EP1007138A1 - Element enroule et procede d'administration intravasculaire pour agents diagnostiques et therapeutiques - Google Patents

Element enroule et procede d'administration intravasculaire pour agents diagnostiques et therapeutiques

Info

Publication number
EP1007138A1
EP1007138A1 EP98906386A EP98906386A EP1007138A1 EP 1007138 A1 EP1007138 A1 EP 1007138A1 EP 98906386 A EP98906386 A EP 98906386A EP 98906386 A EP98906386 A EP 98906386A EP 1007138 A1 EP1007138 A1 EP 1007138A1
Authority
EP
European Patent Office
Prior art keywords
coil
polymer tubing
coil apparatus
fiber core
polymer
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Withdrawn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
EP98906386A
Other languages
German (de)
English (en)
Other versions
EP1007138A4 (fr
Inventor
Joe E. Brown
Matt D. Pursley
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.)
Individual
Original Assignee
Individual
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 Individual filed Critical Individual
Priority claimed from PCT/US1998/002770 external-priority patent/WO1998035717A1/fr
Publication of EP1007138A1 publication Critical patent/EP1007138A1/fr
Publication of EP1007138A4 publication Critical patent/EP1007138A4/fr
Withdrawn legal-status Critical Current

Links

Classifications

    • 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
    • A61M25/0068—Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure
    • 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
    • A61M25/0043—Catheters; Hollow probes characterised by structural features
    • A61M2025/0057—Catheters delivering medicament other than through a conventional lumen, e.g. porous walls or hydrogel coatings

