Suturing device and method Number:7,090,686 from the United States Patent and Trademark Office (PTO) owispatent A suturing device and method allows a physician to remotely suture biological tissue. The device includes an elongate body, first and second arms operably connected to the elongated body, whereby each arm mounts an end portion of a suture, and first and second needles, each needle having a distal end and being mounted such that the distal end of the needle is movable to engage respective end portions of said suture. The suturing apparatus further includes an actuator which drives the needles to engage the suture non-simultaneously.<H Suturing, method, Suturing, device, 7090686.html, Patent, pto, 7090686

Title: Suturing device and method

Abstract: A suturing device and method allows a physician to remotely suture biological tissue. The device includes an elongate body, first and second arms operably connected to the elongated body, whereby each arm mounts an end portion of a suture, and first and second needles, each needle having a distal end and being mounted such that the distal end of the needle is movable to engage respective end portions of said suture. The suturing apparatus further includes an actuator which drives the needles to engage the suture non-simultaneously.

Patent Number: 7,090,686 Issued on 08/15/2006 to Nobles, et al.

Inventors: Nobles; Anthony A. (Fountain Valley, CA), Decker; Steven E. (Anaheim, CA), Brosch; Benjamin G. (Mission Viejo, CA)
Assignee: Sutura, Inc. (Fountain Valley, CA)

Appl. No.: 10/435,928

Filed: May 12, 2003

Related U.S. Patent Documents


Application Number	Filing Date	Patent Number	Issue Date
09881550	Jun., 2001	6562052
PCT/US01/08050	Mar., 2001
09524211	Mar., 2000
09471866	Dec., 1999	6245079
09231177	Jan., 1999	6117144
09036437	Mar., 1998
08702315	Aug., 1996	5860990
60002769	Aug., 1995

Current U.S. Class: 606/144 ; 606/139

Current International Class: A61B 17/04 (20060101)

Field of Search: 606/139,144 66/147

References Cited [Referenced By]

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Other References

Co-pending U.S. Appl. No. 10/420,355, filed Apr. 21, 2003, Amendment filed on Jun. 21, 2005. cited by other.

Primary Examiner: Jackson; Gary
Attorney, Agent or Firm: Knobbe, Martens, Olson & Bear, LLP

Parent Case Text

RELATED APPLICATIONS

This application is continuation of U.S. Utility patent application Ser. No. 09/881,550, filed Jun. 14, 2001 now U.S. Pat. No. 6,562,052, which is a continuation-in-part of International Patent Application No. PCT/US01/08050, filed Mar. 13, 2001 and published in English on Sep. 20, 2001 as PCT Publication WO 01/67963, and a continuation-in-part of U.S. Utility patent application Ser. No. 09/524,211, filed Mar. 13, 2000 now abandoned, which is a continuation-in-part of U.S. Utility patent application Ser. No. 09/471,866, filed Dec. 23, 1999 now U.S. Pat. No. 6,245,079, which is a continuation of U.S. application Ser. No. 09/231,177; now U.S. Pat. No. 6,117,144, filed Jan. 14, 1999, which is a continuation-in-part of U.S. Utility patent application Ser. No. 09/036,437, filed Mar. 9, 1998 now abandoned, which is a continuation-in-part of U.S. application Ser. No. 08/702,315; now U.S. Pat. No. 5,860,990, filed Aug. 23, 1996, which claims the benefit of U.S. Provisional Application No. 60/002,769, filed Aug. 24, 1995. Each of the above-referenced patent applications and issued patents is incorporated in its entirety by reference herein.

Claims

What is claimed is:

1. A method of passing a suture comprised of suture material through tissue, said method comprising: penetrating a first surface of a portion of tissue with a needle; advancing the needle through a second surface of the portion of tissue; circumferentially surrounding a distal end portion of the needle with suture materials at an end portion of the suture, such that the end portion of the suture is engaged by the needle, said circumferentially surrounding comprising advancing the needle into an opening formed by suture material at the end portion of the suture; and drawing a length of suture through the second surface and the first surface of the portion of tissue by withdrawing the needle from the portion of tissue.

2. The method of claim 1, wherein the opening formed by the suture material has a diameter which is approximately the same as a diameter of the needle.

3. The method of claim 1, wherein the diameter of the opening is smaller than a diameter of the needle, such that the needle has an interference fit within the opening.

4. The method of claim 1, further comprising; penetrating a first surface of a second portion of tissue with a second needle; advancing the second needle through a second surface of the second portion of tissue; circumferentially surrounding a distal end portion of the second needle with suture material at a second end portion of the suture, such that the second end portion of the suture is engaged by the second needle, said circumferentially surrounding comprising advancing the second needle into an opening formed by suture material at the second end portion of the suture; and drawing a second length of suture through the second surface and the first surface of the second portion of tissue by withdrawing the second needle from the second portion of tissue.

