WO2018078628A2 - Vascular access apparatus and method - Google Patents

Abstract

An apparatus for vascular access is provided. The apparatus includes a device for engaging a blood vessel and a guide for guiding a tissue-piercing element into the blood vessel.

Description

VASCULAR ACCESS APPARATUS AND METHOD

TECHNICAL FIELD

The present disclosure relates generally to the field of vascular access and methods.

BACKGROUND

Endovascular access through blood vessels close to the surface of the skin (oftentimes referred to as percutaneous vascular access) has been used for decades to access and treat organs and body cavities through the site of vascular access.

Endovascular access is most commonly employed via the Seldinger technique in which the skin and underlying blood vessel are punctured with a sharp hollow needle and a round-tipped guidewire is inserted into the vessel through the lumen of the needle. Following withdrawal of the needle, a device such as a catheter is advanced over the guidewire and used to perform a medical procedure remote from the site of access.

Although percutaneous vascular access has numerous advantages such as minimal trauma to the patient, some remote arteries and veins are not easily accessible via skin-adjacent access sites. For example, in cases in which femoral and iliac arteries are convoluted, too small for access or occluded, open surgery is often required to access abdominal regions of the aorta.

These limitations of percutaneous vascular access can be addressed by using endoscopic techniques to access blood vessels in body cavities such as the abdominal cavity.

For example, US8357190 describes a laparoscopic vascular access device for accessing the aorta through the abdominal cavity wall and delivering a stent to an aneurotic region of the aorta.

One disorder that can be treated using vascular access is uterine fibroids. A uterine fibroid (also referred to as a "myoma") is a benign (non-cancerous) tumor that is fed by the uterine artery and grows within the muscle tissue of the uterus. Myomas are solid fibrous tissue and may grow as a single nodule or in clusters and may range in size from 1 mm to more than 20 cm in diameter. Myomas are the most frequently diagnosed tumor of the female pelvis and the most common reason for a woman to undergo hysterectomy. The most common symptoms of myomas include heavy menstrual bleeding, prolonged menstrual periods, pelvic pressure or pain and LUTS.

One approach for treating myomas is an intravascular approach such as via

Uterine Artery Embolization (UAE) or Uterine Fibroid Embolization (UFE). In such procedures, a catheter is advanced through a radial or femoral access site and is used to deliver small particles into the uterine artery to block blood flow to the uterine fibroids in order to necrose and shrink the fibroid tissue mass.

Although this approach has the potential to treat uterine fibroids, the procedure is complicated and requires the use of a significant radiation dose as well as radiological guidance. Similarly, embolization may be used for stopping acute bleeding from the uterus, such as post-partum bleeding. Hence, despite its potential, the technique is currently not widely used and patients often undergoes hysterectomy instead.

Thus, there remains a need for a simplified vascular access device for blocking blood flow to uterine fibroids or other abnormal tissue, which is simple enough in use to ensure a more widespread implementation of the procedure, thereby saving the patient's uterus and even her life. SUMMARY

Aspects of the disclosure, in some embodiments thereof, relate to a vascular access apparatus and method, and more particularly, to an apparatus for stabilizing and accessing a blood vessel in a body cavity through a laparoscopic port or open surgery, more specifically for treating uterine bleeding, fibroids and/or malignancies.

Although percutaneous delivery of an agent or device to a region of the vasculature (e.g. coronary artery) has numerous advantages, such as minimal trauma to the patient, it may be limited to vascular regions accessible via skin-adjacent access sites. Thus, in cases of remote arteries and veins, which are not easily accessible via skin-adjacent access sites, percutaneous delivery may be of limited applicability. Alternative approaches may include directly accessing a blood vessel of a body cavity from an access port positioned in a wall of the body cavity, yet such approaches require coordinated vessel stabilization and penetration.

Some blood vessels of a body cavity may have a diameter of less than 5 mm. Therefore, penetration of the blood vessel wall, without damaging or perforating the opposite vessel wall, can be difficult to achieve. Advantageously, the apparatus and methods of the present disclosure are configured to gain access to blood vessel lumens at an acute penetration angle (e.g., at an angle of about 30 degrees or less), vis-a-vis the longitudinal axis of the blood vessel.

Angled penetration (typically at an angle of 30 degrees or less) of a blood vessel is challenging due to a roll motion of the vessel away from the needle. The problem of vessel roll may be further augmented when the tissue-piercing device is delivered from a laparoscopic port and controlled from outside the patient's body. Advantageously, the apparatus and methods of the present disclosure, are configured to engage and stabilize the blood vessel so as to allow controlled and accurate access through the vessel wall at a defined angle of less than 90 degrees and/or at an angle substantially aligned with the longitudinal axis of the blood vessel. The apparatuses and methods disclosed herein thereby successfully address the shortcomings of the presently known configurations.

According to some embodiments, the device may further be configured to prevent blood flow at the access site, thereby allowing repeated penetrations of the piercing element to the blood vessel, when necessary, such as in order to withdraw the tissue-piercing element and reintroduce it with an offset in angle or location of access.

Prevention of blood flow at the access site may be achieved, according to some embodiments, by clamping the blood vessel upstream to the access site, optionally at the engagement site. However, a potential problem of ceasing blood flow by clamping the blood vessel is the risk of collapse of the blood vessel. Advantageously, according to some embodiments, the device disclosed herein may be configured to twist the blood vessel at the clamping site, thereby preventing the blood vessel from collapsing by forming a local swelling of the blood vessel lumen.

According to some embodiments, there is provided an apparatus for vascular access including an elongated tubular body, a clamping element for engaging a blood vessel, the clamping element being coupled distally to the elongated tubular body's distal end; and a guide member configured for guiding a tissue-piercing element into the blood vessel at an acute angle thereof.

According to some embodiments, the distal end of the elongated tubular body is bendable. According to some embodiments, bending of the distal end brings about angular movement of the clamping element, thereby twisting the blood vessel engaged by the clamping element, such that the guide member guides the piercing element to pierce into the blood vessel at an acute angle thereof.

According to some embodiments, the apparatus further includes a sleeve configured to accommodate the elongated tubular body. According to some embodiments, the sleeve is configured to retain the distal end of the elongated tubular body in a straight configuration. According to some embodiments, when the elongated tubular body extends out of the sleeve, the distal end bends.

According to some embodiments, the elongated tubular body comprises a shape memory material. According to some embodiments, the shape memory material comprises Nitinol.

According to some embodiments, the apparatus further includes a steering wire configured to control the bending of the distal end.

According to some embodiments, the clamping element is configured to prevent blood flow downstream the site of clamping of the blood vessel by the clamping element. According to some embodiments, the clamping element includes a securing mechanism configured to ensure that a distal end of the clamping member closes before a proximal end thereof, thereby providing an entrapment of the blood vessel within the clamping member prior to it being clamped by the clamping member.

According to some embodiments, the clamping element is a grasper.

According to some embodiments, the device is configured for laparoscopic access.

According to some embodiments, the apparatus further includes a tissue- piercing element positioned within the guide member. According to some embodiments, the tissue-piercing element is a needle. According to some embodiments, the needle is made from a bendable material. According to some embodiments, the needle is hollow.

According to some embodiments, the tissue-piercing element is associated with a cannula. According to some embodiments, the cannula is configured to slide over the tissue-piercing element. According to some embodiments, the cannula is configured to slide through the tissue -piercing element.

According to some embodiments, the apparatus further includes a handle configured to control the operation of the apparatus.

According to some embodiments, controlling the operation of the apparatus includes controlling the bending of said elongated tubular body's distal end, controlling the opening/closing of the clamping element, locking of the clamping element upon proper engagement of the blood vessel, controlling longitudinal movement of the tissue piercing element and/or of the cannula associated therewith, and any combination thereof.

According to some embodiments, the guide member is positioned on an outer surface of the elongated tubular body's distal end.

According to some embodiments, the clamping element further includes lateral supporting walls coextensive with the guide member, the lateral walls configured to stabilize the blood vessel in front of the guide member.

According to some embodiments, the guide member is at least partially positioned within the elongated tubular member, wherein the tubular member includes a side opening and wherein the guide member is configured to extend out of the side opening. According to some embodiments, the guide member defines a curved path when fully extended out of the side opening of the elongated tubular body. According to some embodiments, the guide member, when fully extended, is configured to position the tissue piercing element between jaws of the clamping element and at an angle of less than 30 degrees with respect to the longitudinal axis of the blood vessel, such that the tissue piercing site is directed to pierce into the blood vessel downstream to the engagement site with the clamping element. According to some embodiments, the guide member is a Nitinol tube. According to some embodiments, there is provided a method of accessing a blood vessel including: (a) delivering into a body cavity an apparatus including an elongated tubular body, a clamping element for engaging a blood vessel; and a guide member configured for guiding a tissue -piercing element into the blood vessel at an acute angle thereof; (b) using the clamping element to engage and stabilize the blood vessel; (c) moving/rotating the tissue clamping element angularly, thereby twisting the blood vessel; (d) advancing the tissue-piercing element through the guide member, such that the tissue -piercing element penetrates the blood vessel downstream to the engagement site at an acute angle thereof.

According to some embodiments, the method further includes (e) delivering a cannula through or over the tissue -piercing element and into said blood vessel.

According to some embodiments, the method further includes (f)manipulating said tissue-piercing element and/or the cannula such that a flow; path between the cannula and a target area is generated.

According to some embodiments, the method further includes (g) delivering embolization particles into the blood vessel using the cannula.

According to some embodiments, step b further comprises clamping the blood vessel, such that blood flow downstream the site of clamping of the blood vessel is restricted.

According to some embodiments, clamping the blood vessel includes initially closing a distal end of the clamping member, thereby entrapping the blood vessel within the clamping member followed by a closing of the proximal end of the clamping, thereby restricting the blood flow downstream the clamping site.

According to some embodiments, angular movement of the clamping element is caused by bending of a distal end of the elongated tubular body.

According to some embodiments, there is provided an embolization particle delivery system comprising a hollow tissue-piercing element; wherein at least part of the hollow tissue piercing member is made from a material allowing the tissue-piercing element to bend at a bending angle of at least 90 degrees. According to some embodiments, the hollow tissue -piercing element comprises one or more side opening, the one or more side opening sized and shaped to allow embolization particles to flow therethrough.

