JP2017506973A - Method and apparatus for occluding blood vessels and / or occluding other tubular structures - Google Patents

Abstract

A system for occluding a hollow structure, comprising: a plurality of occluders; and an applicator for storing the plurality of occluders and continuously delivering the occluders to occlude the hollow structures. A system is disclosed. Each of the occluders may be a two-part occluder. The two-part occluder can be configured to be transformed from a first non-occluded state to a second occluded state. The applicator may be configured to deliver the two-part occluder to the hollow structure and to deform the two-part occluder from its first unoccluded state to its second occluded state.

Description

(Reference to pending prior patent application)
This patent application is:
(I) METHOD AND APPARATUS FOR OCCLUDING A BLOOD VESSEL AND / OR FOR OCCLUDING OTHER TUBULAR STRUCTURES AND / OR FOR CLOSING OPENINGS IN STRUCTURES AND / OR FOR SECURING AT LEAST TWO OBJECTS by Amsel Medical Corporation and Arnold Miller et for TOGETHER 05/07 No. 14 / 272,304 (Attorney docket number AM-15), which is a continuation-in-part of pending US patent application Ser.
(1) Previous US Patent Application No. 13 / 857,424 filed on 04/05/13 by Amsel Medical Corporation and Arnold Miller et al. For METHOD AND APPARATUS FOR OCCLUDING A BLOOD VESSEL (attorney document number AM- 9), which is a continuation-in-part of this US patent application:
(A) Part of prior US patent application Ser. No. 13 / 348,416 filed on 01/11/12 by Arnold Miller et al. For METHOD AND APPARATUS FOR TREATING VARICOSE VEINS (attorney document number AM-0708) No. 61 / 431,609, filed on 01/11/11 by Arnold Miller et al. For METHOD AND APPARATUS FOR TREATING VARICOSE VEINS, which is a continuation application. (B) Temporary Arterial OCCULSION FOR MILITARY AND CIVILIAN EXTRE Claims the benefit of prior US Provisional Patent Application No. 61 / 620,787 (Attorney Docket No. AM-9PROV) filed 04/05/12 by Arnold Miller et al. For MITY TRAUMA; 2) Previous US Provisional Patent Application No. 61 / 820,589 filed 05/07/13 by Amsel Medical Corporation and Arnold Miller et al. For INJECTABLE CLAMPS FOR OCCCLUTION OR ATTACHMENT (attorney document number AM-15PROV) Claiming the benefits of;
(Ii) Pending prior US provisional patent application No. 61/48 filed on 03/05/14 by Amsel Medical Corporation and Arnold Miller et al. For ENHANCED TISSUE, ORGAN, DUCT AND VESSEL CLAMPING OR APPRIMATION, and Arnold Miller et al. (Iii) METHOD AND APPARATUS FOR OCCLUDING A BLOOD VESSEL AND / OR FOR OCCLUDING OTHER TUBULAR STRUCTURE AND / OR FOR FORR. Of pending US Provisional Patent Application No. 62 / 084,989 (attorney document number AM-19PROV) filed on 11/26/14 by Amsel Medical Corporation and Arnold Miller et al. For AT LEAST TWO OBJECTS TOGETHER Insist on profit.

  The eight above-identified patent applications are hereby incorporated by reference herein.

(Technical field)
The present invention relates generally to surgical methods and devices, and more particularly to the treatment of vascular occlusions and varicose veins and / or to occlude other tubular structures and / or openings in the structures. And / or a surgical method and apparatus for securing at least two objects together. The invention also relates to a minimally invasive means for fastening a mechanical structure to a tissue or blood vessel, for example for drug delivery.

(General varicose veins)
The legs include (i) superficial veins that are under the skin and can be seen or sensed when standing, (ii) deep veins that are intramuscular and not visible or sensed, and (iii) two systems (ie , Superficial veins and deep veins), there are three sets of veins with penetrating veins or connecting veins.

  The vein is in the whole tissue. The vein returns blood to the heart. As the muscles in the legs contract, blood is pumped back to the heart. A valve inside the vein directs blood flow back to the heart.

  The vein is a relatively fragile tube. There is no support for these veins under the skin, so when the pressure in the veins rises, a fragile area is created and the veins expand in both size and length. In some cases, the veins can be significantly twisted and swollen. This condition is commonly referred to as varicose veins.

  Minimal varices are sometimes called spider veins. Unlike larger varicose veins, these spider veins are in the skin.

  The cause of the increased pressure in the vein is due to the occurrence of a “leaky” valve in the vein. The main valve is in the inguinal region, ie, the great saphenous vein near the femoral vein junction. The patient's leg 5, the femoral vein 10, the great saphenous vein 15, the great saphenous vein femoral vein junction 20, and the main valve 25 in the great saphenous vein near the great saphenous vein femoral vein junction; Please refer to FIG. As this primary valve in the saphenous vein becomes leaky, the pressure in the vein increases and the vein below the saphenous vein begins to expand. This causes the next set of valves in the saphenous vein to leak. The pressure increase caused by the leaky valve in the saphenous vein is transmitted to the supply vein, which expands and the valves also fail and become leaky. As this process continues down the leg, many of the valves in the leg veins fail, and high pressure is generated in the veins, especially when standing.

  First, the problem is mainly aesthetic. The veins swell and become uncomfortable to see. However, in general, there is also discomfort in the legs when standing. This discomfort is the result of venous dilatation due to increased pressure.

  Over time, the high pressure in the vein is transmitted to the surrounding tissue and skin. Small veins in the skin (ie spider veins) expand and become visible. Blood cells can escape into the tissue and collapse, producing discolored portions. Due to the high pressure in the tissue, the skin becomes swollen and the skin nutrition worsens. This reduces local tissue resistance and causes infection. Eventually, the skin can collapse with the onset of erosion (ie, ulcers).

(Incidence of varicose veins)
Approximately 40% of women and 25% of men suffer from lower limb vein failure and associated visible varicose veins. Major risk factors include heredity, gender, pregnancy, and age. Most of these patients have long-lasting leg symptoms that impair their daily routine, and symptoms worsen during the day while patients are at work or simply alive in their lives To do. Without varicose vein treatment, these symptoms can progress to conditions that limit lifestyle.

(Treatment of varicose veins)
Treatment of varicose veins is done to alleviate symptoms, ie to remove unsightly veins and to prevent the aforementioned discomfort and late signs.

(1. Non-surgical treatment)
The simplest treatment is a non-surgical treatment that addresses the high pressure in the varicose veins. More specifically, a wearable elastic stocking is used that is strong enough to overcome the pressure increase caused by the “leakage” valve. These wearable elastic stockings can control symptoms and prevent veins from further enlargement, however, are not curative. Good results require consistent daily use of stockings.

(2. Surgery / intervention)
The purpose of the surgical / interventional treatment is (i) elimination of the cause of high venous pressure (ie, “leak” valve in the groin) and (ii) removal of unsightly veins.

  The initial approach to “extract” the saphenous vein (the main vein in the leg) as the only treatment modality is now largely abolished. This is because the “extraction” approach caused too much trauma and did not remove all of the superficial varices. That is, most superficial varices are tributaries of the main superficial veins of the extracted leg (ie, saphenous veins), and these tributary veins were not removed by this procedure.

  Currently, there are three basic approaches for treating varicose veins: chemical sclerosants and adhesives, vein cauterization using thermal therapy, and open surgery.

(A. sclerotherapy)
Sclerotherapy (use of sclerosants) is generally used to treat smaller varicose veins and spider veins that are not considered to be directly associated with “leaked pancreatic” valves. This is mainly an aesthetic procedure.

  In this approach, a sclerosing agent (ie, a substance that stimulates the tissue) is injected into smaller varicose veins and spider veins, causing inflammation of the walls of these veins. As a result of this inflammation, the vein walls stick together and occlude the vein lumen so that blood cannot pass through the vein. Eventually, these veins contract and disappear.

  Disadvantages of sclerotherapy include: (i) in the presence of high venous pressure (ie with a leaky valve and larger varicose veins), the results are uncertain and the recurrence rate is high; (ii) It is mentioned that massive injection of a sclerosing agent into the surrounding tissue can cause damage to the surrounding tissue and can be accompanied by skin discoloration and even ulceration.

  Recently, a mixture of hardener and air to form a “foam” has been used to break the inner layer of the main vein of the leg (ie, the saphenous vein). Today, the results are somewhat unpredictable and there is a risk that the sclerosing agent escapes through the saphenous vein into the deep vein and then embolizes into the lung, which is harmful and dangerous to the patient. is there.

(B. Vein cautery)
Venous ablation for varicose veins can be effected in two ways: percutaneously and intravenously.

  In a percutaneous approach, superficial smaller varicose veins and spider veins are “heated” and allowed to solidify by irradiating external laser light through the skin. However, if the vein is too large, the amount of energy required to destroy the vein can cause damage to the surrounding tissue. Percutaneous laser treatment is primarily an alternative to the sclerotherapy described above and generally suffers from the same disadvantages described above for sclerotherapy.

  In intravenous ablation, a special laser or high frequency (RF) catheter is introduced into the main superficial vein of the leg (ie, the saphenous vein) through a needle puncture using local anesthesia. An entrance is made in the area around the knee and the catheter is advanced upward toward the groin and advanced to the site where the saphenous vein fuses with the deep vein at the site of the main “leaky” valve. Laser light or high frequency (RF) energy then heats the vein wall, causing the protein to coagulate in the cavity and destroy the inner lining surface of the vein as the catheter is slowly pulled backwards through the vein. The destruction of the inner lining surface of the vein adheres to the vein walls, thereby eliminating the lumen in the vein and thus preventing blood flow. This is a process somewhat similar to sclerotherapy but no substance is injected into the vein. This procedure addresses “leaky” valves and high venous pressure, however, larger superficial varices in the legs may still need to be removed. This can be done either by open surgery (veinectomy) or sclerotherapy simultaneously with or after intravenous cauterization. Laser or high frequency (RF) catheter placement is guided by ultrasound.

  Advantages of intravenous laser / high frequency (RF) therapy include: (i) a minimally invasive procedure that can be performed using local anesthesia in either the operating room or clinic, and (ii) hospitalization (Iii) not requiring open surgery with an incision, and (iv) recovery is easier than using open surgery, most patients within 1 or 2 days Returning to work, and (v) some of the significant varicose-like swellings may disappear and may not require a secondary procedure (ie, either venectomy or sclerotherapy) .

  Disadvantages of intravenous laser / high frequency (RF) therapy include: (i) generally only one leg is performed at a time, and (ii) the procedure typically destroys the lining of the vein Requiring a significant amount of local anesthetic injected into the patient to prevent the thermal complications necessary to do (iii) if too much heat is applied to the tissue, Burns may occur in the upper skin, leaving an ugly scar with possible scarring, and (iv) an interval of up to 8 weeks assesses the effectiveness of the vein ablation procedure prior to performing a subsequent venectomy procedure And (v) the varicose-like swelling that remains after this interval procedure still requires a separate procedure (ie, venous resection or sclerotherapy).

(C. Open surgery)
The purpose of open surgery is the “leaky” valve at the junction of the superficial and deep veins (cause of high venous pressure in the leg) and the saphenous veins, which can expand over the years and lead to recurrence of varicose veins This is to eliminate leaky valves in the tributaries. This open surgery is intended for removal of some or all of the affected vein.

  There are still several issues regarding the amount of saphenous vein that needs to be removed for best results. The current “teaching” is that removing the entire saphenous vein segment in the thigh reduces the incidence of recurrence. However, the data on this is very weak. Removal of the very short segment of the proximal saphenous vein and the main tributary at the great saphenous vein femoral vein junction is an alternative procedure, and when combined with the removal of all visible varicose-like swelling, the result is Very similar to the removal of the entire femoral compartment of the saphenous vein. The advantage of the latter procedure is that it does not participate in the varicose process and is otherwise normal in 50-60% or more varicose patients, and therefore other procedures (such as bypass grafts in the heart or limbs) It is an increase in the preservation rate of the saphenous vein, which can be used for.

  Surgery is performed in the operating room under mild general anesthesia or local (spine or epidural) anesthesia. An incision (e.g., 1-2 inches) is made in the longitudinal groove of the groin, veins are separated, and the proximal saphenous vein and tributaries are excised. The wound is closed with absorbable sutures from the inside. Once this is complete, a small (eg, 2-4 mm) puncture is created over any unsightly varicose veins (these veins are marked just prior to surgery with the patient upright) Removed. The puncture wounds associated with the removal of marked veins are typically small enough that they typically do not require any sutures to close them. When all of the previously marked veins are removed, the wound is cleaned and gauze is applied. The legs are wrapped with an elastic bandage (eg, Ace wrap).

  In post-operative care, gauze and Ace wrap are typically changed in the clinic at the first post-operative visit, typically within 24 hours of open surgical procedures. The patient and family or friends are instructed regarding proper care of the wound. A simple gauze is applied to cover the small wound of the leg for the next 2-3 days. After 2-3 days, no further treatment is generally required. Recovery is generally rapid and the patient returns to work within 5-7 days.

  Advantages of open surgery include: (i) varicose veins on both limbs can be performed in a single motion, generally taking 1-2 hours, and (ii) procedures typically require hospitalization. Not requiring and being an “outpatient” procedure; and (iii) being easily managed with oral analgesics (ie, pain medications) with minimal wounds and minimal discomfort. (Iv) The results are generally excellent with minimal recurrence (open surgery results are “optimal criteria” compared to sclerotherapy and laser / high frequency (RF) venous ablation therapy) And (v) recurrent or residual (ie, missed surgical) veins are generally managed with sclerotherapy or venous resection under local anesthesia in the clinic or outpatient procedure room (Vi) the saphenous vein is normal and varicose-like swelling If no, is preserved, therefore, the future, if needed, for use (e.g., for bypass surgery), and the it is available.

  Disadvantages of open surgery include: (i) open surgical procedures that require anesthetics (either systemic or local), and their associated discomfort and associated risks (depending on patient health or age) And (ii) recovery generally takes 3-5 days.

  Thus, varicose veins present significant problems that must be addressed for many patients, and it can be seen that all current procedures for treating varicose veins suffer from several significant disadvantages. Let's go.

  Hence, for the treatment of vascular occlusions and varicose veins and / or to occlude other tubular structures and / or to close openings in the structures and / or to fix at least two objects together It would be advantageous to provide a new and improved surgical method and apparatus for the purpose.

  It would also be advantageous to provide new and improved surgical methods and devices for fastening mechanical structures to tissue or blood vessels, eg, for drug delivery.

  The present invention provides a new and improved approach for treating varicose veins and other blood vessels.

  More specifically, the invention restricts blood flow through the vein, thereby treating the vein (eg, proximal saphenous vein, small saphenous vein, Including the provision and use of new occluders used to occlude tributaries, penetrating veins, etc.). Significantly, the new occluder is configured to be deployed using a minimally invasive approach (ie, either percutaneously or intracavity) and the visualization is ultrasound and / or other visualization Provided by an apparatus (eg, CT, MRI, X-ray, etc.). As a result, new treatments can be offered in the clinic, with minimal local anesthetics and virtually no postoperative care.

  The present invention also provides a new and improved surgical procedure for closing other tubular structures and / or for closing openings in the structure and / or for fixing at least two objects together. Methods and apparatus are provided.

  The present invention also provides new and improved surgical methods and devices for fastening mechanical structures to tissue or blood vessels, eg, for drug delivery.

  Significantly, the present invention provides for direct visualization (eg, during “open” surgery) or indirect visualization (eg, during laparoscopic surgery, where visualization is provided through the use of a microscope, or visualization). Can be practiced during percutaneous surgery provided through the use of an imaging device such as an ultrasound imager, X-ray imager, etc.

In one form of the invention, a device for occluding a blood vessel is provided, the device comprising:
An occluder, wherein at least a portion of the occluder is (i) a diametrically reduced configuration for placement within the lumen of the tube, and (ii) at least a portion of the occluder is a blood vessel So that when in its diametrically expanded configuration adjacent to a blood vessel, the occlusive device may take a diametrically expanded configuration for placement adjacent to the blood vessel so that it will cause occlusion of the blood vessel. Constructed with an occluder.

In another aspect of the invention, a method for occluding a blood vessel is provided, the method comprising:
Providing a device, comprising:
An occluder, wherein at least a portion of the occluder is (i) a diametrically reduced configuration for placement within the lumen of the tube, and (ii) at least a portion of the occluder is a blood vessel So that when in its diametrically expanded configuration adjacent to a blood vessel, the occlusive device may take a diametrically expanded configuration for placement adjacent to the blood vessel so that it will cause occlusion of the blood vessel. Comprising an occluder comprising:
Positioning the occluder adjacent to the blood vessel so as to cause occlusion of the blood vessel.

In another form of the invention, a device is provided for delivering a substance to a location adjacent to a blood vessel, the device comprising:
A carrier, wherein at least a portion of the carrier is (i) a diametrically reduced configuration for placement within the lumen of a tube, and (ii) a substance is attached to the carrier, When a portion is in its diametrically expanded configuration adjacent to a blood vessel, the material will be diametrically expanded for placement adjacent to the blood vessel so that the substance will be placed adjacent to the blood vessel. A carrier configured to be configured is provided.

In another form of the invention, a method is provided for delivering a substance to a location adjacent to a blood vessel, the method comprising:
Providing a device, comprising:
A carrier, wherein at least a portion of the carrier is (i) a diametrically reduced configuration for placement within the lumen of a tube, and (ii) a substance is attached to the carrier, When a portion is in its diametrically expanded configuration adjacent to a blood vessel, the material will be diametrically expanded for placement adjacent to the blood vessel so that the substance will be placed adjacent to the blood vessel. Having a carrier configured to be configured; and
Positioning the carrier adjacent to the blood vessel such that the substance is disposed adjacent to the blood vessel.

In another aspect of the invention, an apparatus is provided for occluding a space between a first structure and a second structure, the apparatus comprising:
An occluder comprising an occluder comprising a distal implant and a proximal implant, the distal implant comprising a body and a locking shaft mounted on the body, wherein the body of the distal implant is A plurality of legs that may take a diametrically reduced configuration for placement within the lumen of the tube, and (ii) a diametrically widened configuration for placement relative to the first structure And the locking shaft includes a first locking element for selective connection to the proximal implant and a second for selective connection to an inserter for deploying the occluder. With a locking element of
The proximal implant comprises a body having an opening, the body of the proximal implant being (i) a diametrically reduced configuration for placement within the lumen of a tube, and (ii) a second A plurality of legs that can take a diametrically expanded configuration for placement relative to the structure, and wherein the body of the proximal implant is selective to the first locking element of the distal implant A third locking element for connection,
The locking shaft of the distal implant is slidably receivable within an opening in the body of the proximal implant and further includes a first locking element of the distal implant and a third of the proximal implant. The locking elements are selectively engageable with each other to hold the distal and proximal implants in a fixed position relative to each other.

In another aspect of the invention, a method is provided for closing a space between a first structure and a second structure, the method comprising:
Providing a device, comprising:
An occluder comprising an occluder comprising a distal implant and a proximal implant, the distal implant comprising a body and a locking shaft mounted on the body, wherein the body of the distal implant is A plurality of legs that may take a diametrically reduced configuration for placement within the lumen of the tube, and (ii) a diametrically widened configuration for placement relative to the first structure And the locking shaft includes a first locking element for selective connection to the proximal implant and a second for selective connection to an inserter for deploying the occluder. With a locking element of
The proximal implant comprises a body having an opening, the body of the proximal implant being (i) a diametrically reduced configuration for placement within the lumen of a tube, and (ii) a second A plurality of legs that can take a diametrically expanded configuration for placement relative to the structure, and wherein the body of the proximal implant is selective to the first locking element of the distal implant A third locking element for connection,
The locking shaft of the distal implant is slidably receivable within an opening in the body of the proximal implant and further includes a first locking element of the distal implant and a third of the proximal implant. The locking elements are selectively engageable with each other to hold the distal and proximal implants in a fixed position relative to each other.
And
The plurality of legs of the distal implant are disposed with respect to the first structure, the plurality of legs of the proximal implant are disposed with respect to the second structure, and the locking shaft comprises the first Positioning the occluder to extend across the space between the first structure and the second structure.

In another aspect of the invention, a system for occluding a hollow structure comprising:
Multiple occluders;
An applicator for storing a plurality of occluders and continuously delivering the occluders to occlude the hollow structure is provided.

  In another aspect of the present invention, a method for occluding a hollow structure comprising storing a plurality of occluders and a plurality of occluders and continuously delivering the occluders to occlude the hollow structures. An applicator for providing a system, and using the applicator to continuously deliver an occluder to occlude the hollow structure is provided. The

  In another aspect of the invention, a system for occluding a hollow structure, the occluding device, an applicator for delivering the occluding device to occlude the hollow structure, and the applicator hollowing the occluding device. A system is provided comprising a dissecting instrument mounted on an applicator for applying force to the hollow structure as it is delivered to the structure.

  In another aspect of the invention, a method for occluding a hollow structure, the occluding device, an applicator for delivering the occluding device to occlude the hollow structure, and the applicator hollowing the occluding device. Providing a system comprising a dissecting instrument mounted on an applicator for applying force to the hollow structure as delivered to the structure, and applying the force to the hollow structure using the dissecting instrument A method is provided comprising: and using an applicator to deliver an occluder to occlude the hollow structure.

  In another aspect of the present invention, an apparatus for occluding a hollow structure, comprising a two-part occluder comprising a distal implant and a proximal implant, and comprising a distal implant A plurality of bodies, which may have a body, (i) a diametrically reduced configuration for placement within the applicator, and (ii) a diametrically expanded configuration for placement relative to the hollow structure. The proximal implant includes a body, (i) a diametrically reduced configuration for placement within the applicator, and (ii) diametrically expanded for placement relative to the hollow structure. A plurality of legs, so that the distal implant is connected to the proximal implant and the legs of the distal implant are diametrically expanded, the proximal implant Legs In a diametrically expanded configuration, the two-part occluder can occlude the hollow structure, and at least one of the distal implant and the proximal implant An apparatus is provided that is rotatably adjustable relative to the other of the distal implant and the proximal implant such that the circumferential orientation of the legs is adjustable.

  In another aspect of the present invention, a method for occluding a hollow structure comprising a two-part occluder comprising a distal implant and a proximal implant, and comprising a distal implant A plurality of bodies, which may have a body, (i) a diametrically reduced configuration for placement within the applicator, and (ii) a diametrically expanded configuration for placement relative to the hollow structure. The proximal implant includes a body, (i) a diametrically reduced configuration for placement within the applicator, and (ii) diametrically expanded for placement relative to the hollow structure. A plurality of legs, so that the distal implant is connected to the proximal implant and the legs of the distal implant are diametrically expanded, the proximal implant Legs In a diametrically expanded configuration, the two-part occluder can occlude the hollow structure, and at least one of the distal implant and the proximal implant Providing a device that is rotatably adjustable relative to the other of the distal and proximal implants such that the circumferential orientation of the legs is adjustable; and the distal and proximal implants relative to each other A method is provided that includes selecting a circumferential orientation of the implant leg and deploying the two-part occluder to occlude the hollow structure.

