EP0932428A1 - Injection iontophoretique d'une substance active dans les tissus cardiaques - Google Patents

Injection iontophoretique d'une substance active dans les tissus cardiaques

Info

Publication number
EP0932428A1
EP0932428A1 EP98937969A EP98937969A EP0932428A1 EP 0932428 A1 EP0932428 A1 EP 0932428A1 EP 98937969 A EP98937969 A EP 98937969A EP 98937969 A EP98937969 A EP 98937969A EP 0932428 A1 EP0932428 A1 EP 0932428A1
Authority
EP
European Patent Office
Prior art keywords
needle
agent
cardiac muscle
guiding member
cardiac
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Withdrawn
Application number
EP98937969A
Other languages
German (de)
English (en)
Inventor
J. Edward Shapland
Robert G. Walsh
John C. Vanden Hoek
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
eMed Corp
Original Assignee
eMed Corp
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by eMed Corp filed Critical eMed Corp
Publication of EP0932428A1 publication Critical patent/EP0932428A1/fr
Withdrawn legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/20—Applying electric currents by contact electrodes continuous direct currents
    • A61N1/30—Apparatus for iontophoresis, i.e. transfer of media in ionic state by an electromotoric force into the body, or cataphoresis
    • A61N1/303—Constructional details
    • A61N1/306—Arrangements where at least part of the apparatus is introduced into the body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0067—Catheters; Hollow probes characterised by the distal end, e.g. tips
    • A61M25/0082—Catheter tip comprising a tool
    • A61M25/0084—Catheter tip comprising a tool being one or more injection needles
    • A61M2025/0089—Single injection needle protruding axially, i.e. along the longitudinal axis of the catheter, from the distal tip

Definitions

  • the present invention relates to delivery of an agent to a patient's heart, and more particularly, to iontophoretic delivery of an agent directly into cardiac tissue.
  • the human heart is an amazing organ. It is a self regulating pump that cooperates with the respiratory and nervous system to oxygenate and distribute blood throughout the body. This mechanism sustains life.
  • the heart 100 is a muscle that defines atria and ventricles.
  • the atria include a left atrium 102 and a right atrium 104.
  • the ventricles include a left ventricle 106 and a right ventricle 108.
  • the atrial myocardium 110 forms the outer wall of the atria.
  • the ventricular myocardium 112 forms the outer wall of the ventricles.
  • the interventricular septum 114 divides the left and right ventricles 106 and 108.
  • the heart 100 contracts and relaxes in an orderly sequence during each heart beat in order compress these chambers 102, 104, 106, and 108 and pump blood through the systemic circulatory system.
  • the systemic circulatory system includes blood vessels that carry the blood to all areas of the body, including the muscles that forms the heart 100 itself.
  • the heart beat originates in a cardiac conduction system 116 that distributes cardiac impulses, which is an electrical signal, throughout the heart 100. These electrical impulses stimulate the heart 100 and cause it to contract and pump blood.
  • the cardiac conduction system 116 is formed from cells and striated muscle fibers. Although the muscle fibers are striated, the conduction system 116 does not have defined or distinct boundaries.
  • the cardiac impulses originate in a sinoatrial node (SA node) 118 that functions as a type of natural pacemaker.
  • SA node sinoatrial node
  • the signal then radiates throughout the atrial myocardium 110 via atrial pathways 120.
  • the cardiac impulses in the atrial pathways 120 stimulate the atrial myocardium 110 and causes the atria 102 and 104 to contract and blood to flow into the ventricles 106 and 108.
  • the atrial pathways 120 also carry the electrical impulses to another node, called the atrio ventricular node (AV node) 122.
  • AV node atrio ventricular node
  • the cardiac impulses are transmitted along a group of fibers called the bundle of His 124, which runs along the ventricular septum 114.
  • the bundle of His 124 splits into a right bundle branch 126 and a left bundle branch 128.
  • the bundle of His 124 provides the only path for cardiac impulses between the atrial myocardium 110 and the ventricle myocardium 112.
  • the cardiac impulses pass from the left and right branches 126 and
  • the Purkinje system 130 which provide pathways throughout the ventricular myocardium 112.
  • the cardiac impulses in the Purkinje system 130 cause the ventricular myocardium 112 to contract and pump blood from the left and right ventricular chambers 106 and 108 into the systemic circulatory system. There is a slight delay between contraction of the atrial myocardium 110 and the ventricular myocardium 112.
  • the S A node 118 is a cardiac pacemaker that times the rhythm of the heart 100.
  • the AV node 122 introduces a delay in the cardiac impulses received from the SA node 118 and coordinates contraction of the atria and the ventricles 102, 104, 106, and 108. As shown in figure 2, these pathways can become defective after an injury such as myocardial infarction, which is an area of tissue in the wall of the heart that is damaged due to an interruption of the blood supply. Arteriosclerosis is a common cause of myocardial infarction.