5. The method of claim 4, further comprising: disengaging the end portions of the suture from the first and second needles respectively; and securing the first and second lengths of suture proximal to the first and second portions of tissue.

6. The method of claim 4, wherein the act of securing the first and second lengths of suture comprises tying a knot.

7. The method of claim 4, wherein the act of securing the first and second lengths of suture comprises fastening a clip of the first and second lengths suture proximal to the first and second portions of tissue.

8. The method of claim 4, wherein the act of securing the first and second lengths of suture comprises bonding the first and second lengths suture proximal to the first and second portions of tissue.

9. The method of claim 4, further comprising securing a patch over the first and second portions of tissue to occlude a space between the first and second portions of tissue.

10. The method of claim 1, further comprising bending an elongated member to position the needle proximate to the first surface of the portion of tissue, the elongated member being adapted to support the needle.

11. A method of suturing, comprising: inserting a distal end portion of an elongated body into an opening in a living being; positioning said distal end portion in a first location adjacent a first tissue portion; deploying a first needle within said elongated body so as to draw a first end of a suture through said first tissue portion; moving said distal end portion to a second location displaced from said first location and positioning said distal end portion adjacent a second tissue portion; deploying a second needle within said elongate body so as to draw a second end of said suture through said second tissue portion; and pulling the ends of the suture.

12. The method of claim 10, comprising drawing the suture through a patch prior to said inserting.

13. The method of claim 10, wherein said opening in said living being is a body lumen.

14. The method of claim 10, wherein said opening in said living being is a body cavity.

15. The method of claim 10, wherein said opening in said living being is an incision.

Description

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates to suturing devices. Specifically, the present invention relates to suturing devices and methods for suturing biological tissue that may not directly accessible to the physician.

2. Description of the Related Art

Physicians frequently use sutures to close cuts, punctures, incisions and other openings in various biological tissue, such as blood vessels, of the human body.

In an arterial catheterization procedure, a relatively small percutaneous incision is made in the femoral or other artery. A catheter is inserted through the incision and directed along an arterial path to a target area, such as the heart, to perform one or more procedures, such as an angioplasty or angiogram. These procedures are designed to be relatively quick `outpatient` procedures.

Upon completion of the catheterization procedure, the physician typically creates a `thrombus patch` by applying direct pressure to the patient's thigh to make the blood around the incision clot. Because the femoral artery must not be completely blocked (occluded) by the applied pressure, the physician commonly applies direct pressure by hand for the first twenty minutes after the procedure. During this time, the physician can feel the pulse to assure the artery is not occluded. Afterwards, the physician usually turns the procedure over to an assistant who applies direct pressure using sandbags, clamps or other devices. A significant problem with this approach is that it is frequently necessary to apply the pressure for an extended period of time, such as twenty-four hours or longer.

Another problem with the thrombus patch method is that the high blood pressure in the artery can cause the thrombus patch to rupture or burst while direct pressure is being applied to the thigh or after direct pressure is removed. This requires the whole process to be restarted. If the patch ruptures and is not restored, the patient may bleed to death. Because thrombus patches frequently burst, the patient frequently must remain in the hospital or catheterization lab overnight for observation. Thus, these `out-patient` procedures become `in-patient` procedures, simply because a thrombus patch it is difficult to create. Staying in the hospital increases patient discomfort and hospital expenses, which are often disproportionate to the actual medical procedure performed.

Furthermore, if a thrombus patch cannot be formed, the physician may need to anesthetize the patient, occlude blood flow to the artery, make a large incision in the thigh to allow conventional suturing with a needle, suture the artery with conventional means, restore blood flow to the artery, and suture the incision in the thigh. This results in additional discomfort and expenses for the patient.

While the above problems could potentially be avoided by suturing the blood vessel immediately following the catheterization procedure, the size and location of the artery make suturing difficult. Specifically, the opening in the thigh is typically too small and too deep to provide enough working space for suturing the artery using conventional methods. Thus, in order to suture the vessel according to conventional methods, the opening in the thigh would have to be significantly enlarged, potentially exposing the patient to additional pain, scarring, and health risks.

SUMMARY OF THE INVENTION

The present invention addresses the above problems by providing a suturing device and method for suturing biological tissue, such as, for example, an organ or blood vessel. The device is particularly well suited to suture an opening made in an artery, such as the femoral artery, following a catheterization procedure. The device eliminates the need to apply pressure to a patient's thigh for an extended period of time, and eliminates many of the complications and costs associated with the creation of a thrombus patch.

One aspect of the invention relates to a suturing device comprising an elongate body and first and second arms. Each of said arms has a suture mounting portion which mounts an end portion of a suture. The arms are mounted on the elongate body such that said suture mounting portions are movable away from said body to a first position and towards said body to a second position. The suturing device further comprises first and second needles, each of said needles having a distal end. Each of said needles is mounted such that the distal end of the needle is movable (i) in a proximal to distal direction from a position adjacent said elongate body to a position spaced outwardly from said body, and (ii) towards the suture mounting portion of one of the arms when in said first position, wherein the respective distal ends of the first and second needles engage respective end portions of said suture. The suturing apparatus further comprises an actuator which drives the needles in said proximal to distal direction such that the engagement of the respective end portions of the suture is non-simultaneous.