Definitions

  • the present invention relates generally to an apparatus and method for delivering diagnostic and therapeutic agents into a living organism and, in particular, to an infusion coil or coated coil apparatus and method for delivering such therapeutic agents intravascularly.
  • Atherosclerosis containing cholesterol, lipid material, foam cells, lipophages and proliferating smooth muscle cells are within the intima and media of large to small diameter arteries such as the aorta and the iliac, femoral, coronary and cerebral arteries.
  • the resultant stenosis causes reduction in blood flow.
  • Attempts to treat atherosclerosis have included bypass surgery wherein the diseased vascular segments are augmented by prosthetic or natural grafts. This procedure requires general anesthesia and a substantial healing period after surgery and. thus, is generally limited to cases of severe coronary artery disease.
  • PTCA percutaneous transluminal coronary angioplasty
  • atherectomy atherectomy
  • stenting newer modalities of cardiovascular intervention
  • laser angioplasty The primary drawbacks of these procedures has been the appearance of restenosis at or near the site of the original stenosis in the blood vessel that requires a secondary angioplasty procedure or a bypass surgery.
  • Another occurrence that reduces the success of a typical angioplasty procedure is that frequently the stenotic plaque or intima of the blood vessel or both are dissected during the angioplasty procedure by the inflation of the balloon.
  • the expandable region of the prior art stents is formed by a braided wire or balloon attached to the distal end of the catheter body.
  • Such designs are difficult and expensive to manufacture, and create reliability concerns due to the existence of high stress points located at the connection of the braided wire region with the catheter body and at the connections between the intermingled wire strands.
  • stents Alternatively, or in addition to the use of stents, various drugs have been applied to the site of the dilated lesion to prevent or reduce chances of restenosis and to aid in the healing of flaps, dissection or other hemorrhagic conditions that may appear after an angioplasty procedure.
  • the prior art braided wire and balloon stents as disclosed, for example, in U.S. Patents 4,655,771, 5,295,962, 5,368,566 and 5,421,826, cannot be used to deliver or inject fluid-based agents to the specific site of the lesion while maintaining adequate flow in the vascular lumen. The fluid flow through the lumen is substantially blocked by these stents during use.
  • the temporary stenting catheter of the '637 patent functions to hold a collapsed dissected lining or flap against the blood vessel wall for a sufficient time to allow the natural adhesion of the flap to the blood vessel wall.
  • the stenting catheter of the '637 patent also functions to introduce a drug to the site of the vascular procedure to aid in the adhesion process and in the prevention of restenosis while allowing the flow of blood through the vessel to locations distal to the catheter.
  • the catheter assembly of the '637 patent has a number of disadvantages. The catheter assembly is complex and expensive to manufacture.
  • the catheter assembly of the '637 is very expensive to use because it requires a guiding catheter to be maintained within the vessel and the patient to be maintained within the catheter lab during use and deployment.
  • a guiding catheter to be maintained within the vessel and the patient to be maintained within the catheter lab during use and deployment.
  • the coil apparatus of the present invention comprises a resilient fiber core having a linear portion and a coiled portion, and a polymer tubing encasing the resilient fiber core and adapting to the shape of the resilient fiber core, the polymer tubing comprising a first portion encasing the linear portion of the resilient fiber core and a second portion encasing the coiled portion of the resilient fiber core.
  • the polymer tubing has a lumen extending along a length of the polymer tubing, and the second portion of the polymer tubing comprises means for releasing a fluid-based agent delivered through the lumen from the coil apparatus.
  • the releasing means may comprises a series of openings spaced along the second portion of the polymer tubing, or a porous, braided, or stitched material of the polymer tubing.
  • the polymer tubing may comprise multiple lumens for delivering fluid-based agents and/or withdrawing fluid samples. Moreover, an inner sheath may be secured to the polymer tubing to guide fluid-based agents to a wall of a vessel in which the coil is deployed.
  • an outer surface of the coiled portion of the polymer tubing is covered with a soluble coating containing a therapeutic agent. The soluble coating is then dissolved when the coil is placed in a body fluid contained in a vessel.
  • a first portion of the polymer tubing is covered with a soluble coating containing a therapeutic agent, and a second portion of the polymer tubing has a releasing means for delivering fluid-based agents from a lumen of the polymer tubing.
  • the coil apparatus can be extremely small.
  • the resilient fiber core can be formed of a metallic steel heat-tempered spring alloy, such as a titanium-nickel-chromium alloy, or a boron fiber having a diameter of 0.001 to 0.006 inches.
  • the polymer tubing can have an outside diameter of 0.003 to 0.014 inches and an inside diameter of 0.002 to 0.008 inches.
  • the polymer tubing is preferably formed of a very soft material, such as nylon, urethane, PE and TFE polymer materials, and has a Shore D hardness of approximately 40 so as to minimize resistance to the coiled portion of the resilient fiber core and prevent damage to a vessel during use.
  • the polymer tubing is constructed of a polymer compounded with a radio opacifier at a loading high enough to make the polymer radiopaque.
  • the coiled portion of the resilient fiber core is shaped into a forward feed coil shape extending away from the linear portion of the resilient fiber core.
  • the resilient fiber core is shaped into a reverse feed coil shape with a bent transition portion between the linear portion and the coiled portion, the bent transition portion directing the coiled portion in a reverse direction back along the linear portion.
  • the coiled portion of the resilient fiber core is shaped into a forward feed coil shape extending away from the linear portion of the resilient fiber core and includes a distal end portion that can be engaged by a catheter for deployment purposes.
  • the resilient fiber core may also be pre-shaped in a number of different shapes to suit a particular application.
  • the resilient fiber core may be spiral- shaped in plan view, or helical-shaped with a tapered diameter.
  • the present invention comprises a combination of a coil apparatus for delivering diagnostic and therapeutic agents intravascularly and an apparatus for deploying the coil apparatus at a desired location in a vessel, the coil apparatus comprising a resilient fiber core having a linear portion and a coiled portion, and a polymer tubing encasing the resilient fiber core and adapting to the shape of the resilient fiber core, the polymer tubing comprising a first portion encasing the linear portion of the resilient fiber core and a second portion encasing the coiled portion of the resilient fiber core.
  • the apparatus for deploying the coil apparatus comprises a delivery sheath, the delivery sheath having an inside diameter that is smaller than a preset diameter of the coiled portion for compressing the coil apparatus during deployment.
  • the apparatus for deploying the coil apparatus further comprises a push tube for pushing the coil apparatus out of the delivery sheath during deployment, the push tube being slidable over a linear portion of the coil apparatus.
  • the apparatus for deploying the coil apparatus further comprises a deployment catheter that is slidable over the coil apparatus, the deployment catheter comprising a slotted distal end for receiving the bent transition portion of the coil apparatus to permit pushing and twisting of the coil apparatus during deployment.
  • the apparatus for deploying the coil apparatus further comprises a deployment catheter having a means for holding the distal end portion to permit pushing and twisting of the coil apparatus during deployment.
  • the holding means may comprise a notch and snare or other suitable holding structure across a distal end of the deployment catheter for receiving and holding the distal end portion of the infusion coil apparatus.