  • a reentry circuit 132 is formed that provides a path of the cardiac impulses to circle around and move in the wrong direction. These reentry circuits typically cause a form of tachycardia, which is a fast and unnatural heart beat.
  • Some reentry circuits are microscopic, covering only a few millimeters distance, and are isolated in either the atria 102 and 104 or the ventricles 106 and 108.
  • the tachycardia caused by reentry circuits can result in fibrillation in which the heart 100 quivers in a chaotic pattern. In extreme cases the tachycardia can cause a reduced output of the heart and 100 even cause the circulation of blood to stop. This condition can lead to death if it lasts more than a few minutes. This danger is especially high if the reentry circuits are in the ventricle myocardium 112.
  • Other reentry circuits are macroscopic and may even extend between the atrial and ventricle myocardiums 110 and 112.
  • the reentry circuit also can propagate within the AV node causing a form of nodal tachycardia.
  • One way to treat tachycardias is to destroy tissue forming the reentry circuit. In order to destroy this tissue, a caregiver will map the electrical activity of the heart using an electrophysiological catheter or similar probe, which is placed within the heart. After the reentry circuit is located, the caregiver will kill or ablate the tissue forming the reentry circuit with a high energy electric current. Other techniques for killing this target tissue include the application of laser energy, microwave heating, and cryoablation, which is extreme cooling.
  • microwave energy lacks focus and laser energy must cut through the heart muscle to reach the reentry circuit.
  • these techniques often fail to ablate tissue deep within the heart wall and thus fail to kill all of the tissue that forms the reentry circuit.
  • These techniques also kill healthy cardiac tissue surrounding the reentry pathway and may compromise the mechanical function of the heart.
  • cryoablation and laser ablation is very expensive and requires a significant amount of training beyond that required for other forms of ablation.
  • Coronary disease that restricts the flow of blood to the cardiac muscle is another ailment that some people experience.
  • a lack of blood flow is commonly caused by a blockage such as arteriosclerosis.
  • the blockage causes an infarction, which is a localized area of dead tissue cells that is surrounded by an area that has reduced blood flow. This area of reduced blood flow is called a zone of ischemia.
  • Such blockages are usually treated with by-pass surgery or angioplasty in an effort to restore blood flow to the zone of ischemia.
  • diffuse coronary disease which is the blockage of many coronary arteries.
  • the present invention is directed to an apparatus for delivering an agent directly into a cardiac muscle.
  • the apparatus comprises an elongated member.
  • the elongated member defines a deployment lumen and a distal tip.
  • a hollow needle is configured to be inserted into the cardiac muscle.
  • the needle is operably connected to the elongated member.
  • the needle has a side portion and defines an outlet port in the side portion.
  • First and second electrodes are configured to be electrically connected to a power supply.
  • the first electrode is positioned to be in direct electrical communication with agent flowing through the outlet port.
  • Yet another alternative embodiment of the present invention is directed to a method of delivering an agent directly into a cardiac muscle.
  • the method comprises the steps of: introducing an elongated body into the patient, the elongated body having a needle at its distal tip; inserting the needle into the cardiac muscle, the needle being configured to deliver the agent; and iontophoretically transporting the agent into cardiac tissue proximal to the needle.
  • Figure 1 shows a human heart and illustrates the four chambers of the heart and the circuits used to conduct cardiac impulses.
  • Figure 2 shows the circuits that conduct cardiac impulses in the human heart including an abnormal reentry circuit.
  • Figure 3 shows a delivery device for delivering an agent into the cardiac muscle.
  • Figure 4 shows an alternative embodiment of the delivery device illustrated in Figure 3.
  • FIGS 5-7 show alternative embodiments of a needle used with the delivery device shown in Figure 3.
  • Figure 8 shows another alternative embodiment of the delivery device illustrated in Figure 3.
  • Figure 9 shows another alternative embodiment of the delivery device illustrated in Figure 3.
  • FIG. 10 shows another alternative embodiment of the delivery device illustrated in Figure 3.
  • FIG 11 shows another alternative embodiment of the delivery device illustrated in Figure 3 .
  • FIG. 11 shows another alternative embodiment of the delivery device illustrated in Figure 3 .
  • the present invention relates to phoretic delivery of an agent directly into and deep within the heart muscle. Such delivery is useful for several applications including ablation of cardiac tissue and angiogenesis, which is the stimulation of new vessel growth.
  • the device for delivering the agent has a delivery portion such as a needle.
  • a delivery portion such as a needle.
  • Possible embodiments of the needle that are useful for the delivery portion include a straight hypodermic needle or a helical needle that has a corkscrew configuration.
  • the device includes an active driver to actively transport the agent to the abnormal cardiac tissue.
  • An example of such an active driver includes electrodes for iontophoresis.
  • the present invention has many advantages. It provides precise delivery of an agent to an area sufficiently large enough to ensure treatment of the abnormal cardiac tissue while minimizing exposure of normal tissue to the agent. The present invention also provides treatment of tissue that is deep within the cardiac muscle.