Another aspect of the invention relates to a suturing apparatus comprising an elongate body and first and second arms. Each of said arms has a suture mounting portion which mounts an end portion of a suture, and each of said arms is operably connected to the elongate body such that said suture mounting portions are movable away from said body to a first position and towards said body to a second position. The suturing apparatus further comprises first and second needles, each of said needles having a distal end. Each of said needles is mounted such that the distal end of the needle is movable (i) in a proximal to distal direction from a position adjacent said elongate body to a position spaced outwardly from said body, and (ii) towards the suture mounting portion of one of the arms when in said first position. The suturing apparatus further comprises an actuator comprising first and second needle drivers connected to drive the first and second needles, respectively, in said proximal to distal direction. Said needle drivers are independently actuable such that the first needle is movable independent of the second needle.

Another aspect of the present invention relates to a device for suturing biological tissue. The device comprises an elongated body and an arm operably connected to the elongated body to move to an extended position away from the elongated body and to a retracted position toward the elongated body. The arm has a mounting portion which mounts a portion of a suture, and has a tissue contacting surface which faces proximally when the arm is in the extended position. The tissue contacting surface has a projecting portion configured to provide intimate contact with said tissue and to thereby inhibit lateral movement of said arm when said tissue contacting surface is pressed against tissue. The device further comprises a needle having a distal end which is movable distally from a position adjacent the elongated body towards said mounting portion of said arm when the arm is in the extended position, such that said distal end engages said portion of the suture mounted by said mounting portion.

Another aspect of the present invention relates to a suturing apparatus comprising an elongated body. The suturing apparatus further comprises an arm operably connected to the elongated body and movable relative to the elongated body to an extended position away from the elongated body and to a retracted position towards the elongated body. The arm has a mounting portion which mounts a portion of a suture. The suturing apparatus further comprises a needle movable relative to the elongated body. The needle has a distal end movable from a position adjacent the elongated body towards the mounting portion of the arm when the arm is in the extended position, such that the distal end engages the portion of the suture mounted by the mounting portion of the arm. The suturing apparatus further comprises a patch which is tethered by the suture.

Another aspect of the present invention relates to a method of suturing. The method comprises providing an elongate body having first and second arms which mount first and second portions, respectively, of a suture. The method further comprises engaging the first and second portions of the suture with first and second needles, respectively, by driving the first and second needles towards the first and second arms, respectively, in a proximal to distal direction. The engaging comprises engaging the first portion of suture with the first needle prior to engaging the second portion of the suture with the second needle.

Another aspect of the present invention relates to a method of occluding a septal defect. The method comprises inserting a distal end portion of an elongated body into an opening in a living being. The method further comprises positioning the distal end portion in a first location adjacent a first tissue portion in proximity to the septal defect. The method further comprises deploying a first needle within the elongated body so as to draw a first end of a suture through the first tissue portion. The method further comprises moving the distal end portion to a second location displaced from the first location and positioning the distal end portion adjacent a second tissue portion in proximity to the septal defect. The method further comprises deploying a second needle within the elongated body so as to draw a second end of the suture through the second tissue portion. The method further comprises using the suture to secure a patch across the septal defect.

Another aspect of the present invention relates to a method of suturing. The method comprises inserting a distal end portion of an elongated body into an opening in a living being. The method further comprises positioning the distal end portion in a first location adjacent a first tissue portion. The method further comprises deploying a first needle within the elongated body so as to draw a first end of a suture through the first tissue portion. The method further comprises moving the distal end portion to a second location displaced from the first location and positioning the distal end portion adjacent a second tissue portion. The method further comprises deploying a second needle within the elongated body so as to draw a second end of the suture through the second tissue portion. The method further comprises using the suture to secure a patch to the first and second tissue portions.

Another aspect of the present invention relates to a method of suspending a biological structure. The method comprises positioning a distal portion of an elongated body adjacent the biological structure to be suspended. The method further comprises positioning a first arm operably connected to the elongated body on one side of the biological structure, the first arm releasably holding a first end portion of a suture. The method further comprises extending a first needle toward the first end portion of the suture in the first arm. The first needle moves on an opposite side of the biological structure such that when the first needle engages the first end portion of the suture, the biological structure is encircled by the first arm, the first needle, and the elongated body. The method further comprises positioning a second arm operably connected to the elongated body adjacent a tissue portion. The second arm releasably holds a second end portion of the suture. The method further comprises extending a second needle through the tissue portion to engage the second end portion of the suture in the second arm. The method further comprises drawing the first end portion and second end portion of the suture toward the elongated body. The method further comprises tying the first end portion and second end portion of the suture to suspend the biological structure to the tissue portion.