  In another form of the invention, a system for occluding a hollow structure, wherein the occluding device, the electrical power source, and the occluding device occludes the hollow structure, the electrical power source can deliver ablation energy to the hollow structure. As such, a system comprising a conductive network for connecting an electrical power source to an occluder is provided.

  In another aspect of the invention, a method for occluding a hollow structure, wherein the occluding device, the electrical power source, and the occluding device occludes the hollow structure, the electrical power source can deliver ablation energy to the hollow structure. Providing a system comprising a conductive network for connecting an electrical power source to the occluder, deploying the two-part occluder to occlude the hollow structure, and ablating energy Delivering to the hollow structure is provided.

These and other objects and features of the invention will be more fully disclosed or will be more fully understood by the following detailed description, which should be considered in conjunction with the accompanying drawings, in which like reference numerals refer to like parts. Will be apparent.
FIG. 1 is a schematic diagram showing various aspects of the venous system of the leg. 2-4 are schematic diagrams illustrating an occluder for occluding a blood vessel, according to one embodiment of the present invention. 2-4 are schematic diagrams illustrating an occluder for occluding a blood vessel, according to one embodiment of the present invention. 2-4 are schematic diagrams illustrating an occluder for occluding a blood vessel, according to one embodiment of the present invention. FIG. 5 is a schematic diagram illustrating one possible structure for the occluder shown in FIGS. 2-4. 6 and 7 are schematic diagrams illustrating exemplary syringe-type inserters that may be used to deploy the occluder shown in FIGS. 2-4. 6 and 7 are schematic diagrams illustrating exemplary syringe-type inserters that may be used to deploy the occluder shown in FIGS. 2-4. 8-10 are schematic diagrams illustrating an occluder for occluding a blood vessel, in accordance with another aspect of the present invention. 8-10 are schematic diagrams illustrating an occluder for occluding a blood vessel, in accordance with another aspect of the present invention. 8-10 are schematic diagrams illustrating an occluder for occluding a blood vessel, in accordance with another aspect of the present invention. 11-14 are schematic diagrams illustrating an occluder for occluding a blood vessel, according to yet another aspect of the present invention. 11-14 are schematic diagrams illustrating an occluder for occluding a blood vessel, according to yet another aspect of the present invention. 11-14 are schematic diagrams illustrating an occluder for occluding a blood vessel, according to yet another aspect of the present invention. 11-14 are schematic diagrams illustrating an occluder for occluding a blood vessel, according to yet another aspect of the present invention. Figures 15-17 are schematic diagrams illustrating other possible structures for the occluder of the present invention. Figures 15-17 are schematic diagrams illustrating other possible structures for the occluder of the present invention. Figures 15-17 are schematic diagrams illustrating other possible structures for the occluder of the present invention. 18-20 are schematic diagrams illustrating an occluder of the type shown in FIGS. 15-17 that occludes a blood vessel, according to yet another aspect of the present invention. 18-20 are schematic diagrams illustrating an occluder of the type shown in FIGS. 15-17 that occludes a blood vessel, according to yet another aspect of the present invention. 18-20 are schematic diagrams illustrating an occluder of the type shown in FIGS. 15-17 that occludes a blood vessel, according to yet another aspect of the present invention. 21-24 are schematic diagrams illustrating an occluder for occluding a blood vessel, according to another aspect of the present invention. 21-24 are schematic diagrams illustrating an occluder for occluding a blood vessel, according to another aspect of the present invention. 21-24 are schematic diagrams illustrating an occluder for occluding a blood vessel, according to another aspect of the present invention. 21-24 are schematic diagrams illustrating an occluder for occluding a blood vessel, according to another aspect of the present invention. FIGS. 25-27 are schematic diagrams illustrating an occluder for occluding a blood vessel, according to yet another aspect of the present invention. FIGS. 25-27 are schematic diagrams illustrating an occluder for occluding a blood vessel, according to yet another aspect of the present invention. FIGS. 25-27 are schematic diagrams illustrating an occluder for occluding a blood vessel, according to yet another aspect of the present invention. 28 and 29 are schematic diagrams illustrating an occluder for occluding a blood vessel, according to yet another aspect of the present invention. 28 and 29 are schematic diagrams illustrating an occluder for occluding a blood vessel, according to yet another aspect of the present invention. 30 and 31 are schematic diagrams illustrating an occluder for occluding a blood vessel, according to another aspect of the present invention. 30 and 31 are schematic diagrams illustrating an occluder for occluding a blood vessel, according to another aspect of the present invention. 32 and 33 are schematic diagrams illustrating an occluder for occluding a blood vessel, according to yet another aspect of the present invention. 32 and 33 are schematic diagrams illustrating an occluder for occluding a blood vessel, according to yet another aspect of the present invention. 34 and 35 are schematic diagrams illustrating drug / cell delivery bodies attached to blood vessels according to one aspect of the present invention. 34 and 35 are schematic diagrams illustrating drug / cell delivery bodies attached to blood vessels according to one aspect of the present invention. 36 and 37 are schematic diagrams illustrating drug / cell delivery bodies attached to blood vessels according to another aspect of the present invention. 36 and 37 are schematic diagrams illustrating drug / cell delivery bodies attached to blood vessels according to another aspect of the present invention. 38 and 39 are schematic diagrams illustrating drug / cell delivery bodies attached to blood vessels according to yet another form of the present invention. 38 and 39 are schematic diagrams illustrating drug / cell delivery bodies attached to blood vessels according to yet another form of the present invention. 40 and 41 are schematic diagrams illustrating drug / cell delivery bodies attached to blood vessels according to yet another form of the present invention. 40 and 41 are schematic diagrams illustrating drug / cell delivery bodies attached to blood vessels according to yet another form of the present invention. 42-48 are schematic diagrams illustrating a two-part occluder formed in accordance with another aspect of the present invention. 42-48 are schematic diagrams illustrating a two-part occluder formed in accordance with another aspect of the present invention. 42-48 are schematic diagrams illustrating a two-part occluder formed in accordance with another aspect of the present invention. 42-48 are schematic diagrams illustrating a two-part occluder formed in accordance with another aspect of the present invention. 42-48 are schematic diagrams illustrating a two-part occluder formed in accordance with another aspect of the present invention. 42-48 are schematic diagrams illustrating a two-part occluder formed in accordance with another aspect of the present invention. 42-48 are schematic diagrams illustrating a two-part occluder formed in accordance with another aspect of the present invention. 49-58 are schematic diagrams illustrating an installation device that may be used to deploy the two-part occluder of FIGS. 42-48. 49-58 are schematic diagrams illustrating an installation device that may be used to deploy the two-part occluder of FIGS. 42-48. 49-58 are schematic diagrams illustrating an installation device that may be used to deploy the two-part occluder of FIGS. 42-48. 49-58 are schematic diagrams illustrating an installation device that may be used to deploy the two-part occluder of FIGS. 42-48. 49-58 are schematic diagrams illustrating an installation device that may be used to deploy the two-part occluder of FIGS. 42-48. 49-58 are schematic diagrams illustrating an installation device that may be used to deploy the two-part occluder of FIGS. 42-48. 49-58 are schematic diagrams illustrating an installation device that may be used to deploy the two-part occluder of FIGS. 42-48. 49-58 are schematic diagrams illustrating an installation device that may be used to deploy the two-part occluder of FIGS. 42-48. 49-58 are schematic diagrams illustrating an installation device that may be used to deploy the two-part occluder of FIGS. 42-48. 49-58 are schematic diagrams illustrating an installation device that may be used to deploy the two-part occluder of FIGS. 42-48. 59-82 are schematic diagrams illustrating the two-part occluder of FIGS. 42-48 deployed across a blood vessel using the mounting device of FIGS. 49-58. 59-82 are schematic diagrams illustrating the two-part occluder of FIGS. 42-48 deployed across a blood vessel using the mounting device of FIGS. 49-58. 59-82 are schematic diagrams illustrating the two-part occluder of FIGS. 42-48 deployed across a blood vessel using the mounting device of FIGS. 49-58. 59-82 are schematic diagrams illustrating the two-part occluder of FIGS. 42-48 deployed across a blood vessel using the mounting device of FIGS. 49-58. 59-82 are schematic diagrams illustrating the two-part occluder of FIGS. 42-48 deployed across a blood vessel using the mounting device of FIGS. 49-58. 59-82 are schematic diagrams illustrating the two-part occluder of FIGS. 42-48 deployed across a blood vessel using the mounting device of FIGS. 49-58. 59-82 are schematic diagrams illustrating the two-part occluder of FIGS. 42-48 deployed across a blood vessel using the mounting device of FIGS. 49-58. 59-82 are schematic diagrams illustrating the two-part occluder of FIGS. 42-48 deployed across a blood vessel using the mounting device of FIGS. 49-58. 59-82 are schematic diagrams illustrating the two-part occluder of FIGS. 42-48 deployed across a blood vessel using the mounting device of FIGS. 49-58. 59-82 are schematic diagrams illustrating the two-part occluder of FIGS. 42-48 deployed across a blood vessel using the mounting device of FIGS. 49-58. 59-82 are schematic diagrams illustrating the two-part occluder of FIGS. 42-48 deployed across a blood vessel using the mounting device of FIGS. 49-58. 59-82 are schematic diagrams illustrating the two-part occluder of FIGS. 42-48 deployed across a blood vessel using the mounting device of FIGS. 49-58. 59-82 are schematic diagrams illustrating the two-part occluder of FIGS. 42-48 deployed across a blood vessel using the mounting device of FIGS. 49-58. 59-82 are schematic diagrams illustrating the two-part occluder of FIGS. 42-48 deployed across a blood vessel using the mounting device of FIGS. 49-58. 59-82 are schematic diagrams illustrating the two-part occluder of FIGS. 42-48 deployed across a blood vessel using the mounting device of FIGS. 49-58. 59-82 are schematic diagrams illustrating the two-part occluder of FIGS. 42-48 deployed across a blood vessel using the mounting device of FIGS. 49-58. 59-82 are schematic diagrams illustrating the two-part occluder of FIGS. 42-48 deployed across a blood vessel using the mounting device of FIGS. 49-58. 59-82 are schematic diagrams illustrating the two-part occluder of FIGS. 42-48 deployed across a blood vessel using the mounting device of FIGS. 49-58. 59-82 are schematic diagrams illustrating the two-part occluder of FIGS. 42-48 deployed across a blood vessel using the mounting device of FIGS. 49-58. 59-82 are schematic diagrams illustrating the two-part occluder of FIGS. 42-48 deployed across a blood vessel using the mounting device of FIGS. 49-58. 59-82 are schematic diagrams illustrating the two-part occluder of FIGS. 42-48 deployed across a blood vessel using the mounting device of FIGS. 49-58. 59-82 are schematic diagrams illustrating the two-part occluder of FIGS. 42-48 deployed across a blood vessel using the mounting device of FIGS. 49-58. 59-82 are schematic diagrams illustrating the two-part occluder of FIGS. 42-48 deployed across a blood vessel using the mounting device of FIGS. 49-58. 59-82 are schematic diagrams illustrating the two-part occluder of FIGS. 42-48 deployed across a blood vessel using the mounting device of FIGS. 49-58. FIGS. 83-86 are schematic diagrams illustrating another two-part occluder formed in accordance with the present invention. FIGS. 83-86 are schematic diagrams illustrating another two-part occluder formed in accordance with the present invention. FIGS. 83-86 are schematic diagrams illustrating another two-part occluder formed in accordance with the present invention. FIGS. 83-86 are schematic diagrams illustrating another two-part occluder formed in accordance with the present invention. 87-90 is a schematic diagram illustrating yet another two-part occluder formed in accordance with the present invention. 87-90 is a schematic diagram illustrating yet another two-part occluder formed in accordance with the present invention. 87-90 is a schematic diagram illustrating yet another two-part occluder formed in accordance with the present invention. 87-90 is a schematic diagram illustrating yet another two-part occluder formed in accordance with the present invention. FIGS. 91-94 are schematic diagrams illustrating yet another two-part occluder formed in accordance with the present invention. FIGS. 91-94 are schematic diagrams illustrating yet another two-part occluder formed in accordance with the present invention. FIGS. 91-94 are schematic diagrams illustrating yet another two-part occluder formed in accordance with the present invention. FIGS. 91-94 are schematic diagrams illustrating yet another two-part occluder formed in accordance with the present invention. 95-100 are schematic diagrams illustrating another two-part occluder formed in accordance with the present invention. 95-100 are schematic diagrams illustrating another two-part occluder formed in accordance with the present invention. 95-100 are schematic diagrams illustrating another two-part occluder formed in accordance with the present invention. 95-100 are schematic diagrams illustrating another two-part occluder formed in accordance with the present invention. 95-100 are schematic diagrams illustrating another two-part occluder formed in accordance with the present invention. 95-100 are schematic diagrams illustrating another two-part occluder formed in accordance with the present invention. 101-104 are schematic diagrams illustrating another two-part occluder formed in accordance with the present invention. 101-104 are schematic diagrams illustrating another two-part occluder formed in accordance with the present invention. 101-104 are schematic diagrams illustrating another two-part occluder formed in accordance with the present invention. 101-104 are schematic diagrams illustrating another two-part occluder formed in accordance with the present invention. FIGS. 105-113 are schematic diagrams showing an installation device for deploying the two-part occluder shown in FIGS. 101-104. FIGS. 105-113 are schematic diagrams showing an installation device for deploying the two-part occluder shown in FIGS. 101-104. FIGS. 105-113 are schematic diagrams showing an installation device for deploying the two-part occluder shown in FIGS. 101-104. FIGS. 105-113 are schematic diagrams showing an installation device for deploying the two-part occluder shown in FIGS. 101-104. FIGS. 105-113 are schematic diagrams showing an installation device for deploying the two-part occluder shown in FIGS. 101-104. FIGS. 105-113 are schematic diagrams showing an installation device for deploying the two-part occluder shown in FIGS. 101-104. FIGS. 105-113 are schematic diagrams showing an installation device for deploying the two-part occluder shown in FIGS. 101-104. FIGS. 105-113 are schematic diagrams showing an installation device for deploying the two-part occluder shown in FIGS. 101-104. FIGS. 105-113 are schematic diagrams showing an installation device for deploying the two-part occluder shown in FIGS. 101-104. 114-120 are schematic diagrams illustrating another installation device for deploying the two-part occluder shown in FIGS. 101-104. 114-120 are schematic diagrams illustrating another installation device for deploying the two-part occluder shown in FIGS. 101-104. 114-120 are schematic diagrams illustrating another installation device for deploying the two-part occluder shown in FIGS. 101-104. 114-120 are schematic diagrams illustrating another installation device for deploying the two-part occluder shown in FIGS. 101-104. 114-120 are schematic diagrams illustrating another installation device for deploying the two-part occluder shown in FIGS. 101-104. 114-120 are schematic diagrams illustrating another installation device for deploying the two-part occluder shown in FIGS. 101-104. 114-120 are schematic diagrams illustrating another installation device for deploying the two-part occluder shown in FIGS. 101-104. 121-123 are schematic diagrams illustrating another two-part occluder formed in accordance with the present invention. 121-123 are schematic diagrams illustrating another two-part occluder formed in accordance with the present invention. 121-123 are schematic diagrams illustrating another two-part occluder formed in accordance with the present invention. FIGS. 124-126 are schematic diagrams showing means for securing the two-part occluder shown in FIGS. 121-123 to an installation device. FIGS. 124-126 are schematic diagrams showing means for securing the two-part occluder shown in FIGS. 121-123 to an installation device. FIGS. 124-126 are schematic diagrams showing means for securing the two-part occluder shown in FIGS. 121-123 to an installation device. FIG. 127 is a schematic diagram illustrating another two-part occluder formed in accordance with the present invention. 128-133 are schematic diagrams illustrating a placement device for facilitating proper placement of an occluder to occlude a blood vessel (or other hollow tubular body). 128-133 are schematic diagrams illustrating a placement device for facilitating proper placement of an occluder to occlude a blood vessel (or other hollow tubular body). 128-133 are schematic diagrams illustrating a placement device for facilitating proper placement of an occluder to occlude a blood vessel (or other hollow tubular body). 128-133 are schematic diagrams illustrating a placement device for facilitating proper placement of an occluder to occlude a blood vessel (or other hollow tubular body). 128-133 are schematic diagrams illustrating a placement device for facilitating proper placement of an occluder to occlude a blood vessel (or other hollow tubular body). 128-133 are schematic diagrams illustrating a placement device for facilitating proper placement of an occluder to occlude a blood vessel (or other hollow tubular body). FIG. 134 is a schematic showing a tool for lifting a blood vessel (or other hollow tubular body) away from the underlying anatomy to facilitate proper placement of the occluder. 135-137 are schematic diagrams illustrating the use of an occluder to close an organ. 135-137 are schematic diagrams illustrating the use of an occluder to close an organ. 135-137 are schematic diagrams illustrating the use of an occluder to close an organ. FIGS. 138-142 are schematic diagrams illustrating the benefits of using the two-part occluder of the present invention instead of conventional staples. FIGS. 138-142 are schematic diagrams illustrating the benefits of using the two-part occluder of the present invention instead of conventional staples. FIGS. 138-142 are schematic diagrams illustrating the benefits of using the two-part occluder of the present invention instead of conventional staples. FIGS. 138-142 are schematic diagrams illustrating the benefits of using the two-part occluder of the present invention instead of conventional staples. FIGS. 138-142 are schematic diagrams illustrating the benefits of using the two-part occluder of the present invention instead of conventional staples. 143 and 144 are schematic diagrams illustrating a two-part occluder of the present invention used to attach a hernia mesh to tissue. 143 and 144 are schematic diagrams illustrating a two-part occluder of the present invention used to attach a hernia mesh to tissue. 145-165 show how the distal leg and the proximal leg of the two-part occluder are aligned with each other or alternate between each other when the two-part occluder is deployed. FIG. 4 is a schematic diagram showing whether it can be fitted 145-165 show how the distal leg and the proximal leg of the two-part occluder are aligned with each other or alternate between each other when the two-part occluder is deployed. FIG. 4 is a schematic diagram showing whether it can be fitted 145-165 show how the distal leg and the proximal leg of the two-part occluder are aligned with each other or alternate between each other when the two-part occluder is deployed. FIG. 4 is a schematic diagram showing whether it can be fitted 145-165 show how the distal leg and the proximal leg of the two-part occluder are aligned with each other or alternate between each other when the two-part occluder is deployed. FIG. 4 is a schematic diagram showing whether it can be fitted 145-165 show how the distal leg and the proximal leg of the two-part occluder are aligned with each other or alternate between each other when the two-part occluder is deployed. FIG. 4 is a schematic diagram showing whether it can be fitted 145-165 show how the distal leg and the proximal leg of the two-part occluder are aligned with each other or alternate between each other when the two-part occluder is deployed. FIG. 4 is a schematic diagram showing whether it can be fitted 145-165 show how the distal leg and the proximal leg of the two-part occluder are aligned with each other or alternate between each other when the two-part occluder is deployed. FIG. 4 is a schematic diagram showing whether it can be fitted 145-165 show how the distal leg and the proximal leg of the two-part occluder are aligned with each other or alternate between each other when the two-part occluder is deployed. FIG. 4 is a schematic diagram showing whether it can be fitted 145-165 show how the distal leg and the proximal leg of the two-part occluder are aligned with each other or alternate between each other when the two-part occluder is deployed. FIG. 4 is a schematic diagram showing whether it can be fitted 145-165 show how the distal leg and the proximal leg of the two-part occluder are aligned with each other or alternate between each other when the two-part occluder is deployed. FIG. 4 is a schematic diagram showing whether it can be fitted 145-165 show how the distal leg and the proximal leg of the two-part occluder are aligned with each other or alternate between each other when the two-part occluder is deployed. FIG. 4 is a schematic diagram showing whether it can be fitted 145-165 show how the distal leg and the proximal leg of the two-part occluder are aligned with each other or alternate between each other when the two-part occluder is deployed. FIG. 4 is a schematic diagram showing whether it can be fitted 145-165 show how the distal leg and the proximal leg of the two-part occluder are aligned with each other or alternate between each other when the two-part occluder is deployed. FIG. 4 is a schematic diagram showing whether it can be fitted 145-165 show how the distal leg and the proximal leg of the two-part occluder are aligned with each other or alternate between each other when the two-part occluder is deployed. FIG. 4 is a schematic diagram showing whether it can be fitted 145-165 show how the distal leg and the proximal leg of the two-part occluder are aligned with each other or alternate between each other when the two-part occluder is deployed. FIG. 4 is a schematic diagram showing whether it can be fitted 145-165 show how the distal leg and the proximal leg of the two-part occluder are aligned with each other or alternate between each other when the two-part occluder is deployed. FIG. 4 is a schematic diagram showing whether it can be fitted 145-165 show how the distal leg and the proximal leg of the two-part occluder are aligned with each other or alternate between each other when the two-part occluder is deployed. FIG. 4 is a schematic diagram showing whether it can be fitted 145-165 show how the distal leg and the proximal leg of the two-part occluder are aligned with each other or alternate between each other when the two-part occluder is deployed. FIG. 4 is a schematic diagram showing whether it can be fitted 145-165 show how the distal leg and the proximal leg of the two-part occluder are aligned with each other or alternate between each other when the two-part occluder is deployed. FIG. 4 is a schematic diagram showing whether it can be fitted 145-165 show how the distal leg and the proximal leg of the two-part occluder are aligned with each other or alternate between each other when the two-part occluder is deployed. FIG. 4 is a schematic diagram showing whether it can be fitted 145-165 show how the distal leg and the proximal leg of the two-part occluder are aligned with each other or alternate between each other when the two-part occluder is deployed. FIG. 4 is a schematic diagram showing whether it can be fitted FIGS. 166-168 are schematic diagrams illustrating additional methods in which interdigitation of the legs can be used to occlude the structure. FIGS. 166-168 are schematic diagrams illustrating additional methods in which interdigitation of the legs can be used to occlude the structure. FIGS. 166-168 are schematic diagrams illustrating additional methods in which interdigitation of the legs can be used to occlude the structure. FIGS. 169-172 are schematic diagrams illustrating a single use delivery device for delivering an occluder. FIGS. 169-172 are schematic diagrams illustrating a single use delivery device for delivering an occluder. FIGS. 169-172 are schematic diagrams illustrating a single use delivery device for delivering an occluder. FIGS. 169-172 are schematic diagrams illustrating a single use delivery device for delivering an occluder. FIGS. 173-176 are schematic diagrams showing how a reusable handle can be used to deploy multiple occluders. FIGS. 173-176 are schematic diagrams showing how a reusable handle can be used to deploy multiple occluders. FIGS. 173-176 are schematic diagrams showing how a reusable handle can be used to deploy multiple occluders. FIGS. 173-176 are schematic diagrams showing how a reusable handle can be used to deploy multiple occluders. FIGS. 177-219 are schematic diagrams illustrating a multiple occluder delivery device that may be used to deploy multiple occluders. FIGS. 177-219 are schematic diagrams illustrating a multiple occluder delivery device that may be used to deploy multiple occluders. FIGS. 177-219 are schematic diagrams illustrating a multiple occluder delivery device that may be used to deploy multiple occluders. FIGS. 177-219 are schematic diagrams illustrating a multiple occluder delivery device that may be used to deploy multiple occluders. FIGS. 177-219 are schematic diagrams illustrating a multiple occluder delivery device that may be used to deploy multiple occluders. FIGS. 177-219 are schematic diagrams illustrating a multiple occluder delivery device that may be used to deploy multiple occluders. FIGS. 177-219 are schematic diagrams illustrating a multiple occluder delivery device that may be used to deploy multiple occluders. FIGS. 177-219 are schematic diagrams illustrating a multiple occluder delivery device that may be used to deploy multiple occluders. FIGS. 177-219 are schematic diagrams illustrating a multiple occluder delivery device that may be used to deploy multiple occluders. FIGS. 177-219 are schematic diagrams illustrating a multiple occluder delivery device that may be used to deploy multiple occluders. FIGS. 177-219 are schematic diagrams illustrating a multiple occluder delivery device that may be used to deploy multiple occluders. FIGS. 177-219 are schematic diagrams illustrating a multiple occluder delivery device that may be used to deploy multiple occluders. FIGS. 177-219 are schematic diagrams illustrating a multiple occluder delivery device that may be used to deploy multiple occluders. FIGS. 177-219 are schematic diagrams illustrating a multiple occluder delivery device that may be used to deploy multiple occluders. FIGS. 177-219 are schematic diagrams illustrating a multiple occluder delivery device that may be used to deploy multiple occluders. FIGS. 177-219 are schematic diagrams illustrating a multiple occluder delivery device that may be used to deploy multiple occluders. FIGS. 177-219 are schematic diagrams illustrating a multiple occluder delivery device that may be used to deploy multiple occluders. FIGS. 177-219 are schematic diagrams illustrating a multiple occluder delivery device that may be used to deploy multiple occluders. FIGS. 177-219 are schematic diagrams illustrating a multiple occluder delivery device that may be used to deploy multiple occluders. FIGS. 177-219 are schematic diagrams illustrating a multiple occluder delivery device that may be used to deploy multiple occluders. FIGS. 177-219 are schematic diagrams illustrating a multiple occluder delivery device that may be used to deploy multiple occluders. FIGS. 177-219 are schematic diagrams illustrating a multiple occluder delivery device that may be used to deploy multiple occluders. FIGS. 177-219 are schematic diagrams illustrating a multiple occluder delivery device that may be used to deploy multiple occluders. FIGS. 177-219 are schematic diagrams illustrating a multiple occluder delivery device that may be used to deploy multiple occluders. FIGS. 177-219 are schematic diagrams illustrating a multiple occluder delivery device that may be used to deploy multiple occluders. FIGS. 177-219 are schematic diagrams illustrating a multiple occluder delivery device that may be used to deploy multiple occluders. FIGS. 177-219 are schematic diagrams illustrating a multiple occluder delivery device that may be used to deploy multiple occluders. FIGS. 177-219 are schematic diagrams illustrating a multiple occluder delivery device that may be used to deploy multiple occluders. FIGS. 177-219 are schematic diagrams illustrating a multiple occluder delivery device that may be used to deploy multiple occluders. FIGS. 177-219 are schematic diagrams illustrating a multiple occluder delivery device that may be used to deploy multiple occluders. FIGS. 177-219 are schematic diagrams illustrating a multiple occluder delivery device that may be used to deploy multiple occluders. FIGS. 177-219 are schematic diagrams illustrating a multiple occluder delivery device that may be used to deploy multiple occluders. FIGS. 177-219 are schematic diagrams illustrating a multiple occluder delivery device that may be used to deploy multiple occluders. FIGS. 177-219 are schematic diagrams illustrating a multiple occluder delivery device that may be used to deploy multiple occluders. FIGS. 177-219 are schematic diagrams illustrating a multiple occluder delivery device that may be used to deploy multiple occluders. FIGS. 177-219 are schematic diagrams illustrating a multiple occluder delivery device that may be used to deploy multiple occluders. FIGS. 177-219 are schematic diagrams illustrating a multiple occluder delivery device that may be used to deploy multiple occluders. FIGS. 177-219 are schematic diagrams illustrating a multiple occluder delivery device that may be used to deploy multiple occluders. FIGS. 177-219 are schematic diagrams illustrating a multiple occluder delivery device that may be used to deploy multiple occluders. FIGS. 177-219 are schematic diagrams illustrating a multiple occluder delivery device that may be used to deploy multiple occluders. FIGS. 177-219 are schematic diagrams illustrating a multiple occluder delivery device that may be used to deploy multiple occluders. FIGS. 177-219 are schematic diagrams illustrating a multiple occluder delivery device that may be used to deploy multiple occluders. FIGS. 177-219 are schematic diagrams illustrating a multiple occluder delivery device that may be used to deploy multiple occluders. FIG. 220 is a schematic diagram illustrating a multiple occluder delivery device in which multiple occluders are sequentially disposed within the delivery device. 221-223 are schematic diagrams illustrating a two-part occluder having asymmetric legs. 221-223 are schematic diagrams illustrating a two-part occluder having asymmetric legs. 221-223 are schematic diagrams illustrating a two-part occluder having asymmetric legs. 224-252 are schematic diagrams illustrating various structures for separating the tissue to be occluded from the surrounding tissue and / or protecting the surrounding tissue from damage during delivery of the occluder. 224-252 are schematic diagrams illustrating various structures for separating the tissue to be occluded from the surrounding tissue and / or protecting the surrounding tissue from damage during delivery of the occluder. 224-252 are schematic diagrams illustrating various structures for separating the tissue to be occluded from the surrounding tissue and / or protecting the surrounding tissue from damage during delivery of the occluder. 224-252 are schematic diagrams illustrating various structures for separating the tissue to be occluded from the surrounding tissue and / or protecting the surrounding tissue from damage during delivery of the occluder. 224-252 are schematic diagrams illustrating various structures for separating the tissue to be occluded from the surrounding tissue and / or protecting the surrounding tissue from damage during delivery of the occluder. 224-252 are schematic diagrams illustrating various structures for separating the tissue to be occluded from the surrounding tissue and / or protecting the surrounding tissue from damage during delivery of the occluder. 224-252 are schematic diagrams illustrating various structures for separating the tissue to be occluded from the surrounding tissue and / or protecting the surrounding tissue from damage during delivery of the occluder. 224-252 are schematic diagrams illustrating various structures for separating the tissue to be occluded from the surrounding tissue and / or protecting the surrounding tissue from damage during delivery of the occluder. 224-252 are schematic diagrams illustrating various structures for separating the tissue to be occluded from the surrounding tissue and / or protecting the surrounding tissue from damage during delivery of the occluder. 224-252 are schematic diagrams illustrating various structures for separating the tissue to be occluded from the surrounding tissue and / or protecting the surrounding tissue from damage during delivery of the occluder. 224-252 are schematic diagrams illustrating various structures for separating the tissue to be occluded from the surrounding tissue and / or protecting the surrounding tissue from damage during delivery of the occluder. 224-252 are schematic diagrams illustrating various structures for separating the tissue to be occluded from the surrounding tissue and / or protecting the surrounding tissue from damage during delivery of the occluder. 224-252 are schematic diagrams illustrating various structures for separating the tissue to be occluded from the surrounding tissue and / or protecting the surrounding tissue from damage during delivery of the occluder. 224-252 are schematic diagrams illustrating various structures for separating the tissue to be occluded from the surrounding tissue and / or protecting the surrounding tissue from damage during delivery of the occluder. 224-252 are schematic diagrams illustrating various structures for separating the tissue to be occluded from the surrounding tissue and / or protecting the surrounding tissue from damage during delivery of the occluder. 224-252 are schematic diagrams illustrating various structures for separating the tissue to be occluded from the surrounding tissue and / or protecting the surrounding tissue from damage during delivery of the occluder. 224-252 are schematic diagrams illustrating various structures for separating the tissue to be occluded from the surrounding tissue and / or protecting the surrounding tissue from damage during delivery of the occluder. 224-252 are schematic diagrams illustrating various structures for separating the tissue to be occluded from the surrounding tissue and / or protecting the surrounding tissue from damage during delivery of the occluder. 224-252 are schematic diagrams illustrating various structures for separating the tissue to be occluded from the surrounding tissue and / or protecting the surrounding tissue from damage during delivery of the occluder. 224-252 are schematic diagrams illustrating various structures for separating the tissue to be occluded from the surrounding tissue and / or protecting the surrounding tissue from damage during delivery of the occluder. 224-252 are schematic diagrams illustrating various structures for separating the tissue to be occluded from the surrounding tissue and / or protecting the surrounding tissue from damage during delivery of the occluder. 224-252 are schematic diagrams illustrating various structures for separating the tissue to be occluded from the surrounding tissue and / or protecting the surrounding tissue from damage during delivery of the occluder. 224-252 are schematic diagrams illustrating various structures for separating the tissue to be occluded from the surrounding tissue and / or protecting the surrounding tissue from damage during delivery of the occluder. 224-252 are schematic diagrams illustrating various structures for separating the tissue to be occluded from the surrounding tissue and / or protecting the surrounding tissue from damage during delivery of the occluder. 224-252 are schematic diagrams illustrating various structures for separating the tissue to be occluded from the surrounding tissue and / or protecting the surrounding tissue from damage during delivery of the occluder. 224-252 are schematic diagrams illustrating various structures for separating the tissue to be occluded from the surrounding tissue and / or protecting the surrounding tissue from damage during delivery of the occluder. 224-252 are schematic diagrams illustrating various structures for separating the tissue to be occluded from the surrounding tissue and / or protecting the surrounding tissue from damage during delivery of the occluder. 224-252 are schematic diagrams illustrating various structures for separating the tissue to be occluded from the surrounding tissue and / or protecting the surrounding tissue from damage during delivery of the occluder. 224-252 are schematic diagrams illustrating various structures for separating the tissue to be occluded from the surrounding tissue and / or protecting the surrounding tissue from damage during delivery of the occluder. FIGS. 253-263 are schematic diagrams illustrating another novel occluder formed in accordance with the present invention. FIGS. 253-263 are schematic diagrams illustrating another novel occluder formed in accordance with the present invention. FIGS. 253-263 are schematic diagrams illustrating another novel occluder formed in accordance with the present invention. FIGS. 253-263 are schematic diagrams illustrating another novel occluder formed in accordance with the present invention. FIGS. 253-263 are schematic diagrams illustrating another novel occluder formed in accordance with the present invention. FIGS. 253-263 are schematic diagrams illustrating another novel occluder formed in accordance with the present invention. FIGS. 253-263 are schematic diagrams illustrating another novel occluder formed in accordance with the present invention. FIGS. 253-263 are schematic diagrams illustrating another novel occluder formed in accordance with the present invention. FIGS. 253-263 are schematic diagrams illustrating another novel occluder formed in accordance with the present invention. FIGS. 253-263 are schematic diagrams illustrating another novel occluder formed in accordance with the present invention. FIGS. 253-263 are schematic diagrams illustrating another novel occluder formed in accordance with the present invention. FIGS. 264 and 265 are schematic diagrams showing how a substance can be introduced in a conduit between two occluders or upstream of a single occluder. FIGS. 264 and 265 are schematic diagrams showing how a substance can be introduced in a conduit between two occluders or upstream of a single occluder. FIGS. 266-281 are schematic diagrams showing how an occluder can be combined with electrocautery. FIGS. 266-281 are schematic diagrams showing how an occluder can be combined with electrocautery. FIGS. 266-281 are schematic diagrams showing how an occluder can be combined with electrocautery. FIGS. 266-281 are schematic diagrams showing how an occluder can be combined with electrocautery. FIGS. 266-281 are schematic diagrams showing how an occluder can be combined with electrocautery. FIGS. 266-281 are schematic diagrams showing how an occluder can be combined with electrocautery. FIGS. 266-281 are schematic diagrams showing how an occluder can be combined with electrocautery. FIGS. 266-281 are schematic diagrams showing how an occluder can be combined with electrocautery. FIGS. 266-281 are schematic diagrams showing how an occluder can be combined with electrocautery. FIGS. 266-281 are schematic diagrams showing how an occluder can be combined with electrocautery. FIGS. 266-281 are schematic diagrams showing how an occluder can be combined with electrocautery. FIGS. 266-281 are schematic diagrams showing how an occluder can be combined with electrocautery. FIGS. 266-281 are schematic diagrams showing how an occluder can be combined with electrocautery. FIGS. 266-281 are schematic diagrams showing how an occluder can be combined with electrocautery. FIGS. 266-281 are schematic diagrams showing how an occluder can be combined with electrocautery. FIGS. 266-281 are schematic diagrams showing how an occluder can be combined with electrocautery. FIGS. 282-285 are schematic diagrams showing a new handle for deploying the occluder. FIGS. 282-285 are schematic diagrams showing a new handle for deploying the occluder. FIGS. 282-285 are schematic diagrams showing a new handle for deploying the occluder. FIGS. 282-285 are schematic diagrams showing a new handle for deploying the occluder.

