Therapeutic medical appliance delivery and method of use

• US 8,511,310 B2
• Filed: 06/21/2010
• Issued: 08/20/2013
• Est. Priority Date: 08/07/2003
• Status: Active Grant

• Current Assignee: Merit Medical Systems, Inc.
• Original Assignee: Merit Medical Systems, Inc.
• Inventors: Reynolds, Jason, Alexander, Tony D., You, Ji Hwan
• Primary Examiner(s): WOO, JULIAN W
• Application Number:
  US12/819,969
• Publication Number:
  US 20100305390A1
• Time in Patent Office: 1,156 Days
• Field of Search: 606/95, 606/157, 606/158, 606/213, 606/214, 623/1.1, 623/1.15, 623/1.16, 623/1.3, 623/1.31, 623/1.11, 128/831, 128/843, 128/207.15, 128/207.16, 424422-424, 604/57, 604/58, 604/892.1
• US Class Current: 128/207.15
• CPC Class Codes: A61B 17/00491 Surgical glue applicators surgical adhesives A61L24/00; two-component delivery syringes A61M5/19
• CPC Class Codes: A61B 17/0057 Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect sutures A61B17/04; closing rectum or urethra near body surface A61F2/0009
• CPC Class Codes: A61B 17/3468 for implanting or removing devices, e.g. prostheses, implants, seeds, wires devices for implanting seeds A61M37/0069
• CPC Class Codes: A61B 2017/00004 (bio)absorbable, (bio)resorbable, resorptive for implantable prostheses A61F2210/0004
• CPC Class Codes: A61B 2017/00654 entirely comprised between the two sides of the opening
• CPC Class Codes: A61B 2017/00867 shape memory effect for prostheses A61F2210/0014

Abstract

The present invention, in an exemplary embodiment, provides a therapeutic medical appliance, delivery device and method of use. In particular, plug therapeutic medical appliances are provided that allow for the interventional treatment of pulmonary disorders such as defects characterized by pulmonary blebs and/or diffused destructive parenchymal disease. The plug therapeutic medical appliances themselves combine many of the excellent characteristics of both silicone and metal therapeutic medical appliances while eliminating the undesirable ones. In particular, these therapeutic medical appliances are preferably self-expanding in nature and allow the predetermined differential selection of relative hardness/softness of regions of the therapeutic medical appliance to provide additional patient comfort. An exemplary embodiment also provides a family of delivery devices that facilitate flexibility, durability and/or proper installation of one or more medical appliances in a single procedure. Moreover, the preferred embodiment of the delivery device provides for the reloading of the delivery device with additional medical appliances for additional interventional procedures.

Claims

1. A therapeutic medical appliance for introduction into a cavity in the anatomy of a patient, the medical appliance comprising a tube with distal and proximal ends and the tube defining a cavity extending between the distal and proximal ends, and a first self-sealing membrane disposed in the distal end,

wherein the distal end comprises a convex surface arcuately tapered towards a distal tip and defining a distal tip diameter, wherein a medial region between the distal and proximal ends comprises a substantially uniform medial diameter larger than the distal tip diameter, and wherein the proximal end comprises a flared surface with a flare diameter larger than the medial diameter.

2. The therapeutic medical appliance of claim 1, wherein tube forms a scaffolding such that when pressure is exerted along varying points of the extension of the appliance, the appliance does not undesirably foreshorten or elongate.

3. The therapeutic medical appliance of claim 2, wherein the scaffolding comprises a plurality of circumferential bands connected by a connector, and wherein along the extension of the appliance, the scaffolding forms geometrical interstices.

4. The therapeutic medical appliance of claim 3, wherein the dimensions of the scaffolding geometry determine torsionality of the medical appliance.

5. The therapeutic medical appliance of claim 3, wherein the scaffolding is formed of a memory capable alloy.

6. The therapeutic medical appliance of claim 5, wherein the scaffolding is electropolished.

7. The therapeutic medical appliance of claim 3, wherein the connector comprises a crossing member and a plurality of leg members extending from the crossing member.

8. The therapeutic medical appliance of claim 7, wherein the connector further comprises a rectangular detent extending from a leg thereof.

9. The therapeutic medical appliance of claim 7, wherein the length of the leg members and the degree of the angle at which the legs extend from the crossing member determines the relative flexibility of the medical appliance.

10. The therapeutic medical appliance of claim 9, wherein the angle at which the leg members extend from the crossing member is greater than 90°

.