Another aspect of the present invention relates to a method of placing a suture around the exterior of a biological structure. The method comprises advancing an elongate suturing device having an elongate body distally towards the biological structure. The method further comprises positioning a first suture portion mounted on the elongate device so that the first suture portion is proximate the biological structure. The method further comprises advancing a suture retrieving member of the elongate device past the biological structure without piercing the biological structure. Advancing the suture retrieving member comprises moving the suture retrieving member with the biological structure between the suture retrieving member and the elongate body. Advancing the suture retrieving member further comprises coupling the suture retrieving member to the first suture portion. The method further comprises drawing the first suture portion away from the biological structure by moving the suture retrieving member in a direction away from the biological structure. The method further comprises drawing a second suture portion away from the biological structure by moving at least a portion of the elongate device from the biological structure, whereby the suture extends in a loop around the biological structure.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A illustrates one embodiment of the present invention in an exemplary use environment.

FIG. 1B illustrates a cross-sectional view of the device in FIG. 1A in an exemplary use environment, such as a patient's thigh.

FIG. 1C illustrates another embodiment of the present invention in the exemplary use environment of FIG. 1A.

FIG. 1D illustrates a cross-sectional view of the device in FIG. 1C in an exemplary use environment, such as a human thigh.

FIG. 2 is a partial cross-sectional view of the suturing device depicted in FIG. 1A having a suture catch assembly and a suture introducer housing.

FIG. 3 is a bifurcated perspective view of the suture introducer housing of FIG. 2.

FIG. 4A is a partially schematic perspective view of the suture clasp arms of FIG. 2.

FIG. 4B is a partial cross-sectional view of one configuration of suture clasp arms.

FIG. 4C is a partial cross-sectional view of another configuration of suture clasp arms.

FIG. 4D is a partial cross-sectional view of yet another configuration of suture clasp arms.

FIG. 4E is a partial cross-sectional view of yet another configuration of suture clasp arms.

FIG. 5 is an elevational view of one configuration of a suture clasp arm.

FIG. 6 is an elevational view of another configuration of a suture clasp arm.

FIG. 7 is an enlarged elevational view of one configuration of a suture clasp.

FIG. 8 is an enlarged elevational view of a suture having bands crimped thereon.

FIG. 9 is an enlarged elevational view of another configuration of a suture clasp.

FIG. 10 is an elevational view of the suture clasp of FIG. 9 illustrating the action of a suture and the suture clasp as the suture is being removed from the suture clasp.

FIG. 11A is a cross-sectional top view of one configuration of a suture introducer housing, suture clasp arms, a suture, and a triangular spreader.

FIG. 11B is a cross-sectional side view of the suture introducer housing and triangular spreader of FIG. 11A.

FIGS. 12 and 13 are partial cross-sectional views of another configuration of a spreader for deploying the suture clasp arms.

FIG. 14 is a partial cross-sectional view of an alternate configuration of the device for deploying the suture clasp arms.

FIG. 15 is a partial cross-sectional view of an alternate configuration of suture clasp arms.

FIG. 16 is a partial cross-sectional view of the device of FIG. 15 illustrating the suture clasp arms in a deployed position.

FIG. 17 is a bifurcated perspective view of the suture catch assembly of FIG. 2.

FIG. 18 is a partial cross-sectional view of an alternate configuration of the suture catches and the suture clasp arms.

FIG. 19 is a schematic perspective view of a needle tip and one configuration of a suture catch.

FIG. 20 is a cross-sectional view of the suture catch of FIG. 19 taken along line 19--19 illustrating the position of a suture fitting captured by the suture catch.

FIG. 21 is a cross-sectional top view of the suture catch of FIG. 19 taken along line 20--20.

FIG. 22 is a schematic illustration of another configuration of a suture fitting.

FIG. 23 is a side view of a suture clasp arm used to hold the suture fittings of FIGS. 20 and 22.

FIG. 24 is a rear elevational view of a needle tip with an alternate configuration of the suture catch.

FIG. 25 is a cross-sectional view of the needle tip of FIG. 24 taken along line 24--24 of FIG. 24.

FIG. 26 is a partial cross-sectional side view of an alternate configuration of a suture clasp arm to hold a suture fitting.

FIG. 27 is an end view of the suture clasp arm of FIG. 26.

FIG. 28 is a perspective view of a three-sector arm actuator assembly with a catch in a distal position.

FIG. 29 is a perspective view of a button of the assembly of FIG. 28.

FIG. 30 is a perspective view of a guide of the assembly of FIG. 28.

FIG. 31 is a perspective view of the catch of the assembly of FIG. 28.

FIG. 32 is a perspective view of the assembly of FIG. 28 with the catch in a proximal position.

FIG. 33 is a schematic partial cross-sectional view of the assembly of FIG. 28 with the catch in a distal position.

FIG. 34 is a partial cross-sectional view of the suture introducer housing of FIG. 2 with the introducer over the housing.

