection of the needle is controlled by an injection depth gauge mounted on the injection needle. A shaft having a slidable plunger integral therewith is mounted on the frame and is utilized to eject the material from the needle after the needle has been advanced into the muscle. The travel of the plunger within the injection needle is limited by an adjustable depth stop mounted on the end of the shaft opposite the plunger.
U.S. Pat. No. 4,270,537 (Romaine) describes a hypodermic syringe and automatic needle insertion device wherein the syringe is biased against a trigger when the needle is in the retracted position. Upon release of the trigger, the syringe and needle are driven forward extending the needle into the underlying tissue. The depth of insertion may be predetermined by the attachment of an interchangeable stop.
U.S. Pat. No. 4,710,171 (Rosenberg) describes a needle depth setting sheath assembly and needle stop which comprises a locking assembly that may be tightened about a “needle barrel.” A sheath with graduations therein permits the needle depth to be adjusted accurately. An elastomeric bushing is compressible about the “needle barrel,” and the bushing is prevented by a screw-hub arrangement from becoming dislocated.
U.S. Pat. No. 5,141,496 (Dalto, et al.) describes a syringe guide with adjustment of the depth to which the needle penetrates. One end of the syringe guide has a sliding base which is adjustable by means of a screw and the other end includes a spring-loaded sliding portion that is affixed to the syringe and propels the needle to a predetermined depth of injection.
U.S. Pat. No. 5,217,438 (Davis et al.) describes a needle stop for a biopsy needle or the like wherein a coil spring is engaged with the surface of the shaft of the needle. Ends of the spring may be pinched to enlarge the spring coils and permit movement of the stop along the shaft. A guard tube is associated with the stop for covering the point of the needle when not in use.
U.S. Pat. No. 5,250,026 (Ehrlich et al.) describes an implant injector that has an adjustable insertion depth feature. The insertion depth adjusted by moving the nose of the injector relative to the tip of the cannula that extends past the nose. In addition to adjusting the insertion depth, the cannula or needle, may also be rotated to a plurality of positions relative to the injector handle. A spring loaded plunger, when released by a release button, will push the implant out the end of the cannula as the operator withdraws the cannula from the animal. The release button is designed as a safety trigger to avoid premature activation of the plunger during insertion of the needle. Needles, or cannulae of various diameters and lengths, may be interchanged in the injector. Also, the spring loaded plunger for expelling the implant may be removed allowing the operator to replace the plunger with a different diameter and length plunger, if desired, to match different size cannulae.
U.S. Pat. No. 6,623,474 (Ponzi) describes a injection catheter that is equipped with a needle stop. The catheter comprises a catheter body comprising a flexible tubing having proximal and distal ends and at least one lumen therethrough. A tip section comprising a flexible tubing is mounted at the distal end of the catheter body. The tip section has a needle passage extending therethough. The needle passage has a proximal region having a proximal diameter and a distal region having a distal diameter less than the proximal diameter. A needle control handle is provided at the proximal end of the catheter body. An injection needle extends through the tip section, catheter body, and needle control handle and has a proximal end attached to the needle control handle and a distal end within the needle passage. The injection needle is longitudinally slidable so that its distal end can extend beyond the distal end of the tip section upon suitable manipulation of the needle control handle.
U.S. Pat. No. 5,102,393 (Sarnoff et al.) describes an autoinjector that has an intramuscular injection mode and a subcutaneous injection mode. An injection mode converting structure is useable to convert the device back and forth between a subcutaneous mode wherein the needle is allows to advance to a first depth that does not extend substantially beyond subcutaneous tissue at the injection site and an intramuscular mode wherein the needle is allowed to advance to a second depth that is within muscle that underlies the subcutaneous tissue.
Also, copending U.S. patent application Ser. No. 12/108,961 (Macaulay et al.) describes devices and methods for limiting the depth to which a penetrator is advanced into an organ or mass of tissue. This application describes a device that generally comprises a first member and a second member, with a penetrator attached to and extending from the second member. The first member has a penetrator shroud and a hollow bore extending therethrough. The second member is engageable with the first member such that a distal portion of the penetrator extends through the penetrator shroud. The distance to which the penetrator protrudes out of and beyond the distal end of the penetrator shroud is adjustable in accordance with the desired depth of penetration. The penetrator may then be advanced into the organ or tissue mass until the distal end of the shroud abuts against the organ or tissue mass, thereby stopping further advancement of the penetrator. The penetrator may have one or more lumen(s) for aspirating or infusing substances.
There remains a need in the art for the development of additional devices and methods for controlling the depth or positioning of needles, cannulae and other diagnostic/therapeutic devices within the walls of organs or other tissue masses.