  • the holding means may utilize a friction lock formed in the distal end of the deployment catheter into which the distal end portion of the infusion coil apparatus can be inserted and securely held during deployment.
  • a first marker is provided at a forward distal end of the deployment catheter and a second marker is spaced axially rearwardly from the first marker.
  • the first and second markers are radiopaque for determining placement of the infusion coil apparatus within a vessel.
  • the first and second markers are spaced apart a distance equal to an axial length of the coiled portion in a relaxed position of the coiled portion.
  • the deployment apparatus is further provided with a proximal holding tube positioned over a linear portion of the infusion coil.
  • the proximal holding tube has a distal end abutting a coiled portion of the infusion coil and is secured to the infusion coil.
  • the proximal holding tube permits manipulation of the infusion coil during deployment using the proximal holding tube in conjunction with the deployment catheter.
  • the delivery sheath of the deployment apparatus further comprises a guide tube extending from a point adjacent a distal end of the delivery sheath to an opening in a side wall of the delivery sheath.
  • the guide tube is secured to the side wall of the delivery sheath and has an inner diameter large enough to permit a guide wire to pass therethrough.
  • the present invention comprises a method for delivering diagnostic and therapeutic agents into a vessel, comprising the steps of providing an infusion coil apparatus having a resilient fiber core encased by a soft polymer tubing, loading the infusion coil apparatus into a delivery sheath, the delivery sheath having an internal diameter which is smaller than a preset diameter of a coiled portion of the resilient fiber core, inserting the delivery sheath and the infusion coil apparatus into a vessel, and pushing the infusion coil apparatus out of the delivery sheath whereby the resilient fiber core causes the infusion coil apparatus to increase in diameter and lodge in the vessel.
  • the method further comprises the step of feeding a fluid-based agent through the polymer tubing of the infusion coil apparatus into the vessel, or the step of covering an outer surface of the coiled portion of the polymer tubing with a soluble coating containing a therapeutic agent.
  • the method further comprises the steps of sliding a push tube over a linear portion of the infusion coil apparatus, pushing the infusion coil apparatus out of the delivery sheath using the push tube, and removing the push tube and the delivery sheath from the vessel while maintaining the infusion coil apparatus within the vessel.
  • the method further comprises the steps of providing the infusion coil apparatus with a reverse feed coil shape with a bent transition portion between a linear portion and a coiled portion, the bent transition portion directing the coiled portion in a reverse direction back along the linear portion, providing a deployment catheter having a slotted distal end, sliding the deployment catheter over the infusion coil apparatus and receiving the bent transition portion of the infusion coil apparatus in the slotted distal end of the deployment catheter.
  • the method further comprises the steps of providing the infusion coil apparatus with a forward feed coil shape extending away from a linear portion of the resilient fiber core, and a distal end portion, providing a deployment catheter having a holding structure in a distal end of the deployment catheter, and receiving and securing the distal end portion of the infusion coil apparatus in the holding structure of the deployment catheter.
  • the method may further comprise the steps of pushing the infusion coil apparatus out of the delivery sheath into the vessel with the deployment catheter, and twisting the deployment catheter to rewind the infusion coil apparatus into a deployed position against a wall of the vessel.
  • the method also may include the steps of providing first and second radiopaque marks on the deployment catheter, the first and second marks being spaced apart a distance approximately equal to an axial length of the coiled portion in a relaxed position of the infusion coil apparatus, and twisting the deployment catheter to rewind the infusion coil apparatus until the axial length of the coiled portion is approximately the same as the distance between the first and second marks.
  • the method for delivering diagnostic and therapeutic agents further comprises the steps of providing the infusion coil apparatus with a forward feed coil shape extending away from a linear portion of the resilient fiber core, providing a proximal holding tube over a linear portion of the infusion coil, the proximal holding tube having a distal end abutting a coiled portion of the infusion coil, the proximal holding tube being secured to the infusion coil, sliding the proximal holding tube and the deployment catheter in opposite directions to elongate and reduce the diameter of a coiled portion of the infusion coil apparatus, placing the elongated coil into the delivery sheath, pushing the infusion coil apparatus out of the delivery sheath into the vessel using the deployment catheter and the proximal holding tube, and sliding the proximal holding tube and the deployment catheter in opposite directions to compress and increase the diameter of the coiled portion of the infusion coil apparatus, whereby the infusion coil apparatus is placed in a deployed position against a wall of the vessel.
  • the method further comprises the steps of providing a guide tube within the delivery sheath, the guide tube having a first distal end adjacent to a distal end of the delivery sheath, and a second proximal end in communication with an opening through a side wall of the delivery sheath, and sliding the guide tube over a guide wire to facilitate the step of inserting the delivery sheath and the infusion coil apparatus into a vessel.
  • Fig. 1 is a perspective view of an infusion coil assembly according to a first embodiment of the present invention.
  • Fig. 2 is an exploded perspective view of the components shown in Fig. 1.
  • Figs. 3A to 3C illustrate the steps and mechanism for deploying the infusion coil of the first embodiment.
  • Fig. 3 A shows the infusion coil in a loaded position.
  • Fig. 3B shows the infusion coil in a deployed position within an artery wall.
  • Fig. 3C shows the removal of the deployment mechanism.
  • Fig. 4 is a perspective view of a resilient fiber in an alternate coil shape according to a second embodiment of the present invention.
  • Fig. 5 is a perspective view of an infusion coil assembly according to the second embodiment.
  • Figs. 6 to 8 illustrate the steps and mechanism for deploying the infusion coil of the second embodiment.
  • Fig. 6 shows the infusion coil in a relaxed position on a deployment catheter.
  • Fig. 7 shows the infusion coil in a stretched position on the deployment catheter during insertion into a guide catheter.
  • Fig. 8 shows the torquing of the deployment catheter to rewind the infusion coil.
  • Fig. 9 is a perspective view of the infusion catheter deployed in an artery having a round cross-section.
  • Fig. 10 is a perspective view of the infusion catheter deployed in an artery having an oval or oblong cross-section.
  • Fig. 1 1 is a perspective view of an infusion coil, according to a third embodiment of the present invention, in a relaxed position on a deployment catheter.
  • Fig. 12A is a perspective view of an infusion coil held by a friction lock of a deployment catheter according to a fourth embodiment of the present invention.
  • Fig. 12B is a perspective view of the deployment catheter shown in Fig. 12A with a modified friction lock.
  • Figs. 13A to 13C illustrate an infusion coil and deployment apparatus according to a fifth embodiment of the present invention.
  • Fig. 13A shows the infusion coil in a shortened, radially enlarged position.
  • Fig. 13B shows the infusion coil in an elongated, radially reduced position.
  • Fig. 13C shows a perspective view of the infusion coil and deployment apparatus.
  • Fig. 14 is a perspective view of a sixth embodiment of the present invention for deploying the infusion coil assembly over a guide wire.
  • Fig. 15 is an exploded perspective view of an infusion coil showing an alternate construction of the polymer tubing according to the present invention.
  • Fig. 16 is an assembled perspective view of the infusion coil shown in Fig. 15.
  • Figs. 17A to 17C show a series of steps for sealing the distal end of the infusion coil by knotting and thermally consolidating the end of the infusion coil.