  • one possible method of using the delivery device provides for delivering a reversible blocking agent to tissue that is suspected if forming the reentry circuit. While the reversible agent will temporarily block the electrical activity of the tissue, but will not kill any cardiac cells. The caregiver can then use a blocking agent to determine if the abnormal cardiac tissue that forms the reentry circuit is accurately identified.
  • the use of a reversible blocking agent also has many advantages. For example, the caregiver can block tissue and test the heart to determine if the proper tissue was identified. These blocking agents enable the caregiver to accurately isolate the abnormal tissue without unnecessarily ablating healthy tissue or compromise the heart's mechanical function.
  • Another alternative procedure uses the delivery device to deliver angiogenesis agents into the cardiac muscle.
  • the angiogenesis agents promote the growth of new blood vessels that will supply blood to an area that previously had restricted blood flow due to a blockage such as arteriosclerosis.
  • the present invention actively transports the agent throughout the ischemic or abnormal tissue.
  • One possible transport mechanism that can be used is iontophoresis.
  • an iontophoretic device consists of two electrodes in intimate electrical contact with some portion of a patient's tissue and a reservoir containing an agent that is to be introduced into the patient's body or tissue.
  • One electrode called the delivery electrode
  • the other electrode called the return electrode, serves to close the electrical circuit through the body.
  • the target area that is the tissue to which it is desired to deliver the agent, is in the electrical path between the delivery and return electrodes.
  • the circuit is completed by connecting the delivery and/or return electrodes to a source of electrical energy, such as a battery or a direct current power supply. Additionally, the source of electrical energy can be controlled by a signal generator or other circuitry is electrically connected to the energy source in order to shape or otherwise control the signal used to energize the electrodes.
  • a source of electrical energy such as a battery or a direct current power supply.
  • the source of electrical energy can be controlled by a signal generator or other circuitry is electrically connected to the energy source in order to shape or otherwise control the signal used to energize the electrodes.
  • the agent In iontophoresis, the agent either has a natural ionic charge or is combined with a charged carrier molecule. If the agent is positively charged, then the positive electrode (the anode) is the delivery electrode. If the agent is negatively charged, then the negative electrode (the cathode) is the delivery electrode. In this configuration, the agent is transported away from the energized delivery electrode and into the target area. Alternatively, if the agent is neither charged nor combined with a carrier molecule, delivery can rely on electroosmosis, which is a form of iontophoresis and describes the movement of water molecules that are placed within an electric field and the agent that is either suspended or in solution.
  • An agent can include any type of composition. Examples include drugs such as antiseptics and fixatives; compositions useful for diagnostic purposes such as dyes; genetic materials such as DNA, RNA, genes, ribozymes, antisense oligonucleotides, and other antisense materials; therapeutic agents such as cytotoxic, chemotherapeutic, antiviral agents, antibiotics, and antifungal agents; adjuvants; penetration enhancers; and other substances that have medical applications. Additionally, the term agent can mean an agent in any form. Examples of various forms of agents include solutions, solids, liquids, liposomes, dehydrated masses, and gels. Although the term is often used in a singular form, it can connote either a single agent or a combination of agents.
  • an outer, guiding member 134 has a distal tip 136 and defines a lumen 138.
  • the guiding member 134 is used to provide access to the heart 100. If access is through the circulatory system, the guiding member 134 is a flexible catheter that is sized to be threaded through the circulatory system and into either the left 102 and 106 or right 104 and 108 chambers of the heart 100. In various possible embodiments, the delivery system is steerable, torqueable, or deflectable. If access to the heart 100 is through a minimally invasive puncture in the chest or open chest surgery, the guiding member 134 has more rigidity such as a cannula.
  • An inner member 140 is sized to be slidably inserted into the lumen 138 of the guiding member 134.
  • the inner member 140 has an elongated body 142.
  • the elongated body has a distal portion 144 and a distal end 145.
  • the elongated body also has a proximal portion (not shown) that projects from the proximal end (not shown) of the guiding member 134.
  • the elongated body 142 defines a delivery lumen 146.
  • a needle 148 is operably connected to the distal end 145. Alternative configurations for the needle are described in more detail below. Again, if access to the heart 100 is through the circulatory system, the elongated body 142 is flexible. If access is through a puncture or incision in the chest, the elongated body 142 can be substantially rigid.
  • the needle 148 can be deployed from or retracted into the distal tip 136 of the guiding member 134.
  • a gripping member such as a handle or collar is operably connected to the proximal portion of the elongated body 142. Deployment or retraction of the needle 148 is accomplished by pushing or pulling the gripping member.
  • the proximal portion of the elongated body 142 can have graduations so the caregiver can determine the position of the needle 148 relative to the distal tip 136 of the guiding member 134.
