Vascular wound closure system

• US 6,425,901 B1
• Filed: 12/04/1997
• Issued: 07/30/2002
• Est. Priority Date: 12/07/1995
• Status: Expired due to Term

• Current Assignee: LOMA Linda University Medical Center (Mission Healthcare Services LLC)
• Original Assignee: LOMA Linda University Medical Center (Mission Healthcare Services LLC)
• Inventors: Zhu, Yong Hua, Kirsch, Wolff M.
• Primary Examiner(s): WEHNER, CARY ELLEN
• Application Number:
  US08/984,757
• Time in Patent Office: 1,699 Days
• Field of Search: 606/205, 606/207, 606/209, 606/213, 606/142-143, 606/208, 606/51, 606/52, 600/208, 600/222, 600/225, 600/219, 600/210, 600/215, 433/159, 813/21, 813/16, 813/18, 813/22, 813/23, 813/26, 813/28
• US Class Current: 606/142
• 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 17/0206 with antagonistic arms as supports for retractor elements
• CPC Class Codes: A61B 17/128 for applying or removing clamps or clips
• CPC Class Codes: B29K 2067/003 PET, i.e. poylethylene terephthalate

Abstract

A system which facilitates the closure of puncture wounds in the vasculature of a patient by helping locate and isolate the site of the puncture wound in the patient. A tube or catheter having an indicator hole for aspirating blood assists in locating the exact site of the wound. A retractor moves the surrounding tissue laterally forming an access path to the wound, and acts as a guide for the wound closure device. The retractor and accessories are preferably used in combination with a surgical clip applicator which delivers clips to the site of the wound, but can also be used with other methods of wound closure such as suturing and stapling.

Claims

1. A device to facilitate the closure of wounds in the vasculature of a patient, comprising:

a body portion having a retracting portion having two elongate movable halves extending away from and substantially perpendicular to said body portion, said halves forming a channel extending completely through said retracting portion, each half having a first end and a second end, the first end being positioned farther from the body portion than the second end, the halves being movable between a retracted position and an approximated position; and

a handle portion connected to said body portion which controls the movement of the two movable halves, the handle having a grasp portion and a locking mechanism, the grasp portion having two handles, the locking mechanism selectively engagable so as to prevent movement of the halves from the retracted position toward the approximated position, the locking mechanism comprising a loop extending from one handle which surrounds a screw mounted on the other handle.

2. A device to facilitate the closure of wounds in the vasculature of a patient, comprising:

a body portion having a retracting portion having two elongate movable halves extending away from and substantially perpendicular to said body portion, said halves forming a channel extending completely through said retracting portion, each half having a first end and a second end, the first end being positioned farther from the body portion than the second end, the halves being movable between a retracted position and an approximated position;

a handle portion connected to said body portion which controls the movement of the two movable halves, the handle having a grasp portion and a locking mechanism, the locking mechanism selectively engagable so as to prevent movement of the halves from the retracted position toward the approximated position; and

a dual-lumen catheter, having an inner lumen having a proximal end and a distal end, the inner lumen adapted to receive a guidewire therethrough, and an outer lumen having a proximal end and a distal end, the outer lumen surrounding the inner lumen, and the catheter can be inserted through said channel in said retracting portion of said retractor.

3. The device of claim 2, wherein said outer lumen further comprises at least one indicator hole located in an outer wall of said outer lumen.

4. The device of claim 3, further comprising a source of negative pressure in fluid communication with said proximal end of said outer lumen.

5. A method for facilitating the closure of a wound in the vasculature of a patient, comprising the steps of:

inserting a guidewire having a proximal end and a distal end into said vasculature through said wound, until said distal end of said guidewire is within the vasculature and the proximal end remains outside the patient;

mounting a retractor comprising a body portion having a retracting portion having two movable halves extending away from and substantially perpendicular to said body portion, said halves forming a channel extending completely through said retracting portion;

on a distal end of a dual-lumen catheter having an inner lumen and an outer lumen each having a proximal end and a distal end, wherein said outer lumen surrounds the inner lumen, and having at least one indicator hole located in an outer wall of said outer lumen near the distal end of said outer lumen;

inserting the proximal end of the guidewire into the distal end of the inner lumen of the dual-lumen catheter;

advancing said catheter and retractor over the guidewire until the indicator hole enters said wound;

separating the two halves of the retracting portion; and

closing said wound.