According to some embodiments, at least part of the hollow tissue-piercing element is made from braided wires. According to some embodiments, the one or more side openings is formed by the braid.

According to some embodiments, the embolization particle delivery system further includes a cannula configured to slide over and/or slide through the tissue piercing member, wherein the tissue-piercing element is configured to assume a first extended position in which the tissue-piercing is distal to a distal end of the cannula and a retracted position in which the tissue-piercing is proximal to the distal end of the cannula.

According to some embodiments, the cannula includes a first section and an adjacent second section. According to some embodiments, the first section is positioned proximally to the second section. According to some embodiments, the first section has a first inner diameter which is different from a second inner diameter of the second section. According to some embodiments, when the tissue piercing member is in its first extended position, the one or more openings is coaligned with the first section, and wherein, when the tissue piercing member is in its second retracted position, the one or more openings is coaligned with the second section.

According to some embodiments, when the one or more openings is coaligned with the first section, the first section's wall covers the one or more openings, thereby preventing delivery of embolization particles therethrough. According to some embodiments, when the one or more openings is coaligned with the second section, the second section's wall is spaced apart from the one or more openings, thereby enabling embolization particles to pass therethrough.

Certain embodiments of the present disclosure may include some, all, or none of the above advantages. One or more technical advantages may be readily apparent to those skilled in the art from the figures, descriptions and claims included herein. Moreover, while specific advantages have been enumerated above, various embodiments may include all, some or none of the enumerated advantages. BRIEF DESCRIPTION OF THE DRAWINGS

Exemplary embodiments are illustrated in referenced figures. Dimensions of components and features shown in the figures are generally chosen for convenience and clarity of presentation and are not necessarily shown to scale. It is intended that the embodiments and figures disclosed herein are to be considered illustrative rather than restrictive. The figures are listed below:

Fig. 1A schematically illustrates a device for vascular access with a grasper in a closed configuration, according to some embodiments;

Fig. IB shows an enlargement of the distal portion of Fig. 1A, according to some embodiments;

Fig. 1C schematically illustrates the grasper of the vascular access device of Fig. 1A in an open configuration, according to some embodiments;

Fig. ID shows an enlargement of the distal portion of Fig. 1C, according to some embodiments;

Fig. IE schematically illustrates a delivery guide disposed between the jaws of the grasper of Fig. 1C, according to some embodiments;

Fig. IF shows an enlargement of a distal portion of Fig. IE, according to some embodiments;

Fig. 1G schematically illustrates a delivery guide disposed between the jaws of the grasper of Fig. 1A, according to some embodiments;

Fig. 1H shows an enlargement of a distal portion of Fig. 1G, according to some embodiments;

Fig. 2A schematically illustrates a grasper component for engaging a blood vessel of an apparatus that may be used for vascular access in an open configuration, according to some embodiments;

Fig. 2B shows a different perspective of Fig. 2A;

Fig. 2C schematically illustrates the grasper component of Fig. 2A in a closed configuration, according to some embodiments; Fig. 3A-Fig. 3C schematically illustrate a grasper component for engaging a blood vessel of an apparatus that may be used for vascular access in a partially closed, a closed and an open configuration, respectively, according to some embodiments;

Fig. 4A-Fig. 4C schematically illustrate a grasper component for engaging a blood vessel of an apparatus that may be used for vascular access in a partially closed, a closed and an open configuration, respectively, according to some embodiments;

Fig. 5A-Fig. 5C schematically illustrate the steps of gaining vascular access using the apparatus of Fig. lA-Fig. 1H;

Fig. 6A-Fig. 6F illustrate the steps of delivering an agent into a blood vessel using the apparatus of Fig. ΙΑ-Fig. 1H;

Fig. 7A schematically illustrates an apparatus for vascular access, with a distal end of an elongated body of the apparatus in a bended configuration, according to some embodiments;

Fig. 7B schematically illustrates the apparatus of Fig. 7A in a straight configuration, according to some embodiments;

Fig. 7C schematically illustrates a piercing element disposed within a guide of the apparatus of Fig. 7A, according to some embodiments;

Fig. 7D schematically illustrates the piercing element extending distally from the guide of the apparatus of Fig. 7C, according to some embodiments;

Fig. 7E schematically illustrates the apparatus of Fig. 7A-Fig. 7D further including lateral supporting walls coupled to jaws of the apparatus, according to some embodiments;

Fig. 7F shows a different perspective of Fig. 7E, according to some embodiments;

Fig. 8A schematically illustrates a partially closed configuration of a clamper component for engaging a blood vessel of the apparatus of Fig. 7A- Fig. 7F, according to some embodiments;

Fig. 8B schematically illustrates the clamper of Fig. 8A in a closed configuration, according to some embodiments; Fig. 9A schematically illustrates an open configuration of a clamper component for engaging a blood vessel of the apparatus of Fig. 7A-Fig. 7F, according to some embodiments;

Fig. 9B schematically illustrates the clamper of Fig. 9A in a partially closed configuration, according to some embodiments;

Fig. 9C schematically illustrates the clamper of Fig. 9A in a closed configuration, according to some embodiments;

Fig. lOA-Fig. 10F illustrate the steps of a method for delivering an agent into a blood vessel using the apparatus of Fig. 7A-Fig. 7F, according to some embodiments;

Fig. 11A schematically illustrates a distal portion of an apparatus for vascular access with a piercing element housing particles and extending distally from a cannula, according to some embodiments;

Fig. 11B schematically illustrates the apparatus of Fig. 11A with the piercing element in a retracted configuration within the cannula allowing the particles to be released into a blood vessel, according to some embodiments;

Fig. 12A schematically illustrates a distal portion of an apparatus for vascular access with a piercing element extending distally from a cannula housing particles, according to some embodiments;

Fig. 12B schematically illustrates the apparatus of Fig. 12A with the piercing element in a retracted configuration within the cannula allowing the particles to be released into a blood vessel, according to some embodiments;

Fig. 13 is an illustrative flowchart of the method for delivering an agent into a blood vessel, according to some embodiments;

Fig. 14A schematically illustrates a device for vascular access including an elongated elastic member for engaging a blood vessel, according to some embodiments;

Fig. 14B shows the device of Fig. 14A with a tissue piercing element piercing into the blood vessel engaged by the elongated elastic member, according to some embodiments; Fig. 15 schematically illustrates a device for vascular access including a grasper for grasping an elongated elastic member engaging a blood vessel and a tissue piercing element configured for piercing the blood vessel, according to some embodiments.

Fig. 16 is an image showing a vascular access apparatus disposed within a blood vessel;

Fig. 17 is an angiographic image demonstrating direct access of the vascular access apparatus into the artery; and

Fig. 18 is a venographic image demonstrating direct access of the vascular access apparatus into the gonadal vein.

DETAILED DESCRIPTION

In the following description, various aspects of the disclosure will be described. For the purpose of explanation, specific configurations and details are set forth in order to provide a thorough understanding of the different aspects of the disclosure. However, it will also be apparent to one skilled in the art that the disclosure may be practiced without specific details being presented herein. Furthermore, well-known features may be omitted or simplified in order not to obscure the disclosure.

According to some embodiments, there is provided an apparatus for vascular access comprising an elongated tubular body, a clamping element for engaging a blood vessel, and a guide member configured for guiding a tissue-piercing element into the blood vessel at an acute angle thereof.

According to some embodiments, the term "apparatus for vascular access" may refer to an apparatus configured for accessing remote arteries and veins, such as, but not limited to, uterine arteries, and for delivering embolization particles thereto. According to some embodiments, the apparatus may be configured for laparoscopic access.

According to some embodiments, the elongated body may be fabricated from a polymer or an alloy. Examples include stainless steel, Nitinol, nylon, polyurethane polypropylene and the like. The diameter of the elongated body can be in the range of 4-6mm. According to some embodiments, the terms "tissue engaging member", "clamping element" and "clamping member" may be used interchangeably and may refer to a device, or element configured to engage, hold, stabilize and/or immobilize tissue, particularly blood vessels. Each possibility is a separate embodiment. A non- limiting element of a clamping member may be graspers or other jaws-including member. Other non-limiting examples of clamping elements include a hook for hooking (at least partially encircling) the blood vessel, a suction pad for attaching to a blood vessel wall, a grasper, a snare, or combinations thereof. Each possibility is a separate embodiment. According to some embodiments, the device may include an elongated elastic member in addition to and/or instead of the clamping member.

According to some embodiments, the elongated elastic member may be configured to encircle and/or loop around the blood vessel, thereby engaging/grasping the blood vessel. Once encircling the blood vessel, elevation of the elongated elastic member causes the blood vessel to assume a bended configuration having an apex defined by the elongated elastic member. In this configuration, the part of the blood vessel, downstream the engagement site of the elongated elastic member, is positioned at an essentially acute angle relative to the tissue piercing element of the device. According to some embodiments, should re-access into the blood vessel be necessary, the elongated elastic member may be manipulated to prevent flow of blood downstream the engagement site.

According to some embodiments, the clamping member may be configured to clamp blood vessels, such that blood stream downstream the clamping site is impaired or even prevented/abolished. As used herein, an impaired blood flow may refer to a blood flow of 10% or less, 5% or less or 2% or less than that of the normal blood flow. Each possibility is a separate embodiment. According to some embodiments, impairing, preventing, restricting or abolishing the blood flow may enable retracting and repenetrating the blood vessel, if needed. According to some embodiments, impairing, preventing, restricting or abolishing the blood flow may prevent leakage from the access site. According to some embodiments, impairing, preventing, restricting or abolishing the blood flow may prevent or significantly reduce backflow of an agent (e.g. embolization particles) delivered into the blood vessel. According to some embodiments, the clamping member may be configured to clamp blood vessels, in such manner that the blood flow downstream the clamping site can continue essentially undisturbed. As used herein, an essentially undisturbed blood flow may refer to a blood flow of at least 80%, at least 90% or at least 95% of that of a normal blood flow. Each possibility is a separate embodiment. According to some embodiments, the clamping member may be configured to clamp blood vessels, in such manner that a restricted blood flow downstream the clamping site can continue. According to some embodiments, continued blood flow may prevent collapse of the blood vessel as well as enable penetrating the blood vessel without puncturing the blood vessel wall opposite the penetration site. As used herein, a restricted blood flow may refer to a blood flow of 10-80%, 20-70%, 30-50% or any other suitable reduction within the range of 10-80%. Each possibility is a separate embodiment.