  • the gripping member can be positioned to limit the distance that the needle 148 can be deployed from the distal tip 136 of the guiding member 134.
  • the needle 148 is formed with an electrically conductive material and functions as a delivery electrode.
  • the material can be either sacrificial or non- sacrificial.
  • sacrificial materials include silver/silver chloride, copper, tin, nickel, iron, lithium, and amalgams thereof.
  • non-sacrificial materials include platinum, gold, and other noble metals.
  • the needle 148 also can be formed of zirconium; iridium; titanium; certain carbons, and stainless steel, some of which may oxidize under certain circumstances. The grade of stainless steel is one factor that determines whether stainless steel oxidizes. Another factor that determines whether there are obvious signs of oxidation in metals is the surface area of the delivery zone.
  • the needle 148 is formed with a solid material. In another possible embodiment, the needle 148 is formed with a base material that is plated. Plating is advantageous because some of the conductive materials such as gold and platinum are relatively expensive.
  • the needle 148 defines at least one outlet port 150 and has an inner wall 152 that defines a delivery chamber 154.
  • the delivery chamber 154 is in fluid communication with the delivery lumen 146 of the inner member 140.
  • the delivery chamber 154 can form an extension of or be a part of the delivery lumen 146.
  • a first lead 156 extends through the delivery lumen 146 and into the delivery chamber 154.
  • the first lead 156 is electrically connected between the needle 148 and a power supply 158. In this configuration, the needle 148 functions as a first electrode 160.
  • the first lead 156 is connected to a first electrode 162 that is separate from the needle 148.
  • the first electrode 162 is positioned within the delivery lumen 146 and may be within the delivery chamber 154 of the needle 148.
  • the needle 148 may be formed from a nonconductive material.
  • a second electrode 166 is electrically connected to the power supply 158 via a second lead 164.
  • the second electrode 164 is a patch-type electrode configured to be applied to the surface of the patient's skin.
  • Other configurations of the second electrode 164 are possible.
  • the second electrode 164 could be mounted on the surface of the guiding member 134, mounted on the surface of the inner member 140, or otherwise positioned in the patient's body.
  • Figure 5 illustrates one possible embodiment of the needle 148 in more detail.
  • the needle 148 is straight and has a beveled end 168 that aids in inserting the needle 148 into the cardiac muscle.
  • the beveled end 168 of the needle 148 is closed.
  • the needle 148 has a gauge ranging from about 20 to about 27.
  • One factor affecting the gauge of the needle 148 that should be used is the method for introducing the needle 148 into the heart. If the needle 148 is introduced through the circulatory system, a finer and more flexible needle should be used. If the needle 148 is introduced through a puncture or incision in the patient's chest, a larger needle can be used.
  • the needle 148 has a shaft 170 and a delivery zone 172.
  • the length of the delivery zone 172 is between about 0.25 inches and about 2 inches.
  • the outlet ports 150 are defined along the delivery zone 172, and have a diameter of about 0.010 inch or less.
  • the number of outlet ports 150 can range from 1 to 1000 or more.
  • One factor affecting the number of outlet ports 150 is whether it is desirable to diffuse the agent in one direction or entirely around the circumference of the needle 148.
  • Another factor affecting the number of outlet ports 150 is the size of the needle 148 and the size of the outlet ports 150.
  • the area of the outlet ports 150 is maximized, which allow quick and even distribution of the agent.
  • Possible manufacturing methods include laser drilling, electrical discharge machining, photolithography, and chemical etching.
  • outlet ports 150 are distributed around the entire circumference of the delivery zone. Distributing the delivery ports 150 in this manner is advantageous because it distributes the current density in order to minimize the risk of burning tissue adjacent to the delivery ports 150.
  • the delivery ports 150 are defined in only a portion of the circumference around the delivery zone 172.
  • the proximal portion of the shaft 170 is covered with an insulating material 174 that is substantially non-conductive.
  • the insulating material 174 can be a sheath, coating, covering, or similar structure.
  • An advantage of insulting the shaft 170 is that the insulation prevents the burning of tissue at interface where the needle 148 enters the cardiac muscle.
  • the insulting material 174 can be wrapped around the shaft 170.
  • the material used to form the insulating material 174 can be painted onto the shaft 170 and cured, or the shaft 170 can be dipped into a reservoir of the insulating material and cured. This coating technique can be repeated in the order to achieve the desired thickness of the insulating sheath.
  • the insulating material 174 extends along the elongated body 142 to prevent the electric current from becoming prematurely shunted into the patient's body before it reaches the delivery zone 172 of the needle 148.
  • the delivery zone 172 is covered with a spacer that prevents or minimizes direct contact between the outer surface 180 of the needle 148 and the tissue of the heart wall.
  • the spacer is a protective sheath or coating 176.