6. The method of claim 5, wherein said advancing the catheter step further comprises providing a source of negative pressure at the proximal end of said outer lumen, and wherein said advancing step is stopped when blood is drawn into the outer lumen.

7. The method of claim 5, further comprising the steps of:

removing said guidewire from the patient through said inner lumen following said separating step;

inserting an inner catheter having an inflatable balloon mounted on its distal end through said inner lumen and into said patient; and

inflating said balloon prior to said closing step.

8. The method of claim 5, wherein prior to said closing step, the catheter is removed from the patient and a clip applicator is inserted over the guidewire and advanced to the wound.

9. The method of claim 5, wherein said closing step comprises applying at least one clip to the wound using said clip applicator.

10. A device to facilitate the closure of wounds in the vasculature of a patient, comprising:

a body portion having a retracting portion having two elongate movable halves extending away from and substantially perpendicular to said body portion, said halves forming a channel extending completely through said retracting portion, each half having a first end and a second end, the first end being positioned farther from the body portion than the second end, the halves being movable between a retracted position and an approximated position;

a handle portion connected to said body portion which controls the movement of the two movable halves, the handle having a grasp portion and a locking mechanism, the locking mechanism selectively engagable so as to prevent movement of the halves from the retracted position toward the approximated position;

a hollow catheter having an open proximal end and an open distal end, adapted to receive a guidewire therethrough, and said hollow catheter can be inserted through said channel in said retracting portion of said retractor; and

a clip applicator adapted to receive a guidewire.

11. A system for facilitating the closure of wounds in the vasculature of a patient, comprising:

a retractor comprising a body portion having a retracting portion having two movable halves extending away and substantially perpendicular to from said body portion, said halves forming a channel extending completely through said retracting portion; and

a handle portion connected to said body portion which controls the movement of the two moveable halves;

a hollow catheter having an open proximal end and an open distal end, adapted to receive a guidewire therethrough, wherein said hollow catheter can be inserted through said channel in said retracting portion of said retractor; and

a clip applicator adapted to receive said guidewire.

12. A surgical apparatus, which comprises a retractor and a catheter, the retractor including an elongated body portion having proximal and distal ends and defining a longitudinal axis and a handle connected to the body portion and obliquely arranged relative to the longitudinal axis, the distal end of the body portion being positioned farther from the handle than is the proximal end of the body portion, the elongated body portion including at least two separate cooperating members, each cooperating member having internal surfaces dimensioned to define a longitudinal passage extending through the elongated body portion for reception of surgical instrumentation, the cooperating members operatively connected to each other and adapted for relative movement between an approximated position wherein the internal surfaces of the cooperating members engage the surgical instrumentation and a displaced position wherein the surgical instrumentation is movable relative to the cooperating members, the handle including first and second movable members connected about a pin to define a scissors-grip configuration, the first and second movable members operatively connected to respective first and second cooperating members of the body portion to cause relative movement thereof between the approximated and displaced positions, and a locking mechanism operatively connected to the first and second movable members of the handle, the locking mechanism adapted to selectively lock the first and second movable members at desired relative positions to thereby secure the cooperating members of the body portion at corresponding desired relative positions between the approximated and displaced positions, the catheter having a catheter shaft defining proximal and distal ends, and being positionable within the longitudinal passageway of the body portion of the retractor, the catheter including an indicator lumen terminating in an indicator port to permit passage of the body fluids to indicate entry within desired tissue.

13. The surgical apparatus according to claim 12 wherein the body portion defines a distal tapered portion for facilitating entry into tissue.

14. The surgical apparatus according to claim 12 wherein the catheter includes a stop region defining an enlarged cross-sectional dimension relative to a region of the catheter shaft proximal of the stop region, the stop region dimensioned to engage the body portion to prevent advancement of the retractor within the tissue.

15. The surgical apparatus according to claim 14 wherein the catheter shaft includes an aperture in a side wall portion of the step region, the aperture being the indicator port.

16. The surgical apparatus according to claim 14, wherein the catheter shaft further includes a guide lumen dimensioned for reception of a guide element.

17. The surgical apparatus according to claim 16 further including a guide element having a guide shaft defining proximal and distal ends, and an inflatable member adjacent the distal end thereof, the guide element positionable within the guide lumen to introduce the inflatable member into the target site.