According to some embodiments, the clamping element may be coupled distally to the elongated tubular body's distal end.

According to some embodiments, the clamping member may be graspers including jaws. According to some embodiments, the clamping element may include a securing mechanism configured to ensure that a distal end of the clamping member closes before a proximal end thereof closes. Thereby the blood vessel is initially entrapped within the clamping member prior to being clamped, thus preventing the blood vessel from slipping out of the clamping member, as a result of the clamping.

According to some embodiments, the securing mechanism may include a hinge configured to connect a proximal and a distal end of each jaw at a predetermined angle, such that only the distal end of the opposing jaws initially mate, thereby enabling a blood vessel to be entrapped between the jaws. According to some embodiments, the securing mechanism further includes a spring leaf configured to change the angle between the jaws when stretched (e.g. by a ratchet mechanism), thus resulting in a mating of the proximal end of the jaws and in a clamping of the blood vessel entrapped between the jaws. According to some embodiments, the hinges may be configured to enable the clamping element to clamp or otherwise engage the blood vessel in an essentially circumferential manner, thereby entrapping the blood vessel, as further described hereinbelow. According to some embodiments, the securing mechanism may be provided by the jaws of the grasper being offset at their distal, such that a crossover between the distal ends of the jaws is obtained. The crossover may serve to provide an initial entrapment of a blood vessel and only upon applying further pressure on the jaws (or otherwise triggering them being approached), is the blood vessel clamped, as further described hereinbelow.

As used herein, the term guide member may refer to a member configured to guide the longitudinal movement of the tissue -piercing element. According to some embodiments, the guide may be a pre-shaped tube (e.g. shape memory alloy such as Nitinol) for guiding a tissue-piercing element, such as a needle. The guide may be carried on or within the elongated body of the apparatus and deployed following vessel stabilization to guide a needle (positioned within guide or delivered from outside the body) through the blood vessel wall at or near the region of the vessel that is stabilized by the present apparatus. According to some embodiments, the inner diameter of the guide member (receiving the tissue-piercing element) may be in the range of l-2mm.

According to some embodiments, the blood vessel may be remote arteries and/or veins. According to some embodiments, the blood vessel may be a uterine artery, a vaginal artery, an ovarian artery, or any combination thereof. Each possibility is a separate embodiment. According to some embodiments, the blood vessel may be a uterine artery feeding a uterine fibroid.

As used herein, the term "acute angle" may refer to an angle of 80 degrees or less, 60 degrees or less, 45 degrees or less, 30 degrees or less, or 20 degrees or less visa-vis the longitudinal axis of the blood vessel. Each possibility is a separate embodiment. By penetrating the blood vessel at an acute angle, it was advantageously found that the risk of perforating the wall of the blood vessel, opposite the penetration site, is significantly reduced.

According to some embodiments, the distal end of the elongated tubular body may be bendable for example at an angle of 45 degrees or more, 60 degrees or more, or about 90 degrees relative to the longitudinal axis of the tubular body. Each possibility is a separate embodiment. According to some embodiments, the elongated tubular body may include or be made of a shape memory material, such as, but not limited to, Nitinol™. According to some embodiments, bending of the distal end may bring about angular movement of the clamping element, which in turn twists the blood vessel engaged by the clamping element. According to some embodiments, the twisting of the blood vessel may cause it being positioned in front of the guide member (along its longitudinal axis), thereby enabling the piercing element to pierce into the blood vessel at an acute angle thereof, as further illustrated hereinbelow. Additionally or alternatively, the twisting of the blood vessel causes a local accumulation of blood at the clamp site, which in turn prevents the blood vessel from collapsing and eases a secure penetration of the tissue-piercing element.

According to some embodiments, the apparatus may further include a sleeve configured to accommodate the elongated tubular body. The sleeve may be configured to retain the distal end of the elongated tubular body in a straight configuration. According to some embodiments, extending the elongated tubular body out of the sleeve, whether as a result of the sleeve being retracted or the elongated tubular body being pushed out of the sleeve, may result in the bending of the distal end. According to some embodiments, exposure of the distal end may cause it to assume its bent configuration as a result of its shape memory.

According to some embodiments, the apparatus may include a steering wire configured to control the bending of the distal end, for example, as a result of pulling of the wire.

According to some embodiments, the apparatus may further include the tissue- piercing element, positioned within the guide member. According to some embodiments, the tissue-piercing element may be formed integrally with the guide member and/or with the elongated tubular body. According to some embodiments, the tissue-piercing element may be slid into or otherwise reversibly received by the guide member. According to some embodiments, the elongated tubular body, the guide member, the tissue piercing element, or parts thereof may be disposable.

According to some embodiments, the tissue-piercing element may be or include a needle. According to some embodiments, the tissue -piercing element optionally has the external diameter of 0.4-1.3 mm (18-22 G). According to some embodiments, the tissue-piercing element optionally has the external diameter of 0.4-0.8mm (21-22 G). In a non-limiting example, an 18G needle may be used when a catheter is intended to be inserted through the needle.

According to some embodiments, the tissue piercing element or parts thereof may be made from a bendable material, such as, but not limited to, bendable stainless steel. According to some embodiments, at least part of the tissue-piercing element may be made from coiled or braided wires (e.g. braided stainless-steel wires), as further described hereinbelow. According to some embodiments, the tissue-piercing element may include one or more side openings, e.g. at a distal end thereof. According to some embodiments, the openings may be cut through and/or formed by the braid.

According to some embodiments, the tissue -piercing element may be associated with a cannula configured to slide over or through the tissue-piercing element, thereby entering the blood vessel through the opening generating by the tissue -piercing element. According to some embodiments, the cannula may be configured to deliver embolization particles to a target area (e.g. a uterine fibroid) once it enters the blood vessel and/or reaches the target area.

According to some embodiments, the apparatus may further include a handle configured to control the operation of the apparatus. According to some embodiments, the handle may be a multifunctional laparoscopic handle, examples of which are well known in the art of laparoscopic surgery.

According to some embodiments, controlling the operation of the apparatus may include controlling the bending of the elongated tubular body's distal end. As a non-limiting example, the handle may be configured to enable the disposition of the elongated tubular member relative to the sleeve, such as, but not limited to, retraction of the sleeve. As another non-limiting example, the handle may enable a steering wire attached to the distal end of the tubular member to be pulled, thereby bringing about the bending of the distal end.

Additionally or alternatively, controlling the operation of the apparatus may include controlling movement/rotation of the tubular member and/or of the clamping element to enable a correct positioning thereof relative to the target vessel. As a non- limiting example, the handle may be configured to control rotational movement of the clamping element relative to the elongated tubular body. Additionally or alternatively, controlling the operation of the apparatus may include controlling the opening/closing of the clamping element's jaws and/or the locking of the jaws, once the blood vessel has been clamped, thereby enabling the grasping of the blood vessel as well as preventing the blood vessel from slipping out of the clamping element once grasped.

Additionally or alternatively, controlling the operation of the apparatus may include controlling the longitudinal movement of the tissue piercing element. According to some embodiments, the handle may be configured to bring about forward movement of the tissue-piercing element, relative to the guide member, thereby facilitating the tissue -piercing element to penetrate the blood vessel, upon correct positioning. According to some embodiments, the handle may be configured to bring about retraction of the tissue-piercing element once the cannula associated therewith has entered the blood vessel.

Additionally or alternatively, controlling the operation of the apparatus may include controlling the longitudinal movement of the cannula associated with the tissue- piercing element, once penetration of the blood vessel has been achieved. According to some embodiments, the longitudinal movement of the cannula may cause it to protrude out from the lumen of the tissue -piercing element. According to some embodiments, the longitudinal movement of the cannula may cause it to slide over the outer surface of the tissue-piercing element.

According to some embodiments, the guide member may be positioned on an outer surface of the elongated tubular body's distal end.

According to some embodiments, the tubular body and/or the jaws of the clamping element may further include lateral supporting walls coextensive with the guide member. The lateral walls may be configured to stabilize the blood vessel in front of the guide member, thus preventing the blood vessel from "sliding/slipping" around the tubular body.

According to some embodiments, the guide member may be at least partially positioned within the elongated tubular member, in which case the tubular member may include a side opening through which the guide member can exit the tubular body. According to some embodiments, the guide member may be made from a memory shape material, such as, but not limited to, Nitinol™. According to some embodiments, once exiting the tubular body, the guide member may define a curved path, positioning the tissue piercing element between the jaws of the clamping element, and at an angle of less than 60, less than 45, or less than 30 degrees with respect to the longitudinal axis of the blood vessel. Each possibility is a separate embodiment.

According to some embodiments, the apparatus may optionally further include an imaging device (e.g., light, UV light, infrared or ultrasound imaging) for imaging the blood vessel targeted for delivery.

According to some embodiments, the apparatus may optionally further include a closure device (e.g., sutures, biological glue, and biocompatible adhesive) to facilitate closure of the artery access site.

Since the direction of flow in some arteries cannot be determined via visualization, the disclosed apparatus may, according to some embodiments, further include a mechanism for determining a direction of the flow in a blood vessel. Such a mechanism can include, for example, two or more load cells which when contacted with the vessel wall can determine sequential pressure changes in the vessel wall to identify the direction of flow therein.

According to some embodiments, the tissue -piercing element, the cannula or the guide wire passed therethrough may further include markers (e.g. radiopaque marker such as gold or platinum iridium) configured to validate that the wire is in the vessel and/or its distance from a target area (e.g. a uterine fibroid), using imaging modalities.

According to some embodiments, there is provided a method for accessing a blood vessel such as, but not limited to, a uterine artery. According to some embodiments, the method includes the steps of: (a) delivering into a body cavity a vascular access apparatus including an elongated tubular body, a clamping element for engaging a blood vessel; a tissue -piercing element, and a guide member configured for guiding longitudinal movement of the tissue-piercing element; (b) using the clamping element to stabilize the blood vessel; (c) bending the distal end of the tubular body, thereby twisting the blood vessel angularly and aligning the piercing element with the blood vessel; and (d) advancing the tissue-piercing element through/along the guide member, such that the tissue-piercing element penetrates into said blood vessel at an acute angle thereof or in-line with the blood vessel.

