EP1207812A1 - Dispositif de guidage d'implant et d'administration d'un agent - Google Patents

Dispositif de guidage d'implant et d'administration d'un agent

Info

Publication number
EP1207812A1
EP1207812A1 EP00953820A EP00953820A EP1207812A1 EP 1207812 A1 EP1207812 A1 EP 1207812A1 EP 00953820 A EP00953820 A EP 00953820A EP 00953820 A EP00953820 A EP 00953820A EP 1207812 A1 EP1207812 A1 EP 1207812A1
Authority
EP
European Patent Office
Prior art keywords
implant
matrix
tissue
interior
delivery
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Withdrawn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
EP00953820A
Other languages
German (de)
English (en)
Other versions
EP1207812A4 (fr
Inventor
Richard A. Gambale
Stephen J. Forcucci
Michael F. Weiser
Sean Forde
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.)
CR Bard Inc
Original Assignee
CR Bard Inc
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 CR Bard Inc filed Critical CR Bard Inc
Publication of EP1207812A1 publication Critical patent/EP1207812A1/fr
Publication of EP1207812A4 publication Critical patent/EP1207812A4/fr
Withdrawn legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/88—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure the wire-like elements formed as helical or spiral coils
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2493—Transmyocardial revascularisation [TMR] devices
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
    • A61F2250/0067—Means for introducing or releasing pharmaceutical products into the body