In accordance with one aspect of the present invention, there is provided a system for positioning a treatment delivery location (e.g., on opening, port, lens or other location from which a therapeutic or diagnostic substance, flow of energy or device may be delivered) of an elongate treatment device at a desired location within a tissue mass located near an open or fluid-filled space, body cavity or body lumen, said system. In general, this system comprises (A) an elongate treatment device having a treatment delivery location that is advanceable into the tissue mass; (B) an anchoring member comprising a shaft and an anchor, said anchor having a radially collapsed configuration and a radially expanded configuration, said shaft being advanceable into the space, body cavity or body lumen while the anchor is in its collapsed configuration, the anchor being thereafter transitionable to an expanded configuration and the shaft being thereafter retractable to pull the anchor into abutment with a wall of the space, body cavity or body lumen adjacent to the tissue mass and (C) measuring apparatus useable to determine the distance between the location at which the anchor abuts against the wall of the space, body cavity or body lumen and a treatment-delivering location on the elongate treatment device.
Further in accordance with the present invention, there is provided a method for positioning a treatment delivery location of a treatment device within a tissue mass at a desired distance from an open or fluid-filled space, body cavity or body lumen. In general, this method comprises the steps of (A) advancing an anchoring member from the treatment device and into the space, body cavity or body lumen, (B) causing an expandable anchor on the anchoring member to expand, (C) retracting the anchoring member to cause the expanded anchor to abut against a wall of the space, body cavity or body lumen, (D) measuring the distance between the treatment delivery location on the elongate treatment device and the location at which the anchor abuts against the wall of the space, body cavity or body lumen and (E) maneuvering the elongate treatment device as needed until the measured distance indicates that the treatment delivery location of the elongate treatment device is positioned at the desired distance from the space, body cavity or body lumen.
Further aspects, details and embodiments of the present invention will be understood by those of skill in the art upon reading the following detailed description of the invention and the accompanying drawings.
The following detailed description and the accompanying drawings are intended to describe some, but not necessarily all, examples or embodiments of the invention. The contents of this detailed description and accompanying drawings do not limit the scope of the invention in any way.
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In some applications of this invention, the injection cannula 12, 60 may be directly inserted, either percutaneously or via an incision formed in a body wall, and advanced into a desired organ or body structure. For example, if it is desired to deliver a substance or device into the myocardium of the heart, in some embodiments, the injection cannula 12, 60 may be inserted through an open thoracotomy incision or through a thoracoscopic port and then advanced through the epicardial surface of the heart and to a desired position at a predetermined depth within the myocardium in accordance with any of the above-described procedures. In other applications, the injection cannula 12, 60 may comprise a straight or curved cannula that is advanceable from a transluminally inserted tissue penetrating catheter. In such cases, the tissue penetrating catheter will be initially inserted into the subject's vasculature and advanced to a position within a blood vessel near or within the anatomical structure in which it is intended to deliver the substance or device. Thereafter, the injection cannula 12, 60 and accompanying anchoring member 14, 14a will be advanced from the catheter and used to effect the intended delivery of the substance or device in accordance with the procedures described herein. Examples and details of tissue penetrating catheters that may be modified to incorporate the systems 10, 10a, 10b of this invention include but are not limited to those described in U.S. Pat. No. 5,830,222 (Makower); U.S. Pat. No. 6,068,638 (Makower), U.S. Pat. No. 6,159,225 (Makower), U.S. Pat. No. 6,190,353 (Makower, et al.), U.S. Pat. No. 6,283,951 (Flaherty, et al.), U.S. Pat. No. 6,375,615 (Flaherty, et al.), U.S. Pat. No. 6,508,824 (Flaherty, et al.), U.S. Pat. No. 6,544,230 (Flaherty, et al.), U.S. Pat. No. 6,655,386 (Makower et al.), U.S. Pat. No. 6,579,311 (Makower), U.S. Pat. No. 6,602,241 (Makower, et al.), U.S. Pat. No. 6,655,386 (Makower, et al.), U.S. Pat. No. 6,660,024 (Flaherty, et al.), U.S. Pat. No. 6,685,648 (Flaherty, et al.), U.S. Pat. No. 6,709,444 (Makower), U.S. Pat. No. 6,726,677 (Flaherty, et al.) and U.S. Pat. No. 6,746,464 (Makower) and co-pending U.S. patent applications having Ser. Nos. 11/279,993; 11/279,265; 11/279,771; 11/610,092; 11/534,895; 11/613,764; 11/837,718; 12/054,533 and 12/045,120, the entire disclosure of each such patent and patent application being expressly incorporated herein by reference. Also, there exists a commercially available tissue penetrating catheter of this type which includes an on-board ultrasound imaging transducer in combination with a marker that provides an image of the target location along with an indication of the projected penetrator trajectory relative to the target location (i.e., the Pioneer™ Catheter, Medtronic Vascular, Inc., Santa Rosa, Calif.).