FIG. 35 is a partial cross-sectional view of the suture introducer housing of FIG. 2 with the suture clasp arms deployed.

FIG. 36 is a partial cross-sectional view of the suture introducer housing and suture catch assembly of FIG. 2 illustrating the operation of the suture catch assembly.

FIG. 37 is a partial cross-sectional view of the suture introducer housing and the suture catch assembly of FIG. 2.

FIG. 38 is a schematic view of a vessel illustrating the location of the suture.

FIG. 39 is a schematic cross-sectional view of the vessel of FIG. 38 taken along line 40--40.

FIG. 40 is a partial schematic cross-sectional view of one configuration of the suturing device having a detachable arm deployment handle.

FIG. 41 is a cross-sectional view of the embodiment depicted in FIG. 1C with the distal end inserted through an arterial wall.

FIG. 42 is a cross-sectional view of the device of FIG. 41 with the suture clasp member partially deployed.

FIG. 43A is a perspective view of a suture clasp member, an actuator and a hollow elongated body of FIG. 41.

FIG. 43B is an exploded view of the suture clasp member, pivot pin and actuator of FIG. 42.

FIG. 43C is a perspective view of a two-piece suture clasp member.

FIG. 43D is a cross-sectional view of the two-piece suture clasp member of FIG. 43C and a spreader within the suture introducer head of FIG. 41.

FIG. 44 is a perspective view of the suture introducer head and suture clasp member of FIG. 41.

FIG. 45 is perspective view of the device of FIG. 44 with the suture clasp member partially deployed.

FIG. 46 is a rear perspective view of the device of FIG. 44.

FIG. 47 is cross-sectional view of the device of FIG. 41 with the suture clasp member fully deployed.

FIG. 48 is a cross-sectional view of another embodiment of the present invention.

FIG. 49 is a cross-sectional view of one embodiment of a handle capable of being attached to the proximal end of the device of FIG. 41, the device of FIG. 48 or the device of FIG. 52A.

FIG. 50 is a perspective view of the handle of FIG. 49.

FIG. 51 is a cross-sectional view of another embodiment of a handle capable of being attached to the proximal end of the device of FIG. 41, the device of FIG. 48 or the device of FIG. 52A.

FIG. 52A is a perspective view of the suture introducer head and the hollow elongated body of FIG. 41 with another embodiment of the suture clasp arms.

FIG. 52B is a cross-sectional view of the device of FIG. 52A.

FIGS. 53A 53B are perspective views of one configuration of the suture clasp member of FIG. 52A.

FIG. 54 is a perspective view of the device of FIG. 52A with the suture clasp member partially deployed.

FIG. 55 is a perspective view of the device of FIG. 52A with the suture clasp member fully deployed.

FIG. 56 is a perspective view of the device of FIG. 52A with the suture clasp member fully deployed and needles engaging the suture clasp member.

FIG. 57 is a perspective view of the handle of FIG. 49.

FIGS. 58 59 are perspective views of a four-arm suture clasp member used with the device of FIGS. 1C 1D.

FIG. 60 is an exploded view of another embodiment of a handle capable of being attached to the proximal end of the device of FIG. 41, the device of FIG. 48 or the device of FIG. 52A.

FIG. 61 is a perspective view of the handle of FIG. 60.

FIG. 62 is a perspective view of another configuration of the suture introducer head and the hollow elongated body of FIG. 52A with six suture clasp arms.

FIG. 63 is a perspective view of the device of FIG. 62 with the suture clasp arms fully deployed.

FIG. 64 is a perspective view from the distal end of the device of the six suture clasp arms of FIG. 62.

FIG. 65 is a perspective view of the device of FIG. 62 with the suture clasp arms fully deployed and a set of needles engaging the suture clasp arms.

FIG. 66 is a perspective view from the distal end of another suture device configuration of the present invention with four suture clasp arms.

FIG. 67 is a perspective view of the suture device of FIG. 66 with the suture clasp arms fully retracted.

FIG. 68 is a perspective view of the suture device of FIG. 66 with the suture clasp arms partially deployed.

FIG. 69 is a perspective view of the suture device of FIG. 66 with the suture clasp arms fully deployed and a set of needles.

FIGS. 70 71 illustrate a removable sheath that may be used with the suture devices shown in FIGS. 1A 69.

FIGS. 72 73 illustrate occlusion devices that may be used with the suture devices shown in FIGS. 1A 69.

FIG. 74A is an exploded cross-sectional view of another embodiment of a handle capable of being attached to the proximal end of the device of FIG. 41, the device of FIG. 48 or the device of FIG. 52A.

FIG. 74B is an exploded cross-sectional view of another embodiment of a handle adapted to separately actuate the first and second needles.

FIGS. 75A and 75B are exploded, cross-sectional, perspective views of the handle of FIG. 74A.

FIG. 76A is an exploded, cross-sectional, perspective view of the handle of FIG. 74B.