  The present invention provides a new and improved approach for treating varicose veins and other blood vessels.

  More specifically, the present invention restricts blood flow through the veins, thereby treating veins (eg, proximal saphenous veins, small saphenous veins, tributaries) to treat varicose veins below the occlusion point. The provision and use of novel occluders used to occlude penetrating veins, etc. Significantly, the new occluder is configured to be deployed using a minimally invasive approach (ie, either percutaneously or intracavity) and the visualization is ultrasound and / or other visualization Provided by an apparatus (eg, CT, MRI, X-ray, etc.). As a result, new treatments can be offered in the clinic, with minimal local anesthetics and virtually no postoperative care.

  The present invention also provides a new and improved surgical method and apparatus for occluding other tubular structures and / or for closing openings in the structure and / or for securing at least two objects together. I will provide a.

  The present invention also provides new and improved surgical methods and devices for fastening mechanical structures to tissue or blood vessels, eg, for drug delivery.

(Percutaneous approach)
In a percutaneous approach, the occluder is part or all of a blood vessel (eg, the great saphenous vein near the saphenous vein femoral vein junction) so as to occlude the blood vessel, through the intervening tissue, and then the blood vessel. And is delivered by advancing the occluder percutaneously. This occlusion (or a plurality of these occlusions) will thereby treat varicose veins. In one form of the invention, the occluder is configured to occlude the vein by squeezing the vein and closing the lumen, and in another form of the invention, the occluder is a venous lumen. Configured to occlude the vein by depositing a mass within the lumen of the vein to limit blood flow through the vessel. Lumen occlusion can be complete or partial. If the occlusion is partial, some of the blood can continue to flow into the vein. Such partial occlusion acts to relieve some of the pressure on the valve, thereby improving the function of the valve. In some applications, an occlusion of 70% or more of the lumen is desirable and can be achieved in accordance with the present invention. In other applications, an occlusion of 80% or more of the lumen is desirable and can be achieved in accordance with the present invention. In one embodiment, the applied occlusion pressure may exceed a 40 mm mercury column. In another embodiment of the invention, the occlusion pressure may exceed the pressure of typical blood flow in the vein.

  Initially, referring to FIGS. 2-4, in one form of the invention, an occluder 30 is provided. The occluder 30 includes an elastic filament 35 that, in an unconstrained state, has a substantially non-linear configuration (eg, a coiled mass), but when properly constrained, a linear configuration (eg, a needle) The temperature can be maintained within 45 narrow lumens 40, or if the filament is formed from a shape memory material, by appropriately controlling its temperature and thus its shape. When the constraint is removed (eg, the elastic filament 35 is pushed out of the constraining lumen 40 of the needle 45, or the temperature of the shape memory material is increased by body temperature or the like), the elastic filament 35 returns to its substantially non-linear configuration. , Thereby providing an enlarged mass for occluding the vein.

  In one form of the invention, the occluder is formed from a shape memory material (eg, a shape memory alloy or shape memory polymer such as Nitinol), which provides superelasticity, or temperature induced shape change, or both. To be configured).

  In one preferred method of use, the occluder 30 is installed within the narrow lumen 40 (FIG. 2) of the needle 45, and the needle is introduced percutaneously and the vein to be occluded (eg, the great saphenous vein 15). ) And the first length of the occluder is pushed out of the needle on the far side of the vein so that a portion of the occluder is coiled mass configuration 50 (see FIG. 3), the needle is pulled back across the vein, then the rest of the occluder is pushed out on the near side of the vein (FIG. 4), and accordingly the rest of the occluder is coiled mass configuration 55 The occluder portion 57 extends across the lumen 60 of the vein 15 and the distal and near occluder portions of the vein (ie, the coiled masses 50 and 55, respectively) are elastic filaments. Under the coil force inherent to each other, Compressing the vein, occluding the lumen 60, thereby limiting the blood flow through the veins, thereby treating varicose veins.

  As described above, the occluder 30 may be formed from a shape memory material (eg, a shape memory alloy or shape memory polymer such as Nitinol), which is superelastic, or temperature induced shape change, or both. Configured to provide.

  In the form of the invention shown in FIGS. 2-4, the occluder 30 is formed from a single elastic filament 35 and the shape transition (i.e., from approximately linear to a pair of opposed coiled masses 50, 55) is the target vessel. Used to cause blockage. In this regard, the aforementioned coiled masses 50, 55 may comprise substantially random windings of elastic filaments arranged in a substantially three-dimensional structure (ie, somewhat similar to a string ball), or coiled masses. It should be understood that 50, 55 may comprise highly reproducible structures such as loops, coils, etc., which may or may not have a generally planar structure. See, for example, FIG. 5 where the coiled mass 50, 55 comprises highly reproducible loops and coils.

  6 and 7 show an exemplary syringe-type inserter 65 that can be used to deploy the novel occluder of the present invention. The syringe-type inserter 65 may include one occluder 30 or a plurality of preloaded occluders 30, for example, the syringe-type inserter 65 comprises a plurality of occluders 30, the occluder being a syringe type It can be placed continuously in the inserter, or it can be placed parallel to each other in a syringe-type inserter (ie, a “gatling gun” placement mode). When the syringe inserter 65 is actuated, the occluder 30 is deployed from the distal end of the needle 45.

  In FIG. 2-4, the occluder 30 is shown occluding the vein by compressing the vein between the two coiled masses 50, 55, thereby closing its lumen 60. However, in another form of the invention, the occluder 30 can be used to occlude the vein without squeezing the vein. This is done by depositing a coiled mass in the venous lumen, thereby restricting blood flow through the venous lumen. More specifically, referring now to FIGS. 8-10, in this form of the invention, the needle 45 is threaded into the interior of the vein 15 and one coiled mass 50 of the occluder 30 is inserted into the vein. Is pushed into the venous lumen 60 (FIG. 8), the needle 45 is withdrawn to the near side of the vein (FIG. 9), and another coiled mass 55 is then Located on the near side of the vein (FIG. 10), the occluder portion 57 stabilizes the occluder relative to the vein (ie, attaches the occluder to the vein and moves the occluder relative to the vein). Extending through the side wall of the vein.

  FIGS. 11-14 illustrate another approach, where the coiled mass of the occluder 30 is deposited within the interior of the blood vessel so as to obstruct blood flow through the vessel. More specifically, in this form of the invention, the needle 45 is fully penetrated through the vein (FIG. 11) and the coiled mass 50 of the occluder is deposited on the far side of the vein (FIG. 12) The needle is pulled back into the interior of the vein, another coiled mass 55 of the occluder is deposited (FIG. 13), then the needle is withdrawn to the near side of the vein and another coil of the occluder 30 is placed. A mass 70 is deposited (FIG. 14). In this form of the invention, the coiled mass 55 resides in the venous lumen 60 and impedes blood flow, while the coiled masses 50 and 70 compress the veins inwardly, creating an intraluminal coil. Stabilize the arrangement of the mass 55.

  Figures 15 and 16 show an occluder 30 formed from a single thread of elastic filaments. In FIG. 15, the occluder 30 comprises a relatively orderly coil and the coil turns 72 are unidirectional. In FIG. 16, the occluder 30 includes another relatively orderly coil, but the turns rotate in opposite directions on different sides of the midpoint 75. Of course, the occluder 30 can also be constructed to form a relatively unordered coil, i.e., the filament threads follow a relatively random pattern (e.g., FIG. 8- (See the non-ordered coil shown in FIG. 10). In fact, if it is desired that the reshaped coil's own mass provide a flow obstruction (eg, when the reshaped coil is placed in the lumen to prevent blood flow through the vein), In general, elastic filaments are preferably reformed into relatively unordered coils having a relatively random arrangement to provide a denser filament configuration.

  FIG. 17 shows the occluder 30 formed from a plurality of threads of elastic filaments 35. In one form of the invention, the plurality of yarns are joined together at a joint 80. Again, the coils formed by these multiple threads (eg, the coiled masses 50, 55, 70 described above) can be relatively orderly or not orderly. FIGS. 18 and 19 show that the vein is constricted by squeezing the side wall of the vein inward so that the multi-thread occluder of FIG. Fig. 4 illustrates a method that can be used to occlude. FIG. 20 shows that the multi-thread occluder 30 of FIG. 17 occludes the vein by depositing a coiled mass 55 in the vein lumen 60 thereby restricting blood flow through the vein lumen. The method that can be used for In FIG. 20, several elastic filaments 35 are shown puncturing the side wall of the vein to hold the coiled mass 55 in place within the lumen of the blood vessel.

  21-24 show another form of the occluder 30, which is formed by a structure other than a filament. By way of example and not limitation, the occluder 30 may comprise a transluminal section 85, a far side projection 90, and a near side projection 95, the far side projection 90 and close. The lateral side projections 95 are held against each other so as to close the lumen 60 of the vein 15. Such an arrangement can be provided, for example, by many different types of structures, such as the “double T-bar” structure shown in FIGS. 25-27, where the transluminal section 85 of the occluder 30 provides vascular occlusion. As provided, it is formed from an elastic material that pulls the two opposing T-bars 90, 95 of the occluder together. Still other arrangements for connecting and pulling the far side projections 90 and the near side projections 95 together will be apparent to those of skill in the art in light of this disclosure. By way of further example, but not by way of limitation, the far side protuberance 90 and the near side protuberance 95 can be connected together by a suture loop, which can have a slide lock knot. Can be used to lock into a reduced size configuration (ie, to maintain occlusion).

  In addition, multiple occluders 30 are used in a single vessel or tissue to more fully occlude a vessel, or occlude blood vessels in multiple regions, or multiple materials (eg, drug or cell delivery elements). Can be attached to the blood vessel at the location. The occluder can be coated with a drug eluting compound, or the occluder can be electrically charged to improve or prevent clotting, or deliver the desired compound or drug to a blood vessel or the like. If desired, the location of the occlusion or attachment element can be precisely controlled to deliver the desired compound or agent to a particular anatomical location.