  • Fig. 18 is an enlarged perspective view of the infusion coil showing a plurality of circumferentially spaced rows of openings for permitting delivery of diagnostic and therapeutic agents through the polymer tubing.
  • Fig. 19 is a cross-sectional view of a first multiple lumen infusion coil apparatus according to the present invention.
  • Fig. 20 is a cross-sectional view of a second multiple lumen infusion coil apparatus according to the present invention.
  • Fig. 21 is a cross-sectional view of a third multiple lumen infusion coil apparatus according to the present invention.
  • Fig. 22 shows an infusion coil apparatus according to the present invention having a spiral shape in plan view.
  • Fig. 23 shows an infusion coil apparatus according to the present invention having a helical shape tapering from a large proximal end to a small distal end.
  • Fig. 24 shows an infusion coil apparatus according to the present invention having a helical shape tapering from a small proximal end to a large distal end.
  • Fig. 25 is a perspective view of an infusion coil apparatus according to the present invention having an inner sheath affixed to a coiled portion of the apparatus.
  • Fig. 26 is a cross-sectional view of the infusion coil apparatus shown in Fig. 25, in a deployed position within a vessel.
  • Fig. 27 is a perspective view of a coil apparatus according to another embodiment of the present invention, wherein an outer surface of the polymer tubing is covered with a soluble coating.
  • Fig. 28 is an enlarged sectional view of a coated segment of the coil apparatus shown in Fig. 27.
  • Fig. 29 is a perspective view of a coil apparatus according to another embodiment of the present invention, wherein a first portion of the polymer tubing is covered with a soluble coating, and a second portion of the polymer tubing has openings for delivering fluid-based agents from a lumen thereof.
  • an infusion coil 10 according to the first embodiment is shown in a loaded configuration (i.e., prior to deployment) in a delivery sheath 11 for deployment into a vessel of a subject.
  • the infusion coil 10 includes a pre-shaped resilient fiber core 12, as seen in the exploded view of Fig. 2.
  • the resilient fiber core 12 has a first linear portion 13 and a second coiled portion 14.
  • the coiled portion 14 is formed at an end of the device for insertion into a vessel.
  • the resilient fiber core 12 is encased by a soft, radiopaque polymer tubing 15 that adapts to the shape of the resilient fiber core 12, including the coiled portion 14.
  • the resilient fiber core 12 extends through the lumen of the soft polymer tubing 15.
  • the preshape of the coiled portion 14 of the resilient fiber core 12 is a coil configuration with an outer diameter of the coil chosen so that it is slightly larger than the vessel in which the infusion coil 10 will be deployed.
  • the combination of the resilient fiber core 12 and the soft polymer tubing 15 permit the infusion coil 10 to be wound into a much tighter coil than coils for delivering diagnostic and therapeutic agents of the prior art.
  • the soft polymer tubing 15 includes a series of holes 16 therein spaced along the circumference of the coil shape. The holes 16 provide an outlet for fluid-based agents injected through the tubing 15.
  • the holes 16 in the tubing 15 may be formed by drilling, lasing, machining, punching, and so forth. Slots can be used in the coil of the tubing 15 instead of holes.
  • the coiled portion of the tubing 15 can be constructed of porous materials such as PTFE and PVDF, or the end of the tubing can be braided, stitched, and so forth.
  • the infusion coil 10 in its loaded position (Figs. 1 and 3 A) is inserted into the body and directed to the desired site through an appropriate guiding catheter and/or guide wire.
  • the device can be inserted directly over a guide wire already in place, as further explained below.
  • the axial length of the device is minimized because the infusion coil 10 is in compression during deployment.
  • a push tube 17 is used to push the infusion coil 10 out of the delivery sheath 11.
  • the resilient fiber core 12 springs back to its pre-set condition and lodges the infusion coil 10 in a vessel 18.
  • the push tube 17 is fed directly over the linear portion of the infusion coil to provide positive attachment to the coil 10 for pushing and to prevent accidental over-extension of the push tube 17 into the vessel 18.
  • the push tube 17 and delivery sheath 1 1 can be removed (Fig. 3C) leaving the infusion coil 10 in the vessel 18 by itself.
  • the polymer tubing 15 over the resilient fiber core 12 serves to cushion the impact of the infusion coil 10 onto the wall of the vessel 18 and provides a path for infusion of diagnostic and therapeutic diagnostic and therapeutic agents.
  • the holes 16 placed around the entire periphery of the polymer tube 15 in the coil section permit antithrombotic fluid-based agents to be introduced over the entire circumference of the infusion coil 10 to prevent blood clotting problems associated with the deployment of similar devices.
  • the delivery sheath 1 1 can be formed of polymer (nylon) or fluorpolymer tube (teflon) having an outside diameter of 0.066" and an inside diameter of 0.058".
  • the push tube 17 can be formed of a polymer tube (nylon) with or without a wire reinforcement.
  • the push tube 17 can have an outside diameter of 0.032" and an inside diameter of 0.018".
  • the resilient fiber core 12 of the infusion coil 10 can be formed of a metallic steel heat-tempered spring alloy, such as a titanium-nickel-chromium alloy, a boron fiber, or other suitable resilient material.
  • the resilient fiber core preferably has a diameter of 0.002" to 0.006".
  • the polymer tubing 15 can be formed of a nylon, urethane, PE or TFE polymer material having an outside diameter of 0.012" to 0.014" and an inside diameter of 0.006" to 0.008".
  • the polymer tubing 15 of the coil 10 is preferably very soft so that it offers virtually no resistance to the coiled portion 14 of the preformed resilient fiber core 12. This allows the resilient fiber core 12 to have a diameter as small as 0.002" and still maintain enough springback in the coil assembly to be lodged within a vessel 18. This is a crucial aspect of the device in that it is soft enough to prevent damage to the walls of the vessel 18 as it is inserted and removed.
  • an infusion coil 20 is formed using a resilient fiber core 21 that is preshaped into a reverse feed coil shape, as shown in Fig. 4. Specifically, a bent transition portion 22 between a linear portion 23 of the resilient fiber core 21 and a coiled portion 24 of the resilient fiber core 21 directs the coiled portion 24 in a reverse direction back along the linear portion 23, rather than forward away from the linear portion, as in the embodiment of Fig. 1.
  • a polymer tubing 25 is then slid over the resilient fiber core 21, as in the first embodiment, and the infusion coil 20 takes the shape of the resilient fiber core 21, as shown in Fig. 5.
  • FIG. 6 shows the infusion coil 20 in a relaxed position on a deployment catheter 26.
  • the deployment catheter 26 is slid over a linear portion 27 of the infusion tube 20.
  • the deployment catheter 26 includes a slotted distal end 28 for receiving a portion of the infusion coil 20 at or near the transition portion 29 to permit pushing and twisting of the infusion coil 20 during deployment.
  • the infusion coil 20 is pushed through a standard introduction device 30 for deployment, such as a guide catheter (i.e., delivery sheath) or a guide wire.
  • a guide catheter i.e., delivery sheath
  • the infusion coil 20 elongates into a stretched position when inserted into these devices because the coil 20 has a much larger relaxed diameter (e.g., 2.5 mm to 6 mm) than the passage diameter of the guide catheter or other delivery devices 30 (e.g., 1.5 mm to 2.5 mm).
  • the deployment catheter 26 is pushed and twisted to force the infusion coil 20 out of the guide catheter 30 and to rewind into the coil's original configuration, as shown in Fig.
  • the infusion coil 20 can be easily observed during deployment on a fluoroscope or other suitable X-ray device.
  • the deployment catheter includes a first marker 31 at a forward distal end and a second marker 32 spaced axially rearwardly from the first marker 31.
  • the first and second markers 31 and 32 are radiopaque and are spaced apart a distance approximately equal to the axial length of the coil 20 in its relaxed position (Fig. 6).