  • the protective sheath 176 minimizes direct contact between the needle 148 and the cardiac tissue. As a result, burning of tissue that is directly adjacent to the delivery zone 172 of the needle 148 is minimized. Examples of material that can be used to form the protective sheath 176 include nylon and
  • the protective sheath 176 has the form of a mesh, or some similar configuration, that will allow agent and electrical current to flow through the protective sheath 176.
  • the mesh can be a cloth that is wrapped around the delivery zone 172.
  • Examples of meshes include woven materials, knitted materials, or a perforated sheet.
  • Alternative techniques for applying nylon and Teflon® mesh is to apply the material in a fluid form and either paint it on the needle 148 or dip the needle 148 into a reservoir. The fluid material is then cured by an appropriate mechanism such as heating. This coating technique can be repeated in order to achieve the desired thickness of the protective sheath 176.
  • Teflon® is used, one possible method of creating the mesh pattern is to apply a template to the delivery zone of the needle 148 and then apply the Teflon®. After the Teflon® has cured, the template is lifted off of the needle 148 thereby creating a mesh pattern. Yet another alternative manufacturing technique is to coat the needle 148 with the insulating material and then etch the insulating material with acid.
  • the protective sheath 176 should be formed with hollow fibers, which are porous to the agent. Once the hollow fibers become wetted, they will also allow the conduction of electricity. The fibers could be wound around the delivery zone or arranged in a variety of other configurations such as a mesh or a fabric.
  • the protective sheath 176 also could be formed from a microporous membrane. Such a membrane is discussed in more detail in United States Patent 5,569,198, which is entitled MICROPOROUS MEMBRANE and issued on January 23, 1995, the disclosure of which is hereby incorporated by reference. Still other embodiments of the needle do not include a spacer. Rather, the outer surface of the needle at the delivery zone is exposed directly to tissue in the patient's body during use.
  • an alternative embodiment of the needle 182 is substantially similar to the needle 148, and includes a shaft 170, an insulating material 174, a delivery zone 172, and a protective sheath 176.
  • the needle 182 defines at least one slot 184 that extends the length of the delivery zone 172.
  • the needle 182 can define multiple slots 184, depending on the size of the needle 182 and whether the caregiver desires to deliver agent around the entire circumference of the delivery zone 172.
  • yet another alternative embodiment of the needle 186 has a shaft 187, and insulating material 188 covering the shaft, a delivery zone 190, and a protective sheath 191.
  • the delivery zone 190 has a helical or cork screw configuration.
  • the needle 186 defines a delivery chamber (not shown) and at least one outlet port (not shown) in the delivery zone.
  • the helical needle configuration has several advantageous.
  • the helical needle 186 is screwed into the heart muscle and thus securely anchored in a delivery position. As a result, the needle 186 will not readily move while the heart 100 continues to beat.
  • the needle 186 also has a larger delivery zone 190, which helps to distribute the iontophoretic current and thus reduces the risk of burning cardiac tissue.
  • the increased area of the delivery zone 190 also provides a greater treatment area.
  • a related advantage is that the greater delivery zone 190 also enables the use of more delivery ports, which enables the agent to be delivered quicker and more efficiently.
  • the needle 148 is formed from
  • Nitinol memory metal The needle initially has a straight configuration, as shown in Figures 5 and 6, when deployed and inserted into the heart muscle.
  • the needle 148 is then is then warmed to a predetermined temperature, which causes the configuration of the needle 148 to take on a different shape.
  • this different shape helps to secure the needle 148 in a delivery position within the heart wall.
  • the needle can be set to the predetermined temperature from the natural temperature of the heart muscle.
  • a fluid at the predetermined temperature can be injected through the lumen and into the needle 148.
  • One technique is to rotate the needle causing it to unscrew from the heart muscle.
  • the needle 148 is set to a second predetermined temperature, which will cause the needle 148 to either become flexible or to return to a straight configuration. The needle 148 then can be pulled from the heart muscle.
  • an alternative embodiment of the delivery device has an inner member 192 that is unitary and needle-like.
  • the inner member 192 defines a delivery portion 194 and an elongated body 196 that forms an elongated shaft.
  • the first electrode 162 is positioned within the delivery lumen 146.
  • the delivery portion 194 can have a straight or helical configuration similar to needles 148, 182, and 186.
  • the inner member 192 is formed with a conductive material and functions as the first electrode.
  • the elongated body 196 is covered with an insulating material such as a sheath or a coating.
  • the delivery portion 194 can be placed into electrical communication with tissue.
  • Yet another alternative embodiment has an inner member 198 that does not form a delivery lumen. Rather, the agent 206 is coated on the surface of a needle 200 that is operably connected to the end 202 of an elongated body 204. In this embodiment, the needle 200 functions as the first electrode 160.
  • This embodiment also has advantages. For example, natural diffusion of the agent 206 is limited and thus more accurately controlled through iontophoresis. Additionally, a smaller needle can be used, which enables more precision in reaching the abnormal cardiac tissue.
  • Figure 10 illustrates another alternative embodiment that has a guiding member 208 in the form of a catheter.
