Insertion assembly and method of inserting a hemostatic closure device into an incision

• US 6,368,341 B1
• Filed: 08/05/1997
• Issued: 04/09/2002
• Est. Priority Date: 08/06/1996
• Status: Expired due to Term

• Current Assignee: Sherwood Services AG
• Original Assignee: St Jude Medical Puerto Rico LLC (Abbott Laboratories Incorporated)
• Inventors: Abrahamson, Timothy Alan
• Primary Examiner(s): Jackson, Gary
• Application Number:
  US08/906,342
• Time in Patent Office: 1,708 Days
• Field of Search: 606/213, 606/215, 604/60, 604/285, 604/288, 604/15
• US Class Current: 606/213
• 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 2017/00637 for sealing trocar wounds through abdominal wall
• CPC Class Codes: A61B 2017/00654 entirely comprised between the two sides of the opening
• CPC Class Codes: A61B 2017/00672 Locating means therefor, e.g. bleed back lumen

Abstract

A device and method of closing an incision or puncture in a patient by inserting a hemostatic closure device into the incision or puncture until the distal end of the hemostatic closure device is along the outer wall of the blood vessel or target organ so that the hemostatic closure device does not obstruct the flow of fluid through the blood vessel or target organ. The precise positioning of the hemostatic closure device in the incision or puncture is accomplished through the use of a locating device having a proximal end portion and distally extending locating members thereon which are adapted to be positioned along the outer wall of the blood vessel or target organ of the patient and extend along a relatively small portion of the outer surface of the hemostatic closure device.

Claims

1. A sealing assembly for sealing an incision formed in a patient'"'"'s body wherein the incision extends from the skin of a patient into a target organ or blood vessel of a patient, said sealing assembly comprising:

an elongate hemostatic closure device having a longitudinal axis, distal and proximal ends and an outer surface, said hemostatic closure device adapted to be received in the incision such that said distal end is located at a first predetermined position in the incision along the outer surface of a target organ or blood vessel of a patient and said proximal end is located at a second predetermined position along the outer surface of the incision adjacent to the skin of a patient; and

an elongate locating device having a proximal end portion positioned generally adjacent to said proximal end portion of said hemostatic closure device and at least one locating member having a longitudinal axis thereon,

said at least one locating member being non-coaxial with said elongate hemostatic closure device;

wherein

in use, said at least one locating member being dimensioned so as to extend along a portion of said outer surface of said hemostatic closure device while the remainder of said outer surface of said hemostatic closure device is in contact with tissue surrounding the incision.

2. The sealing assembly of claim 1 wherein said at least one locating member extends along less than one half of said outer dimension of said hemostatic closure device.

3. The sealing assembly of claim 1 wherein said at least one locating member includes at least a portion thereof which is movable between first and second positions to assist in the positioning of said hemostatic closure device in the predetermined position in the incision.

4. The sealing assembly of claim 1 wherein said at a portion of said at least one locating member is movable between said first position wherein said locating member is generally aligned with the lengthwise dimension of said locating device and a second position wherein at least a portion of said locating member extends laterally therefrom.

5. The sealing assembly of claim 1 wherein said proximal end of said locating device includes a tubular body portion and said at least one locating member extends distally thereof to allow for the removal of said locating device from the incision or puncture without dislocation of said hemostatic closure device from a predetermined positioned in the incision.

6. The sealing assembly of claim 5 wherein said hemostatic closure device is preloaded in said locating device and said tubular body portion includes a stabilizing member associated therewith.

7. The sealing assembly of claim 1 wherein said at least one locating member is movable along said outer surface of said hemostatic closure device between first and second positions without moving the hemostatic closure device relative to the remainder of said locating device.

8. The sealing assembly of claim 1 wherein said at least one locating member is movable between a first position and a second position wherein said at least one locating member is oriented to extend generally along a lengthwise dimension of said hemostatic closure device in said first position and at least a portion of said at least one locating member extends generally laterally from the longitudinal dimension of said locating device in said second position.

9. The sealing assembly of claim 8 wherein said at least one locating member is extendable from said first position to said second position and retractable from said second position to said first position.

10. The sealing assembly of claim 1 wherein said at least one locating member includes a distal end portion having a loop shaped member thereon.

11. The sealing assembly of claim 1 wherein said at least one locating member includes a distal end portion having a paddle member thereon.

12. The sealing assembly of claim 1 wherein said at least one locating member includes an elongate proximal portion and a distal end portion wherein said distal end portion is oriented generally perpendicular to the lengthwise dimension of said proximal portion.