18. A method for facilitating closure of an opening in a blood vessel where access to the opening is through a tissue passage extending through tissue overlying the blood vessel, comprising the steps of:

introducing a catheter within the tissue passage and at least partially within the blood vessel, the catheter having a catheter shaft defining proximal and distal ends and an enlarged stop region adjacent the distal end;

positioning a retractor about the catheter shaft of the catheter, the retractor including an elongated body having proximal and distal ends and defining a longitudinal axis and a handle connected to the elongated body and arranged in oblique relation to the longitudinal axis, the elongated body having first and second body portions defining a longitudinal passage therebetween and being adapted for selective relative movement between an approximated position and a displaced position to accommodate an outer dimension of a wound closure device, the retractor being positioned such that the distal end of the elongated body is adjacent the stop region of the catheter;

selectively moving at least the first body portion of the retractor relative to the second body portion by manipulating the handle to a predetermined relative position to enlarge the tissue passage;

removing the catheter from the tissue passage and the retractor; and

inserting a wound closure device through the first and second body portions of the retractor, and actuating the wound closure device to close the opening in the blood vessel.

19. The method according to claim 18 wherein the catheter includes an inflatable member disposed adjacent the distal end of the catheter shaft, and wherein the step of introducing includes positioning the inflatable member through the opening and within the blood vessel and further including the step of expanding the inflatable member such that the inflatable member at least partially closes the opening in the blood vessel to minimize flow of blood through the opening.

20. The method according to claim 18 wherein the step of positioning is performed prior to the step of introducing.

21. The method according to claim 18 wherein the catheter includes an indicator lumen terminating in an indicator port in the stop region of the catheter shaft and wherein the step of introducing includes advancing the catheter within the tissue passage whereby the indicator port is disposed within the blood vessel as evidenced by the presence of blood within the indicator lumen.

22. A surgical apparatus comprising a retractor and a catheter, the retractor including an elongated body portion having proximal and distal ends and defining a longitudinal axis and a handle connected to the body portion and obliquely arranged relative to the longitudinal axis, the distal end of the body portion being positioned farther from the handle than is the proximal end of the body portion, the elongated body portion including at least two separate cooperating members, each cooperating member having internal surfaces dimensioned to define a longitudinal passage extending through the elongated body portion for reception of the catheter, the cooperating members operatively connected to each other and adapted for relative movement between an approximated position wherein the internal surfaces of the cooperating members engage the catheter and a displaced position wherein the catheter is movable relative to the cooperating members, the handle including first and second movable members operatively connected to respective first and second cooperating members of the body portion to cause relative movement thereof between the approximated and displaced positions, the catheter having a catheter shaft defining proximal and distal ends, and being positionable within the longitudinal passageway of the body portion of the retractor, the catheter including an indicator lumen configured to permit viewing of body fluids passing through said lumen so as to indicate entry within desired tissue.

23. The surgical apparatus of claim 22, additionally comprising a locking mechanism operatively connected to the first and second movable members of the handle, the locking mechanism adapted to selectively lock the first and second movable members at desired relative positions to thereby secure the cooperating members of the body portion at corresponding desired relative positions between the approximated and displaced positions.

24. The surgical apparatus of claim 23, wherein the catheter has a hole formed through a side of the catheter near a distal end thereof, the hole communicating with the indicator lumen.

25. The surgical apparatus of claim 23, wherein the catheter has a distal opening at a distal end of the catheter, and the distal opening is configured to slidingly accept a guidewire extending therethrough.

26. A device to facilitate the closure of wounds in the vasculature of a patient, comprising:

a body portion having a retracting portion having two elongate movable members extending away from said body portion, said movable members forming a channel through said retracting portion, each movable member having a first end and a second end, the first end being positioned farther from the body portion than the second end, the movable members being movable between a retracted position and an approximated position;

a handle portion connected to said body portion and configured to control the movement of the two movable members, the handle having a grasp portion and a locking mechanism, the locking mechanism selectively engagable so as to prevent movement of the movable members from the retracted position toward the approximated position; and

a catheter adapted to be positionable within the channel, the catheter having an open distal end configured to slidingly receive a guidewire therethrough, the catheter further comprising an indicator lumen configured so that a clinician can view fluids drawn through the indicator lumen.

27. The device of claim 26, wherein the catheter has an arcuate outer surface, and the channel has a substantially complementary surface sized and configured to engage the catheter outer surface.