  • the guiding member 208 forms a lumen 210.
  • a needle 212 is slidably positioned within the lumen 210.
  • the inner member 222 is formed from a stylet or deployment wire.
  • the inner member 222 has a distal end 224 that is operably connected to the needle 212 and a proximal portion (not shown) that extends from the guiding member 208 .
  • a gripping member such as a handle or collar is operably connected to the proximal portion of the inner member 222.
  • the needle 212 functions as the first electrode 160
  • the inner member 222 functions as a lead that provides electrical communication between the needle 212 and the power supply.
  • the needle 212 has a configuration similar to the other needles described herein, including a shaft 214 protected with an insulating material 216 and a delivery zone 218 that defines outlet ports 220.
  • the insulating material can be a sheath or a coating.
  • the insulating material on the shaft 214 engages the wall of the lumen 210 and provides a seal. The seal prevents agent from flowing out the distal tip 230 of the guiding member 208.
  • the caregiver can inject a fluid into the lumen 210. The fluid will then flow into the needle 212 and through the outlet ports 220.
  • another alternative embodiment has a guiding member 232 that defines an inflation lumen 234 and a deployment lumen 236.
  • the guiding member 232 has a distal end 242 to which a balloon 238 is operably connected.
  • the balloon 238 is in fluid communication with the inflation lumen 234 and, when in an inflated state, has a diameter greater than the guiding member 232.
  • An outlet port 240 is defined in the wall of the guiding member 232 and is in fluid communication with the deployment lumen 236.
  • the outlet port 240 is proximal to the distal tip 242 of the guiding member 232.
  • the balloon 238 is positioned on the proximal side of the outlet port 240 rather than at the tip 242 of the guiding member 232.
  • At least one radio opaque marker (not shown) is located on the outer surface 244 of the guiding member 232 so that the caregiver can determine the position and orientation of the outlet port 240.
  • One possible configuration has two radio opaque markers spaced around the circumference of the guiding member 232 and proximal to the distal tip 242 of the guiding member 232.
  • a needle 246, which is illustrated in the deployed position, is slidably positioned within the deployment lumen 236 and has a configuration similar to the other needles described herein.
  • the needle 246 is flexible and bends as it is deployed through the outlet port 240.
  • the needle 246 can have any of the needle configurations described herein.
  • the needle 246 is operably connected to an inner member 248 such as a stylet or deployment wire. As described below, this embodiment is advantageous for accessing the heart muscle through a coronary arterial wall.
  • Other configurations could include multiple delivery lumens and multiple needle/inner member assemblies.
  • the caregiver could also simultaneously deliver agent to several locations of the heart muscle.
  • the elongated body does not define an inflation lumen or include a balloon. Rather, the device is configured to deploy a needle through the distal end as well as through the wall of the guiding member.
  • the caregiver when using the delivery device for cardiac ablation, the caregiver initially maps the electrical activity or cardiac impulses in the patient's heart 100 using techniques such as electrophysiological mapping.
  • the caregiver uses this mapping to identify the location of reentry circuits 132.
  • mapping can be performed with a variety of mapping catheters or other probes placed in, or adjacent to, the patient's heart 100.
  • the catheter or probe has a monitoring electrode that records a signal when in the presence of an electrical field generated by the heart's 100 electrical activity.
  • the first electrode 160 functions a first monitoring electrode.
  • An electrically conductive band (not shown) is wrapped around the guiding member 134 and proximal to the distal end 136. The electrically conductive band functions as a second monitoring electrode. This configuration provides detailed mapping of electrical activity in the heart 100 at a local level.
  • the electrically conductive band is in electrical communication with monitoring equipment.
  • the lead 156 is also placed into electrical communication with the monitoring equipment.
  • the monitoring equipment can then detect a differential signal that is indicative of the electrical activity of the heart 100.
  • the first lead 156 is placed into electrical communication with the power supply 158 for delivery of the agent.
  • An electrically conductive band (not shown) is wrapped around the guiding member 134 and set back from the distal end 136.
  • the electrically conductive band is a second monitoring electrode.
  • This configuration provides detailed mapping of electrical activity in the heart on a local level.
  • the caregiver threads the guiding member 134 through the circulatory system into either the right 104 and 108 or left 102 and 106 chambers of the heart 100.
  • the caregiver then threads the inner member 140 through the guiding member 134 until the needle 148 is deployed from the distal tip 136 of the guiding member 134.
  • the monitoring electrode is also connected to monitoring equipment via the first lead 156.
  • the first electrode 160 functions as a monitoring electrode.
  • the monitoring equipment either records the electrical activity of the heart 100 or displays the electrical activity on a screen. The caregiver uses this information to map the electrical activity of the heart 100 and identify the location of a reentry circuit 132.
  • the caregiver maneuvers the first electrode 160 to various positions along the cardiac muscle and maps the electrical activity to identify the location of the reentry circuit 132.