According to some embodiments, the clamping member may be configured to clamp blood vessels, such that blood stream downstream the clamping site is impaired or even prevented.

According to some embodiments, the bending of the clamping element causes the blood vessel to be twisted, such that its longitudinal axis is coextensive/parallel with the longitudinal axis of the guide member. Additionally or alternatively, the angular movement of the clamping element causes the blood vessel to be twisted, forming a local swelling of the blood vessel lumen. The local swelling of the blood vessel advantageously prevents collapse of the blood vessel and/or enables penetration of the tissue-piercing element into the blood vessel while reducing the risk of perforating the blood vessel wall opposite the penetration site.

According to some embodiments, the method further includes a step (e) of delivering a cannula into the blood vessel. According to some embodiments, the cannula may be sized and shaped to pass through the hollow lumen of the tissue piercing element. According to some embodiments, the cannula may be sized and shaped to slide over the outer wall of the tissue-piercing element. According to some embodiments, the cannula may be sized and shaped to facilitate injection of microspheres with a diameter of up to 700 micrometers.

According to some embodiments, the method further includes a step (f) of manipulating the tissue-piercing element and/or the cannula, such that a flow path between the cannula and a target area (e.g. a uterine tumor, a uterine fibroid or the blood vessel itself) is generated. According to some embodiments, the method further includes a step (g) of delivering embolization to the target area, using the cannula.

According to some embodiments, the tissue piercing elements, may be retrieved or partially retrieved, prior to the injection of the embolization particles, so as to allow their undisturbed flow to the target area. According to some embodiments, the injection of the embolization particles may be done while the tissue piercing element remains positioned within the blood vessel, for example through openings formed in a side wall thereof, as essentially described herein. According to some embodiments, the steps of the method may be controlled and/or carried out through the use of a handle positioned at the proximal end of the apparatus. According to some embodiments, the method may be performed in a laparoscopic procedure. According to some embodiments, the apparatus, described herein, may be utilized to deliver an agent or device into a blood vessel such as a uterine artery from a laparoscopic port or through an incision in the body cavity wall.

In order to deliver both the vessel engagement element and the guide through a laparoscopic port or open incision, and control the vessel engagement element and guide from outside the body, the present apparatus includes an elongated body (e.g. tube) which may be deliverable through a laparoscopic port (e.g. 5-10 mm port) and a handle that is operatively attached to the vessel engagement element and guide carried by the elongated body. The vessel engagement element is attached to a distal end of the elongated body and is deployable to engage and disengage the vessel and optionally clamp the vessel to reduce or abolish flow therein. The guide is enclosed in, or attached to, the elongated body (for delivery) and is deployable to extend out and optionally in a distal direction for delivery of the tissue piercing element. The proximal end of the elongated body is attached to a handle for separately controlling the vessel engagement element and guide.

According to some embodiments there is provided a method for delivering a desired material (e.g. embolization particles) into a blood vessel, the method comprises the steps of grasping a blood vessel and optionally achieving temporary occlusion using a grasper; twisting the blood vessel so as to align a tissue-piercing element (e.g., needle) associated with the grasper with the blood vessel; and using the needle to puncture the blood vessel.

Optionally, the method further comprises the step of monitoring successful access (e.g., by blood return). Optionally, the method further comprises the step of inserting a catheter through or over the needle thereby positioning the catheter within the blood vessel. The position and access of the catheter may be verified, for example, by injecting a contras agent (e.g. indigo carmine or a contrast agent for angiography). Optionally, the method further comprises the step of injecting the desired material (e.g., drugs, contrast agent, and embolic agents) into the blood vessel via the catheter. Optionally, the method further comprises the step of pulling out the needle before, after or during the injection of the desired material). Optionally, the method further comprises the step of pulling out the catheter at the end of the procedure. In order to regain hemostasis, pressure may be applied locally. Alternatively or additionally, commercially available artery sealing materials may be applied. Optionally, the method further comprises the step of releasing the grasp of the blood vessel and withdrawing the grasper, before, after or during the injection of the desired material.

Optionally, a preliminary step of the method may include achieving laparoscopic access. Optionally, the step of achieving laparoscopic access includes trocar insertion and abdominal inflation. Optionally, the blood vessel is exposed or dissected prior to the grasping step.

According to some embodiments, there is provided an embolization particle delivery system comprising a hollow tissue -piercing element. At least part of the hollow tissue piercing member may be made from a material allowing the tissue-piercing element to bend at a bending angle of at least 45 degrees, at least 60 degrees or at least 90 degrees relative to its longitudinal axis. Each possibility is a separate embodiment. According to some embodiments, the tissue piercing element may be made of a material enabling it to bend and/or curve along with a bending of a tubular body to which it is attached or otherwise associated. According to some embodiments, the tissue piercing element may be configured to acquire a bent shape, once released from a straight configuration. According to some embodiments, the tissue piercing element may be made from a shape memory material (e.g. a shape memory alloy), such as, but not limited to, Nitinol™. According to some embodiments, the tissue piercing element may be made from a bendable material configured to adapt to the shape of a member, such as the bendable distal end of the elongated tubular body described herein, to which it is attached or otherwise associated. According to some embodiments, the tissue piercing element or parts thereof may be made from stainless steel. According to some embodiments, the tissue piercing element may be made from braided wires.

According to some embodiments, the hollow tissue -piercing element may include one or more side openings. According to some embodiments, the one or more side openings may be sized and shaped to allow embolization particles to flow out therethrough. According to some embodiments, the one or more openings may be formed through (e.g. cut through) the material from which the tissue -piercing element is made. According to some embodiments, the one or more openings may be formed by the braiding of the wires.

According to some embodiments, the embolization particle delivery system may further include a cannula slidingly associated with the tissue-piercing element. According to some embodiments, the cannula may be sized and shaped to pass through the inner lumen of the tissue -piercing element. According to some embodiments, the cannula may be sized and shaped to slide over the outer surface of the tissue-piercing element. According to some embodiments, the cannula may have low friction inner and outer surfaces (Teflon coating) in order to reduce friction. According to some embodiments, the cannula may be made of a material capable of withstanding fluid pressures of injection through a length of approximately 60 cm. According to some embodiments, the cannula may be kink resistant.

According to some embodiments, the tissue-piercing element may be configured to assume a first extended/protruding position in which it protrudes out distally from the distal end of the cannula. In this position, the tissue-piercing element may penetrate into the blood vessel by piercing the wall thereof. According to some embodiments, the tissue-piercing element may be configured to assume a second retracted position in which the tissue-piercing element's distal end is proximal to the distal end of the cannula. According to some embodiments, the tissue -piercing element may assume its retracted position by being retracted/withdrawn into the lumen of the cannula. According to some embodiments, the tissue-piercing element may assume its retracted position as a result of the cannula being pushed forward, i.e. slided over or through the tissue-piercing element. According to some embodiments, the tissue- piercing element may assume its retracted position by pulling the tissue-piercing element into or over the cannula.

According to some embodiments, the cannula may include a first section and a second section adjacent the first section. According to some embodiments, the first section may be distal to the second section. According to some embodiments, the first section may have an inner diameter which is different from the inner diameter of the second section. According to some embodiments, the inner diameter of the first section may be smaller than the inner diameter of the second section. According to some embodiments, the inner diameter of the first section may be larger than the inner diameter of the second section. According to some embodiments, the inner diameter of the first (distal) section of the cannula may be in the range of 0.5- lmm, such as, for example, 0.75 mm. According to some embodiments, the inner diameter of the second (more proximal) section of the cannula may be in the range of 1-2 mm, such as, for example, about 1.5 mm. According to some embodiments, the inner diameter of tissue piercing member may be in the range of 0.3-5mm, such as for example 0.4 mm.

According to some embodiments, when the tissue piercing member is in its first extended/protruding configuration, the outer wall of the tissue piercing member may abut the inner wall of the cannulas first (distal) section, thereby preventing outflow of particles flowing in the lumen of the cannula. According to some embodiments, when the tissue piercing member is in its second retracted configuration, the outer wall of the tissue piercing member is co-aligned, yet spaced apart, from the inner wall of the cannula's second (proximal) section.

According to some embodiments, the tissue piercing element may include a first section and a second section adjacent the first section. According to some embodiments, the first section may be distal to the second section. According to some embodiments, the first section may have an inner diameter which is different from the inner diameter of the second section. According to some embodiments, the inner diameter of the first section of the tissue piercing member may be smaller than the inner diameter of the second section of the tissue piercing member. According to some embodiments, the inner diameter of the first section may be larger than the inner diameter of the second section. According to some embodiments, the inner diameter of the first section of the tissue piercing member may be in the range of 0.3-0.5 mm, such as for example 0.4mm. According to some embodiments, the inner diameter of the second (more proximal) section may be in the range of 0.6-1.0 mm, such as for example about 0.7mm. According to some embodiments, when the tissue piercing member is in its first extended/protruding configuration, the one or more openings may be coaligned with the first section, and when the tissue piercing member is in its second retracted configuration the one or more openings is coaligned with the second section. According to some embodiments, when the tissue piercing member is in its first extended/protruding configuration, outflow of particles may be prevented. According to some embodiments, when the tissue piercing member is in its first retracted configuration, outflow of particles may be facilitated.

According to some embodiments, when the tissue piercing member is in its first extended/protruding configuration, one or more openings formed in the wall of the second (proximal) section may be coaligned with the first section of the cannula, and when the tissue piercing member is in its second retracted configuration the one or more openings may be coaligned with the second (proximal) section of the cannula.

According to some embodiments, when the one or more openings is coaligned with the first section of the cannula, the wall of the cannula's first section covers the one or more openings, either from within the lumen of the tissue-piercing element (when the cannula is sized and shaped to pass through the lumen of the tissue-piercing element) or from the outer surface of the tissue-piercing element (when the cannula is sized and shaped to slide over the tissue-piercing element). According to some embodiments, when the first section's wall covers the one or more openings, embolization particles are prevented from flowing out of the opening.

According to some embodiments, when the one or more openings is coaligned with the second section of the cannula, the wall of the cannula's second section is spaced apart from the one or more openings, thereby enabling embolization particles to pass therethrough.