13. A sealing assembly for sealing an incision formed a patient'"'"'s body wherein the incision extends generally from the skin of a patient into a target organ of blood vessel of a patient, said sealing assembly comprising in combination:

an elongate locating device having distal and proximal ends and at least one locating member forming part of said distal end and an actuation member associated therewith wherein actuation of said actuation member moves said locating member from a first position wherein said at least one locating member having a longitudinal axis is generally longitudinally aligned with the longitudinal dimension of said locating device to a second position wherein at least a portion of said at least one locating member extends laterally from the longitudinal dimension of said locating device; and

a biodegradable and generally elongate hemostatic closure device having a longitudinal axis and adapted to be positioned in a first predetermined position in said locating device with said at least one locating member generally aligned non-coaxially along said longitudinal axis of said hemostatic closure device, wherein

said hemostatic closure device is further adapted to be retained in a second predetermined position in the incision in the patient after said locating device is removed from the incision.

14. The sealing assembly of claim 13 wherein said locating device includes a proximal member positioned proximally of said hemostatic closure device and said at least one locating member includes a portion thereof which extends along and distally beyond said proximal member and said hemostatic closure device.

15. The sealing assembly of claim 13 wherein said hemostatic closure device is an elongate and generally rod-shaped member having an outer surface and said locating member of said locating device contacts a portion of said outer surface prior to the insertion of said hemostatic closure device in said second predetermined position.

16. The sealing assembly of claim 15 wherein said portion of said outer surface of said hemostatic closure device contacted by said locating member is in contact with less than the entire outer surface of said hemostatic closure device prior to the insertion of said hemostatic closure device in said second predetermined position.

17. The sealing assembly of claim 13 wherein said locating member is movably received in a guide member which is positioned along generally along said lengthwise dimension of said hemostatic closure device.

18. The sealing assembly of claim 17 wherein said guide member is a generally cylindrically shaped member.

19. The sealing assembly of claim 17 wherein said guide member has a generally semicircular cross sectional shape.

20. The sealing assembly of claim 17 wherein said at least one locating member is movable between retracted and extended positions and a distal portion of said locating member is a loop shaped member in said extended position of said locating member.

21. A sealing assembly for sealing an incision formed in the body of a patient wherein the incision extends generally from the skin of the patient into a target organ or blood vessel of the patient, said sealing assembly comprising in combination:

a generally elongate hemostatic closure device having an outer surface and distal and proximal ends adapted to be inserted into the incision of the patient such that said distal end of said hemostatic closure device generally conforms to the outer surface of the target organ or blood vessel of the patient and said proximal end is adapted to be received in the incision proximally thereof; and

a locating device having proximal and distal end portions and said proximal end portion is in contact with said proximal end portion of said hemostatic closure device and includes an actuation member associated therewith and said distal end portion includes a locating member generally aligned along and in contact with less than the entire outer surface of said hemostatic closure device wherein actuation of said actuation member increases the radial circumference of said distal end portion to facilitate the placement of said distal end of said hemostatic closure device in a desired position in the incision.

22. The sealing assembly of claim 21 wherein said hemostatic closure device includes an elongate outer surface and said locating member contacts less than one half of said outer surface of said hemostatic closure device.

23. The sealing assembly of claim 21 wherein said locating member extends beyond said distal end of said hemostatic closure device such that said distal end of said locating member is opeoratively positionable into contact with a portion of the target organ or blood vessel of the patient.

24. A method of sealing an incision formed in a patient'"'"'s body wherein the incision extends generally from the skin of the patient into a blood vessel of the patient, the method comprising:

inserting a sealing assembly having a locating device with a proximal end member and at least one locating member through the previously formed incision and into the blood vessel of the patient, wherein the locating member has a relatively small diameter with respect to the locating device;

pushing the sealing assembly into the incision such that the proximal end portion of the locating device is in contact with the hemostatic closure device during insertion;

causing the lateral extension of the locating member;

withdrawing the laterally extended locating member from the incision and blood vessel until the locating member contacts a predetermined portion of the inner wall of the blood vessel;

retracting the laterally extended locating member and leaving a hemostatic closure device in a desired position in the incision;

withdrawing the locating device from the incision while the hemostatic closure device is retained in the incision.

25. A sealing assembly for sealing an incision formed in a patient'"'"'s body wherein the incision extends generally from the skin of a patient into a target organ or blood vessel of a patient, said sealing assembly comprising in combination:

an elongate locating device having a longitudinal axis, distal and proximal ends and at least one locating member forming part of said distal end and an automatic actuation member associated therewith wherein actuation of said actuation member moves said locating member from a first position wherein said at least one locating member is generally longitudinally aligned with the longitudinal dimension of said locating device to a second position wherein at least a portion of said at least one locating member extends laterally from the longitudinal dimension of said locating device and wherein said locating device is manually movable from said second position to said first position; and

a biodegradable and generally elongate hemostatic closure device having a longitudinal axis, adapted to be positioned in a first predetermined position in said locating device with said at least one locating member generally non-coaxially aligned along said longitudinal axis of said hemostatic closure device and at least a portion of said locating device is positioned proximally of said hemostatic closure device in use and wherein said hemostatic closure device is further adapted to be retained in a second predetermined position in the incision in the patient after said locating device is removed from the incision.