  • the caregiver then places the needle 148 adjacent to the reentry circuit 132 and inserts the needle 148 deep into the cardiac muscle so that the agent will be distributed between the inner and outer surfaces of the muscle.
  • the needle 148 can either be positioned in the center of the reentry circuit 132 or adjacent to the reentry circuit 132 with the outlet ports 150 facing the reentry circuit 132.
  • the caregiver injects and phoretically transports a reversible blocking agent that will temporarily block electrical conduction within the tissue.
  • a reversible agent include adenosine, anesthetic agents, and electrolytes.
  • the caregiver attempts to induce a tachycardia by electrically stimulating the heart 100. If a tachycardia is not induced, the caregiver has accurately reached the site of the reentry circuit 132 and permanent chemical ablation can proceed. If a tachycardia is induced, the caregiver knows that the reentry circuit is in a different position, or that there is a second reentry circuit 132. The caregiver can then relocate or adjust the position of the needle 148 and re-inject the reversible blocking agent. This procedure is repeated until the caregiver has identified the reentry circuit 132.
  • a reversible blocking agent has many advantages. Because the temporary block is fully reversible, tissue initially tested and found to be outside the reentry circuit 132 is not irreversibly damaged. Initial testing with a reversible pharmaceutical agent allows precise location and ablation of only abnormal tissue while sparing normal tissue. As a result, repeated ablation and damage to the healthy, normal cardiac tissue is avoided, and the health of patients already suffering from myocardial failure or other cardiac dysfunctions is not further compromised.
  • the caregiver will ablate the tissue associated with the reentry circuit 132. Ablation is accomplished by injecting an agent through the delivery lumen 146 and outlet ports 150 in the needle 148. The agent is then iontophoretically transported to achieve a uniform and controlled distribution. Examples of agents that could be used to ablate cardiac tissue include ethanol, cytotoxic agents, neurotoxins, and fixatives such as glutaraldehyde, formaldehyde. Upon completion of the procedure, the inner and guiding members 140 and 134 are removed and the patient will continue through a post-electrophysiological recovery period.
  • the ablation agent is locally administered to an area that is large enough to ablate the tissue forming the reentry circuit 132, but also controlled to minimize the ablation of normal tissue.
  • One technique is to administer only a small volume of agent to limit the area in which the agent is diffused.
  • Another technique is to limit the amount of current used during iontophoresis as well as the amount of time that the current is conducted between the first and second electrodes 160 and 166.
  • Yet another technique is to deliver the agent in a gel. A gel with a relatively high viscosity will resist diffusion and thus remain substantially isolated to a controlled area.
  • Another way to minimize the exposure of the ablative agent to normal tissue is to use an agent that has a relatively short life. In this situation, the agent would become inactive by the time that it is diffused to normal cardiac tissue outside the area of the reentry circuit 132. The agent could have a short-half life. Alternatively, the agent could be sensitive to hydrolysis. The water in the heart 100 would cause the hydrolysis-sensitive agent to breakdown and become inactive. The caregiver could use a combination of these or other techniques to minimize exposure of the ablative agent to normal tissue. Referring to Figure 1 , 2, and 9, yet another technique is to use the delivery device in which the needle 200 is coated with the agent.
  • this device is used, natural diffusion from the flow of the liquid agent is minimized, and thus the diffusion is more accurately controlled through the use of iontophoresis. Additionally, a separate inner member is used for mapping the electrical activity of the heart 100 and for delivering a reversible blocking agent, if desired.
  • the delivery devices described herein are also useful for performing angiogenesis, which is a procedure of stimulating the growth of new blood vessels.
  • the growth of vessels are stimulated by angiogenesis agents delivered directly into the cardiac muscle using the delivery techniques substantially similar to those outlined above.
  • angiogenesis agents include vascular endothelial growth factor, basic and acidic fibroblast growth factors, and genes that code for these agents.
  • Genes may represent naked gene plasmids, plasmid-lipid formulations, or viral vectors.
  • a blocked artery can prevent or restrict the flow of blood to a large area of the cardiac muscle, which typically results in a zone of ischemia as described above.
  • the angiogenesis agent is delivered to a relatively large area of the muscle in order to restore blood flow to the entire zone of ischemia, which is in contrast to the procedure for cardiac ablation.
  • the caregiver may deliver agent to several different areas within the zone of ischemia or, if there are multiple blockages, to several different ischemic areas.
  • the caregiver might deliver an angiogenesis agent to several points within a zone of ischemia.
  • Delivery of the angiogenesis agent can be accomplished by delivering the agent from within the atria or ventricles as described above. Delivery of the angiogenesis agent can also be accomplished through the chest via an incision or percutaneous puncture.
  • access to the heart muscle is through a coronary arterial wall.
  • the caregiver inserts the delivery device shown in Figure 11 into the patient's circulatory system and threads the guiding member to the point of the blockage in the coronary artery.