  • the markers 31 and 32 are used to determine coil placement within a vessel. Because the markers 31 and 32 are radiopaque, they can be observed using a fluoroscope or other suitable X-ray device. Once the markers 31 and 32 are observed at the desired deployment site, the deployment catheter 26 is twisted and pushed from the guide catheter 30, as described above.
  • the deployment catheter 26 is preferably twisted until the coil portion of the infusion coil 20 assumes an axial length approximately equal to the axial length in its relaxed position.
  • the deployment procedure described above for the second embodiment allows for simple positive deployment of the infusion coil 20. More importantly, the deployment procedure allows for positioning of the device in an irregularly shaped vessel while maintaining a coil configuration that is in contact with the vessel wall along its entire periphery.
  • Fig. 9 shows the infusion coil 20 of the second embodiment deployed in an artery 33 having a round cross-section, which is an ideal deployment site for most stents and delivery devices.
  • Fig. 10 shows the infusion coil 20 of the second embodiment deployed in an artery 34 having an oblong or other irregularly shaped cross-section.
  • the infusion coil 20 of the present invention is soft enough to conform to any differences and irregularities in the vessel wall. Moreover, the twisting motion ensures that the infusion coil 20 is placed against the vessel wall. A stiffer tube, such as one that relies on polymer resiliency to form a coil, rather than a resilient fiber core as in the present invention, will bridge such irregularities.
  • an infusion coil 40 with a distal end portion 41 is formed using a resilient fiber core that is preshaped into a forward-feed coil shape, as shown in Fig. 1 1.
  • a deployment catheter 42 is provided for deploying the infusion coil 40 in a manner similar to that described above for the second embodiment.
  • the deployment catheter 42 includes a notch 43 and a snare device 44 for holding the distal end portion 41 of the infusion coil 40.
  • the distal end of the infusion coil 40 is grabbed in the snare device 44 or similar clamp at the end of the deployment catheter 42. This allows the coil 40 to be dragged into place and twisted, similar to the procedure described above for deploying the infusion coil 20 of the second embodiment.
  • First and second markers 45 and 46 are provided to determine coil placement within a vessel, similar to the markers 31 and 32 of the second embodiment.
  • Figs. 12A and 12B illustrate an infusion coil apparatus according to a fourth embodiment of the present invention.
  • the infusion coil apparatus includes an infusion coil 50 having a resilient fiber core that is preshaped into a forward-feed coil shape, as in the first and third embodiments.
  • a deployment catheter 51 is provided for deploying the infusion coil 50 in a manner similar to that described above for the third embodiment.
  • the deployment catheter 51 includes a friction lock 52 formed in a distal end thereof for receiving and holding a distal end 53 of the infusion coil 50.
  • the friction lock 52 comprises an axially extending bore at the end of the deployment catheter 51 into which the distal end 53 of the infusion coil 50 is inserted.
  • the resilient nature of the infusion coil 50 created by the resilient fiber core creates a friction holding force between the infusion coil 50 and the axially extending bore upon insertion of the distal end 53 of the infusion coil 50 into the axially extending bore.
  • a push rod 54 is inserted into the deployment catheter 51 to release the friction lock 52 between the infusion coil 50 and the deployment catheter 51 after the infusion coil 50 is positioned in a vessel at a desired location.
  • the push rod 54 engages and pushes the distal end 53 of the infusion coil 50 out of the axial bore of the deployment catheter 51.
  • the deployment catheter 51 of the fourth embodiment in operation, drags the infusion coil 50 into place and deploys the infusion coil 50 into a desired deployment location.
  • the deployment catheter 51 can also be provided with radiopaque markers (not shown) to facilitate observation on a fluoroscope or other suitable X-ray device.
  • Fig. 12B is a perspective view of a deployment catheter 51' with a modified friction lock 52'.
  • the modified friction lock includes a notch 55 in a side wall of the distal end of the deployment catheter 51'.
  • the infusion coil 50 is inserted into the axial bore of the deployment catheter 51 ' and positioned such that a distal end portion of the infusion coil 50 is received in the notch 55.
  • the notch 55 facilitates twisting of the infusion coil 50 during deployment to rewind the infusion coil 50 into its original configuration.
  • the infusion coil 60 and deployment catheter 61 used in the fifth embodiment are essentially the same as the infusion coil 50 and deployment catheter 51 used in the fourth embodiment.
  • the deployment catheter or distal coil holding tube 61 includes a friction lock 62 in the form of an axial bore for securing a distal end 63 of the infusion coil 60 during deployment.
  • a push rod 64 is provided within the distal coil holding tube 61 to release the friction lock 62.
  • the deployment apparatus includes a proximal holding tube 65 positioned over a linear portion 66 of the infusion coil 60.
  • a containment sheath 67 is disposed over both the proximal and distal holding tubes.
  • the assembly shown in Figs. 13A to 13C is particularly useful in instances when a physician desires the ability to position and adjust (compress, elongate, etc.) the infusion coil 60. This is done by first grabbing the distal end 63 of the infusion coil 60 with the friction lock 62, as previously described, and also grabbing the proximal, linear portion 66 of the infusion coil 60 using the proximal holding tube 65. The proximal holding tube 65 is slid over the infusion coil 60 into a position abutting the coiled portion of the infusion coil 60. The proximal holding tube 65 is then clamped or otherwise secured to the infusion coil 60 at the proximal end of the infusion coil 60 outside the containment sheath 67 (at the hub of the deployment apparatus).
  • proximal holding tube 65 and the distal holding tube 61 are slid in opposite directions to elongate the coil 60 and are then pulled into the sheath 67.
  • the distal holding tube 61 is pushed out of the sheath 67 followed by the proximal holding tube 65 (Fig. 13 A).
  • the distal and proximal holding tubes 61, 65 can then be manipulated by the physician to compress and elongate the infusion coil 60 as desired.
  • Fig. 14 a sixth embodiment having a modified deployment assembly for deploying an infusion coil over a guide wire will be described. Guide wires for guiding catheters and deployment devices into a desired location in a vessel of a patient are well known.
  • a modified delivery sheath 70 and push tube 71 are provided for deploying the infusion coil 72 over an existing guide wire (not shown).
  • a guide tube 73 extends from a front opening 74 of the delivery sheath 70 to an opening 75 in a side wall of the delivery sheath 70.
  • the guide tube 73 is permanently secured to the side wall of the delivery sheath 70 by a suitable adhesive or thermal bonding process.
  • the guide tube 73 has an inner diameter large enough to permit the guide wire to pass freely therethrough.
  • the infusion coil 72 is loaded in the delivery sheath 70 by inserting the linear portion 76 of the infusion coil and push tube 71 into the delivery sheath 70 through the front opening 74. In its loaded position, the coiled portion of the infusion coil 72 is positioned coaxially about the front portion of the guide tube 73. In this manner, the infusion coil 72 can be easily pushed out of the delivery sheath 70 during deployment.
  • a proximal end of a guide wire extending outside of a patient is inserted into the front end 77 of the guide tube 73 and pushed through the guide tube 73 until the guide wire exits through the opening 75 in the side wall of the delivery sheath 70.
  • the proximal end of the guide wire is then held by the physician while the loaded delivery sheath 70 and infusion coil assembly are pushed into the vessel of the patient to the desired location using the guide wire for guidance.
  • the guide tube 73 and modified delivery sheath 70 permit deployment of the infusion coil assembly over an existing guide wire without removing the guide wire and without requiring a guide wire extension to be attached to the guide wire. With the present arrangement, only a short portion of the guide wire must be exposed outside of the patient to permit the delivery sheath 70 to be introduced over the guide wire and into the patient.