(Intracavity approach)
In an intraluminal approach, the occluder 30 is delivered to the occlusion site by using a catheter to advance the occluder in the lumen to the vein and then deploying the occluder in the vein, It acts to occlude the vein and thereby treat varicose veins. In this form of the invention, the occluder is preferably threaded through one or more vein sidewalls to stabilize the occluder relative to the vein. In one form of the invention, the occluder is configured to occlude the vein by depositing a mass within the vein lumen to limit blood flow through the vein lumen, In another form, the occluder is configured to occlude the vein by squeezing the vein and closing its lumen.

  More specifically, referring now to FIGS. 28 and 29, the catheter 100 is used to advance the occluder 30 in the lumen to the deployment site within the vein 15. One end of the occluder is then passed through the side wall of the vein so that the coiled mass 50 of the occluder 30 is deposited outside the vein, with the remainder of the occluder remaining in the coiled mass 55 within the vein lumen 60. The occluder portion 57 extends through the side wall of the vein so as to attach the occluder to the side wall of the vein and thereby stabilize the occluder relative to the vein. Thus, in this form of the invention, the occluder coiled mass 55 is deposited within the interior of the vein to limit blood flow through the vein and thereby treat varicose veins.

  FIGS. 30 and 31 show that two separate occluders 30 each used in the manner shown in FIGS. 28 and 29 increase the coiled mass of the occluder contained within the venous lumen, thereby Fig. 4 shows how it can be used to increase the extent of venous lumen occlusion.

  FIGS. 32 and 33 show how the occluder 30 is used to compress the outer wall of a vein so that it is delivered intracavity and occludes blood flow through the lumen of the vein. More specifically, in this form of the invention, the occluder 30 is advanced through the vein to the deployment site and one end of the occluder is deposited with a coiled mass 50 on one side of the vein. One side wall of the vein is penetrated and the other end of the occluder is penetrated through the other side wall of the vein so that another coiled mass 55 is deposited on the other side of the vein. Are connected together by an intermediate portion 57 of the occluder and the two coiled masses apply elastic opposing forces on both sides of the vein, thereby compressing the vein and closing its lumen Are pulled toward each other under the inherent coil force.

(Occlusion combined with venectomy)
If desired, the novel occluder of the present invention can be used in conjunction with removal of a large varicose vein (ie, venous resection). Venectomy can be performed simultaneously with vein occlusion or at another time. For this surgical procedure, minimal local anesthetic is required.

(Occlusion of tubular structure for purposes other than the treatment of varicose veins)
It will be appreciated that the novel occluder of the present invention can also be used to occlude tubular structures for purposes other than the treatment of varicose veins. By way of example, and not limitation, the novel occluder of the present invention occludes other vascular structures (eg, occludes an artery to control bleeding), or other tubular structures within the body (eg, Can be used to occlude the fallopian tube, etc., to induce infertility.

(Drug / cell delivery applications)
Furthermore, using the aforementioned concepts of minimally invasive hollow tube puncture and attachment and fixation of the device to the vessel wall, either percutaneously or intracavitary, the occluder 30 can be Or it can be modified to allow drug / cell delivery to a fixation point in or adjacent to other hollow body structures. In this form of the invention, the device functions as a drug / cell delivery stabilizer and may or may not function as an occluder. For example, an elastic filament 35 having a drug / cell delivery body 105 attached thereto is advanced across the blood vessel 110 using a needle 115 and the distal end of the elastic filament causes the coiled mass 120 to pass through the blood vessel. 34 and 35, where the drug / cell delivery body 105 is fixedly placed within the lumen 125 of the blood vessel. Figures 36 and 37 show a similar arrangement, where a catheter 130 is used to deliver the device intracavity. 38 and 39 show another arrangement in which the device is percutaneous so that the coiled mass is placed inside the vessel lumen 125 and the drug / cell delivery body 105 is placed outside the vessel. 40 and 41 show how the device is such that the coiled mass is placed inside the inner vessel lumen 125 and the drug / cell delivery body 105 is placed outside the vessel. It shows whether it is delivered intracavity. These drug / cell delivery devices can be inert or active polymers or silicon-based, or micro and nanotechnology devices, matrix of materials, or the like.

(2-part occluder)
Referring now to FIG. 42, a two-part occluder 200 formed in accordance with the present invention is shown. The two-part occluder 200 generally comprises a distal implant 205 and a proximal implant 210.

  The distal implant 205 is shown in more detail in FIGS. 43-46. The distal implant 205 includes a distal implant body 215 and a distal implant locking tube 220. The distal implant body 215 includes a tube 225 having a distal end 226, a proximal end 227, and a lumen 230 extending therebetween. The tube 225 has a slit in the middle of its length so as to define a plurality of legs 235. A set of inwardly projecting tabs 240 is formed in the tube 225 between the leg 235 and the proximal end 227. A set of windows 245 is formed in the tube 225 between the inwardly projecting knob 240 and the proximal end 227. The distal implant body 215 is preferably formed from an elastic material (eg, a shape memory material having superelastic properties, such as nitinol or a superelastic polymer, including a superelastic plastic) and its legs 235 are typically tubes. Constructed to project laterally from the longitudinal axis of 225 (eg, in the manner shown in FIGS. 43 and 44), however, due to the elastic nature of the material used to form the distal implant body 215 Due to this, the legs 235 can be constrained inwardly such that the distal implant body 215 can assume a generally linear arrangement (eg, within the lumen of the delivery needle as discussed below). ). See, for example, FIG. 46, which shows the legs 235 moved inward relative to the positions shown in FIGS. However, when any such constraints are removed, the elastic nature of the material used to form the distal implant body 215 causes the leg 235 to return to the position shown in FIGS.

  The distal implant locking tube 220 (FIG. 45) comprises a generally tubular structure having a distal end 250, a proximal end 260, and a lumen 262 extending therebetween. A set of windows 265 is formed in the distal implant locking tube 220 and the window 265 is disposed distal to the proximal end 260.

  Distal implant locking tube 220 is disposed within lumen 230 of distal implant body 215. When the distal implant 205 is in its aforementioned generally linear state (i.e., restrained with the legs 235 aligned), the distal implant locking tube 220 is the proximal end of the distal implant body 215. 227 ends far in front of knob 240 of distal implant body 215 so that 227 can move longitudinally relative to distal end 226 of distal implant body 215. However, when the proximal end 227 of the distal implant body 215 is moved distally enough to allow full radial expansion of the leg 235 (see FIG. 42), the distal implant body 215 The locking knob 240 is received within the window 265 of the distal implant locking tube 220 so that the distal implant 205 is radially expanded (ie, the leg 235 is, for example, FIG. 43). And 44 will protrude laterally away from the longitudinal axis of the tube 225. Spot welding applied through an opening 270 formed in the distal end 226 of the distal implant body 215 locks the distal implant locking tube 220 to the distal implant body 215, thereby It plays the role of forming the body structure (see FIGS. 43 and 46).

  47 and 48, the proximal implant 210 includes a tube 275 having a distal end 280, a proximal end 285, and a lumen 290 extending therebetween. The tube 275 is slit at its distal end so as to define a plurality of legs 295. A set of inwardly projecting tabs 300 is formed in the tube 275 between the leg 295 and the proximal end 285. Proximal implant 210 is preferably formed from an elastic material (eg, a shape memory material having superelastic properties, such as Nitinol), with its legs 295 generally laterally away from the longitudinal axis of tube 275. Protrusions (eg, in the manner shown in FIG. 47), however, the legs 295 can be constrained inwardly such that the proximal implant 210 can assume a generally linear arrangement (eg, in the following). As discussed in the lumen of the delivery tube). See, for example, FIG. 48, which shows the legs 295 moved inward relative to the position shown in FIG. However, if any such constraints are removed, the elastic properties of the material used to form the proximal implant 210 will cause the legs 295 to return to the position shown in FIG.

  As discussed below, distal implant 205 and proximal implant 210 have tube 225 of distal implant body 215 received within lumen 290 of proximal implant 210 and the spread leg of distal implant 205. The portion 235 faces the widened leg 295 of the proximal implant 210 (see, eg, FIG. 82), thereby allowing blood vessels (eg, veins) disposed therebetween as discussed in more detail below. To exert a clamping action on the side wall, thereby occluding the blood vessel (or alternatively, the opposed widened legs of the proximal and distal implants may be combined with each other to provide a clamping action) Configured and sized. Further, the distal implant 205 and the proximal implant 210 are locked in this position, so that the inwardly projecting tab 300 of the proximal implant 210 can project into the window 245 of the distal implant 205. Configured and sized.

  The two-part occluder 200 is intended to be deployed using an associated installation device. This associated mounting device preferably includes a hollow needle 305 for puncturing tissue (FIG. 49) and a distal side of the blood vessel to be occluded through the hollow needle 305, as discussed below. Distal implant delivery tube 310 (FIG. 50) for delivery to the body, composite guidewire 315 (FIGS. 51-56) for providing support to various components during delivery and deployment, and composite guidewire 315 A push rod 320 (FIG. 57) for delivering various components over and a proximal implant delivery tube 330 (FIG. 58) for delivering a proximal implant 210 for mating with the distal implant 205. And.

  The hollow needle 305 (FIG. 49) includes a distal end 335, a proximal end 340, and a lumen 345 extending therebetween. The distal end 335 ends at a sharply pointed tip 350. In one preferred form of the invention, the hollow needle 305 includes a side port 355 that communicates with the lumen 345.

  The distal implant delivery tube 310 (FIG. 50) includes a distal end 360, a proximal end 365, and a lumen 370 extending therebetween.

  The composite guide wire 315 (FIGS. 51-56) includes a guide wire rod 370 and a guide wire sheath 380. Guidewire rod 370 includes a distal end 385 and a proximal end 390. Distal end 385 terminates at enlarged portion 395. Guidewire sheath 380 includes a distal end 400, a proximal end 405, and a lumen 410 extending therebetween. The distal end 400 of the guidewire sheath 380 includes at least one, preferably a plurality of proximally extending slits 415. A proximally extending slit 415 opens at the distal end of the guidewire sheath 380, allowing the distal end of the guidewire sheath 380 to expand slightly radially. As discussed below, guidewire rod 370 and guidewire sheath 380 are configured and sized so that guidewire rod 370 can be received within lumen 410 of guidewire sheath 380. Further, when the guidewire rod 370 is pushed proximally with respect to the guidewire sheath 380, the proximally extending slit 415 in the guidewire sheath 380 causes the distal end of the guidewire sheath 380 to be guided by the guidewire rod 370. Allows for a slight expansion to receive at least a portion of the enlarged portion 395 formed at the distal end of the. As this occurs, the distal end of guidewire sheath 380 will expand radially.

  Push rod 320 (FIG. 57) includes a distal end 420, a proximal end 425, and a lumen 430 extending therebetween.

  Proximal implant delivery tube 330 (FIG. 58) includes a distal end 435, a proximal end 440, and a lumen 445 extending therebetween.

  The two-part occluder 200 and its associated installation device are preferably used as follows.

  Initially, the hollow needle 305 (supports a distal implant delivery tube 310 therein, and the distal implant delivery tube 310 includes a composite guidewire 315 therein, the distal implant over the composite guidewire 315. 205 is carried) through the patient's skin, through the intervening tissue, and across the blood vessel (eg, vein 450) to be occluded. See Figures 59-61. When this is done, any blood flowing out of the side port 355 can be monitored (excess or pulsatile blood flow can indicate that the hollow needle accidentally struck the artery).

  The hollow needle 305 is then retracted, leaving the distal implant delivery tube 310 extending across the blood vessel. See FIG. 62.

  The distal implant delivery tube 310 is then slightly retracted to expose the composite guidewire, ie, the distal end of the rod 315 and the distal end of the distal implant 205. See FIG. 63.

  Next, composite guidewire 315, push rod 320, and distal implant 205 are all advanced to advance the distal end of composite guidewire 315 and distal implant 205 out of the distal end of distal implant delivery tube 310. To the distal end. When this occurs, the leg 235 of the distal implant 205 is released from the constraints of the distal implant delivery tube 310 and expands radially. See FIGS. 64 and 65.

  The composite guidewire 315 then moves the distal end of the distal implant 205 to the proximal end of the distal implant 205 with the push rod 320 held in place relative to the proximal end of the distal implant 205. Pulled proximally, thereby causing the locking knob 240 of the distal implant body 215 to enter the window 265 of the distal implant locking tube 220, thereby causing the leg 235 to move radially thereof. Lock in the unfolded state (see FIG. 66).

  At this point, the hollow needle 305, the distal implant delivery tube 310, and the push rod 320 are removed (FIG. 67), leaving the distal implant 205 mounted on the composite guidewire 315 and the leg 235 being a blood vessel. The distal end of the distal implant 205 can extend into the interior of the blood vessel (FIG. 68).

  Next, the proximal implant delivery tube 330 (supporting the proximal implant 210 therein) is moved along the composite guidewire 315 until the distal end of the proximal implant delivery tube 330 is located immediately proximal to the blood vessel. (Fig. 69-72).

  Push rod 320 is then used to advance the distal end of proximal implant 210 from the distal end of proximal implant delivery tube 330. When this occurs, the legs 295 are released from the constraints of the proximal implant delivery tube 330 and open radially. See Figures 73-76.

  Next, using push rod 320, proximal implant 210 is pushed distally as distal implant 205 is pulled proximally using composite guidewire 315. More specifically, guidewire rod 370 is pulled proximally, and guidewire rod 370 places guidewire sheath 380 in distal implant locking tube 220 within enlarged portion 395 at the distal end of guidewire rod 370. It is expanded to a size larger than the lumen 262, which moves proximally to the guidewire sheath 380, which causes proximal movement of the distal implant 205. As the distal implant 205 and the proximal implant 210 move together, their legs 235, 295 compress the blood vessel, thereby occluding the blood vessel. Distal implant 205 and proximal implant 210 have inwardly projecting tabs 300 of proximal implant 210 enter window 245 of distal implant 205, thereby locking the two members in place relative to each other. Keep moving together until you do. See FIG. 77.

  At this point, push rod 320 and proximal implant delivery tube 330 are removed. See FIG. 78.

  Next, the composite guide wire 315 is removed. This is done by first advancing the guidewire rod 370 distally (FIG. 79), and the distal end of the guidewire sheath 380 relaxes inwardly, thereby reducing its outer diameter distally. Allows to be reduced to a size smaller than the lumen 262 in the implant locking tube 220. As a result, the guidewire sheath 380 can then be withdrawn proximally through the interior of the two-part occluder 200. See FIG. The guidewire rod 370 can then be pulled proximally through the interior of the two-part occluder 200. See FIG. 81.

  The foregoing procedure leaves the two-part occluder 200 locked in place across the blood vessel, and the opposing legs 235, 295 compress the blood vessel, thereby occluding the blood vessel.

  FIGS. 83-86 illustrate another two-part occluder 200A having a distal implant 205A and a proximal implant 210A. The two-part occluder 200A is generally similar to the two-part occluder 200 described above, but the distal implant 205A utilizes a unitary structure.

  87-90 illustrate another two-part occluder 200B. The two-part occluder 200B is generally similar to the two-part occluder 200A described above, but the distal implant 205B utilizes a friction fit to lock the distal implant 205B to the proximal implant 210B.

  FIGS. 91-94 illustrate another two-part occluder 200C having a distal implant 205C and a proximal implant 210C. The two-part occluder 200C is generally similar to the two-part occluder 200 described above, but the distal implant 205C includes a tube 225C that receives and secures the proximal end of the leg 235C. Leg 235C is preferably an elongated element (eg, a bent wire) formed from a superelastic shape memory material so as to provide leg 235C with the desired modulus of elasticity.

  FIGS. 95-100 illustrate another two-part occluder 200D having a distal implant 205D and a proximal implant 210D. The two-part occluder 200D is generally similar to the two-part occluder 200 described above, but the distal implant 205D includes a tube or rod 225D that receives and secures the proximal end of the leg 235D. . Leg 235D is preferably a coil formed from a superelastic shape memory material to provide leg 235D with the desired modulus of elasticity.

  In the foregoing disclosure, a composite guidewire 315 for use in delivering the distal implant 205 and the proximal implant 210 to the anatomy is disclosed. As described above, the composite guidewire 315 is formed from two parts: a guidewire rod 370 and a guidewire sheath 380. By providing this two-part structure for the composite guidewire 315, the composite guidewire 315 allows the composite guidewire 315 to be coupled to or separable from the distal implant 205. Each can have its distal diameter expanded or reduced as desired. However, if desired, the composite guidewire 315 can be replaced by an alternative guidewire that includes a mechanism for releasably coupling the alternative guidewire to the distal implant 205. By way of example and not limitation, such an alternative guidewire may include threads, and the distal implant 205 is secured to the distal implant 205 selectively, i.e., by screw action. A screw recess may be included so that it can be released or released therefrom.

  Referring now to FIGS. 101-104, a two-part occluder 200E formed in accordance with the present invention is shown. The two-part occluder 200E generally includes a distal implant 205E and a proximal implant 210E.

  The distal implant 205E includes a distal implant body 215E and a distal implant locking tube 220E. Distal implant body 215E includes a tube 225E having a distal end 226E and an opposed proximal end. Preferably, the distal implant 205E has a lumen 230E extending distally from its proximal end. Lumen 230E can extend along the entire length of distal implant body 215E or can terminate before the distal end of distal implant body 215E. By way of example and not limitation, if the two-part occluder 200E is to be set over a guidewire, the lumen 230E extends along the entire length of the distal implant body 215E. The tube 225E is slit in the middle of its length so as to define a plurality of legs 235E. The distal implant body 215E is preferably formed, at least in part, from an elastic material (eg, a shape memory material having superelastic properties, such as nitinol or a superelastic polymer, including a superelastic plastic) and its legs. 235E is typically configured to project laterally away from the longitudinal axis of the tube 225E (eg, in the manner shown in FIGS. 101-104), however, at least the legs of the distal implant body 215E Due to the elastic nature of the material used to form 235E, the leg 235E may have a generally linear arrangement with the distal implant body 215E (where the distal most tip of the leg 235E converges). To form the aforementioned proximal end of the distal implant body 215E) (e.g., ) The way, the lumen of the delivery needle is discussed. However, when any such constraints are removed (eg, when the distal implant body 215 is no longer constrained within the delivery needle), it is used to form at least the legs 235E of the distal implant body 215E. The elastic nature of the material made causes leg 235E to assume the position shown in FIGS. 101-104.

  In one preferred form of the invention, as seen in FIGS. 101-103, the leg 235E of the distal implant 205E is such that the leg 235E collectively defines a concave region 236E. It extends at an acute angle on the vertical axis of the.

  The distal implant locking tube 220E (FIGS. 101-104) comprises a generally tubular structure having a distal end 250E and a proximal end 260E. Preferably, the distal implant locking tube 220E has a lumen 262E extending distally from the proximal end 260E. Lumen 262E can extend along the entire length of distal implant locking tube 220E or can terminate before the distal end of distal implant locking tube 220E. By way of example, and not limitation, if the two-part occluder 200E is to be set over a guidewire, the lumen 262E of the distal implant locking tube 220E extends to the full length of the distal implant locking tube 220E. Extend along. A set of circumferential grooves or recesses 265E is formed in the distal implant locking tube 220E, and the grooves or recesses 265E are located intermediate the distal end 250E and the proximal end 260E. The distal implant locking tube 220E is also a first mechanical interlocking half for removably securing the distal implant locking tube 220E (and thus the distal implant 205E) to the distal implant delivery tube 310E. 266E (see below). The distal implant locking tube 220E is preferably relatively inelastic along its length, thereby minimizing longitudinal elongation, but somewhat flexible, Is formed from a biocompatible material that may allow delivery via a curved path. By way of example and not limitation, the distal implant locking tube 220E can be formed from a titanium alloy such as Ti5AL-4V.

  Distal implant locking tube 220E is disposed within lumen 230E of distal implant body 215E and extends proximally therefrom. The distal implant locking tube 220E is secured to the distal implant body 215E in a manner well known in the art (eg, by spot welding, adhesives, mechanical interlocks, etc.), thereby collectively , Forming an integral structure (see FIGS. 101-104). By forming the distal implant body 215E from an elastic material and by forming the distal implant locking tube 220E from a material that is relatively inelastic along its length, the distal implant body 215E is The distal implant locking tube 220E is fixed in configuration (eg, as discussed below), while easily deformable (eg, its legs 235E can be constrained within the delivery needle). Note that it may serve to hold the proximal implant 210E to the distal implant 205E).

  Further, referring now to FIGS. 101-104, the proximal implant 210E includes a tube 275E having a distal end, a proximal end 285E, and a lumen 290E extending therebetween. Tube 275E is slit at its distal end to define a plurality of legs 295E. A set of inwardly projecting tabs 300E, as will be discussed below, to engage the aforementioned groove or recess 265E within the distal implant locking tube 220E, leg 295E and proximal end 285E. (If desired, the location and configuration of the groove or recess 265E and knob 300E can be reversed, i.e., the outwardly protruding knob 300E can be Can be provided on the distal implant locking tube 220E, a groove or recess 265E can be provided on the inner sidewall of the tube 275E, or other means can be provided on the tube 275E of the proximal implant 210E. Note that can be provided to connect the distal implant locking tube 220E of the distal implant 205E). Proximal implant 210E is preferably formed, at least in part, from an elastic material (eg, a shape memory material having superelastic properties, such as Nitinol), with its legs 295E typically away from the longitudinal axis of tube 275E. However, the legs 295E can be configured so that the proximal implant 210E can assume a generally linear arrangement (eg, in the manner shown in FIGS. 101-104). The distal end of the 295E collectively forms the distal end of the proximal implant 210E) and can be constrained inward (eg, within the lumen of the delivery needle, as discussed below) ). However, if any such constraints are removed, the elastic properties of the material used to form at least the leg 295E of the proximal implant 210E will return to the position shown in the leg 295E FIGS. 101-104. Make it.

  In one preferred form of the invention, as seen in FIGS. 101-104, legs 295E of proximal implant 210E are proximal implant 210E such that legs 295E collectively define a concave region 301E. The vertical axis extends at an obtuse angle.

  Note that the concave surface of the concave region 236E of the distal implant 205E is the reverse of the concave surface of the concave region 301E of the proximal implant 210E (in other words, as seen in FIGS. 101-104, The concave surface of the concave region 236E faces the concave surface of the concave region 301E of the proximal implant 210E).