FIGS. 76B D schematically illustrate various embodiments of the needle drivers adapted to separately actuate the first and second needles.

FIG. 77 illustrates the suture device of FIG. 56 adapted to move a first needle distally to engage a first suture clasp arm before moving a second needle distally to engage a second arm.

FIG. 78 illustrates the suture device of FIG. 77 with the second needle moving distally.

FIG. 79 illustrates the suture device of FIG. 77 with the first needle piercing a first biological tissue portion and engaging the first suture clasp arm.

FIG. 80 illustrates the suture device of FIG. 77 with the second needle piercing a second biological tissue portion and engaging the second suture clasp arm.

FIG. 81 illustrates the first and second biological tissue portions being drawn together by a suture inserted by the suture device of FIG. 77.

FIG. 82A illustrates the suture device of FIG. 77 with a patch deployed from the elongated body.

FIG. 82B illustrates the patch of FIG. 82A occluding the suture site.

FIG. 83A illustrates a patch connected to the ends of the suture before distally sliding the patch toward the suture site.

FIG. 83B illustrates the patch of 83A occluding the suture site with a knot securely holding the patch in place.

FIG. 84 illustrates a patch with two pairs of sutures through the patch.

FIG. 85 illustrates a suture device with a steerable portion and a first needle piercing a first biological tissue portion.

FIG. 86 illustrates the suture device of FIG. 85 with a second needle piercing a second biological tissue portion.

FIGS. 87 102 illustrate methods of forming suture ends of a suture which may be used with the suture devices described herein, in which:

FIG. 87 shows a strand of material being brought into a stream of hot gas;

FIG. 88 shows a distal end of the strand being thermally deformed to form a deformed region such as a globule;

FIGS. 89 and 90 show a die for flattening the deformed region;

FIG. 91 shows the strand after the deformed region has been flattened;

FIG. 92 shows the strand after excess material has been cut away from the deformed region;

FIG. 93 shows the strand after an eyelet has been formed in the flattened, deformed region;

FIG. 94 shows a suture in which eyelet portions have been formed at both ends of the suture;

FIG. 95 shows the deformed region placed between two blocks having recessed portions therein;

FIG. 96 shows the deformed region after it has been squeezed between the blocks to form a cylindrically shaped member;

FIG. 97 shows a hole being formed in the deformed region with a hypotube;

FIG. 98 shows the formed hole in the deformed region, resulting in a cup-like member at the end of the strand;

FIGS. 99 and 100 show views of a one embodiment of a surgical needle to be used with the cup-like member of FIG. 98;

FIG. 101 shows the surgical needle having entered the cup-like member and secured to it; and

FIG. 102 shows an embodiment having cup-like members at both ends of the suture.

FIG. 103A shows a side view of the distal portion of the device with one end portion of the suture captured by a needle extended through the tissue structure and a second end portion of the suture looped around a second tissue structure.

FIG. 103B shows a side view corresponding to FIG. 103A once the end portions of the suture have been tied together and tightened.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

The present invention provides a suturing device for suturing biological tissue. The suturing device may be used to seal a blood vessel following an interventional catheterization procedure, such as an angiogram. FIGS. 1A 1B illustrate one embodiment of the present invention in an exemplary use environment. As depicted by FIGS. 1A 1B, the physician makes an initial incision 20 in the upper thigh 12 of a patient 2. The physician then inserts a needle (not shown) into the incision 20. When blood bleeds back from the insertion, the physician knows the needle has pierced the femoral artery 16. The physician then inserts a guidewire (not shown) through the needle and into the artery. The physician may take the needle out and insert a plastic needle (not shown) over the guidewire once the guidewire is in place. The guidewire may then be taken out.

With this needle in place, the physician can insert a catheter sheath introducer (CSI) 6, also called an introducer sheath. This introducer sheath 6 is typically a single lumen catheter with a valve on its proximal end. The valve is used to prevent extraneous bleed back or to introduce medication into the patient's body. The vessel incision 26 provides access for medical instruments and probes inside the arterial vessel 16. Instruments may be inserted into artery 16 via the introducer sheath 6 to perform various procedures in the body.

In FIG. 1A, the suture assembly 4 consists of the suture catch assembly 36 (described below), the suture introducer housing 24, and the introducer sheath 6. FIG. 1B illustrates a cross-sectional view of the device depicted in FIG. 1A in an exemplary use environment, such as a patient's thigh. After the medical procedure described above, the physician withdraws the CSI 6 and inserts the suture catch assembly 36 and the suture introducer housing 24 through the first incision 20. The suture catch assembly 36 and suture introducer housing 24 pass through the flesh 14 of the patient's thigh 12 and through the second incision 26 into the femoral artery 16. In another method, the physician may first insert the suture introducer housing 24, remove the CSI 6, and then insert the suture catch assembly 36.