  • a 0.016 to 0.018 inch diameter guide wire may be used for a 0.14 inch internal vessel diameter.
  • the guide tube 73 in this example preferably has a 0.020 inch internal diameter (0.022 inch external diameter), and the delivery sheath preferably has a 0.058 inch internal diameter (0.065 inch external diameter).
  • FIGs. 15 and 16 an alternate construction of an infusion coil 80 according to the present invention will be described.
  • This alternate construction can be used for any of the coil shapes of the first three embodiments described above, as well as other similar devices.
  • the polymer tubing 81 of the coil 80 is formed from a braided, stitched or porous tube, such as nylon braids, PVDF porous tubing, or PTFE porous tubing.
  • the tubing 81 (preform) is cut to approximately 4' to 5' long.
  • the first 95% of the braid/stitch/porous tubing 81 is consolidated by placing the tubing (preform) on a mandrel and heat consolidating the tubing (preform) with a heat shrink, or coating/impregnating the tubing (preform) with a urethane or similar material.
  • the result of this process is a polymer tubing 81 with a porous or braided end portion 82 and a consolidated (i.e., non-porous) main portion
  • the polymer tubing 81 is then placed over a resilient fiber core 84, as in the previous embodiments.
  • the final result, as shown in Fig. 16, is a soft infusion coil 80 having a porous polymer coating 82 for delivering fluid-based agents about the circumference of the coil.
  • the soft polymer tubing 81 of the present invention is preferably constructed of a polymer compounded with a radio opacifier at a loading high enough to make it radiopaque.
  • the polymer can be compounded with approximately 75% by weight tungsten.
  • the soft polymer tubing 81 can also be made radiopaque using a suitable coating containing a radio opacifier applied over the polymer tubing.
  • the distal end of the infusion coil in each of the disclosed embodiments can be sealed or closed in a number of ways according to the present invention. In some applications, particularly where the coiled portion of the polymer tubing is highly porous, it may be unnecessary to close the distal end of the infusion coil. However, in other applications, particularly where a limited number of openings are provided for delivery of fluid-based agents through the polymer tubing, it may be important to close or seal the distal end to prevent the fluid-based agents from flowing out the end of the infusion coil instead of through the delivery openings.
  • a first way of sealing the distal end of the infusion coil is to knot and consolidate the end of the infusion coil, as shown in Figs. 17A to 17C.
  • a knot 90 is formed in the end of the infusion coil with both the polymer tubing 91 and the resilient fiber core 92.
  • the knot 90 is then pulled tight, as shown in Fig. 17B, and the excess polymer tubing 91 and resilient fiber core 92 extending past the knot 90 are cut off.
  • the knot 90 is then preferably covered by a short length (e.g., 1-2 mm) of heat shrink tubing 93 (e.g., plastic), as shown in Fig. 17C.
  • a short length e.g., 1-2 mm
  • heat shrink tubing 93 e.g., plastic
  • the heat shrink tubing 93 is heated and shrunk so that the heat shrink tubing 93 flows over the cut end 94 of the infusion coil and permanently consolidates the knot 90 and heat shrink tubing 93 at the distal end of the infusion coil.
  • the resilient fiber core 92 is permanently anchored within the polymer tubing 91, and the distal end of the infusion coil is sealed to prevent fluid-based agents from flowing therefrom.
  • a second way to seal the distal end of the infusion coil is to dip the end of the polymer tubing in a potting agent, such as medical grade silicon, cyanoacrylate, or other suitable adhesive.
  • the potting agent moves into the polymer tubing by capillary action and then cures to form an effective seal and anchor for the resilient fiber core in the end of the infusion coil.
  • a third way to seal the distal end of the infusion coil is to merely stretch the polymer tubing past the end of the resilient fiber core. Upon stretching a sufficient length, the polymer tubing necks down and permanently sets in such a way as to close the end of the polymer tubing against the flow of fluid-based agents therethrough. The result is a feathered, closed portion of the polymer tubing that extends slightly past the end of the resilient fiber core.
  • holes 16 may be formed in the polymer tubing of the infusion coil by drilling, lasing, machining, punching, and so forth.
  • the holes 16 are preferably formed in the polymer tubing in a plurality of circumferentially spaced rows extending along the length of the coiled portion of the polymer tubing 15. For example, as shown in Fig. 18, three rows of holes 16 can be formed in the polymer tubing 15 with each row of holes 16 being spaced 120 degrees apart from the other rows.
  • the circumferentially spaced rows of holes 16 provide two significant advantages.
  • the multiple rows of holes 16 ensure that fluid-based agents will flow about an upstream surface of the coiled portion of the polymer tubing 15 to prevent blood clotting at the point where the blood initially contacts the polymer tubing 15.
  • the multiple rows of holes 16 provide manufacturing convenience in that it is unnecessary to take into account the circumferential location of the holes 16 when forming the coiled portion of the infusion coil.
  • multiple lumen infusion coils incorporating the features of the present invention can be formed for delivering fluid-based agents and/or withdrawing fluid samples.
  • the particular shape of the multiple lumen infusion coils shown in Figs. 19 to 21 can be any of the coil shapes described in this application and shown in the other drawings.
  • the particular deployment method used for the multiple lumen infusion coils can be any of the methods described herein and shown in the drawings.
  • the multiple lumen infusion coil 100 shown in Fig. 19 includes a resilient fiber core 101 having a first linear portion and a second portion (not shown) which is preshaped into a coiled shape as in the previously described embodiments.
  • a polymer tubing assembly in this embodiment includes a first polymer tubing 102 secured to a second polymer tubing 103 in a side-by-side manner, each polymer tubing having a lumen extending along a length thereof.
  • the first polymer tubing 102 is slid over the resilient fiber core 101, and the infusion coil 100, including both the first and second polymer tubings 102, 103, takes the shape of the resilient fiber core 101.
  • a multiple lumen infusion coil 100 is provided, which is capable of separately delivering fluid-based agents through the respective lumens of the first and second polymer tubings 102, 103 and/or withdrawing fluid samples.
  • a multiple lumen infusion coil 110 can also be provided having first, second and third polymer tubings 112, 1 13, 1 14 secured together with three distinct lumens for separately delivering fluid-based agents and/or withdrawing fluid samples.
  • a single resilient fiber core As in the embodiment shown in Fig. 19, a single resilient fiber core
  • the 111 extends through the lumen of one of the polymer tubings 1 12, which is sufficient to cause all of the polymer tubings 112, 113, 1 14 to adapt to the coiled shape of the resilient fiber core 111.
  • a multiple lumen infusion coil 120 can also be made by forming multiple lumens 121, 122 through a one-piece polymer member.
  • a resilient fiber core 123 extends through one of the lumens 121 to cause the infusion coil 120 to adapt to a coiled shape of the resilient fiber core 123.
  • the polymer tubing must be made from a very soft and flexible polymer material to permit the polymer tubing to adapt to the shape of the resilient fiber core when the infusion coil is deployed.
  • Fig. 22 shows an infusion coil 130 having a spiral shape in plan view
  • Fig. 23 shows an infusion coil 140 having a helical shape tapering from a large proximal end 141 to a small distal end 142
  • Fig. 24 shows an infusion coil 150 having a helical shape tapering from a small proximal end 151 to a large distal end 152.
  • an infusion coil is formed using a resilient fiber core which is preshaped into the particular shape shown in the drawings.
  • a soft polymer tubing is then slid over the resilient fiber core, as in the embodiments described above, and the infusion coil, including the polymer tubing, takes the shape of the resilient fiber core.