As is mentioned herein, the apparatus disclosed herein may be used to deliver an agent or device into a blood vessel. Such delivery may be directly from the tissue- piercing element of the apparatus. Alternatively, the tissue-piercing element may be utilized to deliver one or more components/devices to perform the delivery. In a non- limiting example, a needle delivered by the guide may be used to directly inject an agent into a blood vessel. In another non-limiting example, the tissue-piercing device may be used to deliver a guidewire into the lumen of the vessel, which can then be used to deliver catheters or cannulas into the blood vessel.

The elongated body and/or the vessel engagement element coupled thereto can be steerable from the handle of the apparatus.

Since the present apparatus is delivered through a delivery port which is positioned through a small incision made in the tissue wall (e.g. abdominal wall), and is utilized in an anatomically constrained space, it is desirable that the apparatus, or at least a portion thereof, (e.g. vessel engagement element) be steerable, or maneuverable from outside the patient's body using, for example, the handle (at the proximal end of the apparatus). Such steering enables an operator to guide the apparatus within the body and accurately position the distally-mounted device at an anatomical landmark.

In order to control deflection of a steerable portion of the apparatus and/or the vessel engagement element, the present apparatus can employ one or more control wires which run the length of the device and terminate at the distal end of the steerable portion or at the distal tip.

The proximal end of each control wire is connected to the user operated handle.

According to some embodiments, pulling of the wire bends the device body and deflects the steerable portion with relation the pulled wire or maneuvers and operates the vessel engagement element.

Numerous examples of steerable devices are known in the art, see for example, U.S. Pat. Nos. 2,498,692; 4,753,223; 6,126,649; 5,873,842; 7,481,793; 6,817,974; 7,682,307 and U.S. Pat. Application Publication No. 20090259141.

Throughout the following description, similar elements of different embodiments of the apparatus are referenced by element numbers differing by integer multiples of 100. For example, an apparatus of Fig. 1 is referenced by the number 110, and an apparatus of Fig. 7, which corresponds to apparatus 110 of Fig. 1, is referenced by the number 710. As another example, an elongated body of Fig. 1 is referenced by the number 112, and an elongated body of Fig. 7, which corresponds to elongated body 112 of Fig. 1, is referenced by the number 712.

Reference is now made to Fig. 1A- Fig. 1H, which schematically illustrate an apparatus 110 that may be used for accessing a blood vessel of a body cavity, according to some embodiments.

Apparatus 110 includes an elongated body 112 (also referred to herein as shaft) coupled to a vessel engagement element 114 which is configured as a grasper 116, and a guide 124 for guiding a tissue piercing element to or near a region of the vessel stabilized by grasper 116. Elongated body 112 can be rigid or elastic or steerable. Grasper 116 includes jaws 118 the may be operated to assume a closed configuration (Fig. IB) and open configuration (Fig. ID) and any configuration in between. Jaws 118 may be operated via a handle (not shown) attached to a proximal end of elongated body 112. Referring to Fig. IB, jaws 118 may include two vessel engagement regions, a first region 120 for encircling a blood vessel without substantially reducing flow therein, such as for stabilization, as best demonstrated in Fig. 1H, and a second region 122 for clamping a blood vessel to partially or fully reduce flow therein. Clamping may be effected following access and positioning of a delivery cannula in the blood vessel.

Grasper 116 may be rotated and angled with respect to the longitudinal axis of elongated body 112 or it may be immovably fixed thereto.

Guide 124 is configured such that when deployed, a tissue piercing element 126

(e.g. needle) is guided to penetrate the blood vessel slightly (e.g. 5-10 mm) downstream of the vessel engagement region.

Referring to Fig. IE, guide 124 may be a nitinol or a steel tube, which is pre- shaped and trapped in a linear configuration within a lumen of elongated body 112 or a slot in elongated body 112. Optionally, elongated body 112 is covered by a sheath 113. Once deployed (via handle) by releasing guide 124 from a lumen or slot of elongated body 112 (via, for example, unsheathing), guide 124 assumes the pre-shaped configuration shown in Fig. IE-Fig. 1H. As demonstrated in Fig. 1H, the configuration of guide 124 positions tissue piercing element 126 between jaws 118 and at an acute angle with respect to the longitudinal axis of blood vessel 128.

Referring to Fig. IF, tissue-piercing element 126 can include a needle 127 associated with a cannula 129. Alternatively, tissue-piercing element 126 may include a cannula having a tissue piercing head. In any case, tissue piercing element 126 can be sequestered within guide 124 and pushed out via handle for delivery into vessel wall, or it can be delivered from outside the body via a dedicated port at a proximal end of elongated body 112 and manually advanced (via push wire or cannula) for delivery. Tissue piercing element 126 may further include a guidewire positioned within a lumen thereof.

Needle 127 may be a Nitinol needle (22G) bent with an approximate radius of curvature of about 13 mm. Needle 127 may accommodate a 0.014" guide wire. Needle 127 and attached cannula 129 may support injection of microspheres with a diameter of up to 700 um.

Guide 124 and tissue piercing element 126 can be combined into a single element e.g., the pre-shaped guide 124 can include a tissue piercing end and thus serve as a long needle for piercing the wall of the blood vessel.

Apparatus 110 may be used in any direction with respect to the blood vessel, i.e. it can be rotated 180 degrees with respect to the position shown in Fig. 1H although penetration of the blood vessel wall at an acute angle with the direction of flow is preferred.

Apparatus 110 may further include a mechanism for visualizing penetration of the blood vessel wall. Visualization can be at the cannula or handle, such as blood flowing out from cannula 129 attached to tissue piercing element 126, or via an imaging device. The imaging device may be used to view blood in the needle or cannula.

A difference between an outer diameter (OD) of needle 127 and an inner diameter (ID) of elongated body 112 and/or guide 124 may be used to enable visualization of blood.

The transition between cannula 129 and needle 127 should prevent blood from flashing distally, and force it to flash proximally, thus enabling visualization.

The transition between cannula 129 and needle 127 should also support smooth penetration of cannula 129 and needle 127 into the artery. Such a transition may be conical (taper from cannula 129 to needle 127).

Optionally, cannula 129 is transparent in order to visualize blood flash and flexible in order to support advancement within a tortuous uterine artery. Optionally, cannula 129 is kink-resistant to enable smooth advancement through a curve.

Cannula 129 may include low friction inner and outer surfaces (Teflon coating) in order to reduce friction. Cannula 129 may also be able to withstand fluid pressures of injection through a length of approximately 60 cm.

Tissue piercing element 126 may be used to deliver an agent into the blood vessel (e.g. embolizing agent such as microspheres or beads for blocking blood flow to a tumor), or it may be used to deliver a guidewire into the blood vessel. The guidewire (e.g. diameter of 0.012"-0.018") may be used to guide a cannula or catheter into the blood vessel. Alternatively, tissue piercing device 126 may be constructed from a needle 127 attached to a cannula 129 or a sharpened cannula 129 can be used to guide a catheter into the blood vessel by sliding the catheter over the cannula and into the blood vessel. Steps of guidewire and cannula/catheter placement are described in detail with respect to Fig. 6A-Fig. 6F hereinbelow.

The handle of apparatus 110 may be a multifunctional laparoscope handle, examples of which are well known in the art of laparoscopic surgery. The handle may be utilized to perform one or more or all of the following functions: rotate and manipulate grasper 116 with respect to the longitudinal axis of elongated body 112; actuate vessel engagement element 124 to engage and stabilize the vessel and/or surroundings tissues; actuate vessel engagement element 124 to clamp and reduce flow in the blood vessel; deploy guide 124; deploy tissue piercing element 126 from guide 124, optionally using a controlled (e.g. ratchet) mechanism which allows fine control over advancement of tissue piercing element 126; control and lock a guidewire delivered through tissue piercing element 126; advancement of a device (e.g. catheter/cannula) over the wire, with optional fine control over movement; retraction of tissue piercing element 126 and the guidewire from guide 124; delivery of an agent through tissue piercing element 126 or cannula/catheter delivered over wire; such delivery can be from a syringe connectable to a port (Luer lock) at the handle; and may actuate vessel engagement element 124 to clamp and eliminate flow in the blood vessel.

Thus, apparatus 110, according to some embodiments, may provide some or all of the following features: delivery through a laparoscopic port, preferably a 5 mm port; stabilization of the blood vessel; penetration of blood vessel wall at an angle of 30 degrees or less; controlled blood vessel clamping (partial and full) upstream of vessel wall access site; and delivery of an agent into the blood vessel.

Reference is now made to Fig. 2A-Fig. 2C, Fig. 3A-Fig. 3C and Fig. 4A-Fig. 4C that illustrate different embodiments of a grasper 116 of apparatus 110 of Fig. 1A- Fig. 1H, graspers 116 of Fig. 2A-Fig. 2C, Fig. 3A-Fig. 3C and Fig. 4A-Fig. 4C are referenced as graspers 216, 316 and 416, respectively.

Grasper 216 shown in Figures 2A, 2B, and 2C include two pivoting grasper plates 217 with jagged/serrated vessel-engaging surfaces 219. Grasper 316 shown in Figs. 3A, 3B, and 3C include jaw ends 321 that are configured to mate (tongue 323 in groove 325) and close on each other, thereby clamping/blocking the vessel. As shown in Figs. 3A-C, jaws 318 are offset laterally, such that when closed, a gap 327 forms between jaws 318 to enable visualization and access to the access site in the clamped vessel.

Grasper 416 shown in Fig. 4A-Fig. 4C include finger-like projections 431 that mate to enable vessel clamping. In this configuration, jaws 418 are curved (433) and offset to one side in order to enable access site visualization.

According to some embodiments, the configurations shown in Fig. 3A-Fig. 3C and Fig. 4A-Fig. 4C may be advantageous in that the angled (and laterally offset) jaws 318 and 418 facilitate grasping of tissue (vessel and/or surrounding tissue), jaws 318 and 418 close and mate with each other further stabilizing vessel clamping, and closure of jaws 318 and 418 allows maximum visualization of the vessel access site.

Reference is now made to Fig. 5A-Fig. 5C which illustrate laparoscopic or open surgical deployment of the apparatus of Fig. lA-Fig. 1H in a procedure for delivering an embolizing agent into a uterine artery, in accordance with some embodiments. Reference is further made to Fig. 6A-Fig. 6F illustrating specific steps of the procedure in detail. In a non-limiting example, the illustrated procedure may be utilized for a purpose of blocking blood flow in arterioles or capillary bed feeding a uterine myoma.