Definitions

  • the present invention relates to delivery of a therapeutic agent into tissue in combination with an implant device Specifically, the agent is contained in a matrix form capturable within the implant device to provide the therapeutic advantages provided by both in a single treatment
  • Ischemia causes pain in the area of the affected tissue and, in the case of muscle tissue, can interrupt muscular function
  • ischemic tissue can become infarcted and permanently non-functioning Ischemia can be caused by a blockage in the vascular system that prohibits oxygenated blood from reaching the affected tissue area
  • ischemic tissue can be revived to function normally despite the deprivation of oxygenated blood because ischemic tissue can remain in a hibernating state, preserving its viability for some time Restoring blood flow to the ischemic region serves to revive the ischemic tissue
  • ischemia can occur in various regions of the body, often myocardial tissue of the heart is affected by ischemia Frequently, the myocardium is deprived of oxygenated blood flow due to coronary artery disease and occlusion of the coronary artery, which normally provides blood to the myocardium
  • the ischemic tissue causes pain to the individual affected
  • CABG coronary artery bypass grafting
  • Angiogenesis the growth of new blood vessels in tissue, has been the subject of increased study in recent years
  • Such blood vessel growth to provide new supplies of oxygenated blood to a region of tissue has the potential to remedy a variety of tissue and muscular ailments, particularly ischemia
  • study has focused on perfecting angiogenic factors such as human growth factors produced from genetic engineering techniques It has been reported that injection of such a growth factor into myocardial tissue initiates angiogenesis at that site, which is exhibited by a new dense capillary network within the tissue Schumacher et al , "Induction of Neo- Angiogenesis in Ischemic Myocardium by Human Growth Factors", Circulation, 1998, 97 645-650
  • the present invention provides a system for delivering a therapeutic agent in combination with an implantable device to maximize a therapeutic benefit offered by each
  • the therapeutic agent is contained within a solid matrix form such as a pellet or gel to facilitate its handling and to regulate its rate of dissipation into the tissue after delivery
  • the implant device is specially configured to receive and retain the pellet but permit blood to interact with the pellet so that the agent can be released to the blood in and around the device and the surrounding tissue
  • a delivery system comprises an implant delivery device having an obturator capable of piercing the tissue and an agent matrix delivery device to place a matrix form, such as a pellet, into the interior of the implant after it has been implanted
  • the implant delivery device and the pellet delivery device are contained in one apparatus to facilitate delivery of the pellet into the embedded implant
  • the present invention is useful for treating tissue in any area of the body, especially ischemic tissue experiencing reduced blood flow
  • the present devices and methods are especially useful for treatment of ischemia of the myocardium In treatment of the myocardium, the present implant
  • revascularization by angiogenesis and vessel recruitment can be encouraged in the ischemic tissue by use of the present invention
  • a wide range of therapeutic agents conducive to revascularization can be introduced via the matrix pellet including growth factors, gene therapies or other natural or engineered substances that can be formed or added to the pellet
  • the pellet formation is well known in the medical field and typically comprises an inert powder pressed together to form a tablet or pill-like article
  • the implant device also provides therapeutic benefit to the subject tissue in several ways
  • First the structure of the implant device provides an interior cavity within the tissue which permits blood to pool, mix with the agents of the matrix and coagulate The coagulation occurs in and around the device as part of the coagulation cascade, that will eventually lead to new vessel formation and recruitment
  • the presence of a device in the moving tissue of a muscle such as the myocardium, creates an irritation or injury to the surrounding tissue which further promotes an injury response and the coagulation cascade that leads to new vessel growth
  • the implant causes a foreign body response, which causes inflammation attracting macrophages, which cause secretion of growth factors
  • Suitable implant devices should be flexible, define an interior, be anchorable within tissue and permit fluid such as blood to transfer between the surrounding tissue and the interior of the device Examples of tissue implant devices are disclosed in pending U S Patent Application Serial Nos 09/164,163, 09/164,173, 09/211 ,332 and 09/299,795, all of which are herein incorporated by reference Delivery of therapeutic agents in
  • FIG 1 is a side view of an implant device configured to accept a matrix
  • FIG 2 is a side view of an implant device containing a matrix
  • FIG 3 is a side view of an alternate embodiment of the tissue implant device
  • FIG 4 is a partial sectional view of the tissue implant device shown in FIG 3
  • FIG 5A is a partial sectional side view of an implant delivery device delivering an implant device
  • FIG 5C is a detail of the distal tip of an implant delivery device shown in FIG 5B delivering an agent matrix into an implant Description of the Illustrative Embodiments
  • FIG 1 shows a side view of an implant device 2 of the present invention
  • the implant device 2 comprises a flexible helical coil having a plurality of individual coils 4 that define an interior 6
  • the device preferably has a distal region 8 and proximal region 10
  • the coils at the distal region 8 define a diameter that is smaller than that defined by the coils of proximal region 10
  • an agent carrying matrix such as a pellet
  • the coils 4 of the distal region 8 are sized smaller than the pellet so that the pellet cannot slip out of the implant through the distal region
  • proximal is understood to mean the direction leading external to the patient and distal is understood to mean a direction leading internally to the patient
  • the agent carrying matrix may, but need not be a pellet form
  • a pellet may comprise a pill or tablet like article formed from inert substances compressed together, the substances are normally absorbable in the body
  • the pellet may be formed with a radiopaque seed to provide radiographic visibility of the implant location
  • the pellet may have a generally cylindrical shape having a diameter on the order of 060 inch and a thickness of 028
  • FIG 2 shows the implant device 2 implanted in tissue 3 and having captured with its interior 6 an agent carrying matrix 14, such as a pellet
  • the implant device maintains a cavity 18 within the tissue defined by the interior 6 of the device where the matrix may reside and blood may pool and mix with agents contained in the matrix 14
  • a tail 16 joined to the proximal end 22 of the device 2 serves to prevent the device from migrating out of the tissue
  • the tail may comprise a variety of configurations but should extend to have a profile that is greater than the diameter of the coiis along the body 24 of the device
  • the tail projects into the tissue and is submerged beneath the surface 26 of the tissue 3 to prevent axial migration as well as rotation of the device, which could permit the device to move from the tissue location
  • the pellet may be maintained in position within the interior 6 of the device 2 by reducing the diameter of the coils 4 of the proximal portion 10 of the device after the matrix 14 has been inserted As mentioned above, the coils
  • the matrix is restrained in the implant by a close or a friction fit between the pellet and the inside diameter of the coils 4 So configured, there would be no clearance around an installed matrix and the implant device coils The friction fit permits the matrix to be delivered into the device and retained without crimping the proximal coils behind the matrix to retain it, thereby eliminating an additional step after delivery
  • the implant device may be configured to have coils of approximately constant diameter
  • the pellet may be shaped to have a smaller profile distal end (leading edge) to be more easily insertable into the narrow opening of the device
  • An example of such a shape would be a cone shape pellet (not shown)
  • the matrix is supported in position within the device and within the capturing portion 28 by herniation points 20 of the surrounding tissue 3, as shown in FIG 2
  • surrounding tissue attempts to resume its previous position, collapsing around the individual coils 4 of the device and tending to hemiate at points 20 through the spaces between the coils 4
  • the herniation points extending into the interior 6 of the device 2 engage the matrix 14 to help maintain it is position so that it does not migrate through either end or through the spaces between the coils 4
  • FIGS. 5A - 5C show an example of a surgical delivery device 178 that may be used to deliver the implants into tissue such as that of the myocardium of the heart.
  • the delivery device 178 shown in FIG. 5A, is, generally, a hollow rigid tubular structure formable or machined from a polymer that comprises an obturator 180 for delivering the implant and a matrix delivery tube 210 for delivering the agent matrix 14. Both are independently advanceable and retractable through the interior 174 of the device 178 to a distal port 172.
  • the distal end 181 of the device 178 is shown in detail in FIG 5C.
  • the matrix delivery tube 210 has slidable within its interior lumen 214 a push rod 216.
  • the push rod is slidably controllable by slide 220, slidably mounted to the exterior of the body 200 of the device 178.
  • a matrix pellet is sized to be retained in the lumen 214 of the delivery tube by the resilient force of the radially flexible tube against the matrix.
  • the obturator 180 Prior to delivery of an implant and matrix, the obturator 180 is advanced distally to a delivery position, as shown in FIG 5A, by screwing knob 183 so that knob threads 188 engage threaded sleeve 190
  • the delivery position of the obturator is reached after the threads of the knob have been advanced entirely through the threaded sleeve
  • the support segment 184 of the obturator is advanced past the distal end 181 of the delivery device
  • implant devices 2 or 40 may be manually loaded onto the support segment 184 Once mounted, the implant and underlying support segment 184 remain distal to the distal end 181 of the delivery device until the implant is placed in tissue and released
  • the implant In use, the intended tissue location is first accessed surgically, such as by a cut-down method
  • the implant In the delivery position of the delivery device, the implant may be delivered into tissue by manually advancing the delivery device to the tissue location With application of a delivery force, the sharp tip 176 of the obturator pierces the tissue permitting the obturator and implant to be pushed inward into the tissue until the distal end 181 of the device contacts the tissue indicating that the support segment 184 and implant have been fully inserted into the tissue
  • the advancement of the obturator and implant into the tissue may be aided by rotating the screw knob while applying the delivery force
  • the rotation may serve to provide a screwing action between the mounted implant and tissue being penetrated that will facilitate insertion
  • Retractable projecting barbs or vacuum suction may be added to the distal end of the delivery device to help maintain position of the distal end of the device on the tissue 26 during the matrix pellet delivery step that follows