  • the polymer tubing has a lumen extending over its length and openings, pores, braids, or the like for releasing fluid-based agents delivered through the lumen into a vessel.
  • the shape of the infusion coil can be selected to adapt the infusion coil to a particular use or position within a patient's vessel.
  • the spiral-shaped infusion coil 130 shown in Fig. 22 may be particularly useful in a relatively wide, flat vessel or body cavity, while the helical-shaped infusion coils 140, 150 shown in Figs. 23 and 24 may be particularly useful in tapered vessels.
  • an infusion coil 160 having an inner sheath 161 affixed to a coiled portion 162 of the infusion coil will be described.
  • the infusion coil 160 shown in Figs. 25 and 26 is essentially the same as the infusion coil 10 shown in Figs. 1 to 3. except that the inner sheath 161 is affixed to an inner diameter of the coiled portion of the polymer tubing 163.
  • the inner sheath 161 is preferably a soft flexible tubing that takes the shape of the coiled portion 162 of the infusion coil 160.
  • the inner diameter of the inner sheath 161 defines a passage 165 that permits body fluids to continue flowing through the vessel 164.
  • the outer diameter of the inner sheath 161 and the coils 166 of the infusion coil 160 define pockets 167 along the length of the inner sheath 161.
  • the pockets 167 function to trap fluid-based agents delivered by the infusion coil 160 against the inner wall of the vessel 164 to enhance contact of the agents with the vessel and/or absorption of the agents into the vessel. Referring to Figs.
  • the coil apparatus 170 includes a resilient fiber core 171 that has a first linear portion and a second coil-shaped portion.
  • the particular shape of the coil-shaped portion of the resilient fiber core 171 can be any of the shapes described above and shown in the accompanying drawings.
  • the particular deployment method used for the coil apparatus 170 can be any of the methods described above and shown in the drawings.
  • a forward feed coil shape extending away from the linear portion of the resilient fiber core 171 is shown, for example, in Fig. 27.
  • a soft polymer tubing 172 is slid or formed over the resilient fiber core 171, and the coil apparatus 170, including the polymer tubing 172, takes the shape of the resilient fiber core 171.
  • An outer surface of the polymer tubing 172 is covered by a soluble coating 173 containing a therapeutic agent.
  • the soluble coating 173 is made of a material that dissolves after the coil apparatus 170 is in place in a blood vessel or the like. Thus, the blood flow or other body fluid dissolves the soluble coating 173 and accomplishes generally the same thing as if a fluid-based drug is infused through the lumen of the polymer tubing 172.
  • the soluble coating 173 can be made, for example, of a gelatin substance in which a therapeutic agent is suspended, or a hollow molecule material that has a therapeutic agent supplanted therein.
  • the soluble coating 173 will leach or break off over time as the substance wets out in a body fluid, such as blood.
  • the soluble coating 173 placed on the outer surface of the polymer tubing 172 simplifies the introduction of therapeutic agents into the body by making it unnecessary to inject and regulate minute amounts of fluid-based agents through the lumen of the polymer tubing. Moreover, the use of a soluble coating allows a smaller size polymer tubing 172 and resilient fiber core 171 to be used, since no fluid-based agent has to be passed through the lumen of the polymer tubing 172.
  • the resilient fiber core 171 can be in the form of a spring steel alloy having a diameter of 0.001 to 0.002 inches, and the polymer tubing 172 can have an inside diameter of 0.002 to 0.003 inches and an outside diameter of 0.003 to 0.005 inches.
  • the soluble coating 173 covering the outer surface of the polymer tubing 172 has, for example, a thickness of approximately 0.001 inches, thereby making the overall outside diameter of the coil apparatus 0.005 to 0.007 inches. These dimensions are given by way of example only.
  • the polymer tubing 172 shown in Figs. 27 and 28 need not have a lumen extending over its length for delivering fluid-based agents through the coil apparatus. Rather, the soluble coating 173 provides the means for delivering therapeutic agents as it dissolves in body fluids.
  • a coil apparatus 180 according to an alternative arrangement is shown in Fig. 29.
  • the coil apparatus 180 has a soluble coating applied over a first portion 181 of the coiled portion of the polymer tubing, while a second portion 182 of the coiled portion has openings, pores, braids, or the like for releasing fluid-based agents from a lumen of the polymer tubing.
  • This alternative arrangement provides a means for delivering a plurality of therapeutic or diagnostic agents into a vessel, wherein part of the agents are fluid-based and part of the agents are integrated into the soluble coating.
  • This arrangement might be particularly useful, for example, for introducing two or more agents designed to react with each other within the vessel in which the coil is disposed, rather than outside the vessel.
  • a multiple lumen tubing, as described above, could also be used with this arrangement.
  • the disclosed embodiments of the present invention provide an infusion coil or coated coil apparatus that can be wrapped into a much smaller coil without permanently deforming the coil so that it will spring back to its original configuration.
  • the limiting factor of how small a coil can be wound is the thickness of the element to be coiled. For instance, a 0.25" diameter metallic steel heat-tempered spring alloy wire must be wound around a very large radius (several feet) to keep from permanently deforming, while a very thin diameter (e.g., 0.001 ”) spring alloy wire can be wound around a very small radius (0.010") without being permanently set.
  • Use of "dead" soft polymer tube will follow the coil without hindering recovery of the coil to its original size during deployment.
  • the preferred Shore D hardness of the polymer selected for the polymer tube is approximately 40, whereby any permanent set in the polymer itself due to coiling will not hinder the coil's recovery.
  • the size of the resilient fiber core can be tailored to make the springiness of the coil variable so that the device produces a very small force on the vessel wall while still maintaining enough force to recover its coil shape during deployment.
  • the polymer tube can be tailored to reduce the pressure exerted by the coil on the artery wall.
  • the configuration of the embodiments of the present invention allow for positive and accurate deployment of the coil through existing devices and prevents the coil from dragging through the vessel during deployment.
  • the deployment method permits positive and accurate deployment of the coil through existing devices.
  • the terms "diagnostic,” “therapeutic” and “fluid- based” agents encompass any diagnostic compound, such as dyes for markers, as well as any therapeutic compound that has a desired pharmacologic effect in a particular subject.
  • the therapeutic agent can be an anticoagulant, such as D-Phe- Pro-Arg chloromethyl ketone, an RGD peptide-containing compound, heparin, antithrombin compounds, platelet receptor antagonists, antithrombin antibodies, antiplatelet receptor antibodies, aspirin, protagladin inhibitors, platelet inhibitors, or tick antiplatelet peptide.
  • the therapeutic agent could also be a promoter of vascular cell growth, such as a growth factor promotor, growth factor receptor agonist, transcriptional activator, translational promoter, or endothelia cells.
  • the therapeutic agent can be an inhibitor of vascular cell growth, such as a growth factor inhibitor, growth factor receptor antagonist, transcriptional repressor, translational repressor, antisense DNA, antisense RNA, replication inhibitor, inhibitory antibodies, antibodies directed against growth factors, bifunctional molecules consisting of a growth factor and a cytotoxin, and bifunctional molecules consisting of an antibody and a cytotoxin.
  • the therapeutic agent could be a cholesterol-lowering agent, a vasodilating agent, and agents that interfere with endogenous vasoactive mechanisms.
  • the present invention has been disclosed primarily in connection with treating coronary artery disease, the invention may also be used for treatment of various other body organs, including the biliary ducts, or the genital-uretal organs.
  • the term vessel as used in this application, encompasses any duct, canal, or other tube that contains or conveys a body fluid.