FIGS. 1C and 1D illustrate another embodiment of the present invention in the exemplary use environment of FIG. 1A. Unlike the device illustrated in FIGS. 1A 1B, the device illustrated in FIGS. 1C 1D does not require the removal of the CSI 6 in order for the device to deploy a suture. Several embodiments of the device shown in FIGS. 1A and 1B will now be described with reference to FIGS. 2 40. The device depicted in FIGS. 1C 1D will thereafter be described in further detail below with reference to FIGS. 41 50.

Embodiments of FIGS. 1A 1B and 2 40

FIG. 2 shows one embodiment of the suturing device for suturing vessel walls and other biological tissue. Preferably, the device is for use in suturing arterial vessel walls 22. However, the device could be used to suture other tissue such as a patent ductus arteriosus, a patent foramen ovale, a heart defect, a puncture wound, and the like. The suturing device comprises a suture introducer housing 24 for insertion into an opening 26 in the arterial wall 22.

Suture clasp arms 28, 30 are deployably housed in the housing 24 during insertion. After insertion into the vessel 16, the arms 28, 30 are deployed to the position shown in FIG. 2. When deployed, the suture clasp arms 28, 30 extend outside the circumference of the suture introducer housing 24. In certain embodiments, the arms 28, 30 extend from the housing in a symmetric configuration, in which each arm 28, 30 has the same angle with respect to the axis of the housing 24. Alternatively, in other embodiments, each arm 28, 30 can extend from the housing in an asymmetric configuration, in which each arm 28, 30 has a different angle with respect to the axis of the housing 24. Furthermore, in certain embodiments, the arms 28, 30 are spaced equidistantly around the circumference of the housing 24. Equidistant spacing as used herein means that the azimuthal angle between the two arms 28, 30 is 180 degrees, where the azimuthal angle between the two arms 28, 30 is the angle between the plane defined by the axis of the housing 24 and the first arm 28 and the plane defined by the axis of the housing 24 and the second arm 30. Alternatively, in still other embodiments, the arms 28, 30 are spaced non-equidistantly around the circumference of the housing 24 (e.g., the azimuthal angle between the two arms 28, 30 is 90 degrees).

Each arm has at least one suture clasp 32, schematically illustrated, for clasping a suture 40. A penetrating mechanism, generally designated 34, is provided for penetrating the vessel wall 22. The penetrating mechanism 34 is provided on either the suture introducer housing 24 or on a suture catch assembly, generally designated 36. When, as shown in FIG. 2, the penetrating mechanism 34 is part of the suture catch assembly 36, the penetrating mechanism 34 also comprises suture catches 38 for catching the suture 40 and dislodging it from the suture clasps 32. The suture catch assembly 36 operates to pull the suture 40 held by the suture catches 38 through the vessel wall 22. After the ends of the suture 40 are pulled outside the vessel wall 22, the introducer housing 24 can be removed and the suture 40 tied to close the vessel opening 26.

FIG. 3 shows one configuration where the suture introducer housing 24 is a generally cylindrical and thin walled hypo tube. The term "hypo tube" is used to describe a hollow elongated cylindrical member with a thin wall such that the inner diameter and outer diameter vary by a relatively small amount in the range of few thousandths of an inch to tens of thousandths of an inch. The outer surface 42 of the housing 24 comprises a key way groove 44 (exaggerated for clarity) to align the housing 24 with a key 46 (FIG. 17) on the inner surface 48 of the suture catch assembly 36. An arm actuation assembly 170, to be described below, for deploying the suture clasp arms 28, 30 protrudes from the proximal end of the housing 24, and an actuating wire or rod 50 extends from the actuation assembly 170 through the housing 24 to the suture clasp arms 28, 30.

FIG. 2 shows one configuration where the suture clasp arms 28, 30 are attached to the distal end 54 of the actuating rod 50. In this configuration, the arms 28, 30 are pivotally attached to the actuating rod 50 and pivot around pivot shaft 56. The suture 40 is held inside the housing 24 and is positioned underneath the spreader 102, so that it can be removed from the entire housing 24. The arms 28, 30, which are shown in more detail in FIGS. 4A and 4B, terminate with the suture clasps 32 (schematically illustrated). Each arm 28, 30 has an elongated body 58 which attaches to the pivot shaft 56 at one end and to the suture clasp 32 at the other. The length of the body 58 controls how far beyond the circumference of the suture introducer housing 24 the arms 28, 30 extend when they are deployed by the actuating rod 50.