Landscapes

  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Cardiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Transplantation (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Prostheses (AREA)

Abstract

La présente invention concerne un système (178) permettant d'administrer un agent thérapeutique conjointement à un dispositif implanté (2), et ce afin d'optimiser leurs bienfaits thérapeutiques respectifs. Afin d'en faciliter la manipulation, l'agent thérapeutique est contenu de préférence au sein d'une matrice solide, telle qu'un granule ou un gel, ce qui permet également de réguler sont taux de dissipation dans le tissu après administration. Le dispositif d'implant (2) est spécialement conçu pour recevoir et retenir la matrice, mais il permet au sang d'interagir avec ladite matrice pour que l'agent puisse être libéré dans le sang dans le dispositif, autour de celui-ci et dans les tissus voisins. Un système d'implantation (178) comprend un dispositif de guidage d'implant doté d'un obturateur (180) pouvant percer le tissu, ainsi qu'un dispositif (210) d'administration d'une matrice d'agent permettant de placer une matrice, telle qu'un granule, à l'intérieur de l'implant (2), après implantation de ce dernier. Le dispositif d'implantation (178) et le dispositif d'administration (210) sont contenus de préférence dans un appareil afin de faciliter l'administration du granule dans l'implant installé. La présente invention convient dans le traitement de tissus situés dans toute partie du corps, et particulièrement des tissus ischémiques souffrant d'une réduction du débit sanguin. Les dispositifs et les procédés de l'invention s'avèrent particulièrement utiles dans le traitement de l'ischémie du myocarde. Dans le traitement du myocarde, le dispositif d'implant et la matrice associée peuvent être administrés à travers l'épicarde du coeur.
EP00953820A 1999-08-04 2000-08-03 Dispositif de guidage d'implant et d'administration d'un agent Withdrawn EP1207812A4 (fr)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US14709499P 1999-08-04 1999-08-04
US147094P 1999-08-04
US14847599P 1999-08-12 1999-08-12
US148475P 1999-08-12
PCT/US2000/021215 WO2001010350A1 (fr) 1999-08-04 2000-08-03 Dispositif de guidage d'implant et d'administration d'un agent

Publications (2)

Publication Number Publication Date
EP1207812A1 true EP1207812A1 (fr) 2002-05-29
EP1207812A4 EP1207812A4 (fr) 2007-06-20

Family

ID=26844569

Family Applications (1)

Application Number Title Priority Date Filing Date
EP00953820A Withdrawn EP1207812A4 (fr) 1999-08-04 2000-08-03 Dispositif de guidage d'implant et d'administration d'un agent

Country Status (3)

Country Link
EP (1) EP1207812A4 (fr)
JP (1) JP2003506143A (fr)
WO (1) WO2001010350A1 (fr)