11. The therapeutic medical appliance of claim 10, wherein the medical appliance is relatively rigid.

12. The therapeutic medical appliance of claim 11, wherein the medical appliance is relatively flexible.

13. The therapeutic medical appliance of claim 10, wherein the angle at which the leg members extend from the crossing member is 90°

or less.

14. The therapeutic medical appliance of claim 3, wherein the connector is substantially U-shaped.

15. The therapeutic medical appliance of claim 3, wherein the connector is substantially W-shaped.

16. The therapeutic medical appliance of claim 3, wherein the connector is substantially V-shaped.

17. The therapeutic medical appliance of claim 3, wherein the connector is substantially Z-shaped.

18. The therapeutic medical appliance of claim 3, wherein the connector is substantially S-shaped.

19. The therapeutic medical appliance of claim 2, wherein the scaffolding further comprises a coating coupled with the scaffolding, the coating of sufficient thickness to prevent the medical appliance from becoming epithelialized when installed in the desired portion of the patient'"'"'s anatomy.

20. The therapeutic medical appliance of claim 19, wherein the coating does not inhibit flexing or radial expansion of the medical appliance.

21. The therapeutic medical appliance of claim 20, wherein the coating is coupled with the medical appliance about the first and second ends thereof.

22. The therapeutic medical appliance of claim 1, further comprising a second self-sealing membrane about the proximal end thereof.

23. A method of treating a defect characterized by pulmonary blebs and/or diffused destructive parenchymal disease in a patient, the method comprising the steps of:

providing a therapeutic medical appliance comprising;

a tube with distal and proximal ends and the tube defining a void extending between the distal and proximal ends, the medical appliance further comprising a self healing membrane coupled with the distal end thereof, wherein the distal end comprises a tapered, arcuate, convex surface, wherein a medial region between the distal and proximal ends comprises a substantially uniform medial diameter, and wherein the proximal end comprises a flared surface with a flare diameter larger than the medial diameter;

placing the therapeutic medical appliance about a target site in a lung of a patient; and

introducing an adhesive into the lung through the self sealing membrane;

whereby the adhesive causes surfaces of lung sections to coalesce and seal the defect.

24. The method of claim 23, wherein the adhesive is a localized inflammatory response causing and gas-absorbing agent.

25. The method of claim 24, further comprising the step of collapsing sections of the lung by evacuating the inflammatory response causing and gas-absorbing agent.

26. The method of claim 23, wherein the medical appliance further comprises anti-microbial agents coupled therewith.

27. The method of claim 23, wherein the medical appliance further comprises chemotherapeutic agents coupled therewith.

28. A kit for treating a defect characterized by pulmonary blebs and/or diffused destructive parenchymal disease in a patient, the kit comprising:

at least one therapeutic medical appliance comprising;

a tube with distal and proximal ends and the tube defining a void extending between the distal and proximal ends, the medical appliance further comprising a self healing membrane coupled with the distal end thereof, wherein the distal end comprises a tapered, arcuate, convex surface, wherein a medial region between the distal and proximal ends comprises a substantially uniform medial diameter, and wherein the proximal end comprises a flared surface with a flare diameter larger than the medial diameter; and

a delivery device for delivery of the therapeutic medical appliance(s),

wherein the delivery device is capable of placement of a plurality of therapeutic medical appliances in a single procedure.

29. The kit of claim 28, wherein the plurality of therapeutic medical appliances are contained in a single housing.

30. The kit of claim 29, wherein the delivery device can be reloaded with additional housings of therapeutic medical appliances in order to perform multiple procedures.

31. A therapeutic medical appliance for introduction into a cavity in the anatomy of a patient, the medical appliance comprising a tube with first and second ends and the tube defining a cavity extending between the first and second ends, the medical appliance further comprising a self-sealing membrane coupled about the first end thereof,

wherein the tube forms a scaffolding, the scaffolding configured to prevent the appliance from undesirably foreshortening or elongating when pressure is exerted along varying points of the longitudinal extension of the appliance,

wherein the scaffolding comprises a plurality of circumferential bands connected by one or more connectors,

wherein along the longitudinal extension of the appliance, the scaffolding form geometrical interstices,

wherein the first end comprises a convex surface arcuately tapered towards a first tip and defining a first tip diameter, wherein a medial region between the first and second ends comprises a substantially uniform medial diameter larger than the first tip diameter, and wherein the second end comprises a flared surface with a flare diameter larger than the medial diameter.