  As discussed below, distal implant 205E and proximal implant 210E are configured such that distal implant locking tube 220E of distal implant 205E is lumen 290E of proximal implant 210E, as discussed in further detail below. And the widened leg 235E of the distal implant 205E is opposed to the widened leg 295E of the proximal implant 210E (see, eg, FIGS. 103 and 104), thereby providing a clamping action therebetween. Can be applied to the side wall of a deployed blood vessel (eg, a vein), thereby occluding the blood vessel (or alternatively, the opposed widened legs of the proximal and distal implants further enhance the clamping action Are configured and sized. Further, the distal implant 205E and the proximal implant 210E are locked in this position, so that the inwardly projecting knob 300E of the proximal implant 210E is a circle of the distal implant locking tube 220E of the distal implant 205E. It is configured and sized to project into the circumferential groove or recess 265E, thereby securing the proximal implant 210E to the distal implant 205E. The position of the circumferential groove or recess 265E of the distal implant locking tube 220E and the inward projecting knob 300E of the proximal implant 210E is such that the inward projecting knob 300E of the proximal implant 210E is the distal implant. When placed in the circumferential groove or recess 265E of the locking tube 220E, the leg 235E of the distal implant 205E and the leg 295E of the proximal implant 210E are placed between the blood vessels (or other Note that it is adjusted to be close enough to ensure proper clamping of the tubular structure).

  Two-part occluder 200E is intended to be deployed using an associated mounting device. In one preferred form of the invention, such an associated installation device preferably includes a hollow needle 305E (FIG. 109) for puncturing tissue and a distal needle 205E as a hollow needle, as discussed below. A distal implant delivery tube 310E (FIG. 110) for delivery to the far side of the blood vessel (or other tubular structure) to be occluded through 305E and a proximal implant 210E for mating with the distal implant 205E. A proximal implant delivery tube 330E (FIG. 110) for delivery.

  If desired, the associated mounting device can be provided in the form of a laparoscopic device 331E, as shown in FIGS. 105-113. Laparoscopic device 331E includes handle 332E, outer sheath 333E, knob 334E, first trigger 336E, second trigger 337E, and release lever 338E with the functionality described below. ing.

  More specifically, the hollow needle 305E (FIG. 109) includes a distal end 335E, a proximal end (not shown but included within the laparoscopic device 331E), and a lumen 345E extending therebetween. ing. The distal end 335E of the hollow needle 305E ends with a sharp pointed point 350E.

  Distal implant delivery tube 310E (FIG. 110) includes a distal end 360E and a proximal end (not shown but included within laparoscopic device 331E). The distal end 360E of the distal implant delivery tube 310E also removably secures the distal end of the distal implant delivery tube 310E to the proximal end of the distal implant 205E, i.e., a first mechanical interface. Locking half 266E (supported by the proximal end of distal implant locking tube 220E) and second mechanical interlocking half 361E (supported by the distal end of distal implant delivery tube 310E) A second mechanical interlock half 361E is provided for securing by the releasable interconnects.

  Proximal implant delivery tube 330E (FIG. 110) includes a distal end 435E, a proximal end (not shown but included within laparoscopic device 331E), and a lumen 445E extending therebetween.

  The two-part occluder 200E and its associated installation device (eg, laparoscopic device 331E) are preferably used as follows.

  Initially, the hollow needle 305E is preferably passed through the occlusion site while the needle 305E is contained within the sheath 333E of the laparoscopic device 331E (FIG. 107). The sheath 333E is then retracted, for example, by pivoting the knob 334E (FIG. 108), and the hollow needle 305E is passed (or occluded) across the blood vessel (eg, vein) to be occluded. Passed through another tubular structure to be made, or penetrated through tissues or objects to be fixed to each other, such as a solid organ or a layer of tissue).

  The hollow needle 305E is then retracted proximally rearward across the blood vessel, for example, via the first trigger 336E (FIG. 109). This action allows the leg 235E of the distal implant 205E to expand radially on the far side of the blood vessel. At this point, the distal implant locking tube 220E extends proximally through the blood vessel.

  The distal implant delivery tube 310E was then held in place via the distal implant delivery tube 310E and its interlocking with the distal implant locking tube 220E (and thus the distal implant 205). In that state, the hollow needle 305E is withdrawn further proximally (eg, via the first trigger 336E) until the proximal implant 210E is no longer constrained within the hollow needle 305E (FIG. 110). When this occurs, the legs 295E of the proximal implant 210E are released from the constraints of the hollow needle 305E and open radially.

  Proximal implant delivery tube 330E is then advanced distally using second trigger 337E, for example, until proximal implant 210E and distal implant 205E merge (FIG. 111). As distal implant 205E and proximal implant 210E move together, their legs 235E, 295E compress the blood vessel therebetween, thereby occluding the blood vessel. Distal implant 205E and proximal implant 210E have an inwardly projecting tab 300E of proximal implant 210E that enters circumferential groove or recess 245E of distal implant 205E, thereby allowing the two members to move together. Continue to move together until they lock into place.

  At this point, the proximal implant delivery tube 330E is withdrawn (FIG. 112) and the distal implant delivery tube 310E is released from the distal implant 205E (ie, using the lever 338E, a second mechanical interaction). Locking half 361E (supported by the distal end of distal implant delivery tube 310E) is mechanically interlocked first half 266E (supported by the proximal end of distal implant locking tube 220E) ) And then the mounting device is withdrawn (FIG. 113).

  The foregoing procedure leaves the two-part occluder 200E to be locked in place across the blood vessel, and the opposing legs 235E, 295E compress the blood vessel therebetween, thereby occluding the blood vessel. .

  In the foregoing disclosure, the two-part occluder 200E uses the elasticity of its legs 235E, 295E to constrict its legs 235E, 295E in a diametrically reduced configuration (eg, constrained within a delivery needle). From the point of view) to reconfigure to a diametrically expanded configuration (e.g. when released from delivery needle constraints). However, also when the legs 235E, 295E are formed from a shape memory material (eg, Nitinol), the temperature change is from a diametrically reduced configuration to a diametrically expanded configuration of the legs 235E, 295E. It should be understood that it can be used to reconfigure. By way of example and not limitation, in this form of the invention, the legs 235E, 295E may be constructed to have a diametrically reduced configuration when maintained at a temperature below body temperature, the legs 235E. 295E can be constructed to have a diametrically expanded configuration when maintained at body temperature. As a result, the leg 235E, by cooling the 2-part occluder 200E to a temperature below body temperature, inserting the 2-part occluder into the body, and then heating the 2-part occluder to body temperature. The 295E can be reconfigured from its diametrically reduced configuration to a diametrically expanded configuration.

  114-120 illustrate an alternative form of installation device. More specifically, FIGS. 114-120 illustrate another laparoscopic device 331E. The laparoscopic device 331E shown in FIGS. 114-120 is generally similar to the laparoscopic device 331E shown in FIGS. 105-113, but the second trigger 337E is omitted and the lever 338E is (i) Advance the proximal implant delivery tube 330E until the proximal implant 210E and the distal implant 205E merge (FIG. 119), and (ii) release the distal implant 205E from the distal implant locking tube 220E ( That is, the second mechanical interlock half 361E (supported by the distal end of the distal implant delivery tube 310E) is the first mechanical interlock half 266E (the distal implant lock tube 220E). Used to do both (by unlocking from the proximal end) (FIG. 120).

  FIGS. 121-123 illustrate another two-part occluder 200E that is similarly formed in accordance with the present invention. The occluder 200E shown in FIGS. 121-123 is substantially the same as the occluder 200E shown in FIGS. 101-120, but the legs 235E of the distal implant 205E and the legs 295E of the proximal implant 210E are: Legs 235E, 295E have their concave surfaces enforced in the same direction so as to be nested with each other rather than facing each other. In addition, as seen in FIGS. 121-123, the tube 225E of the distal implant 205E is partially received within the lumen 290E of the proximal implant 210E.

  FIGS. 124-126 illustrate one preferred structure for releasably securing the distal implant 205E of the two-part occluder 200E of FIGS. 121-123 to the distal implant delivery tube 310E. More specifically, in this form of the invention and referring now to FIGS. 124-126, the first mechanical interlocking half 266E (supported by the proximal end of the distal implant locking tube 220E) ) Comprises a stepped configuration 433E and the second mechanical interlocking half 361E (supported by the distal end of the distal implant delivery tube 360E) comprises another stepped configuration 434E and is stepped. Configuration 433E and stepped configuration 434E are opposite to each other so that they fit together. The second mechanical interlock half 361E (supported by the distal end of the distal implant delivery tube 310E) is coupled to the first mechanical interlock half 266E (proximal to the distal implant lock tube 220E). After being secured to the distal end), the connection between the distal implant delivery tube 310E and the distal implant 205E can be achieved, for example, by locking the rod 436E from the central lumen 437E of the distal implant delivery tube 310E. It can be strengthened by telescoping into the lumen 262E of the implant locking tube 220E. In this form of the invention, the installation device (eg, the laparoscopic device 331E of FIGS. 105-113 or the laparoscopic device 331E of FIGS. 114-120) attaches the locking rod 436E to the central tube of the distal implant delivery tube 310E. Appropriate control means (eg, release lever 338E) for telescoping from lumen 437E into lumen 262E of implant locking tube 220E is included. Alternatively, in another form of the invention, the internal locking rod 436E projects telescoping over the distal implant delivery tube 310E and the distal implant locking tube 220E of the distal implant 205E, thereby inter-member Can be replaced by an overtube (not shown) which improves the connection of

  It will also be appreciated that other forms of mechanical interlocks for removably securing the distal implant 205E of the two-part occluder 200E of FIGS. 121-123 to the distal implant delivery tube 310E may also be used. I want to be. As an example, but not by way of limitation, a screw interlock can be used, for example, a first mechanical interlock half 266E (supported by the proximal end of the distal implant lock tube 220E) A second mechanical interlocking half 361E (supported by the distal end of the distal implant delivery tube 360E) may comprise a threaded strut and a distal implant delivery tube The threaded strut supported by the distal end of 360E may be received within the threaded bore of the distal implant locking tube 220E. Alternatively, other configurations of screw interlocks can be used, or other forms of mechanical interlocks can be used.

  In the structure shown in FIGS. 101-143, mechanical interlocks (eg, the first half 266E supported by the proximal end of the distal implant locking tube 220E and the distal end of the distal implant delivery tube 310E). Is used to connect the distal implant locking tube 220E (and thus the distal implant 205E) to the distal implant delivery tube 310E. Alternatively, if desired, the distal implant locking tube 220E can be integrally formed with the distal implant delivery tube 310E, the fragile section being disposed at the intersection thereof, and the two members being Separated by mechanical destruction.

  It will be appreciated that in certain situations it may be desirable to increase the surface area of those portions of the occluder that contact the tubular structure in order to better distribute the load applied to the tissue. In this situation, increasing the width of the leg (eg, leg 235E and / or leg 295E of the two-part occluder 205E) and / or the flexible material may also support the load. Providing flexible material in the area between adjacent legs (eg, in an umbrella style) (ie, essentially increasing the effective width of legs 235E and / or legs 295E) Can be useful. For example, see FIG. 127, which shows a flexible material 438E that extends between legs 235E and between legs 295E.

  128-133 illustrate a placement device 500 for facilitating proper placement of an occluder (eg, two-part occluder 200E) to occlude a blood vessel (or other hollow tubular body). Placement device 500 generally includes a blood vessel detector needle 505, which is a relatively small diameter (eg, 21 gauge or smaller) needle, and a guiding component 510 (which can be manufactured from an inexpensive material such as plastic). I have. Guiding component 510 sets seat 515 for receiving angiodetector needle 505 and an occluder (eg, laparoscopic device 331E of FIGS. 105-113 or laparoscopic device 331E of FIGS. 114-120). And an opening 520 for slidably receiving the shaft of the mounting device for

  In use, the vascular detector needle 505 is positioned within the seat 515 of the guidance component 510 and then the vascular detector needle 505 is advanced through the target vessel (eg, under ultrasound guidance). See FIG. 129. Proper placement of the blood vessel detector needle 505 is confirmed when blood begins to flow out of the proximal end of the blood vessel detector needle 505. Next, the shaft of the mounting device for setting the occluder (eg, the laparoscopic device 331E of FIGS. Is advanced through. See FIG. Advancement occurs until a stop 525 on the shaft of the mounting device engages the proximal end of the guide component 510. See FIG. 131. If a stop 525 on the shaft of the mounting device engages the proximal end of the guide component 510, the distal end of the shaft of the mounting device will penetrate the target vessel. See FIG. 132. At this point, the blood vessel detector needle 505 is withdrawn (see FIG. 133) and the deployment of the occluder proceeds as described above.

  It will be appreciated that in certain situations, the blood vessel (or other tubular structure) to be occluded may be located in proximity to the underlying layer anatomy, eg, organ, nerve, another tubular structure, etc. It will be. In this situation, any such engagement with the underlying layer anatomy can cause trauma to the underlying layer anatomy so that the sharpened distal tip of the deployment needle is Disengage the underlying layer anatomy and the distal end of the occluder (eg, the distal implant 205E of the two-part occluder 200E) engages the underlying layer anatomy It may be useful to lift the blood vessel (or other tubular structure) upward and away from the underlying layer anatomy. To that end, referring now to FIG. 134, the clamp forceps 530 (or other tool having a bifurcated distal end) includes a blood vessel (or other tubular structure) and an underlying layer anatomy. And then pulled upward away from the underlying layer anatomy to separate the target vessel (or other tubular structure or tissue) from the underlying layer anatomy. Can be. An occluder (eg, two-part occluder 200E) is then safely penetrated through the target vessel (or other tubular structure), deployed between the two distal ends of the tool and deployed as described above. Can be done.

(Use of an occluder to occlude tubular structures other than blood vessels)
It will be appreciated that the occluder of the present invention can also be used to occlude tubular structures other than blood vessels. By way of example, and not limitation, the temporary occluder of the present invention may be used for other structures in the body (eg, tubes such as fallopian tubes and / or vas deferens for temporary or permanent sterilization, chest tubes, fistulas, etc. And bile ducts for cholecystectomy and gallbladder ducts, lymphatic ducts, etc.).

(Use of an occluder to close an opening in the structure and / or to fix at least two objects together)
In the foregoing disclosure, the occluder is discussed in terms of occluding tubular structures (eg, blood vessels, fallopian tubes, lymphatic vessels, etc.) by clamping together opposing sidewalls of the tubular structure to occlude the tubular structure. . In such applications, the occluder effectively secures one side wall of the tubular structure to the opposite side wall of the tubular structure. However, it should be understood that the occluder of the present invention can also be used to close an opening in a structure and / or to secure two or more objects together for other applications.

  By way of example and not limitation, the occluder of the present invention can be used to secure two or more portions of tissue together to close the incision.

  By way of further example, but not by way of limitation, the occluder of the present invention can be used in a “gastric stapling” procedure to coalesce the opposite side walls of the stomach to reduce the size of the stomach.

  Further, the occluder of the present invention can be used in organ resection (eg, liver resection) to seal the periphery of the resected organ.

  By way of further example and not limitation, referring now to FIGS. 135-137, the occluder of the present invention can be used to selectively stop blood flow or blood loss in various regions through tissue compression. It can be used to selectively tighten or occlude areas of the organ. The occluder can be used in solid organ resection of the kidney or liver or other organs. Blood loss and secretion leakage (eg, bile, urine, etc.) can be a problem in existing solid organ resection procedures. The average blood loss for liver resection is 700-1200 ml. By tightening the desired area of the solid organ using the occluder of the present invention, the amount of undesirable fluid loss (blood loss, secretion leakage, etc.) can be significantly reduced. The occluder of the present invention can be used to selectively apply pressure to a large area organ, in addition to closing selective tubular structures and vessels connecting the organ and other areas of the body. Can also be used for. In one embodiment and method, a plurality of individual occluder elements can be selectively deployed individually across the region of the organ. See, for example, FIG. 135, which shows a plurality of single separate puncture locations of an occluder for closing the resected liver. Note that if multiple single separate puncture arrangements of the occluder are used, different regions of the solid organ can be compressed to different controllable degrees.

  In the novel embodiment of the invention, the length of the distal implant locking tube 220E (of the distal implant 205E) remaining in the body is fragile to the distal implant locking tube 220E and / or the distal implant delivery tube 310E ( For example, providing a segment that is fragile and severing the distal implant locking tube 220E from the distal implant delivery tube 310E in the region above the proximal implant 210E resulted in occluder tightening. Can be determined at a time. This detachment may cause the distal implant locking tube 220E to move closer to the proximal implant 210E when the selectively fragile region is subjected to torsion, torque, bending, or pulling, or other selective strain or stress. This is accomplished by incorporating a selective fragile region into the distal implant locking tube 220E and / or the distal implant delivery tube 310E so that it will separate from the distal implant delivery tube 310E at the location. be able to. The distal implant delivery tube 310E will move away from the distal implant locking tube 220E, but the distal implant connecting the distal implant body 215 and the proximal implant 210E because clamping is effected across the tissue. The locking tube 220E will not move. The distal implant locking tube 220E that connects the distal implant body 215E and the proximal implant 210E can be solid or flexible.

  In other embodiments of the present invention, the distal implant locking tube 220E consists of a plurality of interlocking sections and can be constrained by an encapsulating sheath or, when deployed, by the surrounding tissue. Once tissue clamping is achieved, the sheath can be retracted beyond the proximal implant, exposing the interlocking region between the distal implant locking tube 220E sections, and then twisting or appropriate engagement. A detent mechanism is used to allow the occluder to be disconnected from the distal implant delivery tube 310E.

  This structure allows the clamping distance between the distal implant 205E and the proximal implant 210E to be controllable and allows significant tissue thickness to be clamped.

  In the embodiment shown in FIG. 136, the occluder is in conjunction with single or multiple compression bands 550, which can be a polymer or other tissue material or metal or other commonly used material known in the art. Delivered. The compression band 550 can be wrapped into a delivery needle or sheath and deployed prior to delivery of the occluder. The compression band 550 spreads pressure across a larger area of the organ or tissue that receives the occluder of the present invention.

  In other embodiments, the occluder leg is flexible, but is a thin metal or polymer that connects between the fingers and allows further distribution of pressure on the tissue, vessel, organ, etc. to be clamped Can have a mesh or film.

  In the embodiment of FIG. 137, multiple occluders can be delivered in parallel to organs, tissues, tubular structures, and the like. In this form of the invention, an installation device 555 comprising a body 560 having a plurality of deployment needles 565 extending therefrom can be used to set a plurality of occluders. The mounting devices 555 are deployed one at a time, but in a spatially constrained manner with a predefined spacing between the occluders (determined by a predetermined spacing between the deployment needles 565). Either a single occluder can be delivered, or multiple occluders can be delivered all at once using a single actuation control. This structure can reduce the amount of time required for procedures such as ablation by providing simultaneous occluder deployment.

  In other embodiments of the invention, the occluder can be deployed across multiple tissues or multiple folds of the same tissue, organ, or tubular structure. In certain embodiments of the present invention, the distal implant locking tube 220E is elastic and allows some movement of the clamped tissue, but can still maintain the desired clamping force or pressure on the tissue. .

  The occluder of the foregoing invention can also be used for bariatric surgery, or to reduce or fold the stomach, or to create a gastrostomy sleeve.

  In another embodiment of the present invention, the unreleased distal implant 205E is used as a retractor to retract tissue away from any organ or tissue or the main blood vessel below it, and subsequent deployment of other occluders Can be performed in a manner that allows for reduction of the size of the organs, joining the organs together, and closing the dehiscence in the intestines and the like. Once the other desired occluder is deployed, the deployment of the first occluder (ie, the integration of proximal implant 210E and distal occluder 205E) can be completed.

(Use of the invention under direct and / or indirect visualization)
Significantly, the present invention provides direct visualization (eg, during “open” surgery) or indirect visualization (eg, during laparoscopic surgery where visualization is provided through the use of a microscope, or visualization is ultrasound). Under percutaneous surgery provided through the use of an imaging device such as an imager, x-ray imager, etc.

(Enhanced tissues, organs, transport tubes, and / or vascular crimping or close proximity)
(Advantages of using a 1.2 part occluder)
The present invention relates to, among other things, a novel two-part occluder that crimps together at least two layers of hollow tubes, vessels, and / or materials (ie, biological or synthetic materials), such as clamps or staples An improvement over existing occlusive devices that can connect different or similar tissues together and / or connect the tissues to a synthetic material.

  More specifically, the present invention relates to an apparatus and method for aligning at least two surfaces at least partially in contact with or in close proximity to each other in a permanent and controllable manner. The present invention can be used for occlusion of tubular structures such as veins, arteries, bile ducts, fallopian tubes, gallbladder ducts and the like. The present invention can also be used to join, attach, and / or connect at least two folds (eg, both sides of the stomach or other parts of the intestine, etc.) together so that they are connected. .

  The present invention can also be used to connect tissue and other materials, such as graft materials, hernia meshes, drug delivery materials, and the like. The present invention is also intended to connect the two structures together without the need to protect the underlying tissue layer from possible injury due to possible needle sticks.

(2. Disadvantages of using staples)
Advantages of the present invention include, but are not limited to, a two-part occluder that dislodges or slides off the vessel (or tissue) with adverse consequences such as intravascular bleeding and tissue detachment. Crimping the vessel (or tissue) tightly by making the vessel (or tissue) immobile so that it cannot be done. In addition, compression of the vessel (or tissue) surrounding the through-hole is performed using pressure distribution across the vessel (or tissue) from the two-part occluder, and any leakage of blood or fluid from the occluded structure. Also prevent.

  More specifically, the two-part occluder 200 removes the vessel to be occluded such that the distal implant 205 resides on one side of the vessel and the proximal implant 210 resides on the other side of the vessel. Disposed across (or across the tissue to be crimped together), the distal implant locking tube 220 passes through the vessel and connects the distal implant 205 and the proximal implant 210 together thereby A crimping force is generated in the meantime. This distributed pressure (ie, compression) around the through-hole is adjusted together with the fluid (eg, blood or bile) centered around the tissue to which the aforementioned distal implant 205 and proximal implant 210 are to be crimped. After that, it helps to prevent leakage through the through hole (ie, the hole in the vessel where the distal implant locking tube 220 passes through the vessel). Unlike staples, which can cause bleeding where the leg of the staple passes through the vessel and can “slide” from the vessel, the distal implant 205 and the proximal implant 210 cannot “slide” from the tissue. . The distributed pressure around the through-hole significantly reduces the possibility of tissue tear.

  Bleeding, “sliding” from the tissue, and tearing through the tissue are common problems associated with the use of staples and other clips (such as hemostatic clips) and clamps. The two-part occluder 200 of the present invention is capable of sealing and closing vessels that experience pressures from 0 mm up to 700 mm Hg and above (ie, the pressure that causes the aforementioned problems associated with staples and prior art clamps). It is.

  FIG. 138 shows a staple used to connect two tissue regions (ie, close an incision in the skin). Continuous bleeding may occur at the site where the staple leg penetrates through the tissue. The area surrounding the staples is susceptible to tearing or tearing, especially if the tissue is thin, fragile, or damaged.

  The novel two-part occluder 200 of the present invention also eliminates the need for additional support materials when crimping delicate tissue.

  For example, one prior art medical stapling device requires the provision of additional support material when stapling fragile tissue. More specifically, the prior art medical stapling device uses an additional advanced polymer felt material that is placed on and stapled with the tissue.