Families Citing this family (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6254564B1 (en) 1998-09-10 2001-07-03 Percardia, Inc. Left ventricular conduit with blood vessel graft
US20050177180A1 (en) * 2001-11-28 2005-08-11 Aptus Endosystems, Inc. Devices, systems, and methods for supporting tissue and/or structures within a hollow body organ
US7641621B2 (en) * 2003-08-25 2010-01-05 Boston Scientific Scimed, Inc. Elongated intra-lumenal medical device
DE102005003632A1 (de) 2005-01-20 2006-08-17 Fraunhofer-Gesellschaft zur Förderung der angewandten Forschung e.V. Katheter für die transvaskuläre Implantation von Herzklappenprothesen
US8002738B2 (en) 2005-05-17 2011-08-23 Boston Scientific Scimed, Inc. Self-adhering lesion formation apparatus and methods
US7896915B2 (en) 2007-04-13 2011-03-01 Jenavalve Technology, Inc. Medical device for treating a heart valve insufficiency
US9044318B2 (en) 2008-02-26 2015-06-02 Jenavalve Technology Gmbh Stent for the positioning and anchoring of a valvular prosthesis
WO2011104269A1 (fr) 2008-02-26 2011-09-01 Jenavalve Technology Inc. Stent pour le positionnement et l'ancrage d'une prothèse valvulaire dans un site d'implantation dans le cœur d'un patient
JP2013526388A (ja) 2010-05-25 2013-06-24 イエナバルブ テクノロジー インク 人工心臓弁、及び人工心臓弁とステントを備える経カテーテル搬送体内プロテーゼ
JP6563394B2 (ja) 2013-08-30 2019-08-21 イェーナヴァルヴ テクノロジー インコーポレイテッド 人工弁のための径方向に折り畳み自在のフレーム及び当該フレームを製造するための方法
EP3632378B1 (fr) 2015-05-01 2024-05-29 JenaValve Technology, Inc. Dispositif à faible débit de stimulateur cardiaque dans le remplacement de valvule cardiaque
CN109475419B (zh) 2016-05-13 2021-11-09 耶拿阀门科技股份有限公司 用于通过引导鞘和装载系统来递送心脏瓣膜假体的心脏瓣膜假体递送系统和方法

Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5487739A (en) * 1987-11-17 1996-01-30 Brown University Research Foundation Implantable therapy systems and methods
WO1997032551A1 (fr) * 1996-03-04 1997-09-12 Energy Life Systems Corporation Dispositif et methode de revascularisation transmyocardique
WO1998016161A1 (fr) * 1996-10-11 1998-04-23 Transvascular, Inc. Procedes et appareil pour realiser le pontage d'obstructions arterielles et/ou effectuer d'autres interventions transvasculaires
WO1999021510A1 (fr) * 1997-10-29 1999-05-06 Kensey Nash Corporation Systeme de revascularisation transmyocardique
WO1999022655A1 (fr) * 1997-11-04 1999-05-14 Scimed Life Systems, Inc. Dispositifs et procede ayant trait au facteur de croissance de revascularisation myocardique percutanee
WO2000018326A1 (fr) * 1998-09-30 2000-04-06 C. R. Bard, Inc. Angiogenese induite par un implant transmyocardique souple
WO2000069504A1 (fr) * 1999-05-14 2000-11-23 C.R. Bard, Inc. Systemes d'apport d'un agent

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Publication number Priority date Publication date Assignee Title
US5891108A (en) * 1994-09-12 1999-04-06 Cordis Corporation Drug delivery stent

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5487739A (en) * 1987-11-17 1996-01-30 Brown University Research Foundation Implantable therapy systems and methods
WO1997032551A1 (fr) * 1996-03-04 1997-09-12 Energy Life Systems Corporation Dispositif et methode de revascularisation transmyocardique
WO1998016161A1 (fr) * 1996-10-11 1998-04-23 Transvascular, Inc. Procedes et appareil pour realiser le pontage d'obstructions arterielles et/ou effectuer d'autres interventions transvasculaires
WO1999021510A1 (fr) * 1997-10-29 1999-05-06 Kensey Nash Corporation Systeme de revascularisation transmyocardique
WO1999022655A1 (fr) * 1997-11-04 1999-05-14 Scimed Life Systems, Inc. Dispositifs et procede ayant trait au facteur de croissance de revascularisation myocardique percutanee
WO2000018326A1 (fr) * 1998-09-30 2000-04-06 C. R. Bard, Inc. Angiogenese induite par un implant transmyocardique souple
WO2000069504A1 (fr) * 1999-05-14 2000-11-23 C.R. Bard, Inc. Systemes d'apport d'un agent

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
See also references of WO0110350A1 *

Also Published As

Publication number Publication date
EP1207812A4 (fr) 2007-06-20
WO2001010350A1 (fr) 2001-02-15
JP2003506143A (ja) 2003-02-18

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