A standard laparoscopic or open surgery is performed exposing the target vessel. Optionally, a needle, a guidewire and a catheter are loaded into elongated body 112 of apparatus 110 and air is removed from the catheter lumen. Apparatus 110 may be advanced into the abdominal cavity through a laparoscopic port or an open incision. Referring to Fig. 5A, grasper 116 of apparatus 110 is positioned perpendicular to the target vessel (V). Optionally, the positioning of grasper 116 is performed under imaging from a separate device (e.g. endoscopic imaging device - light, IR or US). Referring to Fig. 5B grasper 116 is deployed and the target vessel (V) and/or its surrounding tissues is grasped. Referring to Fig. 6A, guide 124 is deployed to position a needle 127 parallel to the target vessel and slightly downstream of the engagement site of grasper 116. Optionally, the deployment of guide 124 is via unsheathing of elongated body 112 (pulling back sheath 113) to release guide 124 (constrained into linear configuration via sheath) and allow self-formation of the curved configuration of guide 124. Referring to Fig. 5C and Fig. 6B, needle 127 is deployed to puncture through the vessel wall optionally using a ratchet mechanism that allows fine control over needle advancement. Optionally, thermal or ultrasound imaging may be used to verify complete puncture. Visualization of blood return, such as through a cannula or a catheter associated with needle 127, is used to verify that needle 127 is located within the vessel lumen. If no blood return is visualized, needle 127 is retracted and re-advanced into the vessel until blood return is observed.

Referring to Fig. 6C, a guidewire 140, preloaded with needle 127, is advanced about 2-3 cm past the needle tip and is locked with respect to apparatus 110. Referring to Fig. 6D, catheter 141, preloaded into apparatus 110, is advanced, optionally using a ratchet mechanism, into the vessel lumen over guidewire 140 (if needle 127 was removed) or over needle 127 and guidewire 140. Referring to Fig. 6E, guidewire 140 and needle 127 are withdrawn, optionally together, from the vessel lumen. Alternatively, guidewire 140 is withdrawn optionally leaving needle 127 inside the vessel. A syringe loaded with an embolizing agent (e.g. microspheres in suspension) or contrast dye may be associated with a proximal port of catheter 141. Referring to Fig. 6F, the vessel is clamped using grasper 116 and the syringe (not shown) is used to inject a contrast dye or an embolizing agent into the vessel through catheter 141. Next, catheter may be withdrawn and the vessel may be clamped to allow closure of the vessel wall puncture via glue, plugs or a closure device, which may be integrated into the present apparatus (not shown). Optionally, Apparatus 110 is then withdrawn and the port or open incision is closed.

Reference is now made to Fig. 7A and Fig. 7B, which schematically illustrate an apparatus 710 that may be used for accessing a blood vessel of a body cavity, in a bended and a straight configuration, respectively, according to some embodiments.

Apparatus 710, includes an elongated body 712. Notably, elongated body 712 includes a bendable distal end 712b. Apparatus 710, similarly to apparatus 110 of Figs. 1A-H, includes a vessel engagement element, here in the form of a clamper 714 coupled to bendable distal end 712b. Notably, clamper 714 is for stabilizing and clamping the engaged blood vessel. Apparatus 710, further includes a guide member 724 for guiding longitudinal movement of a tissue-piercing element. Guide member 724 may be configured for guiding the tissue -piercing element to a region of the vessel downstream the site clamped by clamper 714. Notably, guide member 724 is parallelly coupled to bendable distal end 712b.

Clamper 714 includes jaws 718 that may assume a closed configuration (Figure 7A and 7B) and an open configuration (as best shown in Fig. 10A) and any configuration in between. Optionally, jaws 718 may be operated via a handle (not shown) attached to a proximal end of elongated body 712 to assume a desired configuration. Clamper 714 may be rotated and/or angled with respect to the longitudinal axis of distal end 712b or alternatively be immovably fixed thereto.

Referring to Fig. 7B, elongated tubular body 712 may be made of a shape memory material, and may be trapped in a linear configuration within a lumen of a sleeve/cover 713. Once released from sleeve 713 elongated body 712 assumes its pre- shaped configuration in which distal end 712b is curved/bended with respect to a proximal portion 712a of elongated body 712, as shown in Fig. 7A. Optionally, the release of elongated body 712 may be achieved by retracting sleeve/cover 713 in a proximal direction. Alternatively, the release of elongated body 712 may be achieved by distally extending elongated body 712 out of sleeve 713.

As best demonstrated in Fig. IOC, the bended/curved configuration of elongated body 712 angularly moves clamper 714, thereby twisting the blood vessel at the clamping site and positions tissue -piercing element 726 at an acute angle with respect to the longitudinal axis of blood vessel 1028, downstream to the engagement site with the clamper 714 (also referred to herein as "clamping site", "twist").

Referring to Fig. 7C and Fig. 7D, a tissue -piercing element 726, here a needle, may be disposed within guide member 724 (Fig. 7C). As demonstrated in Fig. 7D, tissue piercing element 726 may advance distally from guide member 724 to puncture through a wall of a target blood vessel (not shown). Advancement of tissue piercing element 726 may be performed by utilizing a ratchet mechanism that allows fine control over needle advancement.

Tissue piercing element 726 may be a Nitinol needle (22G) bent with an approximate radius of curvature of about 13 mm. According to some embodiments, tissue piercing element 726 may accommodate a 0.014" guide wire. Tissue piercing element 726 may be further associated with a cannula and may facilitate injection of microspheres with a diameter of up to 700 micrometers.

Alternatively, guide member 724 and tissue piercing element 726 may be combined into a single element e.g., guide member 724 can include a tissue-piercing end and thus serve as a long needle for piercing the wall of the blood vessel.

Optionally, apparatus 710 is further equipped with a mechanism for preventing rolling of the blood vessel laterally away from the advancement path of tissue piercing element 726. As demonstrated in Fig. 7E and Fig. 7F, such a mechanism may be achieved by protrusions (also referred to as lateral supporting walls) 743 coupled to jaws 718 to provide lateral support to a blood vessel 728 downstream to the twist and preventing it from laterally rolling away from the advancement path of tissue piercing element 726.

To prevent the blood vessel from slipping out of the clamper (e.g., clamper 714) when the jaws moves towards each other (e.g., jaws 718 during clamping), the clamper may include a securing mechanism configured to ensure that a distal end of the jaws entraps the blood vessel, prior to the blood vessel being clamped by a distal part of the jaws.

Reference is now made to Fig. 8A and Fig. 8B, which illustrate a clamper 816 for facilitating entrapment of a blood vessel prior to the clamping thereof, in a partially closed and a closed configuration, respectively, according to some embodiments. Each of opposing jaws 818 of clamper 816 include distal finger-like projections 831 positioned offset to one another, such that a crossover between distal finger-like projections 831 is obtained upon movement of opposing jaws 818 towards one another. Referring to Fig. 8A, when opposing jaws 818 are partially closed, distal finger-like projections 831 mate to entrap the blood vessel between proximal portions 818a of opposing jaws 818. In such a configuration, proximal portions 818a of jaws 818 define a gap 832a therebetween for engaging the blood vessel essentially without causing its clamping. Referring to Fig. 8B, clamping may be achieved by additional movement of opposing jaws 818 towards each other thereby, facilitating proximal portions 818a to approach, such that a gap 832b defined therebetween is substantially smaller than gap 832a shown in Fig. 8A. Reference is now made to Fig. 9A, Fig. 9B and Fig. 9C, which illustrate a clamper 916 for facilitating entrapment of a blood vessel prior to its clamping, in an open, a partially closed, and a closed configuration, respectively, according to some embodiments. Each of opposing jaws 918 include a hinge 918c configured to connect a proximal end 918a to a distal end 918b of each of jaws 918 at a predetermined angle. The predetermined angle may be defined such that only distal end 918b of opposing jaws 918 initially mate, thereby enabling entrapment of a blood vessel (not shown) between jaws 918 (as best shown in Fig. 9B). Optionally, a spring leaf 933 is further provided, configured to change the angle between proximal end 918a and distal end 918b of jaws 918 when stretched (e.g. by a ratchet mechanism). Referring to Fig. 9B, when jaws 918 are in a partially closed configuration, distal ends 918b mate to entrap the blood vessel between each of proximal ends 918a. In such a configuration, proximal ends 918a define a gap 932a therebetween for engaging the blood vessel without clamping it. As demonstrated in Fig. 9C, opposing proximal ends 918a of jaws 918 mate upon stretching of leaf spring 933.

Reference is now made to Fig. lOA-Fig. 10F, which illustrate the steps of a method for delivering a catheter 741 into a blood vessel using apparatus 710 of Fig. 7A-Fig. 7F, according to some embodiments. Optionally, an agent is further delivered via catheter 741.

Optionally, needle 727 and a catheter 741 may initially be loaded onto apparatus

710 and air may be removed from the lumen of catheter 741. Referring to Fig. 10A, elongated body 712 of apparatus 710, in its linear configuration within sleeve 713, is positioned substantially perpendicular to target blood vessel 1028 such that blood vessel 1028 is disposed between open jaws 718 of clamper 716. Optionally, the positioning of grasper 716 is performed under imaging from a separate device (e.g. endoscopic imaging device - light, IR or US). Referring to Fig. 10B, grasper 716 assumes its closed configuration and target blood vessel 1028 and/or its surrounding tissues is clamped between jaws 718 to stabilize blood vessel 1028 and prevent blood flow downstream to the clamping site. Referring to Fig. IOC, tubular body 712 assumes a bended/curved configuration, such that distal end 712b of tubular body 712 is bent relative to proximal portion 712a, for example, due to its release from sleeve 713. Optionally, the release of tubular body 712 from sleeve 713 is by proximal retraction of sleeve 713. Upon bending of distal end 712b clamping element 716 moves angularly, thereby twisting blood vessel 1028 at the clamping site. As a result, guide member 724 is positioned to allow needle 727 to pierce into blood vessel 1028 downstream to the clamping site at an acute angle relative to the longitudinal axis of blood vessel 1028. Optionally, the angle is less than 30° relative to a longitudinal axis of blood vessel 1028. Referring to Fig. 10D, needle 727 is operated to puncture through the wall of blood vessel 1028, optionally using a ratchet mechanism that allows fine control over needle distal advancement from guide member 724. Advantageously, the twisting of blood vessel 1028 results in a local accumulation of the blood at the clamping site, thus preventing collapse of blood vessel 1028 at the clamping site and enabling its smooth penetration. Optionally, thermal or ultrasound imaging may be used to verify complete puncture. Visualization of blood return, such as through a cannula or catheter 741 associated with needle 727 may be used to verify that needle 727 is located within a lumen of blood vessel 1028. If no blood return is visualized, needle 727 may be retracted and re-advanced into blood vessel 1028 until blood return is observed.