As illustrated in FIG. 4B, the proximal sides of the suture clasp arms 28, 30 near the slots 76 which receives the suture 40 are substantially parallel to the vessel wall 22 when the arms 28, 30 are deployed within the vessel 16. The proximal sides of the suture clasp arms 28, 30 can then provide mechanical support for the vessel wall 22 in the region of the opening 26. In an alternative configuration, as illustrated in FIG. 4C, the proximal sides of the suture clasp arms 28, 30 have an upward curvature near the slots 76, thereby defining a proximally projecting portion on the proximal side of each of the arms 28, 30. In this configuration, the proximal side of the arms 28, 30 provide mechanical support for the vessel wall 22 while the proximally projecting portions provide an improved purchase on the vessel wall 22. This configuration then reduces the probability of slippage of the arms 28, 30 relative to the vessel wall 22 when the arms 28, 30 are deployed within the vessel 16. Other configurations can have multiple proximally projecting portions on each arm 28, 30, or can have proximally projecting portions which are protuberances on the proximal sides of arms 28, 30 without upward curvature. These proximally projecting portions can have various cross-sectional shapes, such as triangular or trapezoidal. Still other embodiments can have relatively small proximally projecting portions which have areas smaller than the area of the proximal side of the arms 28, 30. In addition, other embodiments have proximally projecting portions which are in proximity to the portion of the arms 28, 30 which mount the end portions of the suture, such as the slots 76 illustrated in FIG. 4C. The proximally projecting portions can also be located in proximity to the ends of the arms 28, 30 away from the pivot shaft 56.

Similarly, other configurations of suture clasp arms 28, 30 can have proximally projecting portions on each of the arms 28, 30. FIG. 4D illustrates such proximally projecting portions on arms 28, 30 such as those described below in conjunction with FIGS. 43 47, and FIG. 4E illustrates such proximally projecting portions on arms 28, 30 such as those described below in conjunction with FIGS. 52 56.

FIG. 5 shows an alternate configuration of the arms 28, 30. In FIG. 5, the arms 28, 30 are Y-shaped with an offset body 64, and there is a suture clasp at each tip 60, 62 of the Y-shaped arm. The body 64 is off center from the tips 66, 68, so that a complimentary arm can pivot on the same pivot shaft 56 without interference. Thus, the Y-shape of the arms allows them to pivot beside each other outwardly from and inwardly to their undeployed position without interference from the other arm. The Y-shape of the arm also provides an open area or suture catch receiving area 80 into which the suture catch 30 fits to catch the suture 40. Other arm shapes such as the h-shaped arm shown in FIG. 6 may provide the same or additional benefits. The h-shaped arm has a body 70 with an aperture 71 for attachment to a pivot shaft 56 and each tip 72, 74 of the arm is provided with a suture clasp. The body of the h-shaped arm is positioned all the way to the side of the arm and functions similarly to the Y-shaped arm. The configuration of the suture clasp arm shown in FIG. 6 also has a suture catch receiving area 80A.

FIGS. 7 and 8 illustrate one configuration of the suture clasp 32, which comprises a key hole shaped slot 76 which widens toward the end of the tip to receive the suture 40. As illustrated in FIG. 4, a loop 78 is tied in each end of the suture 40. The loop 78 is sized to fit tightly between the suture clasps 32 on each arm 28, 30. The key hole shaped slot 76 is elongated and narrows away from the end of the tip 60 to a neck 82 having a width W. The end 84 of the slot 76 is circular with a diameter greater than the neck width W. The diameter of the circular end 84 of the slot 76 is sized to receive either the outer diameter of a suture 40, shown in FIG. 8, or the outer diameter of cylindrical bands 86 which are crimped onto the suture 40. The suture 40 or the bands 86 have an outer diameter approximately the same size as the diameter of the end of the slot 76 but smaller than the neck width W. Because the diameter of the bands 86 (or suture 40) is smaller than the width of the neck 83, the bands 86 snap into the end of the slot 76 and are securely held therein until removed by the suture catch 38. In an alternate configuration (FIG. 14), it is desirable for the slots 76 to open upwardly when they are in the deployed position, so that the suture 40 is pulled straight up out of the slots 76.

FIG. 9 shows another configuration of the suture clasps 32. In this configuration, the arm 28, 30 comprises a shaft 88 extending to a plate or bar 90. A resilient element 92, such as a spring, is attached at each end of the bar 90, and tips 94 are attached to the end of each resilient member 92. The tips 94 have slots as previously described and shown by FIG. 7. The suture 40 has beads 96 fixed thereto or knots tied therein. The beads are spaced apart by a distance just less than the distance between the outer edges 98 of the tips 94. With this distance between the beads 96, the tips 94 must be slightly bent toward each other thereby loading the resilient members 92 to receive the suture 40. When the tips 94 are pulled inwardly and the resilient members 92 loaded, the suture 40 is held in place by the force from the resilient members 92. Therefore, the suture 40 is held in tension between the tips 94.

When the suture catch 38 is guided through the suture catch receiving area 100, the resilient members 92 are further deformed as the suture 40 is forced to make an arc to receive the suture catch 38 as illustrated in FIG. 10. The resilient members 92 then bend in the direction that the suture catch 38 is retracted, so that the suture 40 slides smoothly out of the clasp 32. If desired, the outer edges 98 of the tips may be indented 99 to receive and more securely hold the beads 96 or knots on the suture 40.

FIG. 14 illustrates a