  139 and 140 illustrate staples used to occlude blood vessels. The area around the area where the staple penetrates the blood vessel is prone to bleeding and tearing. 141 and 142 show a cross-section of one embodiment of the two-part occluder 200 of the present invention connecting the side walls of the blood vessel, and the area around the two-part occluder 200 is compressed together, Support for the two-part occluder 200 is provided to prevent the surrounding tissue from moving or tearing and to prevent blood flow through the blood vessel.

(3. Use two-part occluder 200 to attach two objects together)
As described above, the two-part occluder 200 may be used for occlusion of tubular structures such as veins, arteries, bile ducts, gallbladder ducts, and fallopian tubes. However, the two-part occluder 200 may also be used to attach non-tissue elements to tissue (eg, attach a hernia mesh to tissue or a vascular stent graft to a natural vessel). I want you to understand. The two-part occluder also attaches the first non-tissue element to the second non-tissue element, eg, to shape or reconfigure the non-tissue element (eg, a synthetic hernia mesh at the edge of the hernia site). Attached to another section of normal tissue or hernia mesh).

  From the foregoing disclosure, the distal implant locking tube 220 of the two-part occluder 200 passes through the tubular structure to be crimped, however, the entire area around the distal implant locking tube 220 does not cause any bleeding. Alternatively, it is understood that fluid leakage is compressed / closed to prevent it from occurring at the entry / exit point site of the distal implant locking tube 220 through the sidewall of the tubular structure.

  FIGS. 143 and 144 illustrate a two-part occluder 200 used, for example, to crimp a hernia mesh to tissue.

(4. Two-part occluder 200 with interdigitated fingers)
In addition to the aforementioned advantages of using a two-part occluder 200 to occlude a tubular structure (over prior art clamps and staples), also interdigitated legs (ie, legs of distal implant 205). The provision and use of a two-part occluder 200 having a part 235 and a leg 295 of the proximal implant 210) is a problem where the tubular structure is associated with staples or clips (eg, hemostatic clips, Ligaclips, etc.) (see above). It is understood that it can be safely occluded so as to allow the crimping force used to be adjustable.

  In a preferred embodiment, the present invention generally comprises two compression elements: a proximal implant 210 for compressing the proximal side wall of the vessel and a distal implant 205 for compressing the far side wall of the vessel. Prepare. Proximal implant 210 and / or distal implant 205 is a shape memory metal (eg, nitinol), etc. that assumes its designated configuration when the two-part occluder 200 is used to occlude a vessel. Of biocompatible metals and / or ceramics, and / or various polymers and biodegradable polymers. The proximal implant 210 includes a plurality of legs 295 for applying a crimping pressure to the proximal side of the vessel to be occluded, and the distal implant 205 is distal to the vessel to be crimped. A plurality of legs 235 for applying to the side are provided.

  FIGS. 145 and 146 illustrate a two-part occluder 200 used to occlude a blood vessel (or crimp tissue). In one preferred embodiment of the present invention, the distal implant 205 is a distal implant locking tube 220 (sometimes referred to herein as an implant locking rod, and is also an organic, ceramic, or biodegradable polymer. Can be pre-attached (or formed integrally with it). In one embodiment of the invention, distal implant 205 is secured to distal implant locking tube 220 through welding. By way of example and not limitation, the distal implant 205 uses a welding material introduced at least partially into a welding hole 600 (see FIG. 150) formed in the distal implant locking tube 220. And may be welded to the distal implant locking tube 220. In another embodiment of the invention, the distal implant 205 is secured to the distal implant locking tube 220 through a mechanical locking, latching, or threaded screw arrangement. In another embodiment of the invention, distal implant 205 and distal implant locking tube 220 are formed from one continuous piece and material. Proximal implant 210 is preferably locked to distal implant locking tube 220 by an inwardly oriented flap formed in the body of proximal implant 210 (ie, inwardly projecting tongue 300). And locks into a corresponding opening (ie, window 265) formed in the distal implant locking tube 220. If desired, a flap (ie, an inwardly projecting tongue 300) may be formed on the distal implant locking tube 220 as an outwardly projecting tongue, with a corresponding opening (ie, window 265). ) Is formed in the proximal implant 210 (ie, accepts a flap formed on the distal implant locking tube 220). There may be one window 265, or two windows 265, or three or more windows 265.

  The window 265 is 1% to 100% of the circumference of the distal implant locking tube 220 or 1% to 95% of the circumference of the distal implant locking tube 220 when the window 265 is located on the proximal implant 210. May be covered.

  The two-part occluder 200 can generate an occlusion pressure (ie, a crimping force between the proximal implant 210 and the distal implant 205) that is sufficient to crimp the blood vessel with a pressure of at least 100 mmHg. In another embodiment of the invention, the two-part occluder 200 can withstand pressures up to 300 mmHg, and in a further embodiment of the invention, the two-part occluder 200 has a pressure above 700 mmHg. Can be supported. FIG. 145 shows the interdigitation (ie, circumferential offset) of the leg 295 of the proximal implant 210 and the leg 235 of the distal implant 205.

(5. Adjustable crimping force)
In a further embodiment of the present invention, the amount of pressure (ie, the amount of crimping force) that the two-part occluder 200 applies to tissue or across a blood vessel can be variably controlled.

  More specifically, FIG. 147 shows how the gap between the leg 235 of the distal implant 205 and the leg 295 of the proximal implant 210 is controlled and the pressure applied to the tissue being crimped. Or the extent to which the vascular opening (ie, lumen) that has been impeded by the two-part occluder 200 can be effectively controlled.

  FIG. 148 illustrates one embodiment of the present invention, where the distal implant locking tube 220 selectively controls the spacing between the proximal implant 210 and the distal implant 205 of the two-part occluder 200. Controllable ratchet mechanism. In this form of the invention, the leg 235 of the distal implant 205 and the leg 295 of the proximal implant 210 are generally oriented primarily in mutually parallel orientations, with the distal and proximal fingers overlapping. To be aligned. FIG. 149 shows an external view of the ratchet mechanism of the present invention that allows for variable placement of the proximal implant 210 and distal implant 205 relative to each other.

  In this form of the invention, the distal implant locking tube 220 includes a plurality of windows 265 (eg, a plurality of circular grooves) formed along its length. Proximal implant 210 includes a plurality of inwardly projecting tongues 300 formed at points along its length. As the proximal implant 210 is advanced distally toward the distal implant 205, the inwardly projecting tongue 300 enters the window 265, thereby causing the proximal implant 210 to move into the distal implant 205. Lock to. Inwardly projecting tongue 300 is configured such that proximal implant 210 can only move in a single direction (ie, distally) relative to distal implant 205. As the proximal implant 210 is advanced distally relative to the distal implant 205, the inwardly projecting tongue 300 can slide out of the window 265 and enter the distally located window 265. . If desired, window 265 includes a chamfered distal edge, and movement of inwardly projecting tongue 300 from window 265 as proximal implant 210 moves distally relative to distal implant 205. May be promoted.

  Also, referring to FIG. 150, a “notch distance” that governs the ability to vary the degree of compression established between legs 235 of distal implant 205 and legs 295 of proximal implant 210. Note that the distance between the windows 265).

  The overlap and / or degree of alignment of legs 235 of distal implant 205 and legs 295 of proximal implant 210 can be controllably adjusted in several ways. Initially, the locking mechanism (eg, the inwardly projecting tongue 300 of the proximal implant 210 and the window 265 of the distal implant 205) is positioned on the proximal implant 210 relative to the distal implant 205 prior to locking. Can be properly positioned relative to each other to set the orientation.

  In one form of the invention, referring to FIGS. 151-154, a mechanism for setting the rotational orientation of the proximal implant 210 relative to the distal implant 205 is provided. FIG. 151 illustrates an alignment groove (or notch) 605 formed in the proximal end of the proximal implant 210 and a corresponding alignment alignment post (or tab) 610 formed in the proximal implant delivery tube 330. FIG. 6 shows a mechanism for alignment and / or orientation control of the proximal implant 210 through the device. If desired, a plurality of alignment grooves 605 and a plurality of corresponding alignment alignment posts 610 may be provided. By controlling the degree of rotation of the proximal implant delivery tube 330, once the proximal implant delivery tube 330 is advanced distally to engage the proximal implant 210 and the tab 610 is engaged with the groove 605. The rotational orientation of the proximal implant 210 relative to the distal implant 205 can be varied. FIG. 154 illustrates how a rotor knob 615 can be provided in one form of the invention that can be used to control the orientation of the proximal implant 210 relative to the distal implant 205. The rotor knob 615 applies a rotational force to the proximal implant tube 330 such that the rotor knob 615 rotates the implant tube 330 when the rotor knob 615 is rotated. By way of example and not limitation, in one form of the invention, when the rotor knob 615 is fully rotated clockwise, the leg 235 of the distal implant 205 and the leg 295 of the proximal implant 210 are fully Are duplicated and aligned. The gradual increase of the rotor knob 615 in half rotations can be configured to provide a 9 degree orientation difference between the legs 235 and 295. The rotor knob 615 may have discrete set points (or stop points) corresponding to each 9 degree increment of the rotor. Each one of these set points is 9 degrees, 18, 36 degrees (maximum misalignment between legs), 45, 54, 63, and 72 degrees between the two legs 235 and legs 295 ( Can correspond to the angle of the leg). The delivery device has an indication that indicates the angle between the legs 235 and 295 that is gradually increased or decreased by 9 degrees in response to a half rotation of the rotor knob 615 in a clockwise or counterclockwise direction. Also good. Other discrete angle steps or increments between legs 235 and legs 295, or a continuous range of angles, are also possible depending on the particular configuration of the rotor knob 615 design.

  The design and mechanism of action of the two-part occluder 200 is preferably individual proximal when deployed and locked (eg, with the inwardly projecting tongue 300 positioned within the window 265). It is such that the legs 295 of the implant 210 alternate and interdigitate with the individual legs 235 of the distal implant 205. FIGS. 157-159 show the fully deployed two-part with the proximal and distal walls juxtaposed when looking down (ie, viewed from the distal), the deployed two-part occluder 200 FIG. 3 is a schematic view (including a plan view) of the structural occluder 200. FIG. 155 is a photograph of the deployed occluder with the legs 235 of the distal implant 205 and the legs 295 of the proximal implant 210 offset. The variable offset between legs 235 and legs 295 allows adjustment of the crimp tension applied to the tissue. By way of example, and not limitation, with respect to tissue that is delicate or easily damaged or torn (eg, brain tissue), or tissue with limited elasticity, generally, leg 235 and leg 295 have lateral tension. Are preferably substantially completely opposite (ie, aligned with each other) so that they are not applied to the tissue. Similarly, for lung tissue, it is generally preferred that the legs 235 and legs 295 have substantial overlap so as to minimize the tension applied to the tissue.

  On the other hand, for many vascular applications, maximum interdigitation (i.e., minimal overlap of legs 235, 295) is generally used to maximize the tension applied to the tissue and thereby occlude the vessel. Preferred (eg, a 36 degree angle between leg 235 and leg 295 may be desired).

  In the interdigitated state of legs 235 and legs 295, tension is projected across the tissue and the closing force extends beyond the physical dimensions of legs 235 and legs 295 themselves.

  Accordingly, the placement of the legs 235 of the distal implant 205 relative to the placement of the legs 295 of the proximal implant 210 can be controlled to apply a desired crimping force according to the type and / or condition of the tissue to be crimped. I understand that.

  FIG. 160 shows several photographs that more clearly illustrate how the two-part occluder 200 can effectively crimp tissue (in this case, a simulated blood vessel). The legs 235 of the distal implant 205 and the legs 295 of the proximal implant 210 are shown interdigitated. This creates a fold or fold in the tissue that acts to dilate effective closure and applies a closing force to the vessel beyond the area directly contacted by the occluder legs 235,295. By way of example, but not limitation, a two-part occluder 200 having a physical occlusion diameter of 5.5 mm can close a vessel with a diameter greater than 7 mm (or even greater than or equal to 1 cm). .

  In one embodiment of the present invention, and looking now at FIG. 161, the legs 295 of the proximal implant 210 and the distal implant 205 are oblique so that the legs 295, 235 are not sharp. The legs 295, 235 should be crimped at the free end of each leg (ie, on the end of the leg remote from the distal implant locking tube 220). It may be designed to be oriented away from the organization. This is to minimize any capture or damage that can be imparted to the tissue by the legs 235, 295, thereby minimizing tissue tearing or tearing. In other embodiments of the invention, it may be desirable to provide a sharp end to the legs 235, 295 so that the legs 235, 295 capture or puncture tissue for better grasping. . The legs 235, 295 may be smooth, or the surface of the legs 235, 295 may be chemically etched, for example, to improve implant reflectivity or provide maximum tissue capture and grasping. Alternatively, it may be roughened through mechanical means.

  160 and 161, (i) the legs 295 of the proximal implant 210 and the legs 235 of the distal implant 205 are interdigitated and interdigitated with each other, and (ii) the legs 295 of the proximal implant 210. It can be seen that the distal end of is passed distally from the proximal end of leg 235 of distal implant 205 and vice versa. Indeed, when fully deployed on an artery or vein, or transport tube, or other organ tissue, the distal implant locking tube 220 by the legs 235, 295 of the distal implant 205 and proximal implant 210, respectively. There is a dominant circular occlusion of the vessels around The circular occlusion is, in some respects, that the proximal and distal walls of the vessel are brought into close contact with each other with the distal implant locking tube 220 in the center of the “pie”. Similar to “puff pastry” pattern.

  FIG. 161 shows the shear stress induced during the interdigitation of the legs 235 and legs 295 and acting to pull the tubular structure opening closed.

  FIG. 162 illustrates how multiple forces can be applied across the vessel using the interdigitation of the legs 235, 295 of the two-part occluder 200 of the present invention.

  FIG. 163 shows the strain induced in the vessel by the crimping force generated by the interdigitated legs 235, 295 of the two-part occluder 200 using cross sections ab and bc.

  FIG. 164 is a plan view showing tissue hatching when the legs 235 and legs 295 of the two-part occluder 200 are interdigitated. Dashed lines indicate areas that can be pulled together to touch the tissue. When the legs 235, 295 are interdigitated, a force is applied and spreads radially beyond the physical length of the legs 235, 295, causing the crimped tissue closure to reduce the physical leg diameter. Extend beyond.

  Due to the interdigitated mode of operation, the estimated sum of the proximal and distal wall thicknesses of the vessel to be occluded does not necessarily determine whether effective occlusion can be achieved. . When the occlusion component (ie, leg 235 and leg 295) is deployed, the proximal and distal walls of the vessel, regardless of their summed wall thickness, intersect each other's plane. 3.5 mm muscular arteries that are mated opposite each other, ie, about 0.6 mm wall thickness (1.2 mm total when combined), plus about 1.0 mm wall thickness (2.0 mm when combined) Compared to a 7.0 mm muscular artery with a 2.0 mm vein has an approximately 0.2 mm wall thickness (0.4 mm when combined). Each of these vessels with variable dimensions can be effectively occluded using the two-part occluder 200 due to the way the two-part occluder 200 ligates the vessel. . Interdigitation of the leg 295 of the proximal implant 210 and the leg 235 of the distal implant 205 results in the occluder component legs 295, 235 when the two-part occluder 200 is deployed across tissue. However, since it intersects each other's planes, it means that effective closure can be achieved even with very thin tissue.

  In one embodiment of the invention, when the leg 295 of the proximal implant 210 and the leg 235 of the distal implant 205 are interdigitated, a two-part occluder 200 is used to The force required to close the vessel placed between the distal implant 205 is much less than the force required to close the same vessel using a conventional ligation clip. In the case of the two-part occluder 200, the interdigitated legs 295, 235 are pressed against the tissue, causing tissue undulation, bending, or hatching, but the opposite set of legs 295, This is due to the fact that it cannot be pushed up to the full power of 235. This means that vascular closure can be achieved with reduced levels of force or pressure on the tissue.

  FIG. 165 is a histological section showing the residual effect on vessel cross-section occluded by legs 295, 235 after vessel healing up to 30 days. The vessels are completely occluded and the vessel wall tissue is compressed together and “healed” together with early healing. The effect of shear forces that collapse the vessel walls together can be seen in FIG. A “puff pastry” closure can likewise be observed more clearly. The arrow indicates a collapsed wavy artery. AVO indicates the location of the alternating mating legs of the two-part occluder 200.

  The two-part occluder 200 of the present invention can be used to occlude vessels, transport vessels, and / or compress tissue so that it is occluded / compressed with a force of less than 700 grams while The force required to use to seal the vessel or crimp the tissue is about 10 times greater. The delivery system for the two-part occluder 200 provides a force that is transmitted directly from the operator to the two-part occluder 200. This reduces the requirements and dependence on the delivery device and the amount of force or pressure that an operator may need to apply. The two-part occluder 200 of the present invention can maintain operation within the elastic range and need not be plastically deformed to achieve occlusion.

(6. New clip with interdigitated fingers)
It should be understood that the use of interdigitated legs to occlude the vessel can be expanded beyond use with the two-part occluder 200. By way of example and not limitation, a new clip 625 can be provided that includes interdigitated and at least partially horizontally spaced legs 630 connected at a common end 635.

  FIGS. 166-168 show a new ligation clip 625 that uses an interdigitated leg 630 (deployed alternately on the proximal and distal sides of the vessel) to provide vessel closure. Again, shear stress is induced to close the vessel or transport tube. Interdigitation of the legs 630 may also reduce the likelihood that the tissue being crimped may slip or the crimp may be diminished. In this case, like the hemostatic clip, the legs 630 of the ligating clip 625 are “collapsed” together across the vessel to be occluded or the tissue to be attached. In one embodiment of the invention, the leg 630 has a tip of the leg 630 deployed on the distal side of the vessel, now above the tip of the leg 630 deployed on the proximal side of the vessel. And are pushed to cross each other's planes, thus the tissue between them is stretched to close.

(7. Delivery of multiple two-part occluders)
The ability to deploy multiple two-part occluders 200 during the procedure can be an important advantage in many applications. By way of example, and not limitation, when treating venous return disease, multiple return sites may need to be occluded or a length of vessel may need to be occluded, It may be desirable to achieve this utilizing a two-part occluder 200. As a further example, but not limited to, when preparing a vein or artery to be used for a bypass procedure, multiple branches or tributary vessels need to be occluded, and multiple parts of the present invention A configuration occluder 200 may be used. By way of example, but not limitation, when it is desired to isolate the area between two parts of a vessel or transport tract by excising the area between the two parts (eg, when removing the bile duct) One two-part occluder 200 may be deployed on each side of the area to be ablated to prevent blood loss. For example, when it is desired to remove the gallbladder, the gallbladder duct needs to be ligated to prevent extravasation of bile from the common bile duct, or when collecting organs such as the kidney for transplantation, Alternatively, for the purpose of therapeutic consideration, there is a case where a part or the whole of an organ such as the spleen is removed.

  There are several ways in which multiple two-part occluders 200 can be delivered.

(8. Reusable handle with disposable tip)
Referring now to FIGS. 169 and 170, a plurality of two-part occluders 200 can be delivered using a plurality of single-use disposable delivery devices 640, each single-use delivery device 640 being a single A two-part occluder 200 is included. With this form of the invention, each single-use disposable delivery device 640 is used to deploy a single two-part occluder 200, and then the single-use disposable delivery device 640 is used after Discarded. A plurality of single-use disposable delivery devices 640, each incorporating a two-part occluder 200, are packaged as a single sterilization package (eg, 3 or 6 single-use delivery devices in a sterilization package). Also good. After the sterilization package is opened and some (or all) of the single use delivery devices are used, all single use delivery devices must be discarded. Alternatively, each single use disposable delivery device 640 may be packaged in its own sterile package.

  Turning now to FIG. 170, in one form of the invention, a disposable delivery device for delivering a single two-part occluder 200 is provided. 171 and 172 illustrate the deployment steps for the delivery device embodiment. FIG. 172 shows (a) hollow needle 305 passing through a blood vessel, (b) deployment of distal implant 205, (c) retracting hollow needle 305 and deploying proximal implant 210, (d) proximal implant 210 and distal. The use of the push rod 320 to lock the positioning implant 205 together is shown. The next step (not shown) involves retracting the proximal implant delivery tube 330. Exposing the junction between the distal implant locking tube 220 and the distal implant delivery tube 310, rotating the knob 620 (FIG. 170), rotating the distal implant delivery tube 310, and connecting it to the distal implant Release from the stop tube 220 and release the two-part occluder 200 from the delivery device. The delivery device is then removed, leaving the two-part occluder 200 deployed.

  In another embodiment of the invention, and looking now at FIG. 173, the hollow needle 305 of the delivery device may include a two-part occluder 200, and once deployed, the hollow needle 305 is A new hollow needle 305 (including a two-part occluder 200 disposed therein) is affixed to the delivery device and may be removed from the delivery device handle during a given procedure. It may be used to deploy the part occluder 200. Thus, the handle and delivery element are retained throughout the procedure, while the hollow needle 305 (and thus the two-part occluder 200 is included therein) is replaced. This form of the invention allows the delivery device to be reused multiple times during the procedure, while individual two-part occluder 200 is deployed and multiple hollow needles 305 are discarded. Is done. The hollow needle 305 is attached to the handle (preloaded with the two-part occluder 200) prior to delivery of the two-part occluder 200 and is attached and detached following delivery of the two-part occluder 200. Can be replaced with a new hollow needle 305 (preloaded with another two-part occluder 200). This approach allows the delivery of multiple two-part occluders 200 during a single procedure, and the handle and delivery element are generally less expensive than the hollow needle 305 that is pre-delivered with the two-part occluder 200. Therefore, the cost of the system is reduced.

  In one form of the invention, the handle and delivery element can be sterilized and reused for multiple procedures.

  In one form of the invention, the hollow needle 305 is threaded and configured to be screwed into a delivery device. See FIG. 173, which is a cross-sectional view of the two-part occluder 200 preloaded into the hollow needle 305 that is attached to the delivery device using the releasable locking mechanism 645.

  FIG. 174 shows a cross section of a hollow needle 305 preloaded with a two-part occluder 200 and a releasable locking mechanism 645 for attaching the hollow needle 305 to a delivery device. FIG. 175 is an external view of the hollow needle 305 showing the releasable locking mechanism 645. See also FIG. 176 showing a reusable delivery device.

(9. Rotating barrel)
In yet another form of the invention, a plurality of two-part occluders 200 can be placed in a single delivery device. In one preferred form of the invention, and looking now at FIGS. 177-187, a plurality of two-part occluders 200, each contained within its own hollow needle 305, is a chamber 650 in a barrel-shaped cartridge 652. Which, in turn, are mounted on the housing 665 and thereby deployed one by one as discussed below. In other words, in this embodiment of the present invention, rather than having a hollow needle 305 pre-loaded with a two-part occluder 200 and attached to the same delivery device, a plurality of two-part occluders 200 are provided. Each is loaded into its own hollow needle 305 and into the chamber 650 of the cartridge 652 so that delivery of multiple occluders is once through its own corresponding hollow needle 305. Allows one to be expanded.