Referring to Fig. 10E and Fig. 10F, catheter 741, preloaded into apparatus 710, is advanced, optionally using a ratchet mechanism, into the lumen of blood vessel 1028. Optionally, as demonstrated in Fig. 10E, catheter 741 is advanced over needle 727 into blood vessel 1028. Alternatively, as demonstrated in Fig. 10F, catheter 741 is advanced through needle 727 into blood vessel 1028. A syringe loaded with an embolizing agent (e.g. microspheres in suspension) and/or contrast dye may be associated with a proximal port of catheter 741 to inject the contrast dye or the embolizing agent into blood vessel 1028 through catheter 741.

According to some embodiments, the piercing element and/or the catheter/cannula may be designed such as to facilitate delivery of particles (e.g., embolization particles) having a diameter larger than the internal diameter of a distal end of the piercing elements. As a non-limiting example, the piercing element and/or the catheter/cannula may have a distal end configured to penetrate into the blood vessel, the distal end having an external diameter of 0.7 mm and an internal diameter of 0.4 mm, yet still being able to deliver 0.7mm embolization particles without a need to completely retrieve the piercing element from the blood vessel. Reference is now made to Fig. 11A and Fig. 11B, which illustrate a vascular access apparatus 1110 having a hollow tissue-piercing element 1126 that may be used for delivering particles 1145 (e.g., embolization particles), according to some embodiments. It is noted that for illustrative purposes, some of the elements may be out of scale.

Vascular access apparatus 1110, similarly to vascular access apparatus 710 of Fig. 7A-Fig. 7F, includes a clamper 1116 for engaging a blood vessel and a guide member 1124 configured for guiding tissue -piercing element 1126 into the blood vessel at an acute angle thereof. Notably, hollow tissue-piercing element 1126 has a proximal portion 1126a having a first inner diameter 1127a configured to allow flow of particles 1145 therethrough. According to some embodiments, first inner diameter 1127a may be in the range of 0.5-1 mm, 0.6-0.8 or 0.7-0.75 mm in diameter. Each possibility is a separate embedment. A distal portion 1226b of hollow tissue -piercing element 1126 has a second inner diameter 1127b configured to pierce into the blood vessel. It is understood that second inner diameter 1127b should be relatively small (e.g. around 0.4 mm) and may thus prevent outflow of embolization particles. Hollow tissue- piercing element 1126 further includes side openings 1144 sized and shaped to allow particles 1145 (e.g., embolization particles) to flow out therethrough. According to some embodiments, side openings 1145 may have a smallest diameter of at least 0.5, or at least 0.7 mm, or at least 0.75mm (each possibility is a separate embodiment), so as to allow outflow of particles, such as 0.5 mm or 0.7 mm particles. Hollow tissue- piercing element 1126 may be disposed within a cannula 1141 which includes a distal section 1141b and a proximal section 1141a having an inner diameter larger than an inner diameter of distal section 1141b.

Referring to Fig.llA, hollow tissue-piercing element 1126 may assume an extended/protruding position in which it protrudes out distally from distal end 1141c of cannula 1141 and which facilitates penetration into a blood vessel by piercing a wall thereof. In this position, openings 1144 are co-aligned with distal section 1141b of cannula 1141 such that walls of distal section 1141b covers openings 1144, and particles 1145 are prevented from flowing out of opening 1144.

Referring to Fig.llB, hollow tissue-piercing element 1126 may (e.g. after penetration into the blood vessel is completed) assume a retracted position in which a distal end of tissue-piercing member 1126 is proximal to distal end 1141c of cannula 1141. In this position, openings 1144 are co-aligned with proximal section 1141a, in which the wall of proximal section 1141a is spaced apart from openings 1144, thereby enabling particles 1145 to pass into the lumen of proximal section 1141a of cannula 1141 and therethrough into blood vessel 1128.

Reference is now made to Fig. 12A and Fig. 12B, which illustrate a vascular access apparatus 1210 having a cannula 1241 sized and shaped to slide over a hollow tissue-piercing element 1226 and for delivering particles 1245 without a need for complete retrieval of a hollow tissue-piercing element 1226 from the blood vessel, according to some embodiments.

Vascular access apparatus 1210, similarly to vascular access apparatus 710 of Fig. 7A-Fig. 7F, further includes a clamper 1216 for engaging the blood vessel and a guide member 1224 configured for guiding tissue-piercing element 1226 into the blood vessel at an acute angle thereof.

Cannula 1241 includes a distal section 1241b and a proximal section 1241a having an inner diameter 1247a larger than an inner diameter 1247b of distal section 1241b and a distal end 1241c sized and shaped to allow particles 1245 (e.g., embolization particles) to flow out therethrough. According to some embodiments, inner diameter 1247a of proximal section 1241a may be in the range of 1.0 mm - 2mm, or 1.2 -1.5 mm. According to some embodiments, inner diameter 1247b of distal section 1241b may be in the range of 0.5 mm - 1mm, or 0.7 -0.8 mm.

Referring to Fig.l2A, hollow tissue-piercing element 1226 may assume an extended/protruding position in which it protrudes out distally from distal end 1241c of cannula 1241 which facilitates penetration into a blood vessel by piercing a wall thereof. In this position, hollow tissue-piercing element 1226 is co-aligned with distal section 1241b of cannula 1241 such that outer walls of hollow tissue-piercing element 1226 abuts the inner wall of distal section 1241b, thus preventing particles 1245 from passing therethrough.

Referring to Fig.l2B, hollow tissue -piercing element 1226 assumes a retracted position in which a distal end of tissue -piercing member 1226 is proximal to distal end 1241c of cannula 1241. In this position, the outer wall of tissue-piercing member 1226 is spaced apart from the inner wall of proximal section 1241a, thereby enabling particles 1245 to pass from proximal section 1241a to distal end 1241b and into a blood vessel 1228 via distal end 1241c of cannula 1241.

Reference is now made to Fig. 13, which is a flowchart of a method for delivering an agent into a blood vessel, in accordance with some embodiments.

An apparatus including an elongated body, a clamping element for engaging a blood vessel, and a guide member configured for guiding a tissue-piercing element into the blood vessel at an acute angle thereof, is delivered into a body cavity (step 1350). Optionally, the elongated body includes a bendable distal end and the clamping element is coupled thereto. The tissue-piercing element may be incorporated into the guide member prior to the delivering step or alternatively introduced post the delivery step. The clamping element is used to engage and stabilize the blood vessel (step 1352). Optionally, the clamping element is further used to clamp the blood vessel at the engagement site, such that blood flow downstream the site of clamping of the blood vessel is restricted. Optionally, the clamping may be achieved by initially closing a distal end of the clamping member, thereby entrapping the blood vessel within the clamping member followed by a closing of the proximal end of the clamping, thereby restricting the blood flow downstream the clamping site. Optionally, the clamping element is moved/rotated angularly to twist the blood vessel (step 1354). The angular movement/rotation may be actuated by bending of the distal end of the elongated body. The tissue -piercing element is then advanced through the guide member such that the tissue-piercing element penetrates the blood vessel at an acute angle thereof, downstream to the engagement site (step 1356). Following penetration of the tissue- piercing element into the blood vessel, a cannula may be delivered into the blood vessel through or over the tissue-piercing element. Optionally, the tissue-piercing element and/or the cannula are manipulated, such that a flow path between the cannula and a target area is generated and embolization particles are delivered into the blood vessel using the cannula.

Reference is now made to Fig. 14A and Fig. 14B, which schematically illustrate a device 1400 for vascular access including an elongated elastic member 1420 for engaging a blood vessel of the apparatus, according to some embodiments. Elongated elastic member 1420 may be configured to loop around a blood vessel, such as blood vessel 1428. Once looped around the vessel, elongated elastic member 1420 may be fastened, to the device using a fastener 1422, such as, but not limited to, a hook, as best seen in Fig 14A.

Once blood vessel 1428 is encircled by elongated elastic member 1420, a pull force may be applied on elastic member 1420 causing blood vessel 1428 to assume a bended configuration having an apex defined by elongated elastic member 1420. In this configuration, the part of blood vessel 1428 which is downstream the engagement site 1424 of elongated elastic member 1420, is positioned at an essentially acute angle relative to a tissue piercing element 1426 of device 1400, when tissue piercing element 1426 is advanced distally from a guide member (not shown) to puncture through a wall of blood vessel 1428, as best seen in Fig 14B. According to some embodiments, in case re-access into blood vessel 1428 is necessary, elongated elastic member 1420 may be manipulated (e.g. further lifted and/or twisted) to prevent flow of blood downstream of engagement site 1424.

Reference is now made to Fig. 15 which schematically illustrates a device 1500 for vascular access including a grasper 1516 for grasping an elongated elastic member 1520 engaging a blood vessel 1528, and a tissue piercing element 1526 configured for piercing blood vessel 1528, according to some embodiments. It is understood that, according to this embodiment, elongated elastic member 1520 may be an integral part of device 1500 or a separate element and is configured to be loop around blood vessel 1528. Once blood vessel 1528 is encircled by elongated elastic member 1520, grasper 1516 may pull elastic member 1520 so as to cause blood vessel 1528 to assume a bended configuration having an apex defined by elongated elastic member 1520. In this configuration, the part of blood vessel 1528 which is downstream the engagement site 1524 of elongated elastic member 1520, is positioned at an essentially acute angle relative to a tissue piercing element 1526 of device 1500. Accordingly, when tissue piercing element 1526 is advanced distally from a guide member (not shown) blood vessel 1528 is punctured at an acute angle. According to some embodiments, in case re-access into blood vessel 1528 is necessary, elongated elastic member 1520 may be manipulated (e.g. further lifted and/or twisted) to prevent flow of blood downstream of engagement site 1524. The terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting. As used herein, the singular forms "a", "an" and "the" are intended to include the plural forms as well, unless the context clearly indicates otherwise. It will be further understood that the terms "comprises" or "comprising", when used in this specification, specify the presence of stated features, integers, steps, operations, elements, or components, but do not preclude or rule out the presence or addition of one or more other features, integers, steps, operations, elements, components, or groups thereof. Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. As used herein the term "about" refers to ± 10 %.