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  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
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Abstract

L'invention concerne un élément enroulé (170) et un procédé d'administration intravasculaire pour agents diagnostiques et thérapeutiques. On place l'élément enroulé dans une artère ou autre vaisseau sur un site malade, puis on délivre les agents diagnostiques ou thérapeutiques à l'endroit spécifique, via ledit élément. Cet élément (170) comprend un fibre centrale souple (171) enveloppée dans un tube creux en polymère souple (172). La fibre centrale souple possède un enroulement préformé à une extrémité pour éliminer les risques de déroulement du tube en polymère, tout en permettant la conception d'un élément enroulé de très faible diamètre. Le tube en polymère est radio-opaque, et il a une surface douce qui se prête à l'insertion dans un vaisseau. L'élément est déployé par un dispositif de déploiement en un point précis de traitement du vaisseau. Une fois ce point atteint, le dispositif de déploiement éjecte dans le vaisseau l'élément enroulé hors d'une gaine d'acheminement. Le tube-enveloppe en polymère peut être perforé ouporeux, afin que des agents sous forme de fluides traversant une ou plusieurs lumières de ce tube s'écoulent hors de l'élément pour le traitement in situ. Une variante consiste à appliquer un revêtement soluble (173) contenant les agents diagnostiques ou thérapeutiques sur la surface extérieure du tube en polymère, au lieu de faire passer ces agents sous forme de fluides par une lumière du tube. L'invention concerne également certaines variations dans la forme de l'élément enroulé et du dispositif de déploiement.
EP98906386A 1997-02-14 1998-02-13 Element enroule et procede d'administration intravasculaire pour agents diagnostiques et therapeutiques Withdrawn EP1007138A4 (fr)

Applications Claiming Priority (3)

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US80157697A 1997-02-14 1997-02-14
US801576 1997-02-14
PCT/US1998/002770 WO1998035717A1 (fr) 1996-02-14 1998-02-13 Element enroule et procede d'administration intravasculaire pour agents diagnostiques et therapeutiques

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EP1007138A4 EP1007138A4 (fr) 2000-06-21

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Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5649958A (en) 1993-12-08 1997-07-22 Aesculap Ag Instrument for surgical purposes

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5256146A (en) * 1991-10-11 1993-10-26 W. D. Ensminger Vascular catheterization system with catheter anchoring feature
US5523092A (en) * 1993-04-14 1996-06-04 Emory University Device for local drug delivery and methods for using the same
US5603694A (en) * 1995-10-17 1997-02-18 Brown; Joe E. Infusion coil apparatus and method for delivering fluid-based agents intravascularly

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5649958A (en) 1993-12-08 1997-07-22 Aesculap Ag Instrument for surgical purposes

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
See also references of WO9835717A1

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AU6162498A (en) 1998-09-08
EP1007138A4 (fr) 2000-06-21

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