  In one preferred form of the invention, the cartridge 652 is rotated and the preloaded preload contained within the cartridge 652 across the tubular structure (or tissue) to be closed (or crimped). Used to deploy the hollow needle 305 and then used to deliver the preloaded two-part occluder 200 contained within the hollow needle 305.

  FIGS. 177-187 show in more detail a device and delivery mechanism for deploying multiple occluders. FIG. 177 shows six hollow needles 305 each contained within its own chamber 650 within cartridge 652. The cartridge 652 is controllably rotatable through the rotation of the knob 653. The rotation of the knob 653 rotates the rotor element 654 which serves to rotate the barrel 652 to the next stop notch 655, which corresponds to the next chamber 650 of the barrel 652. Needle push rod 660 is actuated by lever 656, proximal implant delivery rod 680 is actuated by lever 657, and proximal implant delivery tube 690 (or 330) is actuated by lever 658. When actuated, the lever moves the corresponding support struts 659, 661, and 662 forward toward the barrel 652. Needle push rod 660 has a reversible latching mechanism 663 provided on the distal end of needle pushrod 660 which is configured so that needle pushrod 660 pushes hollow needle 305. Similar to the releasable locking mechanism 645 of the single use delivery device 640 in that the needle push rod 660 allows it to reversibly latch onto the hollow needle 305 so that it can be moved or pulled. Please note that.

  In use, looking now at FIGS. 178-181 to deliver the two-part occluder 200 across the tubular structure, the lever 656 is activated and the needle push rod 660 is hooked onto the hollow needle 305. The needle pushrod 660 is pulled proximally to stop and move the needle pushrod 660 distally into the chamber 650 to push the hollow needle 305 at least partially out of the cartridge 652. The hollow needle 305 (and delivery device) is then positioned across the tubular structure to be occluded. The next lever 657 is pulled proximally so that the proximal implant delivery rod 680 locks onto a hook formed on the proximal end of the distal implant locking tube 220, thereby causing the proximal implant Push delivery rod 680 distally. Next, the lever 658 is proximal to deliver the proximal implant delivery tube 690 so as to cover the latching or locking region between the distal implant locking tube 220 and the proximal implant delivery rod 680. Pull on. The next lever 657 is pulled back further proximally, thereby deploying the distal implant 205. See FIG. 183. The levers 658 and 657 are then pulled back further proximally to deploy the proximal implant 210 and lock the distal implant 205 and the proximal implant 210 together via the distal implant locking tube 220. Referring now to FIG. 185, levers 657 and 658 may be moved distally forward to retract proximal implant delivery tube 690 proximally and release implant 220 from delivery device and hollow needle 305. Pressed. The lever 656 is then pushed distally forward to retract the deployed hollow needle 305 back into the barrel 652. See FIG. 186. The barrel 652 is then rotated to the next chamber 650 location containing a new hollow needle 305 preloaded with the two-part occluder 200. The cartridge 652 is rotated by rotating the knob 653 of the delivery device. The delivery device is now ready to deliver another two-part occluder 200 in the same manner as described above. Note that after the two-part occluder 200 is deployed, the empty hollow needle 305 is retracted proximally and contained within the cartridge 652, as shown in FIG.

  FIGS. 188 and 189 are plan views of a delivery device in which a cartridge 652 (sometimes referred to herein as a “barrel”) includes a plurality of two-part occluders 200, each two parts Constructive occluder 200 comprises a pair of crimping elements (eg, distal implant 205 and proximal implant 210) and an associated hollow needle 305. In this form of the invention, all two-part occluders 200 disposed within the cartridge 652 are delivered one at a time through separate hollow needles 305. In this form of the invention, multiple hollow needles 305 are used, but only a single delivery mechanism is required. The advantage of using multiple hollow needles 305 where each two-part occluder 200 is deployed via a separate hollow needle 305 is that each hollow needle 305 is sharp and has a tubular structure, organ or tissue. It is not slowed down by multiple penetrations through. Using the embodiment shown in FIGS. 188-191, the hollow needle 305, proximal implant delivery tube 690, and proximal implant delivery rod 680 are preloaded into the chamber 650. Each two-part occluder 200 is deployed in a manner similar to that previously described (ie, FIGS. 177-187), however, the proximal implant delivery rod 680 does not require a hook in this case. Accordingly, the delivery mechanism of the delivery device can be simplified from the delivery device shown in FIGS. 177-187.

  As seen in FIGS. 192-196, in another preferred form of the invention, a plurality of two-part occluders 200 are contained within the cartridge 652 and delivered through the same hollow needle 305. Since there is only a single hollow needle 305, the two-part occluder 200 contained within the cartridge 652 is a single hollow needle 305 positioned in the center of the delivery device from the cartridge 652 for deployment. It is loaded one by one.

  FIG. 196 shows a top view of the multiple occluder single needle device shown in FIGS. 192-195, with the hollow needle 305 located in the center of the cartridge 652. FIG. In this form of the invention, each two-part occluder 200 is contained within a tube 664. A plurality of tubes 664, each including the two-part occluder 200, are loaded into the cartridge 652 and into the pre-deployment clamp area 666, and a spring moves them toward and into the hollow needle 305. To push. Once each two-part occluder 200 is deployed, a lever or button is depressed, allowing an empty container 667 to be pushed into the waste receptacle 668 after deployment. The push rod for deploying the two-part occluder 200 is located perpendicular to the clamp deployment area shown and can be operated in the same manner as shown for the multi-needle deployment device described above.

  FIGS. 197-219 illustrate another operational concept of a multiple occluder delivery device formed in accordance with the present invention, wherein the two-part occluder 200 is delivered through the same hollow needle 305. FIG. The barrel 670 having a plurality of chambers 675 into which a plurality of two-part occluders 200 can be loaded is a single unit without the need for the plurality of two-part occluders 200 to remove the hollow needle 305 from the patient body or laparoscopic port. It is embolized in the delivery device so that it can be delivered one by one through one hollow needle 305.

  FIG. 198 shows a multiple occluder barrel 670 loaded with a two-part occluder 200. The number of the two-part occluder 200 and which chamber 675 is loaded with the two-part occluder 200 may be selected and controlled by the user.

  FIG. 199 shows one embodiment where the two-part occluder 200 is preloaded into the exchangeable barrel 670 of the delivery device.

  FIG. 200 shows a side view of a multiple occluder delivery device 665.

  201-204 show the proximal implant delivery rod 680 and hook 685 locked onto the distal implant locking tube 220 of the two-part occluder 200. FIG. Proximal implant delivery tube 690 covers the hook region of the two hooks, thereby securing the connection.

  FIGS. 205-209 illustrate how in a coordinated manner, the proximal implant delivery rod 680 and the proximal implant delivery tube 690 push the two-part occluder into (and through) the hollow needle 305. Indicates whether it is pushed down (ie, distally) (ie, together).

  FIGS. 210-214 and 215-219 illustrate how a hollow needle 305 pierces a tubular structure (or blood vessel or tissue) using steps similar to and similar to those shown in FIGS. 106-120. Shows whether the occluder 200 is deployed across a vessel or transport tube. Once the distal implant 205 is deployed, the hollow needle 305 is retracted to deploy the proximal implant 210. Proximal implant delivery tube 690 then pushes and locks proximal implant 210 onto distal implant locking tube 220, which is placed between proximal implant 210 and distal implant 205, which Is pushed downward (ie, distally) to compress and secure the tubular structure between the proximal implant 210 and the distal implant 205. Proximal implant delivery tube 690 is then lifted (ie, moved proximally) to expose the crimped region between proximal implant delivery rod 680 and distal implant locking tube 220. The proximal implant delivery rod 680 is then rotated to unlock it from the distal implant locking tube 220. The delivery device, along with the hollow needle 305, leaves the two-part occluder 200 withdrawn and pierced for implantation to be placed across the tubular structure, vessel, or tissue to be crimped.

(Continuous deployment of 10.2-part occluder 200)
In another form of the invention, the multiple two-part occluder 200 may be disposed within the same hollow needle 305 and deployed one by one in a continuous manner. See FIG.

(11. Occlusion using asymmetric legs 235, 295)
FIG. 221 shows a two-part occluder 200 of the present invention that prevents bleeding caused by a piercing rod (ie, distal implant locking tube 220). For example, after removal of the aneurysm, the vascular edge is fragile and the synthetic graft attachment necessary to close the intravascular gap with sutures is complicated by bleeding from the needle entry point, There are many applications where such a device may prove useful, particularly in aortic aneurysm repair in the thoracic aorta. This can result in clinical failure and endanger the patient or cause complications. Another example is the resection and suturing of this appendage of the heart, which can be resected in a patient with an arrhythmia due to an embolus from the heart atrial appendage. Suturing the atrial appendage wall with a support (buttress) synthetic material often results in significant bleeding from the point of entry of the hollow needle 305.

  FIG. 221 also shows the two-part occluder 200 and the effective pressure area surrounding it. Note that the different overlap between the leg 295 of the proximal implant 210 and the leg 235 of the distal implant 205 can be controllably adjusted to provide the desired pressure range and occlusion level.

  In one form of the invention, the pressure zone generated by the two-part occluder 200 is a circular area (FIG. 222) that extends around the entry point of the piercing distal locking tube 220, but other In an embodiment, the pressure zone is the length of the leg 235 of the distal implant 205 and the length of the leg 295 of the proximal implant 210, as shown in FIG. 223, the two-part occluder 200 is a bifurcated vessel or tissue. It may be non-circular so that it can be positioned proximally, meaning that it is not equal along one axis to another axis.

  More specifically, FIG. 223 shows that the legs 235 of the distal implant 205 and the legs 295 of the proximal implant 210 are not symmetrical, but rather oval (ie, one dimension over the other dimension). 2) shows a two-part occluder 200 that allows placement close to the interconnect region. In one form of the invention, the orientation of the two-part occluder 200 may be determined using markings (eg, arrows indicating the longitudinal direction of the legs 235, 295) placed on the delivery device handle. it can. In a laparoscopic or open procedure, the orientation of the two-part occluder 200 can also be visually confirmed. In percutaneous applications, ultrasound or CT imaging can further be used to determine the orientation of the two-part occluder 200 relative to the vessel, transport tube, organ, tissue to be crimped or occluded.

(12. Organizational protection)
It should be appreciated that it is often desirable to stabilize (eg, via crimping) a vessel (or other tubular structure) to be occluded using a two-part occluder 200. In addition, in many cases, as the hollow needle 305 punctures the vessel (or other tubular structure) to be occluded, the vessel (or other tubular structure) that is occluded so as not to damage the underlying tissue. It is desirable to provide a “needle shield” below.

  FIG. 224 shows the underlying tissue (via the needle stop) while holding the vessel (or tissue) in place while being pierced, and so as not to be injured by the hollow needle 305 as the vessel is punctured. That is, a delivery device comprising a grasper (or dissecting instrument) 695 that protects tissue that should not be pierced) is shown. The needle stop also has a sharp female edge and can initially serve to dissociate the tissue to be occluded from the tissue to be protected.

(13. Lifting for protection)
FIGS. 225-227 show examples of prior art dissecting instruments for open and laparoscopic surgery.

  Turning now to FIGS. 228 and 229, under certain conditions (eg, when the hollow needle 305 is being used to pierce a vessel proximate to a tissue, organ, or other vessel), it is hollow. For example, tissue, organs, nerves, or other biological materials and vessels that are positioned between the tip of the needle 305 and the vessel, for example, which may otherwise contact the tip of the hollow needle 305 undesirably. It is desirable to deploy a device 700 that can be protected. Other applications in which the present invention may be used may require a needle (or other sharp element) to pierce tissue or organ, and contemplated devices of the present invention may be “shielders” (or stops) ) And may protect any tissue or biological material that is not desired to be penetrated beyond the desired penetration site or depth.

  FIGS. 228 and 229 show the dissociation of the tubular structure “lifted” so that it can be released from the surrounding tissue prior to penetration of the tubular structure by the hollow needle 305 and delivery of the two-part occluder 200. FIG. 229 shows anti-traction by raising the “projection of the dissecting instrument” 705, 710, which allows easy penetration of the tubular structure by the hollow needle 305, but increases the depth of penetration by the hollow needle 305. Without control, thereby allowing the underlying tissue to be penetrated and / or damaged by the hollow needle 305.

  FIG. 230 shows another form of dissecting instrument formed in accordance with the present invention that can be used for dissociation of the tubular structure to release the tubular structure from the surrounding tissue. The dissecting instrument 715 provides lift and anti-traction and provides a shield 720 to limit the penetration of the hollow needle 305 into the surrounding (ie, underlying) tissue, structure, or internal organs. More specifically, FIG. 230 shows the dissection instrument 715 in a closed neutral position. The dissecting instrument preferably comprises two protrusions 705, 710 having a curved distal tip 725. One distal tip 725 of the dissecting instrument 715 includes two superimposed curved blades 730, 735 that are connected to a control rod 740. FIG. 231 shows how to depress the control rod 740 and pull the two curved blades 730, 735 of the dissecting instrument 715 apart. The rotation of the control rod 740 rotates the movable portion (ie, the curved blades 730, 735) of the dissecting instrument tip. As desired, the second protrusion 710 of the dissecting instrument 715 has a single fixed curved blade 730. In another embodiment of the invention, the dissecting instrument tip 725 can be flat, can be controllably rotated, and can protrude outward from the blade.

  FIG. 232 shows the closed neutral position of the adjustable protrusions 705, 710 and the two curved blades 730, 735 are in close contact (ie, on top of each other). The movable curved blade 735 is connected to a control rod 740 that can be depressed and rotated. In this embodiment, the dissecting instrument 715 is designed such that the protrusions 705, 710 can overlap and thus can be easily delivered through a standard cannula, for example, for laparoscopic procedures. FIG. 233 illustrates that rotation of the dissecting instrument protrusions 705, 710 may cause the dissecting instrument to be in an operational configuration.

  FIG. 234 is now open and comprises two “protrusions”, the first protrusion 750 having a single tip 755 and the second protrusion 760 having a double adjustable tip 765. Fig. 8 shows another form of dissection instrument 745 formed in accordance with the present invention. Rod 770 is mounted on the movable component of double dissecting instrument tip element 765. FIG. 235 shows the vessel (or tubular structure) to be pierced by the hollow needle 305 and the surrounding or underlying tissue.

  FIG. 236 shows that the vessel (or tubular structure) is dissociated from the surrounding tissue and raised by two distal tips (or blades) 755, 765 and the hollow needle 305 is ready to penetrate the vessel (or tubular structure). Indicates the completed state.

  FIG. 237 shows a rod 770 that is depressed to separate the two elements 775, 780 of the double adjustable tip 765.

  FIG. 238 shows the distractor tip extended distal blade (shield) by rotating the rod 770 such that the extended distal blade is directed toward the second dissector tip 755. 780 shows the state being rotated.

  FIG. 239 shows the shield 780 in place when the hollow needle 305 penetrates the vessel (or tubular structure). The shield 780 limits the distal penetration of the hollow needle 305 and protects surrounding tissues, organs, and structures (eg, nerves, arteries, veins, etc.). Although the embodiment of FIG. 239 shows a needle separate from the dissecting instrument 745, in another embodiment of the present invention, the needle may be configured so that once the dissecting instrument 745 is deployed and the shield 780 is positioned, the hollow needle 305 is positioned. Crimp vessel, tissue, transport tube, organ, dissection instrument 745 so that it can be positioned across the vessel, tissue, transport tube, or organ for deployment of two-part occluder 200 May be connected.

(14. Dissecting instruments)
In yet another form of the invention, and looking now at FIGS. 240-242, the needle stop (or “shield”) 785 is an integral part of the dissection instrument 695 support and the two-part occluder 200 delivery device. And / or the hollow needle 305 of the delivery device may be attached to the dissecting instrument 695 support. The needle stop 785 may be sharp so that the needle stop 785 functions as a dissecting instrument and separates the tissue located above the stop from the tissue located below the stop. In one embodiment of the invention, a support 790 is provided on the dissecting instrument 695 to support the tissue to be raised above the needle stop 785. The gap between the needle stop 785 and the support 790 is preferably 1 cm or more, and in another embodiment of the invention, the gap between the needle stop 785 and the support 790 is 0. Equal to or above 25 cm, in another embodiment, the needle stop 785 is movable and / or controllable to a point where the needle stop 785 and the support 790 contact.

  FIG. 240 shows the hollow needle 305 attached to the dissecting instrument 695. If desired, the needle stop 785 can serve as a dissecting instrument, and prior to deployment, to minimize the cross-section of the needle stop 785 (eg, the needle stop 785 cannulate the cannula. And may be configured to be “folded” (or rolled up, similar to the dissecting instrument shown in FIGS. 230 and 231).

  FIG. 241 shows the vessel or tissue held in place by the support 790 creating a gap between the vessel and the needle stop 785. With the above structure, in one embodiment of the present invention, the dissecting instrument 695 may be used to provide sufficient space to deploy the two-part occluder 200.

  FIG. 242 illustrates another embodiment of the present invention, where an additional support 790 is provided, and further the support 790 is movable relative to each other, thereby acting as a clamp and tissue Together, thereby facilitating vascular penetration by the hollow needle 305.

  In yet another form of the invention, the tissue retention element and the protective stop create a sufficient gap for the hollow needle 305 to be delivered across the vessel, organ, or tissue to be penetrated by the hollow needle 305. And can be pulled together (or pulled apart) so that the distal implant 205 can be deployed into the gap. The protective stop and tissue holder can be sized for easy passage through a laparoscopic cannula.

  FIG. 243 shows that the protective needle stop 785 is used as a dissecting instrument, thereby separating the biological element of interest from other biological materials, and the protective needle stop 785 is composed of two hollow needles 305. FIG. 4 illustrates one embodiment of the present invention that can serve to prevent biological material from being penetrated by the hollow needle 305 when used to deliver the occluder 200. The gap between the guard stop 785 and the tissue holder is preferably adjustable and can be controlled by depressing or pulling up the lever 786, which is (i) tissue Whether the needle stop 785 is moved distally when the lever 786 is pushed distally in either a discrete or continuous manner to increase the gap between the retainer element and the protective needle stop 785. Or (ii) when the lever 786 is pulled proximally, it reduces the gap between the tissue retainer element and the protective needle stop 785.

(15. “J” shaped needle stop deployed in parallel with hollow needle 305)
In another form of the invention, and looking now at FIGS. 244-247, the hollow needle 305 and the new needle stop 795 contained within the sheath 800 once the hollow needle 305 has been deployed from the sheath 805. The needle stops 795 extend parallel to each other so that they can be bent and aligned under the hollow needle 305, thereby preventing contact between the hollow needle 305 and the tissue just below the needle stop 795. It may be configured to be. In one embodiment of the present invention, the hollow needle 305 and the needle stop 795 are used in conjunction with forceps (or a dissecting instrument) that supports the tissue to be pierced by the hollow needle 305.

  FIG. 244 illustrates how the hollow needle 305 and needle stop 795 can be deployed using a cannula (eg, laparoscopic cannula) 810 to facilitate delivery through a laparoscopic port. Show. This approach may be used in conjunction with a separate dissecting instrument (not shown) and may include a housing rather than a cannula.

  FIG. 245 shows that the hollow needle 305 and needle stop 795 are deformable or shape memory material, ie, material that has been cut to allow the needle stop 795 to curve (eg, laser machined). 3 shows another embodiment of the present invention comprising (stainless steel). Needle stop 795 may comprise a tubular structure, ribbon, or solid rod.

  FIG. 246 shows the deployment of the needle stop 795. Once in the desired location, the needle stop is pushed out of its sheath 800 and delivered and deployed just below the structure to be punctured by the hollow needle 305 (setting the two-part occluder 200). The depth, length, and rotation angle of the needle stop 795 are typically set in advance such that the needle stop 795 is located where the tip of the hollow needle 305 is located below and around. The

  FIG. 247 shows how once the puncture is complete, the hollow needle 305 is first removed from the vessel (ie, removed proximally) and then the needle stop 795 is removed. . In another embodiment of the invention, the needle sheath 805 and the needle stop sheath 800 are not connected together.

  As described above, the hollow needle 305 and the needle stop 795 are preferably arranged as two separate parallel elements, and the needle stop 795 preferably comprises a shape memory or superelastic material (eg, Nitinol). Attached to the containing hollow tube (or entirely made from the hollow tube). However, it should also be understood that the needle stop 795 and the hollow needle 305 may be at least partially arranged in a coaxial direction, if desired. See FIG. 248.

  More specifically, FIG. 248 illustrates protection of tissue at the distal side of the vessel, where the tissue is protected from damage by the two-part occluder 200 or the hollow needle 305. This structure ensures that the two-part occluder 200 can be fully deployed without interfering with the tissue surrounding the target tissue, vessel, or organ.

(16. Tissue separation)
FIGS. 249 and 250 allow deployment of the distal implant 205 of the two-part occluder 200 so that the tissue spacing mechanism 815 creates a gap between the target tissue, vessel or organ and the underlying tissue at the desired distance. 18 shows a tissue spacing mechanism 815 that can be used to pull tissue located near the distal tip of the hollow needle 305 away from the hollow needle 305, as used to form. This form of the present invention simplifies the robotic surgical procedure because it can eliminate the need for a separate instrument to dissociate and create a safe space for deployment of the two-part occluder 200 May be used. See FIGS. 251 and 252.

  In another embodiment of the present invention, the ratchet and locking mechanism limits the movement of the hollow needle 305 to only a fixed amount beyond the end of the sheath or the end of the laparoscopic cannula, thereby It may be deployed to limit the depth of deployment of the hollow needle 305 beyond the vessel, tissue, or organ to be pierced.

  In another embodiment of the invention, the hollow needle 305 is spring retractable so that as soon as the hollow needle 305 punctures a vessel, the hollow needle 305 retracts immediately, thereby protecting the underlying tissue. is there.

(17. Two-part occluder that punctures a vessel from the bottom)
In the foregoing disclosure, the two-part occluder 200 is delivered through a hollow needle 305 that punctures a vessel (or other tubular structure to be occluded). More specifically, using the two-part occluder 200, when the distal implant 205 is placed distal to the vessel (or other tubular structure) to which the distal implant 205 is to be occluded, The distal implant locking tube 220 is delivered through the hollow needle 305 such that it extends through the vessel (or other tubular structure) to be occluded when the hollow needle 305 is retracted proximally. However, if desired, the hollow needle 305 can be omitted and the distal implant locking tube 220 can puncture the vessel to be occluded distally to proximally (ie, the vessel). To puncture tissue from the distal side to the proximal side of the vessel.

  Another embodiment of the invention is shown in FIG. In this form of the invention, the delivery device 825 includes a retainer 830 for the distal implant 205, and the proximal implant 210 is then occluded with the distal implant locking tube 220 as discussed below. After the distal implant 205 is deployed to puncture a vessel (or other tubular structure) to be slid, it is slid down to the top of the distal implant 205. In this form of the invention, the distal implant 205 comprises a distal implant locking tube 220 having a sharp end 835 that pierces the vessel (or other tubular structure) to be occluded, while proximally. The implant 210 includes a cap 840 that attaches to the sharp end 835 and protects adjacent tissue from inadvertent injury due to the sharp end 835 of the distal implant locking tube 220. This configuration of the two-part occluder 200 is particularly advantageous for use in open surgical procedures, but may also be used in laparoscopic and other procedures.