While a number of exemplary aspects and embodiments have been discussed above, those of skill in the art will recognize certain modifications, additions and subcombinations thereof. It is therefore intended that the following appended claims and claims hereafter introduced be interpreted to include all such modifications, additions and sub-combinations as are within their true spirit and scope.

It is appreciated that certain features of the invention, which are, for clarity, described in the context of separate embodiments, may also be provided in combination in a single embodiment. Conversely, various features of the invention, which are, for brevity, described in the context of a single embodiment, may also be provided separately or in any suitable subcombination.

Although the invention has been described in conjunction with specific embodiments thereof, it is evident that many alternatives, modifications and variations will be apparent to those skilled in the art. Accordingly, it is intended to embrace all such alternatives, modifications and variations that fall within the spirit and broad scope of the appended claims. All publications, patents and patent applications mentioned in this specification are herein incorporated in their entirety by reference into the specification, to the same extent as if each individual publication, patent or patent application was specifically and individually indicated to be incorporated herein by reference. In addition, citation or identification of any reference in this application shall not be construed as an admission that such reference is available as prior art to the present invention. EXAMPLES

Reference is now made to the following examples, which together with the above descriptions, illustrate the invention in a non-limiting fashion.

EXAMPLE 1

Trials were performed in order to assess the feasibility of directly accessing uterine arteries using a 21 G venflon through open surgery as essentially described in Figures 6A-6G. The venflon needle was positioned in an acute angle relative to the uterine artery in the abdominal cavity, and the needle advanced to puncture the vessel, as essentially described with reference to FIGs 6A and 6B herein. The needle, with an attached cannula (fitted over needle), was then introduced into the uterine artery, and a 0.018" guide wire was introduced into the uterine artery through the needle and advanced approximately 1-2 cm into the artery in the direction of the flow, as essentially described with regards to FIG. 6C. and FIG. 6D herein. At this stage the needle was removed and the cannula was advanced over the wire into the artery. The wire was then removed and blood was detected in the cannula's proximal end, demonstrating that successful direct access to the uterine artery was achieved.

EXAMPLE 2

Trials were performed in order to assess the feasibility of accessing uterine arteries using an 18G needle laparoscopically. The procedure was performed as essentially described in FIG. 13.

Initially, a clamping element was used to occlude the artery. Upon clamping, the clamping element was bent so that the artery was twisted and the needle, lining the clamping element body, resultingly became positioned in-line (at an acute angle) relative to the artery's longitudinal axis. The needle was subsequently advanced, thereby puncturing the artery. Advantageously, the clamping allowed withdrawal and reentering of the needle a few times, until access was successfully achieved, as the artery occlusion prevented pronounced bleeding, as essentially shown in FIG. 16. Once successful access was achieved, the needle was advanced approximately 0.5-1 cm into the artery in the direction of flow, and the catheter (fitted over the needle) was pushed inside the artery approximately 0.5 cm further than the needle. At this stage a contrast agent was injected into the artery and, as seen in the angiographic image of FIG. 17, direct access was verified. The same procedure was shown for a gonadal vein, and successful direct access was once again demonstrated (FIG. 18).

These results demonstrate, for the first time, a direct laparoscopic access to uterine arteries and veins, facilitating procedures such as embolization for treating uterine bleeding, fibroids and/or malignancies.

Claims

CLAIMS What is claimed is:

1. An apparatus for vascular access comprising:

an elongated tubular body;

a clamping element for engaging a blood vessel, said clamping element being coupled distally to the elongated tubular body's distal end; and

a guide member configured for guiding a tissue-piercing element into the blood vessel at an acute angle thereof.

2. The apparatus of claim 1, wherein the distal end of said elongated tubular body is bendable and wherein bending of said distal end brings about angular movement of said clamping element, thereby twisting the blood vessel engaged by the clamping element, such that the guide member guides said piercing element to pierce into the blood vessel at an acute angle thereof.

3. The apparatus of claim 2, further comprising a sleeve configured to accommodate said elongated tubular body.

4. The apparatus of claim 3, wherein said sleeve is configured to retain the distal end of the elongated tubular body in a straight configuration and wherein when said elongated tubular body extends out of said sleeve said distal end bends.

5. The apparatus of claim 4, wherein said elongated tubular body comprises a shape memory material.

6. The apparatus of claim 5, wherein said shape memory material comprises Nitinol.

7. The apparatus of claim 2, further comprising a steering wire configured to control the bending of said distal end.

8. The apparatus of claim 1, wherein said clamping element is configured to prevent blood flow downstream the site of clamping of the blood vessel by the clamping element.

9. The apparatus of claim 8, wherein the clamping element comprises a securing mechanism configured to ensure that a distal end of the clamping member closes before a proximal end thereof, thereby providing an entrapment of the blood vessel within the clamping member prior to it being clamped by the clamping member.

10. The apparatus of claim 1, wherein said clamping element is a grasper.

11. The apparatus of claim 1, configured for laparoscopic access.

12. The apparatus of claim 1, further comprising said tissue-piercing element positioned within said guide member.

13. The apparatus of claim 12, wherein said tissue-piercing element is a needle.

14. The apparatus of claim 13, wherein said needle is made from a bendable material.

15. The apparatus of claim 13, wherein said needle is hollow.

16. The apparatus of claim 12, wherein said tissue-piercing element is associated with a cannula.

17. The apparatus of claim 16, wherein said cannula is configured to slide over said tissue-piercing element.

18. The apparatus of claim 16, wherein said cannula is configured to slide through said tissue-piercing element.

19. The apparatus of claim 1, further comprising a handle configured to control the operation of said apparatus.

20. The apparatus of claim 19, wherein controlling the operation of the apparatus comprises controlling the bending of said elongated tubular body's distal end, controlling the opening/closing of said clamping element, locking of the clamping element upon proper engagement of the blood vessel, controlling longitudinal movement of said tissue piercing element and/or of the cannula associated therewith, and any combination thereof.

21. The apparatus of claim 1, wherein said guide member is positioned on an outer surface of said elongated tubular body's distal end.

22. The apparatus of claim 1, wherein said clamping element further comprises lateral supporting walls coextensive with said guide member, said lateral walls configured to stabilize said blood vessel in front of said guide member.

23. The apparatus of claim 1, wherein said guide member is at least partially positioned within said elongated tubular member, wherein said tubular member comprises a side opening and wherein said guide member is configured to extend out of said side opening.

24. The apparatus of claim 23, wherein said guide member defines a curved path when fully extended out of said side opening of said elongated tubular body.

25. The apparatus of claim 24, wherein said guide member when fully extended is configured to position said tissue piercing element between jaws of said clamping element and at an angle of less than 30 degrees with respect to the longitudinal axis of the blood vessel such that the tissue piercing site is directed to pierce into the blood vessel downstream to the engagement site with the clamping element.

26. The apparatus of claim 23, wherein said guide member is a Nitinol tube.

27. A method of accessing a blood vessel comprising:

(a) delivering into a body cavity an apparatus including an elongated tubular body a clamping element for engaging a blood vessel; and a guide member configured for guiding a tissue-piercing element into the blood vessel at an acute angle thereof;

(b) using said clamping element to engage and stabilize the blood vessel;

(c) moving/rotating said tissue clamping element angularly, thereby twisting the blood vessel;

(d) advancing said tissue-piercing element through said guide member such that said tissue-piercing element penetrates said blood vessel downstream to the engagement site at an acute angle thereof.

28. The method of claim 27, further comprising: (e) delivering a cannula through or over said tissue-piercing element and into said blood vessel.

29. The method of claim 27, further comprising:

(f) manipulating said tissue -piercing element and/or said cannula such that a flow path between the cannula and a target area is generated; and

(g) delivering embolization particles into said blood vessel using said cannula.

30. The method of claim 27, wherein step b further comprises clamping said blood vessel such that blood flow downstream the site of clamping of the blood vessel is restricted.

31. The method of claim 30, wherein clamping the blood vessel comprises initially closing a distal end of the clamping member, thereby entrapping the blood vessel within the clamping member followed by a closing of the proximal end of the clamping, thereby restricting the blood flow downstream the clamping site.

32. The method of claim 27, wherein said angular movement of said clamping element is caused by bending of a distal end of said elongated tubular body.

33. An embolization particle delivery system comprising a hollow tissue-piercing element; wherein at least part of said hollow tissue piercing member is made from a material allowing said tissue-piercing element to bend at a bending angle of at least 90 degrees.

34. The embolization particle delivery system of claim 30, wherein said hollow tissue- piercing element comprises one or more side openings, said one or more side openings sized and shaped to allow embolization particles to flow therethrough.

35. The embolization particle delivery system of claim 31, wherein at least part of said hollow tissue-piercing element is made from braided wires, and wherein said one or more side openings is formed by the braid.

36. The embolization particle delivery system of claim 31, further comprising a cannula configured to slide over and/or slide through said tissue piercing member, wherein said tissue-piercing element is configured to assume a first extended position in which said tissue -piercing is distal to a distal end of said cannula and a retracted position in which said tissue -piercing is proximal to the distal end of said cannula.

37. The embolization particle delivery system of claim 33, wherein said cannula comprises a first section and an adjacent second section, wherein said first section is positioned proximally to said second section and wherein said first section has a first inner diameter which is different from a second inner diameter of the second section, wherein when said tissue piercing member is in its first extended position said one or more openings is coaligned with said first section, and wherein when said tissue piercing member is in its second retracted position said one or more openings is coaligned with said second section.

38. The embolization particle delivery system of claim 34, wherein when said one or more openings is coaligned with said first section, said first section's wall covers said one or more openings, thereby preventing delivery of embolization particles therethrough and wherein when said one or more openings is coaligned with said second section, said second section's wall is spaced apart from said one or more openings, thereby enabling embolization particles to pass therethrough.