Vascular inducing implants

• US 6,802,858 B2
• Filed: 01/31/2001
• Issued: 10/12/2004
• Est. Priority Date: 09/30/1998
• Status: Expired due to Fees

• Current Assignee: C.R. Bard, Inc. (Becton, Dickinson & Co)
• Original Assignee: C.R. Bard, Inc. (Becton, Dickinson & Co)
• Inventors: Weiser, Michael F., Gambale, Richard A., Forcucci, Stephen J., Forde, Sean, Choh, Richard T.
• Primary Examiner(s): KENNEDY, SHARON E
• Application Number:
  US09/774,320
• Publication Number:
  US 20010004683A1
• Time in Patent Office: 1,350 Days
• Field of Search: 623/1.35, 623/1.36, 623/1.15, 623/1.16, 623/1.2, 623/1.21, 623/1.22, 267/166, 267/167, 267/168, 267/180
• US Class Current: 623/1.35
• CPC Class Codes: A61B 17/00234 for minimally invasive surgery A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61F 2/06 Blood vessels
• CPC Class Codes: A61F 2/2493 Transmyocardial revascularisation [TMR] devices
• CPC Class Codes: A61F 2/94 Stents retaining their form, i.e. not being deformable, after placement in the predetermined place
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2220/005 using adhesives
• CPC Class Codes: A61F 2220/0058 soldered or brazed or welded
• CPC Class Codes: A61F 2230/0076 ellipsoidal or ovoid
• CPC Class Codes: A61F 2230/0091 helically-coiled or spirally-coiled, i.e. having a 2-D spiral cross-section
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body

Abstract

Implants and associated delivery systems for promoting angiogenesis in ischemic tissue are provided. The implants may be delivered percutaneously, thoracically or surgically and are particularly well suited for implantation into the myocardium of the heart. The implants are configured to have a first configuration having a low profile and an expanded, second configuration having a large profile. The implants are delivered to the ischemic tissue location in the first configuration, implanted then expanded to the second configuration. The expanded implants maintain a stress on the surrounding tissue, irritating and slightly injuring the tissue to provoke an injury response that results in angiogenesis. The flow of blood from the surrounding tissue into the implant and pooling of the blood in and around the implant leads to thrombosis and fibrin growth. This healing process leads to angiogenesis in the tissue surrounding the implant. Additionally, the implants may contain an angiogenic substance or a thrombus of blood, preloaded or injected after implantation to aid in initiating angiogenesis.

Claims

1. A tissue implant device for implantation into ischemic tissue comprising:

an implant having a first configuration with a first profile and a second configuration having a second profile that is greater than the first profile whereby surrounding tissue into which the implant is placed in stress and is irritated sufficiently to cause an injury response including thrombosis formation that initiates angiogenesis;

the implant comprising a plurality of expandable members each having a free end and an end joined to the implant, each member configured to diverge away from a substantially common central longitudinal axis of the implant during self-expansion from the first configuration to the second configuration.

2. An implant as defined in claim 1 further comprising a spring that is resiliently expandable from the first configuration to the second configuration.

3. An implant device as defined in claim 1 wherein the implant defines a hollow interior.

4. An implant device as defined in claim 1 wherein the implant is flexible after assuming the second configuration.

5. An implant device as defined in claim 1 wherein the implant is bifurcated defining a trunk portion aligned along the longitudinal axis of the implant and defining expandable members that are legs extending from the trunk portion and that diverge away from the longitudinal axis upon expansion.

6. An implant device as defined in claim 1 wherein a first portion of the body aligned along the longitudinal axis of the implant remains static during and after delivery and a second portion of the body is defined by expandable members that move to a different position relative to the first portion after implantation to comprise a second configuration of the device.

7. An implant device as defined in claim 6 wherein the implant comprises an elastic material and the motivational energy to cause the implant to move from the first to the second configuration is the inherent resiliency of the material.

8. An implant device as defined in claim 7 wherein the first portion is a cylinder and the second portion is defined by at least one cylinder, smaller than the cylinder of the first portion, extending from and attached to the first portion at one end, and a second end being free.

9. An implant device as defined in claim 8 wherein the free end of the second portion is configured to pierce the tissue.

10. An implant device as defined in claim 1 wherein a portion of the body lying along the longitudinal axis is defined by an axial member and the expandable members are defined by a plurality of C-shaped rings joined to the axial member and lying within a plane that is substantially perpendicular to the axial member.

11. An implant device as defined in claim 2 wherein the body is comprised of a tube rolled from a flat sheet.

12. An implant as defined in claim 1 wherein the implant comprises a brush comprising a core that lines along the longitudinal axis and expandable members that comprise a plurality of resilient bristles extending from the core at a first angle, acute to the core, in its low profile first configuration and extending from the core at an angle greater than the first angle in its large profile second configuration.

13. An implant as defined in claim 12 wherein the core defines an interior.

14. An implant as defined in claim 12 wherein the bristles are tubular, each defining an interior.

15. An implant as defined in claim 12 wherein the bristles are configured to carry an angiogenic substance.