In some embodiments where the systems and methods of the present invention are used to deliver a therapeutic substance to a desired location (e.g., an ischemic or infracted region) within the myocardium of a subject's heart, the types of therapeutic substances that may be injected include but are not limited to angiogenic substances, cell preparations or other substances establish new functional cardiac muscle cells, deter ventricular remodeling, deter scar formation at an infarct site or otherwise improve/maintain myocardial function. In some instances, these therapeutic substances may be combined with other ancillary agents (e.g., potentiators or radiographic markers) when injected into the myocardium. Examples of angiogenic substances that may be delivered using the systems and methods of the present invention include peptide growth factors, small molecule drugs and other active compounds, biologically active carbohydrates, recombinant biopharmaceuticals, agents that are active in the regulation of vascular physiology, cellular and gene therapy agents, nitric oxide, agents that affect transcription or turnover of cellular mRNA or the efficiency with which specific mRNA translates into its protein product, antisense agents, hormones, soluble receptors, receptor ligands, synthetic and naturally occurring peptides, peptidomimetic compounds, specific and non-specific protease inhibitors, postaglandins, inhibitors of prostaglandin synthase and/or other enzymes involved in the regulation of prostaglandin synthesis, fibroblast growth factors (FGF's), acidic (aFGF, FGF-II) and basic (bFGF, FGF-I) fibroblast growth factors, vascular endothelial growth factors (VEGF), agents that stimulate endogenous production of VEGF such as platelet-derived growth factor (PDGF), purified monocyte-derived angiogenic substance (angiotropin), angiogenin, transforming growth factor alpha (TGF-α), transforming growth factor beta (TGF-β) and angiogenic cell precursors (e.g., stem cells). Examples cell preparations that may be delivered using the systems and methods of the present invention for the purpose of establishing new functional heart muscle include; myocyte preparations, pluripotent cells (e.g., embryonic, adult and mesenchymal stem cell preparations), myoblast (including in some cases skeletal myoblast) preparations, bone marrow mononuclear cell preparations, etc. Also, the systems and methods of the present invention may be used to deliver platelet gel through a single infusion lumen or components of platelet gel (e.g., platelet concentrate and a thrombin containing solution) through separate lumens of the injection cannula 12, 60 so that they become combined to form platelet gel immediately before or after entering the myocardium.
Although specific reference has been made to use of the invention to deliver substances or implantable devices into the myocardium adjacent to a chamber of the heart, it is to be appreciated that the invention may be used to deliver substances or devices to various other normal or aberrant tissue masses located adjacent to other open or fluid-filled spaces, cavities or lumens of a subject's body. For example, the systems and methods of the present invention may be used to deliver various diagnostic, cosmetic or therapeutic substances (drugs, chemotherapeutic agents, other anti-cancer agents, radiographic contrast materials, biologics, cell preparations, gene therapy preparations, bulking agents, fillers, etc.) or to deliver implantable devices (e.g., drug delivery implants, electrodes, radiographic markers or tags, nanotechnology devices, etc.) through needles, cannulae or other elongate devices that have been positioned, in accordance with the present invention, at specific desired locations within organs or tissue masses (normal or aberrant) within the bodies of human or animal subjects.
For example, the systems and methods of the present invention may be used to deliver a substance or device into brain tissue at a predetermined distance from a ventricle of the brain. Also, in subjects who suffer from certain bladder cancers, the systems and methods of the present invention may be used to deliver substances (e.g., cancer treatment agents) or devices (e.g., drug delivery or radiotherapy implants) into tumor tissue at a predetermined distance from the interior cavity of the urinary bladder. The systems and methods of the present invention may also be used for delivery of a substance or device into tissue of the eye (e.g. corneal or scleral tissue) at a predetermined distance from an intraocular space such as the anterior chamber of the eye.
It is to be further appreciated that the invention has been described hereabove with reference to certain examples or embodiments of the invention but that various additions, deletions, alterations and modifications may be made to those examples and embodiments without departing from the intended spirit and scope of the invention. For example, any element or attribute of one embodiment or example may be incorporated into or used with another embodiment or example, unless to do so would render the embodiment or example unsuitable for its intended use. Also, where the steps of a method or process are described, listed or claimed in a particular order, such steps may be performed in any other order unless to do so would render the embodiment or example not novel, obvious to a person of ordinary skill in the relevant art or unsuitable for its intended use. All reasonable additions, deletions, modifications and alterations are to be considered equivalents of the described examples and embodiments and are to be included within the scope of the following claims.