  • the distal tip 242 of the guiding member 232 is positioned adjacent to the blockage and oriented so that the outlet port 240 opens toward the heart wall.
  • Radio opaque markers are used to ensure that the outlet port 240 opens toward the heart muscle.
  • the balloon 238 is inflated, which provides stability to the guiding member 232 and prevents the guiding member 232 from shifting as the needle 246 is deployed.
  • the caregiver then pushes the inner member 248, which deploys the needle 246 and causes the needle 246 to be inserted through the arterial wall and into the heart-muscle at the site of the blockage.
  • An angiogenesis agent is then delivered and phoretically transported in order to restore blood flow into the zone of ischemia from a point upstream from the blockage.
  • this delivery is accomplished by injecting the needle 246 through the coronary arterial wall at a point adjacent to the blockage and guiding the needle 246 to a point that is underneath the blockage.
  • this technique provides for delivery of the angiogenesis agent at the site of the blockage, which is typically the site of the ischemia and the site where it is desired to stimulate new vessel growth in order to restore blood flow to the heart muscle.
  • the blockage provides a marker for the caregiver to easily locate the ischemia and hence the target area.
  • access through the arterial wall causes minimal trauma to the patient.
  • the caregiver uses a delivery device that can deploy multiple needles.
  • a delivery device that can deploy multiple needles.
  • the caregiver can deliver agent to several areas of the ischemia without moving the guiding member.
  • delivery of the angiogenesis agent is quicker and trauma to the patient is minimized.
  • the caregiver can access the treatment area through the chambers of the heart as described herein, through a minimally invasive puncture in the chest, or through an open chest surgery.
  • the caregiver can use any of the embodiments of the delivery devices described herein, including the device capable of deploying multiple needles.
  • Iontophoresis is accomplished by providing a voltage gradient, and resulting electrical current, between the first and second electrode.
  • the voltage gradient causes the agent to migrate to the abnormal tissue.
  • the current passed between the two electrodes has a net flow in one direction in order to transport the agent from a position directly adjacent to the tissue to the abnormal tissue.
  • the current can be direct or have a variety of waveforms. Examples of various wave forms are described in United States Patent 5,499,971, which is entitled Internal Iontophoresis Drug Delivery Apparatus and Method and issued on March 19, 1996, the disclosure of which is hereby incorporated by reference.
  • the current is an varying waveform, such as an alternating current, that has a net flow of current in one direction.
  • varying waveform may enhance cellular uptake and increase efficiency of the agent delivery.
  • a direct current or other waveform is used to transport the agent to the abnormal tissue. The current is then switched to a varying current to enhance cellular uptake. In one possible configuration, the varying current has a reduced net flow. In another possible configuration, the varying waveform has no net flow. An advantage of switching between waveforms in this manner is that a direct current will efficiently and quickly transport the agent. Once the agent is distributed throughout the desired target area, the varying waveform may enhance cellular uptake.
  • the heart 100 is least susceptible to arrhythmia during the refectory period of the heart beat, which is that period between ventricular depolarization and repolarization of the heart.
  • the risk of inadvertently inducing an arrhythmia can be reduced by synchronizing the electric current with the refectory period.
  • the caregiver can pace the heart beat by sending a pulse into the heart 100 that would cause the heart 100 to depolarize and initiate beat. The caregiver could then more accurately synchronize the iontophoretic current to the refectory period of the heart beat. Synchronization to and pacing of the heart beat is described in more detail in United States Patent 5,634,899, which is entitled Simultaneous Cardiac Pacing and Local Drug Delivery Method and issued on June 3, 1997, the disclosure of which is hereby incorporated by reference.
  • the heart 100 is access through a puncture or incision in the chest rather than through the circulatory system.
  • an active transport mechanism such as phonophoresis or magnetophoresis is used rather than iontophoresis.

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Abstract

Cette invention se rapporte à un dispositif servant à injecter une substance active directement dans le muscle cardiaque. Ce dispositif comprend un élément allongé, lequel forme une lumière de déploiement et une pointe distale. Une aiguille creuse est conçue pour être introduite dans le muscle cardiaque. Cette aiguille est raccordée de façon opérationnelle à l'élément allongé. Elle comporte une partie latérale et définit un orifice de sortie dans cette partie latérale. Des première et seconde électrodes sont conçues pour être connectées électriquement à une source de courant. La première électrode est disposée de façon à se trouver en communication électrique directe avec une substance active s'écoulant par l'orifice de sortie.
EP98937969A 1997-07-22 1998-07-22 Injection iontophoretique d'une substance active dans les tissus cardiaques Withdrawn EP0932428A1 (fr)

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US89865697A 1997-07-22 1997-07-22
US898656 1997-07-22
PCT/US1998/015051 WO1999004851A1 (fr) 1997-07-22 1998-07-22 Injection iontophoretique d'une substance active dans les tissus cardiaques

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