  More specifically, FIGS. 253 and 254 have a spiked distal implant locking tube 220 (ie, the distal implant locking tube has a sharp end 835) and a deployment delivery device 825 (eg, A distal implant 205 is shown mounted on a clamp or forceps.

  FIGS. 255 and 256 show the delivery device 825 and the distal implant 205 positioned just below the vessel to be occluded, and the distal implant locking tube 220 distally from the distal side of the vessel Puncture the vessel in the proximal direction, and the distal implant locking tube 220 penetrates through the vessel, thereby causing the vessel (or other tubular structure) or tissue far to be crimped (ie, proximal) ) When the delivery device 825 is moved into contact with the vessel so that it exits the wall and thus the sharp end 835 of the distal implant locking tube 220 is exposed to the proximal side of the vessel. Figure 2 shows a delivery device.

  FIGS. 257 and 258 are mounted on a delivery device 825 and through a hole 845 in which a cap 840 is formed in the retainer 850 so that the proximal implant 210 is removably retained on the distal side of the retainer 850. The proximal implant 210 is shown extending. Note that the proximal implant 210 includes a locking shaft (ie, a tube 275) that extends substantially perpendicular to the legs 295 of the proximal implant 210. Tube 275 also includes a cap 840 for locking proximal implant 210 to distal implant locking shaft 220.

  FIGS. 259 and 260 show the proximal implant 210 and the distal implant 205 being brought into contact with each other by aligning the distal implant 205 and the proximal implant 210. The tube 275 (and cap 840) of the proximal implant 210 that is hollow is locked to the distal implant locking tube 220 (which may or may not be hollow) of the distal implant 205. The Tube 275 (and cap 840) and distal implant locking tube 220 may be made of different materials (eg, titanium and stainless steel) or tube 275 (and cap 840) and distal implant locking tube 220. May be made from the same material. If desired, distal implant locking tube 220 and proximal tube 275 may be configured to be continuous with leg 235 of distal implant 205 and leg 295 of proximal implant 210, respectively. .

  FIGS. 261 and 262 show how the delivery device 825 is removed after the distal implant 205 and the proximal implant 210 are locked together.

  More specifically, FIG. 263 shows the delivery device being removed and leaving the vessel occluded using the two-part occluder 200. The tube 275 of the proximal implant 210 (only part of the proximal implant 210 and may be made from nitinol or titanium or other metal) is engaged with the distal implant locking tube 220 of the distal implant 205. Not only does it serve to stop, but also protects the surrounding tissue by covering the sharp end 835 of the distal implant locking tube 220.

(18.2 part use occluder example use)
By way of example and not limitation, the two-part occluder 200 of the present invention may be used for and in procedures such as left atrial appendage occlusion. The two-part occluder 200 is also useful in cardiothoracic vascular applications such as internal thoracic artery bypass surgery, and for dissecting an aortic aneurysm, where reliable ligation of the bifurcation is important for prevention of bleeding. It should be understood that it may be used for treatment (generally performed by suturing a patch over a natural artery to allow suture attachment to an intervening graft). When using such a procedure, one problem is typically bleeding through the needle hole of the piercing suture. The present invention can be used to pressurize the tissue around the puncture point and prevent bleeding.

  In a similar manner, when the atrial appendage is occluded to prevent clot formation and embolism during surgery, the atrial appendage tends to bleed around the needle when sutured using the needle. The novel two-part occluder 200 of the present invention can reduce this bleeding by providing a sealing pressure where the two-part occluder 200 punctures the atrial appendage.

  It should be understood that the two-part occluder 200 may be used as a vascular anastomosis device for mechanically joining various vessels together.

  In addition, the two-part occluder 200 allows for secure fixation of the coated stent to the aortic wall in endovascular treatment of aortic aneurysms, especially when the stent attachment area is short and non-uniform May be used to This may be done percutaneously or through a catheter-guided endovascular approach.

  It should also be appreciated that the two-part occluder 200 may be used in applications involving solid organs where the use of staples may be undesirable or unacceptable.

  For example, solid organs generally do not tolerate conventional staplers because solid organs bleed through staple entry points. The two-part occluder 200 of the present invention avoids these problems and is suitable for the substantial resection of organs such as the liver, spleen, kidney, and lung. The pressure zone around the puncture wound prevents bleeding that occurs using standard suture techniques through the needle entry point.

  For such applications, the present invention can be used to form a multi-vascular occluder that can simultaneously deploy rows of clips and / or apply clips laterally to a solid tissue edge. It may be desirable to modify the two-part occluder 200.

  The two-part occluder 200 of the present invention may also be used for other applications. By way of example and not limitation, the two-part occluder 200 of the present invention can be used in general surgical applications such as spermatic cord occlusion, gallbladder and bile duct occlusion, intestinal obstruction as an alternative to vasectomy in male infertility surgery It may be used in fistulas or other fistulas. Alternatively, the present invention may be used for tissue attachment during hernia repair, for example, where synthetic materials (eg, hernia mesh) are used to reinforce the site of hernia repair. The two-part occluder 200 of the present invention may also be used for secure ligation of the fallopian tubes for infertility procedures. This can be accomplished by simple application of the two-part occluder 200 of the present invention to the fallopian tube using open, laparoscopic or robotic surgery.

  It should also be appreciated that the two-part occluder 200 may be used for orthopedic applications, for example, as an anchor in joint surgery or tendon or ligament repair.

  The two-part occluder 200 also includes, but is not limited to, interventional radiology performed under imaging (eg, ultrasound, CT, fluoroscopy, etc.), including ligation of a tubular or vascular structure or joining of tissue. It may be used for guided procedures.

  When using conventional staples, a brace (buttress) is also generally used, and the integration of tissue stapling and brace provides the surgeon both greater functionality and efficiency. The present invention does not require the use of a support or support material as in the Endo GIA product, thereby simplifying the two-part occluder 200 and avoiding the need for additional material in the body, Reduce the cost and complexity of these procedures. However, as desired, in certain cases, the present invention can also be used in conjunction with similar support or support materials.

  The present invention can be used in a manner similar to a stapler for open surgical procedures (eg, open anastomosis).

  By way of example and not limitation, the two-part occluder 200 may be used for the prevention or treatment of clot embolism in the pulmonary or peripheral systemic circulation. The present invention percutaneously transects a vein in the presence of a vein (superficial or deep) having a blood clot that may propagate and release into the bloodstream in the vena cava that returns the blood to the heart and lungs. (Or in laparoscopic or even open surgery). Two or more two-part occluders 200 are placed on either side of the clot so that they can capture and contain the clot, or the occlusive element is deployed upstream from the clot, and thus the heart or lungs Propagation of blood clots toward the head may be prevented.

(19. Ligation and sclerosing or adhesive injections such as those involving ligation and cyanoacrylate) Injection of adhesives such as those containing cyanoacrylate When a long segment of a vein is to be safely occluded, A two-part occluder 200 is used as a clamp at the proximal end of the vein so that chemicals (ie, sclerosants or adhesives containing cyanoacrylate) are directly into the systemic circulation of the bloodstream. It may be prevented from flowing. This allows for safer use of either a sclerosing agent or an adhesive that can be injected into the intervening venous compartment where the occlusion is in place. See FIG. 264. Large tributaries within isolated venous compartments can also be occluded by placing two-part occluder 200 at the origin of these tributaries. Due to the injection of a sclerosing agent or adhesive to occlude the vascular compartment, only a single two-part occluder 200 (ie, only a single occlusion site) will cause the sclerosing agent to be more proximal to the vessel. It is necessary to prevent overflowing into the duct and systemic circulation. See FIG. 265.

  In one embodiment of the present invention, there is provided a method and apparatus for occluding a vessel using a two-part occluder of the present invention and comprising a protruding side needle for delivering a sclerosing agent or adhesive. Is done. In this form of the invention, an occluder (eg, two-part occluder 200) may be delivered into the upstream region of the vein, and another occluder (eg, two-part occluder 200) is downstream. May be delivered. A curing agent or adhesive is then injected between these occluder elements.

(20. Two-part occluder using electric / RF cautery)
In another form of the invention, a modified version of the two-part occluder 200 may be used to cauterize vessels, tubular structures, and / or join different tissues. More specifically, in this form of the invention, at least a portion of the two-part occluder 200 is preferably connected to an electrocautery unit (eg, monopolar, bipolar, etc.) contained within the delivery device. To do.

  In one form of the invention, the two-part occluder 200 is connected to an energy source (or multiple energy sources) and the vessel or transport tube or tissue can be occluded (or taken from each other) by the application of RF energy. Worn, fused or connected). The RF energy is between the two-part occluder 200 and an electrode located in or on the patient at another location (eg, a patient return electrode) or with the proximal implant 210 of the two-part occluder 200 It may be applied between electrodes located between the distal implant 205 and the distal implant 205. The same potential may be applied to both the proximal implant 210 and the distal implant 205 in a monopolar electrosurgical mode, or a potential difference may be applied between the proximal implant 210 and the distal implant 205 in a bipolar electrosurgical mode. It may be applied between. The energy source may generate an RF current, the current and voltage optimize tissue attachment or vascular and transport tract obstruction, and / or collagen and other protein denaturation, fusion or binding or coagulation. Alternatively, it may be monitored and controlled using a controllable duty cycle at a frequency of 200 Khz to 3.3 MHz to provide hybridization. Once energy is delivered to the tissue, the occlusive elements (eg, distal implant 205 and proximal implant 210) and delivery device are removed. See FIG. 275. In one form of the invention, the distal implant 205 and the proximal implant 210 are controlled for an amount of controllable time after application of energy and prior to removal to help ensure better occlusion. It may be held at the occlusion site. Distal implant 205 and proximal implant 210 bring the various tissues close to controllability, thereby reducing the amount of energy that needs to be imparted to the tissues and vessels, thus reducing damage, Maximize bonding. In this form of the invention, the distal implant 205 comprises a plurality of legs 855 and the proximal implant 210 comprises a plurality of legs 860. Leg 855 of distal implant 205 and leg 860 of proximal implant 210 provide a significant surface area or contact area between the occluding element electrode and the tissue. Thus, tissue bonding or sealing or connection, or occlusion of a vessel or transport tube can occur over a large surface area. This area can be much larger than the cross-section of the delivery element probe or device that penetrates the patient's skin. See FIGS. 272 and 273. In one embodiment of the invention, the effective ratio of the diameter of the distal implant 205 and proximal implant 210 to the diameter of the delivery element probe or device may be greater than or equal to 2: 1 (and up to 10: 1 or more). Further, the surface area of tissue that can be connected is large and can depend on the dimensions of the leg 860 of the proximal implant 210 and the leg 855 of the distal implant 205. These legs are functional equivalents of the legs 235 and 295 of the two-part occluder 200.

  When the distal implant 205 and the proximal implant 210 are removed, a hole may remain that is sealed around the edge within the occluded vascular transport tube or tissue compartment. However, as desired, various coagulants or sealants or adhesives (eg, cyanoacrylates) may be used with a needle or delivery device or separate so as to close the pores in the tissue and / or facilitate healing. Different delivery devices (injected through a second needle placed in the vicinity of the site).

  In one embodiment of the invention, distal implant 205 and proximal implant 210 are withdrawn through the same hollow needle 305 that delivered them.

  In one form of the invention, the distal implant 205 and proximal implant 210 are disconnected from the electrical energy source once they deliver electrical energy to the tissue and then locked together and treated with RF energy. May be disconnected from the delivery device so that it remains sandwiched and remains implanted. This approach may deform (or increase) tissue integrity (eg, in the intestine or stomach tissue) so as to reduce the likelihood that the two-part occluder 200 may move through the tissue.

  FIG. 266 illustrates a preferred embodiment of the present invention in which the distal implant 205, proximal implant 210, and insulating element 865 are shown prior to deployment. FIG. 267 shows an embodiment of the present invention where the occlusion element is deployed. All three elements generally include a delivery device and a needle (eg, hollow needle 305) that controls its deployment and delivery of the two-part occluder 200 through multiple tissue layers or vessels, transport tubes, or fallopian tubes. ) Included.

  More specifically, FIG. 266 shows individual electrode elements (ie, distal implant 205 and proximal implant 210) and insulating element 865 prior to deployment.

  FIG. 267 also shows the distal and proximal implants 205, 210 and insulating element 865 after deployment.

  FIG. 268 shows the delivery device with the hollow needle 305 attached.

  FIG. 269 shows a delivery device with a hollow needle 305 penetrating through a vessel or tissue.

  FIG. 270 shows the advancement of the distal implant 205.

  FIG. 271 illustrates the deployment / release of the distal implant 205 such that the legs 855 of the distal implant 205 extend radially outward.

  FIG. 272 shows the raising of the hollow needle 305 and the deployment of the proximal implant 210 beyond the tip of the hollow needle 305.

  FIG. 273 shows the leg 860 of the proximal implant 210 opening (or in its open state) once released from the hollow needle 305.

  FIG. 274 shows the proximal implant 210 and the distal implant 205 connected to the electrical energy source 870. In the embodiment shown in FIG. 274, there is a potential difference between the proximal implant 210 and the distal implant 205. In other embodiments of the invention, the potential difference between the proximal implant 210 and the distal implant 205 may be the same, and another electrode may be placed in or on the patient.

  FIG. 275 illustrates, for example, the application of radio frequency (RF) current and voltage between electrodes penetrating through the tissue (ie, the leg 855 of the distal implant 205 and the leg 860 of the proximal implant 210) of energy to the tissue. Indicates application. The duty cycle and frequency of the RF energy can be adjustably controlled to optimize tissue or vessel sealing while minimizing any tissue burns.

  FIG. 276 shows how the distal implant 205 is first retracted after application of RF energy to the pinched tissue. In this case, the distal implant 205 is retracted into the insulating element 865.

  FIG. 277 shows the distal implant 205 fully retracted.

  FIG. 278 shows the assembly slightly elevated relative to the tissue, with the hollow needle 305 being pushed down to begin compressing the leg 860 of the proximal implant 210.

  FIG. 279 illustrates how the hollow needle 305 compresses the leg 860 or finger (eg, leg 295) of the proximal implant 210 while the proximal implant 210 is raised relative to the hollow needle 305. Indicates.

  FIG. 280 shows how the hollow needle 305 (and assembly) is removed from the body and leaves the vessel or tissue sealed.

  FIG. 281 shows a sealed tissue region with a possible needle hole sealed around its periphery.

  In another embodiment of the present invention, the leg 235 of the distal implant 205 is placed at the tip of the hollow needle 305 and then opened and deployed by removal of the hollow needle 305 while the distal implant 205 remains in place. Is done.

  In another embodiment of the present invention, the two-part occluder 200 is used in conjunction with a robotic arm for robotic surgery. The ability to deliver the two-part occluder 200 through the needle reduces the number of steps and operations that the surgeon must perform, thereby simplifying vascular occlusion and / or tissue attachment or access. Also, the amount of surrounding tissue required to be removed from around the vessel is reduced.

(21. New handle)
As described above, the sequence of events required to deliver the occlusion device may be automated using a motor and spring system, may be rechargeable, or not. It may be powered by a power source or a battery. It should also be understood that the device may be powered by solar cells built into the system, if desired. In one embodiment of the invention, the entire delivery may be activated through a single button.

  FIG. 282 illustrates a novel handle 875 formed in accordance with the present invention that can include a battery (not shown) to provide the necessary energy, seal tissue, or automate various delivery device actions. The present invention may be connected to a transformer and / or an electrical outlet. In other embodiments, the present invention is simply a mechanical device and is not connected to any energy source, such as AC or DC voltage and current.

  FIGS. 283 and 284 show a refined handle design of a delivery device for the occluder implant 200. The refined handle design uses sliders to actuate the deployment of proximal implant 210 and distal implant 205 and lock them together.

  In practice, the vessel is occluded by sliding the handle 875 sideways and then fully sliding it down as seen in FIG. This combines with the proximal implant 210 and the distal implant 205, thereby occluding the vessel.

  Delivery device removal is accomplished by rotating the handle 875 counterclockwise until the delivery device disengages from the clip, as shown in FIG. The delivery device is then removed and retracted (Figure 285).

  In particular, (i) the handle 875 is designed to provide tactile feedback in response to clip closure, and (ii) the ratchet control of the two-part occluder 200 deployment is Providing precise and controlled deployment, (iii) The design of the handle 875 provides a stable and secure retention of the two-part occluder 200 and the firm hand provides comfort to the physician.

(Modification of Preferred Embodiment)
Details, materials (eg, shape memory polymers that dissolve permanently or over time, or carbon nanotube-based), steps, and arrangements of components described and illustrated herein to illustrate the nature of the invention It should be understood that many additional modifications can be made by those skilled in the art and still remain within the principles and scope of the present invention.

Claims (21)

A system for closing a hollow structure,
Multiple occluders;
An applicator for storing the plurality of occluders and continuously delivering the occluders to occlude the hollow structure;
A system comprising:   The system of claim 1, wherein each occluder is a two-part occluder.   The system of claim 2, wherein the two-part occluder is configured to be deformed from a first non-occluded state to a second occluded state.   The applicator is configured to deliver the two-part occluder to the hollow structure and to deform the two-part occluder from its first unoccluded state to its second occluded state. Item 4. The system according to Item 3. The two-part occluder comprises a distal implant and a proximal implant;
The distal implant has a configuration in which at least a portion of the distal implant is (i) a diametrically reduced configuration for placement within the applicator, and (ii) for placement adjacent to the hollow structure. Configured to be able to take a diametrically expanded configuration,
The proximal implant has a configuration in which at least a portion of the proximal implant is (i) a diametrically reduced configuration for placement within the applicator, and (ii) for placement adjacent to the hollow structure. Configured to be able to take a diametrically expanded configuration,
Accordingly, the distal implant is connected to the proximal implant, wherein at least a portion of the distal implant is in a diametrically expanded configuration, and at least a portion of the proximal implant has a diameter thereof. The system of claim 2, wherein the two-part occluder is capable of occluding the hollow structure when in a directional expanded configuration.   The system of claim 1, wherein the applicator comprises a cartridge comprising a plurality of chambers, and wherein each of the occluders is disposed within a chamber.   The system of claim 6, wherein the applicator comprises a hollow tube, and wherein the cartridge is configured to rotate relative to the hollow tube.   The system of claim 1, wherein the applicator comprises a hollow tube, and wherein a plurality of occluders are disposed within the hollow tube. A method for closing a hollow structure, comprising:
Multiple occluders;
An applicator for storing the plurality of occluders and continuously delivering the occluders to occlude the hollow structure;
Providing a system comprising:
Continuously delivering the occluder to occlude the hollow structure using the applicator;
Including the method. A system for closing a hollow structure,
An occluder,
An applicator for delivering the occluder to occlude the hollow structure;
A dissecting instrument mounted on the applicator for applying a force to the hollow structure as the applicator delivers the occluder to the hollow structure;
A system comprising:   The system of claim 10, further comprising a shield for limiting movement of the applicator relative to the hollow structure.   The system of claim 11, wherein the dissecting instrument and the shield are independently movably mounted on the applicator.   The system of claim 10, wherein the dissecting instrument is configured to provide a shield to limit movement of the applicator relative to the hollow structure. A method for closing a hollow structure, comprising:
An occluder,
An applicator for delivering the occluder to occlude the hollow structure;
A dissecting instrument mounted on the applicator for applying a force to the hollow structure as the applicator delivers the occluder to the hollow structure;
Providing a system comprising:
Applying force to the hollow structure using the dissecting instrument;
Using the applicator to deliver the occluder to occlude the hollow structure;
Including the method. An apparatus for closing a hollow structure,
A two-part occluder comprising a two-part occluder comprising a distal implant and a proximal implant;
The distal implant comprises a body, (i) a diametrically reduced configuration for placement within an applicator, and (ii) a diametrically expanded configuration for placement relative to the hollow structure. With multiple legs that can be taken,
The proximal implant has a body, (i) a diametrically reduced configuration for placement within an applicator, and (ii) a diametrically expanded configuration for placement relative to the hollow structure. With multiple legs that can be taken,
Thus, the distal implant is connected to the proximal implant, the distal implant leg is diametrically expanded, and the proximal implant leg is diametrically expanded. Taking the configuration, the two-part occluder can occlude the hollow structure,
At least one of the distal implant and the proximal implant is configured such that a circumferential orientation of legs of the distal implant and the proximal implant is adjustable. Adjustable to be rotatable relative to the other,
apparatus.   The number of legs of the distal implant and the number of legs of the proximal implant are equal, and the circumferential orientation of the legs of the distal and proximal implants is: (i) the axial direction of the legs 16. The device of claim 15, adjustable between alignment and (ii) an axial interfit of the legs.   The apparatus of claim 15, further comprising an applicator, wherein the applicator is configured to adjust a circumferential orientation of legs of the distal and proximal implants relative to each other. A method for closing a hollow structure, comprising:
A two-part occluder comprising a two-part occluder comprising a distal implant and a proximal implant;
The distal implant comprises a body, (i) a diametrically reduced configuration for placement within an applicator, and (ii) a diametrically expanded configuration for placement relative to the hollow structure. With multiple legs that can be taken,
The proximal implant has a body, (i) a diametrically reduced configuration for placement within an applicator, and (ii) a diametrically expanded configuration for placement relative to the hollow structure. With multiple legs that can be taken,
Thus, the distal implant is connected to the proximal implant, the distal implant leg is diametrically expanded, and the proximal implant leg is diametrically expanded. Taking the configuration, the two-part occluder can occlude the hollow structure,
At least one of the distal implant and the proximal implant is configured such that a circumferential orientation of legs of the distal implant and the proximal implant is adjustable. Adjustable to be rotatable relative to the other,
Providing a device;
Selecting the circumferential orientation of the legs of the distal and proximal implants relative to each other;
Deploying the two-part occluder to occlude the hollow structure;
Including the method. A system for closing a hollow structure,
An occluder,
An electrical power source,
A conductive network for connecting the power source to the occluder so that when the occluder occludes the hollow structure, the electrical power source can deliver ablation energy to the hollow structure;
A system comprising:   The occluder includes a two-part occluder having a distal implant and a proximal implant, the conductive network includes a first conductor and a second conductor, and the first conductor includes the first conductor 20. The system of claim 19, wherein an electrical power source is connected to the distal implant and the second conductor connects the electrical power source to the proximal implant. A method for closing a hollow structure, comprising:
An occluder,
An electrical power source,
A conductive network for connecting the power source to the occluder so that when the occluder occludes the hollow structure, the electrical power source can deliver ablation energy to the hollow structure;
Providing a system comprising:
Deploying the two-part occluder to occlude the hollow structure;
Delivering ablation energy to the hollow structure;
Including the method.

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